Use of dialectical behavior therapy significantly reduced suicide attempts in adolescents with bipolar disorder, compared with standard of care, based on data from 100 individuals aged 12-18 years.

University of Pittsburgh

Bipolar spectrum disorder (BP) is known to substantially increase the risk for suicide in youth, but no psychosocial intervention for this population has targeted suicidal behavior in particular, wrote Tina R. Goldstein, PhD, of the University of Pittsburgh, and colleagues.

Dialectical behavior therapy (DBT) had shown effectiveness for decreasing suicide attempts in adults with borderline personality disorder, and previous studies of DBT have shown reduced suicidal ideation, self-harm, and suicide attempts in suicidal adolescents, but these studies have mainly excluded BP teens, the researchers said.

In a study published in JAMA Psychiatry, the researchers recruited adolescents aged 12-18 years with a diagnosis of BP who were treated at an outpatient clinic between November 2014 and September 2019. Of these, 47 were randomized to 1 year of DBT (a total of 36 sessions) and 53 to standard of care (SOC) psychotherapy. All participants also received medication using a flexible algorithm.

The primary outcomes were suicide attempts over a 1-year period and measurements of mood symptoms and states, specifically depression and hypomania/mania. Secondary analyses included the effect of DBT on individuals with a history of suicide attempt and on improving emotion dysregulation. The mean age of the participants was 16.1 years; 85 were female, and 74% were White.

Participants in both DBT and SOC groups reported similar rates of suicide attempt rates at study enrollment based on the Adolescent Longitudinal Follow-Up Evaluation (ALIFE) with a mean of 2.0 and 1.8 attempts, respectively (P = .80). Based on the Columbia–Suicide Severity Rating Scale Pediatric Version (C-SSRS), participants in the DBT group had slightly more suicide attempts than the SOC group at study enrollment, with a mean of 1.4 and 0.6 attempts, respectively (P = .02).

Controlling for baseline attempts, participants in the DBT group had significantly fewer suicide attempts over the study period, compared with the SOC group as measured by both ALIFE (mean 0.2 vs. 1.1) and C-SSRS (mean 0.04 vs. 0.10, P = .03 for both measures). The incidence rate ratios for reduced suicide attempts were 0.32 for ALIFE and 0.13 for C-SSRS, both significant in favor of DBT, compared with SOC.

Overall, both groups showed similarly significant improvement on measures of mood symptoms and episodes over the study period. The standardized depression rating scale slope was –0.17 and the standardized mania rating scale slope was –0.24.

DBT was significantly more effective than SOC psychotherapy at decreasing suicide attempts over 1 year (ALIFE: incidence rate ratio, 0.32; 95% CI, 0.11-0.96; C-SSRS: IRR, 0.13; 95% CI, 0.02-0.78).

On further analysis, the decrease in suicide attempts in the DBT group was greater over time and among those with a lifetime history of suicide attempts (IRR, 0.23). “Decreased risk of suicide attempt in DBT was mediated by improvement in emotion dysregulation, particularly for those with high baseline emotion dysregulation,” the researchers wrote in their discussion.

The findings were limited by several factors including the mainly female, non-Hispanic White study population, and controlled clinical setting, the researchers noted. Data from a forthcoming community implementation field trial will address some generalizability issues, although more work is needed to address disparities in BP diagnosis and treatment, they added.

However, the results support the potential of DBT for mood management and for reducing suicide attempts in a high-risk adolescent population, especially those with high levels of emotional dysregulation, on par with other established psychosocial treatments, the researchers concluded.
 

More options needed to manage increased risk

“It was important to conduct this study at this time because, while still relatively rare, bipolar spectrum disorders in adolescents confer increased risk for suicide,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. The complexity of BP and the increased risk of suicide in these patients challenge clinicians to identify robust evidence-based interventions beyond pharmacotherapy that mitigate this risk, said Dr. Loper, who is triple board certified in pediatrics, general psychiatry, and child & adolescent psychiatry, but was not involved in the study.

The current study findings were not surprising, because DBT has proven effective in decreasing suicidal ideation and suicide attempts in other high-risk adolescent patient populations, Dr. Loper said. “Given the therapeutic content of DBT, with emphasis on mindfulness, distress tolerance, social skills, and emotional regulation, I think it is reasonable to hypothesize that DBT might be a globally applicable intervention, independent of mental health diagnosis or etiology of suicidal ideation,” he said.

The take-home message for clinicians is that the results support the efficacy of DBT as an intervention for adolescents with BP and suicidal ideation, self-injurious behavior, or suicide attempts, said Dr. Loper. For these patients, given their increased suicide risk, “DBT should certainly be recommended as a component of their treatment plan,” he said.

However, barriers to the use of DBT in clinical practice exist, notably access and cost, Dr. Loper noted. “I think that the most prominent barrier in accessing DBT in clinical practice is the availability of certified, structured DBT treatment programs, and particularly those willing to provide services to adolescents,” he said. “Additionally, certified DBT programs, which are the gold standard, are often not covered by third-party payers, making cost yet another potential barrier.”

Looking ahead, Dr. Loper agreed with the study authors that additional research with a more diverse patient population representative of adolescents with bipolar spectrum disorder “is a crucial area of focus.”

The study was funded by the National Institutes of Mental Health through a grant to Dr. Goldstein, who also disclosed royalties from Guilford Press unrelated to the current study. Dr. Loper had no financial conflicts to disclose.
 

Use of dialectical behavior therapy significantly reduced suicide attempts in adolescents with bipolar disorder, compared with standard of care, based on data from 100 individuals aged 12-18 years.

University of Pittsburgh

Bipolar spectrum disorder (BP) is known to substantially increase the risk for suicide in youth, but no psychosocial intervention for this population has targeted suicidal behavior in particular, wrote Tina R. Goldstein, PhD, of the University of Pittsburgh, and colleagues.

Dialectical behavior therapy (DBT) had shown effectiveness for decreasing suicide attempts in adults with borderline personality disorder, and previous studies of DBT have shown reduced suicidal ideation, self-harm, and suicide attempts in suicidal adolescents, but these studies have mainly excluded BP teens, the researchers said.

In a study published in JAMA Psychiatry, the researchers recruited adolescents aged 12-18 years with a diagnosis of BP who were treated at an outpatient clinic between November 2014 and September 2019. Of these, 47 were randomized to 1 year of DBT (a total of 36 sessions) and 53 to standard of care (SOC) psychotherapy. All participants also received medication using a flexible algorithm.

The primary outcomes were suicide attempts over a 1-year period and measurements of mood symptoms and states, specifically depression and hypomania/mania. Secondary analyses included the effect of DBT on individuals with a history of suicide attempt and on improving emotion dysregulation. The mean age of the participants was 16.1 years; 85 were female, and 74% were White.

Participants in both DBT and SOC groups reported similar rates of suicide attempt rates at study enrollment based on the Adolescent Longitudinal Follow-Up Evaluation (ALIFE) with a mean of 2.0 and 1.8 attempts, respectively (P = .80). Based on the Columbia–Suicide Severity Rating Scale Pediatric Version (C-SSRS), participants in the DBT group had slightly more suicide attempts than the SOC group at study enrollment, with a mean of 1.4 and 0.6 attempts, respectively (P = .02).

Controlling for baseline attempts, participants in the DBT group had significantly fewer suicide attempts over the study period, compared with the SOC group as measured by both ALIFE (mean 0.2 vs. 1.1) and C-SSRS (mean 0.04 vs. 0.10, P = .03 for both measures). The incidence rate ratios for reduced suicide attempts were 0.32 for ALIFE and 0.13 for C-SSRS, both significant in favor of DBT, compared with SOC.

Overall, both groups showed similarly significant improvement on measures of mood symptoms and episodes over the study period. The standardized depression rating scale slope was –0.17 and the standardized mania rating scale slope was –0.24.

DBT was significantly more effective than SOC psychotherapy at decreasing suicide attempts over 1 year (ALIFE: incidence rate ratio, 0.32; 95% CI, 0.11-0.96; C-SSRS: IRR, 0.13; 95% CI, 0.02-0.78).

On further analysis, the decrease in suicide attempts in the DBT group was greater over time and among those with a lifetime history of suicide attempts (IRR, 0.23). “Decreased risk of suicide attempt in DBT was mediated by improvement in emotion dysregulation, particularly for those with high baseline emotion dysregulation,” the researchers wrote in their discussion.

The findings were limited by several factors including the mainly female, non-Hispanic White study population, and controlled clinical setting, the researchers noted. Data from a forthcoming community implementation field trial will address some generalizability issues, although more work is needed to address disparities in BP diagnosis and treatment, they added.

However, the results support the potential of DBT for mood management and for reducing suicide attempts in a high-risk adolescent population, especially those with high levels of emotional dysregulation, on par with other established psychosocial treatments, the researchers concluded.
 

More options needed to manage increased risk

“It was important to conduct this study at this time because, while still relatively rare, bipolar spectrum disorders in adolescents confer increased risk for suicide,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. The complexity of BP and the increased risk of suicide in these patients challenge clinicians to identify robust evidence-based interventions beyond pharmacotherapy that mitigate this risk, said Dr. Loper, who is triple board certified in pediatrics, general psychiatry, and child & adolescent psychiatry, but was not involved in the study.

The current study findings were not surprising, because DBT has proven effective in decreasing suicidal ideation and suicide attempts in other high-risk adolescent patient populations, Dr. Loper said. “Given the therapeutic content of DBT, with emphasis on mindfulness, distress tolerance, social skills, and emotional regulation, I think it is reasonable to hypothesize that DBT might be a globally applicable intervention, independent of mental health diagnosis or etiology of suicidal ideation,” he said.

The take-home message for clinicians is that the results support the efficacy of DBT as an intervention for adolescents with BP and suicidal ideation, self-injurious behavior, or suicide attempts, said Dr. Loper. For these patients, given their increased suicide risk, “DBT should certainly be recommended as a component of their treatment plan,” he said.

However, barriers to the use of DBT in clinical practice exist, notably access and cost, Dr. Loper noted. “I think that the most prominent barrier in accessing DBT in clinical practice is the availability of certified, structured DBT treatment programs, and particularly those willing to provide services to adolescents,” he said. “Additionally, certified DBT programs, which are the gold standard, are often not covered by third-party payers, making cost yet another potential barrier.”

Looking ahead, Dr. Loper agreed with the study authors that additional research with a more diverse patient population representative of adolescents with bipolar spectrum disorder “is a crucial area of focus.”

The study was funded by the National Institutes of Mental Health through a grant to Dr. Goldstein, who also disclosed royalties from Guilford Press unrelated to the current study. Dr. Loper had no financial conflicts to disclose.
 

Use of dialectical behavior therapy significantly reduced suicide attempts in adolescents with bipolar disorder, compared with standard of care, based on data from 100 individuals aged 12-18 years.

University of Pittsburgh

Bipolar spectrum disorder (BP) is known to substantially increase the risk for suicide in youth, but no psychosocial intervention for this population has targeted suicidal behavior in particular, wrote Tina R. Goldstein, PhD, of the University of Pittsburgh, and colleagues.

Dialectical behavior therapy (DBT) had shown effectiveness for decreasing suicide attempts in adults with borderline personality disorder, and previous studies of DBT have shown reduced suicidal ideation, self-harm, and suicide attempts in suicidal adolescents, but these studies have mainly excluded BP teens, the researchers said.

In a study published in JAMA Psychiatry, the researchers recruited adolescents aged 12-18 years with a diagnosis of BP who were treated at an outpatient clinic between November 2014 and September 2019. Of these, 47 were randomized to 1 year of DBT (a total of 36 sessions) and 53 to standard of care (SOC) psychotherapy. All participants also received medication using a flexible algorithm.

The primary outcomes were suicide attempts over a 1-year period and measurements of mood symptoms and states, specifically depression and hypomania/mania. Secondary analyses included the effect of DBT on individuals with a history of suicide attempt and on improving emotion dysregulation. The mean age of the participants was 16.1 years; 85 were female, and 74% were White.

Participants in both DBT and SOC groups reported similar rates of suicide attempt rates at study enrollment based on the Adolescent Longitudinal Follow-Up Evaluation (ALIFE) with a mean of 2.0 and 1.8 attempts, respectively (P = .80). Based on the Columbia–Suicide Severity Rating Scale Pediatric Version (C-SSRS), participants in the DBT group had slightly more suicide attempts than the SOC group at study enrollment, with a mean of 1.4 and 0.6 attempts, respectively (P = .02).

Controlling for baseline attempts, participants in the DBT group had significantly fewer suicide attempts over the study period, compared with the SOC group as measured by both ALIFE (mean 0.2 vs. 1.1) and C-SSRS (mean 0.04 vs. 0.10, P = .03 for both measures). The incidence rate ratios for reduced suicide attempts were 0.32 for ALIFE and 0.13 for C-SSRS, both significant in favor of DBT, compared with SOC.

Overall, both groups showed similarly significant improvement on measures of mood symptoms and episodes over the study period. The standardized depression rating scale slope was –0.17 and the standardized mania rating scale slope was –0.24.

DBT was significantly more effective than SOC psychotherapy at decreasing suicide attempts over 1 year (ALIFE: incidence rate ratio, 0.32; 95% CI, 0.11-0.96; C-SSRS: IRR, 0.13; 95% CI, 0.02-0.78).

On further analysis, the decrease in suicide attempts in the DBT group was greater over time and among those with a lifetime history of suicide attempts (IRR, 0.23). “Decreased risk of suicide attempt in DBT was mediated by improvement in emotion dysregulation, particularly for those with high baseline emotion dysregulation,” the researchers wrote in their discussion.

The findings were limited by several factors including the mainly female, non-Hispanic White study population, and controlled clinical setting, the researchers noted. Data from a forthcoming community implementation field trial will address some generalizability issues, although more work is needed to address disparities in BP diagnosis and treatment, they added.

However, the results support the potential of DBT for mood management and for reducing suicide attempts in a high-risk adolescent population, especially those with high levels of emotional dysregulation, on par with other established psychosocial treatments, the researchers concluded.
 

More options needed to manage increased risk

“It was important to conduct this study at this time because, while still relatively rare, bipolar spectrum disorders in adolescents confer increased risk for suicide,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. The complexity of BP and the increased risk of suicide in these patients challenge clinicians to identify robust evidence-based interventions beyond pharmacotherapy that mitigate this risk, said Dr. Loper, who is triple board certified in pediatrics, general psychiatry, and child & adolescent psychiatry, but was not involved in the study.

The current study findings were not surprising, because DBT has proven effective in decreasing suicidal ideation and suicide attempts in other high-risk adolescent patient populations, Dr. Loper said. “Given the therapeutic content of DBT, with emphasis on mindfulness, distress tolerance, social skills, and emotional regulation, I think it is reasonable to hypothesize that DBT might be a globally applicable intervention, independent of mental health diagnosis or etiology of suicidal ideation,” he said.

The take-home message for clinicians is that the results support the efficacy of DBT as an intervention for adolescents with BP and suicidal ideation, self-injurious behavior, or suicide attempts, said Dr. Loper. For these patients, given their increased suicide risk, “DBT should certainly be recommended as a component of their treatment plan,” he said.

However, barriers to the use of DBT in clinical practice exist, notably access and cost, Dr. Loper noted. “I think that the most prominent barrier in accessing DBT in clinical practice is the availability of certified, structured DBT treatment programs, and particularly those willing to provide services to adolescents,” he said. “Additionally, certified DBT programs, which are the gold standard, are often not covered by third-party payers, making cost yet another potential barrier.”

Looking ahead, Dr. Loper agreed with the study authors that additional research with a more diverse patient population representative of adolescents with bipolar spectrum disorder “is a crucial area of focus.”

The study was funded by the National Institutes of Mental Health through a grant to Dr. Goldstein, who also disclosed royalties from Guilford Press unrelated to the current study. Dr. Loper had no financial conflicts to disclose.
 

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

If you are a pediatrician, babies are your bread and butter. In fact, they are the whole enchilada. Without them you are going to starve. Even if you are an adolescent medicine specialist, the pipeline feeding your business begins with babies. The number of babies entering the conveyor belt that eventually ends up in your office is something that should interest you. It probably doesn’t surprise you to learn that the fertility rate in this country has fallen. In fact, it has now dipped below the “replacement” threshold of 2.1%.

Another number that might interest you is ideal family size. In others words, the number of children American adults consider when they are envisioning the ideal family. You may be surprised to learn that despite the downward dip on the fertility rate during the 2007-2009 recession and the pandemic, a significant number of Americans still believe that the ideal family includes three children. Looking at the broader population, the ideal family is around 2.5 children, which is a number that is up a little from the 1990s but has scarcely changed over the last 5 decades. Obviously, there is a gap between what the population as a whole believes and the reality of how many children the fertile population is producing. And, there is research that suggests that this gap between personal intention and ideal family size is growing. In other words, people may be saying they believe bigger families are a good thing ... if everything is going well in their life.

What is behind this gap and why is it growing? As people are delaying building their families, realities and expectations collide. Some examples? The impact of their student loans is greater than they anticipated. Climate change and news stories focused on political uncertainty can be unsettling. A person may end up marrying someone who doesn’t concur with their view of an ideal family. Fertility problems crop up with advancing age. The first child may have presented more of a challenge both physically, emotionally, and economically than new parents had expected.

If we agree that the fertility rate is an important number for our survival as a profession, can we agree that because of this vested interest we should become involved in helping families widen this growing gap between their view of the ideal family size and the realities of actually producing that family?

Maybe we don’t need to get involved. When the national climate – meteorologically, politically, and economically – improves families will start making more babies. Right now maybe the better option is to adjust our business model to the fluctuations in demand.

On the other hand, we could ask the American Academy of Pediatrics to join with the American Academy of Obstetricians and Gynecologists and hire a big name advertising agency to launch an ad campaign encouraging young and not so young adults to have more children. However, this might appear rather transparent and self-serving.

The best option is probably to continue to do what we are already doing, but try to do it better. If the challenges of having a first child are a major deterrent to having a second child, we should redouble our efforts toward making, if only in retrospect, that first parenting experience rewarding and enjoyable. That could come in the form of speaking out for parental leave, breastfeeding-friendly workplaces, and more affordable daycare. But it could also come in those scores of encounters we have every day in the office where we give solid, realistic, and compassionate advice on breastfeeding, sleep hygiene, and behavior management. If we can make those tough first 6 months of parenting go more smoothly and make the twos seem less terrible, we may see the average family size in our practice grow before our eyes.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A precision treatment model for internet-delivered cognitive behavioral therapy provides a low-cost, accessible, and effective alternative for treating anxiety and depression, according to a study published in JAMA Psychiatry . The intervention was developed by researchers from the United States, Mexico, and Colombia and studied in undergraduate university students.

The research included 1,319 students with anxiety and depression. The students were randomly assigned to three groups that received either remote (internet-based) cognitive behavioral therapy guided by a therapist, self-guided cognitive behavioral therapy (without support from a therapist), or standard treatment provided by the health care services within their community (the control condition).

Students who received guided cognitive behavioral therapy had higher combined rates of remission of these disorders (51.8%) than students who received self-guided therapy (37.8%) or conventional therapy (40%). These differences were not significant for remission of anxiety, however.

Guided cognitive behavioral therapy was associated with the highest probability of remission of anxiety and depression in 91.7% of students, the highest probability of remission of anxiety in all students, and the highest probability of remission of depression in 71.5% of participants.

The results of this analysis could be used to improve psychological care by optimizing how different treatment methods are assigned, especially in mental health institutions where available technical and human resources are limited, according to the investigators.

“We started designing this study before COVID-19 with the idea of optimizing care for these mental health problems,” said study author Corina Benjet Miner, PhD, an epidemiological and psychosocial researcher at the Ramón de la Fuente National Institute of Psychiatry, Mexico City. “We wanted to find additional strategies to achieve better care. The pandemic helped us because, even though this has been undergoing research for many years, internet-delivered interventions were not as well accepted. But during the pandemic, there weren’t any other options.”

Given the high prevalence of mental disorders before and after the pandemic, no health care system in the world would be able to provide in-person care to each patient with depression or anxiety, said Dr. Benjet Miner. “So, the idea is to look for other cost-effective strategies that can ramp up our interventions and reach a greater number of people without negatively impacting the quality of care,” she explained.

“I believe that [the precision model] is an excellent proposal that can save financial resources and avoid transfers,” said Juana Olvera Méndez, PhD, research professor working with the cognitive behavioral approach at the Iztacala Faculty of Higher Studies (FESI) of the National Autonomous University of Mexico, Mexico City. “It also makes it possible to provide patients with immediate care, in contrast to when someone has to go in for [in-person] therapy, which will depend a lot on how the therapist approaches the situation.”

Students from seven universities in Colombia and Mexico were included in the study. They were aged 18 years or older and had a score of 10 or greater on the self-administered Generalized Anxiety Disorder scale-7 test, or had depression with scores of 10 or greater on the nine-item Patient Health Questionnaire, which is also self-administered.

The study’s exclusion criteria included a history of bipolar disorder, nonaffective psychosis, or suicidal ideation with suicide attempts. The investigators used 284 prescription predictors to anticipate the differential response to antianxiety and antidepression therapy.

By grouping these predictors into 11 conceptual categories (such as demographic characteristics, COVID-19–linked stressors, or mental disorder comorbidities) and using machine learning algorithms, the investigators were able to predict in an individualized manner the probability of remission for participants in each of the groups.

“For depression, we found that 28.5% of patients could experience better or equivalent effects from the self-guided program (in comparison to the guided program). Once you have this program, it doesn’t cost anything, so there could be a massive number of people who could benefit from a cost-free therapy,” said Dr. Benjet Miner.

While numerous studies in precision medicine have tried to determine the most appropriate treatment for each patient, “they don’t have the high number of predictors that we used in this research, and I feel like this gives us a significant edge,” she added.

She also explained that they found no differences in user satisfaction between the guided and unguided version of the therapy, so now they must discover why the guided version works better. One notable point is that patients accessed (online) the guided program twice as many times as those who used the self-guided version, but the number of times used is not enough to explain the better outcomes.

“We believe that patients develop some sort of connection with the guides, who are not providing therapy but only making recommendations in brief interactions with patients once a week. It has something to do with that connection, in addition to the longer time spent interacting with the platform, which provides better results with the guided version,” stated Dr. Benjet Miner.

One of the main limitations of this study is that, though it compares three treatment methods, the third one (standard care) is not homogeneous, because each of the seven universities from which the students were selected has different resources for this purpose. “Some universities, like the National Autonomous University of Mexico, have very formal services, with teams of psychologists and psychiatrists, while others don’t have this type of service, or they cover additional aspects, like vocational counseling. So, it’s very difficult to determine exactly what kind of care patients are receiving, because it’s not homogeneous,” she said.

As many as nine assessments using psychometric tests are sometimes required before the intervention can be evaluated, said Dr. Méndez. “This study doesn’t go into too much detail in that area, focusing rather on treatment. So, it would be important to know the diagnoses of the users, who may be experiencing different degrees of depression or anxiety. It would be worth asking what happens if a user requires psychiatric treatment or support.”

Dr. Méndez, who provides psychological therapy in person and online at the Student Support and Counselling Center at FESI, pointed out that it would be important to provide close follow-up on these results to see whether they are sustained in the short and long terms. In her opinion, this model could be presented to other users requiring treatment for anxiety or depression, provided that they can use information and communication technologies.

This precision model, which can also be supported on mobile phones or tablets, could be transferred to primary care facilities or vulnerable populations in rural areas, said Dr. Benjet Miner. “The idea is to reach a point where these algorithms become accurate enough and have a really strong predictive power so that clinicians can use them. The goal is always to find the best treatment at the lowest cost, so that it’s sustainable,” she concluded.

This study was funded by grant number R01MH120648 from the National Institute of Mental Health and the Fogarty International Center. Dr. Benjet Miner reports no relevant financial relationships; the declarations of the remaining authors can be found at the publication’s website.

This article was translated from Medscape’s Spanish Edition and a version first appeared on Medscape.com.

A precision treatment model for internet-delivered cognitive behavioral therapy provides a low-cost, accessible, and effective alternative for treating anxiety and depression, according to a study published in JAMA Psychiatry . The intervention was developed by researchers from the United States, Mexico, and Colombia and studied in undergraduate university students.

The research included 1,319 students with anxiety and depression. The students were randomly assigned to three groups that received either remote (internet-based) cognitive behavioral therapy guided by a therapist, self-guided cognitive behavioral therapy (without support from a therapist), or standard treatment provided by the health care services within their community (the control condition).

Students who received guided cognitive behavioral therapy had higher combined rates of remission of these disorders (51.8%) than students who received self-guided therapy (37.8%) or conventional therapy (40%). These differences were not significant for remission of anxiety, however.

Guided cognitive behavioral therapy was associated with the highest probability of remission of anxiety and depression in 91.7% of students, the highest probability of remission of anxiety in all students, and the highest probability of remission of depression in 71.5% of participants.

The results of this analysis could be used to improve psychological care by optimizing how different treatment methods are assigned, especially in mental health institutions where available technical and human resources are limited, according to the investigators.

“We started designing this study before COVID-19 with the idea of optimizing care for these mental health problems,” said study author Corina Benjet Miner, PhD, an epidemiological and psychosocial researcher at the Ramón de la Fuente National Institute of Psychiatry, Mexico City. “We wanted to find additional strategies to achieve better care. The pandemic helped us because, even though this has been undergoing research for many years, internet-delivered interventions were not as well accepted. But during the pandemic, there weren’t any other options.”

Given the high prevalence of mental disorders before and after the pandemic, no health care system in the world would be able to provide in-person care to each patient with depression or anxiety, said Dr. Benjet Miner. “So, the idea is to look for other cost-effective strategies that can ramp up our interventions and reach a greater number of people without negatively impacting the quality of care,” she explained.

“I believe that [the precision model] is an excellent proposal that can save financial resources and avoid transfers,” said Juana Olvera Méndez, PhD, research professor working with the cognitive behavioral approach at the Iztacala Faculty of Higher Studies (FESI) of the National Autonomous University of Mexico, Mexico City. “It also makes it possible to provide patients with immediate care, in contrast to when someone has to go in for [in-person] therapy, which will depend a lot on how the therapist approaches the situation.”

Students from seven universities in Colombia and Mexico were included in the study. They were aged 18 years or older and had a score of 10 or greater on the self-administered Generalized Anxiety Disorder scale-7 test, or had depression with scores of 10 or greater on the nine-item Patient Health Questionnaire, which is also self-administered.

The study’s exclusion criteria included a history of bipolar disorder, nonaffective psychosis, or suicidal ideation with suicide attempts. The investigators used 284 prescription predictors to anticipate the differential response to antianxiety and antidepression therapy.

By grouping these predictors into 11 conceptual categories (such as demographic characteristics, COVID-19–linked stressors, or mental disorder comorbidities) and using machine learning algorithms, the investigators were able to predict in an individualized manner the probability of remission for participants in each of the groups.

“For depression, we found that 28.5% of patients could experience better or equivalent effects from the self-guided program (in comparison to the guided program). Once you have this program, it doesn’t cost anything, so there could be a massive number of people who could benefit from a cost-free therapy,” said Dr. Benjet Miner.

While numerous studies in precision medicine have tried to determine the most appropriate treatment for each patient, “they don’t have the high number of predictors that we used in this research, and I feel like this gives us a significant edge,” she added.

She also explained that they found no differences in user satisfaction between the guided and unguided version of the therapy, so now they must discover why the guided version works better. One notable point is that patients accessed (online) the guided program twice as many times as those who used the self-guided version, but the number of times used is not enough to explain the better outcomes.

“We believe that patients develop some sort of connection with the guides, who are not providing therapy but only making recommendations in brief interactions with patients once a week. It has something to do with that connection, in addition to the longer time spent interacting with the platform, which provides better results with the guided version,” stated Dr. Benjet Miner.

One of the main limitations of this study is that, though it compares three treatment methods, the third one (standard care) is not homogeneous, because each of the seven universities from which the students were selected has different resources for this purpose. “Some universities, like the National Autonomous University of Mexico, have very formal services, with teams of psychologists and psychiatrists, while others don’t have this type of service, or they cover additional aspects, like vocational counseling. So, it’s very difficult to determine exactly what kind of care patients are receiving, because it’s not homogeneous,” she said.

As many as nine assessments using psychometric tests are sometimes required before the intervention can be evaluated, said Dr. Méndez. “This study doesn’t go into too much detail in that area, focusing rather on treatment. So, it would be important to know the diagnoses of the users, who may be experiencing different degrees of depression or anxiety. It would be worth asking what happens if a user requires psychiatric treatment or support.”

Dr. Méndez, who provides psychological therapy in person and online at the Student Support and Counselling Center at FESI, pointed out that it would be important to provide close follow-up on these results to see whether they are sustained in the short and long terms. In her opinion, this model could be presented to other users requiring treatment for anxiety or depression, provided that they can use information and communication technologies.

This precision model, which can also be supported on mobile phones or tablets, could be transferred to primary care facilities or vulnerable populations in rural areas, said Dr. Benjet Miner. “The idea is to reach a point where these algorithms become accurate enough and have a really strong predictive power so that clinicians can use them. The goal is always to find the best treatment at the lowest cost, so that it’s sustainable,” she concluded.

This study was funded by grant number R01MH120648 from the National Institute of Mental Health and the Fogarty International Center. Dr. Benjet Miner reports no relevant financial relationships; the declarations of the remaining authors can be found at the publication’s website.

This article was translated from Medscape’s Spanish Edition and a version first appeared on Medscape.com.

A precision treatment model for internet-delivered cognitive behavioral therapy provides a low-cost, accessible, and effective alternative for treating anxiety and depression, according to a study published in JAMA Psychiatry . The intervention was developed by researchers from the United States, Mexico, and Colombia and studied in undergraduate university students.

The research included 1,319 students with anxiety and depression. The students were randomly assigned to three groups that received either remote (internet-based) cognitive behavioral therapy guided by a therapist, self-guided cognitive behavioral therapy (without support from a therapist), or standard treatment provided by the health care services within their community (the control condition).

Students who received guided cognitive behavioral therapy had higher combined rates of remission of these disorders (51.8%) than students who received self-guided therapy (37.8%) or conventional therapy (40%). These differences were not significant for remission of anxiety, however.

Guided cognitive behavioral therapy was associated with the highest probability of remission of anxiety and depression in 91.7% of students, the highest probability of remission of anxiety in all students, and the highest probability of remission of depression in 71.5% of participants.

The results of this analysis could be used to improve psychological care by optimizing how different treatment methods are assigned, especially in mental health institutions where available technical and human resources are limited, according to the investigators.

“We started designing this study before COVID-19 with the idea of optimizing care for these mental health problems,” said study author Corina Benjet Miner, PhD, an epidemiological and psychosocial researcher at the Ramón de la Fuente National Institute of Psychiatry, Mexico City. “We wanted to find additional strategies to achieve better care. The pandemic helped us because, even though this has been undergoing research for many years, internet-delivered interventions were not as well accepted. But during the pandemic, there weren’t any other options.”

Given the high prevalence of mental disorders before and after the pandemic, no health care system in the world would be able to provide in-person care to each patient with depression or anxiety, said Dr. Benjet Miner. “So, the idea is to look for other cost-effective strategies that can ramp up our interventions and reach a greater number of people without negatively impacting the quality of care,” she explained.

“I believe that [the precision model] is an excellent proposal that can save financial resources and avoid transfers,” said Juana Olvera Méndez, PhD, research professor working with the cognitive behavioral approach at the Iztacala Faculty of Higher Studies (FESI) of the National Autonomous University of Mexico, Mexico City. “It also makes it possible to provide patients with immediate care, in contrast to when someone has to go in for [in-person] therapy, which will depend a lot on how the therapist approaches the situation.”

Students from seven universities in Colombia and Mexico were included in the study. They were aged 18 years or older and had a score of 10 or greater on the self-administered Generalized Anxiety Disorder scale-7 test, or had depression with scores of 10 or greater on the nine-item Patient Health Questionnaire, which is also self-administered.

The study’s exclusion criteria included a history of bipolar disorder, nonaffective psychosis, or suicidal ideation with suicide attempts. The investigators used 284 prescription predictors to anticipate the differential response to antianxiety and antidepression therapy.

By grouping these predictors into 11 conceptual categories (such as demographic characteristics, COVID-19–linked stressors, or mental disorder comorbidities) and using machine learning algorithms, the investigators were able to predict in an individualized manner the probability of remission for participants in each of the groups.

“For depression, we found that 28.5% of patients could experience better or equivalent effects from the self-guided program (in comparison to the guided program). Once you have this program, it doesn’t cost anything, so there could be a massive number of people who could benefit from a cost-free therapy,” said Dr. Benjet Miner.

While numerous studies in precision medicine have tried to determine the most appropriate treatment for each patient, “they don’t have the high number of predictors that we used in this research, and I feel like this gives us a significant edge,” she added.

She also explained that they found no differences in user satisfaction between the guided and unguided version of the therapy, so now they must discover why the guided version works better. One notable point is that patients accessed (online) the guided program twice as many times as those who used the self-guided version, but the number of times used is not enough to explain the better outcomes.

“We believe that patients develop some sort of connection with the guides, who are not providing therapy but only making recommendations in brief interactions with patients once a week. It has something to do with that connection, in addition to the longer time spent interacting with the platform, which provides better results with the guided version,” stated Dr. Benjet Miner.

One of the main limitations of this study is that, though it compares three treatment methods, the third one (standard care) is not homogeneous, because each of the seven universities from which the students were selected has different resources for this purpose. “Some universities, like the National Autonomous University of Mexico, have very formal services, with teams of psychologists and psychiatrists, while others don’t have this type of service, or they cover additional aspects, like vocational counseling. So, it’s very difficult to determine exactly what kind of care patients are receiving, because it’s not homogeneous,” she said.

As many as nine assessments using psychometric tests are sometimes required before the intervention can be evaluated, said Dr. Méndez. “This study doesn’t go into too much detail in that area, focusing rather on treatment. So, it would be important to know the diagnoses of the users, who may be experiencing different degrees of depression or anxiety. It would be worth asking what happens if a user requires psychiatric treatment or support.”

Dr. Méndez, who provides psychological therapy in person and online at the Student Support and Counselling Center at FESI, pointed out that it would be important to provide close follow-up on these results to see whether they are sustained in the short and long terms. In her opinion, this model could be presented to other users requiring treatment for anxiety or depression, provided that they can use information and communication technologies.

This precision model, which can also be supported on mobile phones or tablets, could be transferred to primary care facilities or vulnerable populations in rural areas, said Dr. Benjet Miner. “The idea is to reach a point where these algorithms become accurate enough and have a really strong predictive power so that clinicians can use them. The goal is always to find the best treatment at the lowest cost, so that it’s sustainable,” she concluded.

This study was funded by grant number R01MH120648 from the National Institute of Mental Health and the Fogarty International Center. Dr. Benjet Miner reports no relevant financial relationships; the declarations of the remaining authors can be found at the publication’s website.

This article was translated from Medscape’s Spanish Edition and a version first appeared on Medscape.com.

Investigational muvalaplin (Eli Lilly), the first oral therapy being developed to lower lipoprotein (a) levels, was shown to reduce levels in a phase 1 trial, with no safety concerns, researchers report.

In a separate phase 2 study, olpasiran (Amgen), which is given by injection, lowered Lp(a) levels for nearly 1 year after the last dose, also without safety concerns, in a phase 2 trial extension.

Researchers presented these findings in two late breaking science sessions at the recent annual congress of the European Society of Cardiology. The muvalaplin trial was also simultaneously published online as a preliminary communication in JAMA.
 

Phase 1 trial of muvalaplin

Epidemiologic and genetic evidence suggests that Lp(a) has a causal role in cardiovascular disease (CVD) events, Stephen J. Nicholls, MBBS, PhD, and colleagues wrote.

In initial studies, Lp(a) was reduced by approximately 80% with an antisense oligonucleotide (pelacarsen, Ionis) and by up to 98% with RNA interference (olpasiran) – both injectable therapies.

Muvalaplin is a small molecule that disrupts the binding of apolipoprotein(a) to apo B100 that forms Lp(a), said Dr. Nicholls, from Monash University and Victoria Heart Institute, both in Melbourne.

In this first-in-human, phase 1 trial in 114 healthy individuals, Lp(a) levels were reduced up to 65% following daily administration of 100-800 mg of muvalaplin for 14 days, without safety or tolerability concerns or significant effects on plasminogen, a homologous protein, he said in an interview.

Approximately 20% of the population have high LP(a) levels, Dr. Nicholls noted.

“We saw in the PCSK9 [proprotein convertase subtilisin/kexin type 9] inhibitor trials that Lp(a) lowering is associated with benefit, but those agents substantially lower LDL cholesterol,” he said. “Now, here for the first time we have an oral agent” that lowers Lp(a) levels. However, “we will still need to determine if this leads to a reduction in cardiovascular risk,” in longer and larger trials.

The researchers randomly assigned healthy adults aged 18-69 with a BMI of 30 kg/m² or less, into two groups.

The 55 participants in the single ascending dose group were randomly assigned to receive muvalaplin (1 mg, 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 800 mg) or matching placebo daily for 14 days. They had a mean age of 29 years; 64% were female and 91% were White. Their median Lp(a) level was 10.3 mg/dL.

The 59 participants in the multiple ascending dose group, who were required to have Lp(a) of at least 30 mg/dL, were randomly assigned to receive muvalaplin (30 mg, 100 mg, 300 mg, 500 mg, or 800 mg) or placebo daily for 14 days. They had a mean age of 32; 58% were female and 80% were White. Their median Lp(a) level was 58.4 mg/dL.

The maximum placebo-adjusted Lp(a) reduction was 63% to 65%, which occurred on days 14 and 15, in participants who received doses of at least 100 mg.

The levels returned to baseline by day 29 for the 30-mg dose, day 43 for the 100-mg dose, and day 64 for the 300- to 800-mg doses. 

There were no deaths or serious adverse events. Treatment-associated adverse events were reported by 62% in the single ascending dose group and by 80% in the multiple ascending dose group; these were mild and transient and included headache, fatigue, and vomiting.  

Muvalaplin had no significant effects on LDL cholesterol, HDL cholesterol, or total cholesterol or apo B100, and did not significantly affect plasminogen levels or activity.

The team is currently conducting the phase 2 KRAKEN trial. They plan to enroll 233 patients aged 40 and older with elevated Lp(a) levels (≥ 175 nmol/L) and high risk for cardiovascular events. The primary outcome is change in Lp(a) levels at 12 weeks, and the estimated primary trial completion is this coming January.
 

OCEAN (a)-DOSE extended study of olpasiran

In a separate presentation, Michelle L. O’Donoghue, MD, MPH, reported findings from an extension of the phase 2 trial of olpasiran in patients with atherosclerotic CVD and elevated Lp(a).

courtesy Brigham and Women's Hospital

Olpasiran is a small interfering RNA (siRNA) molecule directed to the liver that prevents the assembly of Lp(a).

Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School in Boston, presented the main results from the OCEAN(a) DOSE (TIMI 67) study of olpasiran, at the 2022 annual scientific sessions of the American Heart Association, and the trial was simultaneously published online in the New England Journal of Medicine.

The trial included 281 patients with established atherosclerotic CVD and Lp(a) greater than 150 nmol/L (60 mg/dL). Participants were randomly assigned to one of four doses of olpasiran (10 mg, 75 mg, or 225 mg every 12 weeks, or 225 mg every 24 weeks) or matching placebo, administered subcutaneously.

At 36 weeks, doses of 75 mg or more of olpasiran every 12 weeks led to reductions of more than 95% in levels of Lp(a).

The extension study aimed to examine the effects of olpasiran on levels of the oxidized phospholipids on apolipoprotein B100 (OxPL-apoB) and on levels of Lp(a), as well as safety, after the last administered dose.

The minimum extended off-treatment period was 72 weeks from randomization (in 276 patients). Complete follow-up was a median of 86 weeks (50 weeks after the last administered dose).

The study showed that “olpasiran is an siRNA that robustly lowers Lp(a) levels” and “leads to a marked and durable reduction” in proatherogenic OxPL-apoB, Dr. O’Donoghue reported.

Patients on doses of at least 75 mg every 12 weeks “sustained around a 40%-50% placebo-adjusted reduction in Lp(a) levels close to 1 year after the last dose.”

The long-term clinical efficacy and safety of olpasiran are being further evaluated in the ongoing phase 3 OCEAN(a)-Outcomes trial which has as an estimated enrollment of 6000 and projected completion in December 2026.

These are “exciting” results, and “we’re all waiting with bated breath for more news,” said session cochairperson Louise Bowman, MD, University of Oxford (England).

In reply to questions from the audience, Dr. O’Donoghue said that the only adverse events that were imbalanced during the on-treatment phase were injection-site reactions and localized hypersensitivity reactions, which were not reported during the off-treatment period. There was also no evidence of a proinflammatory increase in phospholipids, or of a rebound effect on Lp(a) levels after stopping olpasiran.

The muvalaplin study was funded by Eli Lilly. Dr. Nicholls reported numerous conflicts of interest with various pharmaceutical companies. Dr. O’Donoghue reported receiving research grants from Amgen, AstraZeneca, Merck, and Novartis; consulting with Amgen and Novartis; and serving as a data and safety monitor for AstraZeneca and Janssen.

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

Investigational muvalaplin (Eli Lilly), the first oral therapy being developed to lower lipoprotein (a) levels, was shown to reduce levels in a phase 1 trial, with no safety concerns, researchers report.

In a separate phase 2 study, olpasiran (Amgen), which is given by injection, lowered Lp(a) levels for nearly 1 year after the last dose, also without safety concerns, in a phase 2 trial extension.

Researchers presented these findings in two late breaking science sessions at the recent annual congress of the European Society of Cardiology. The muvalaplin trial was also simultaneously published online as a preliminary communication in JAMA.
 

Phase 1 trial of muvalaplin

Epidemiologic and genetic evidence suggests that Lp(a) has a causal role in cardiovascular disease (CVD) events, Stephen J. Nicholls, MBBS, PhD, and colleagues wrote.

In initial studies, Lp(a) was reduced by approximately 80% with an antisense oligonucleotide (pelacarsen, Ionis) and by up to 98% with RNA interference (olpasiran) – both injectable therapies.

Muvalaplin is a small molecule that disrupts the binding of apolipoprotein(a) to apo B100 that forms Lp(a), said Dr. Nicholls, from Monash University and Victoria Heart Institute, both in Melbourne.

In this first-in-human, phase 1 trial in 114 healthy individuals, Lp(a) levels were reduced up to 65% following daily administration of 100-800 mg of muvalaplin for 14 days, without safety or tolerability concerns or significant effects on plasminogen, a homologous protein, he said in an interview.

Approximately 20% of the population have high LP(a) levels, Dr. Nicholls noted.

“We saw in the PCSK9 [proprotein convertase subtilisin/kexin type 9] inhibitor trials that Lp(a) lowering is associated with benefit, but those agents substantially lower LDL cholesterol,” he said. “Now, here for the first time we have an oral agent” that lowers Lp(a) levels. However, “we will still need to determine if this leads to a reduction in cardiovascular risk,” in longer and larger trials.

The researchers randomly assigned healthy adults aged 18-69 with a BMI of 30 kg/m² or less, into two groups.

The 55 participants in the single ascending dose group were randomly assigned to receive muvalaplin (1 mg, 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 800 mg) or matching placebo daily for 14 days. They had a mean age of 29 years; 64% were female and 91% were White. Their median Lp(a) level was 10.3 mg/dL.

The 59 participants in the multiple ascending dose group, who were required to have Lp(a) of at least 30 mg/dL, were randomly assigned to receive muvalaplin (30 mg, 100 mg, 300 mg, 500 mg, or 800 mg) or placebo daily for 14 days. They had a mean age of 32; 58% were female and 80% were White. Their median Lp(a) level was 58.4 mg/dL.

The maximum placebo-adjusted Lp(a) reduction was 63% to 65%, which occurred on days 14 and 15, in participants who received doses of at least 100 mg.

The levels returned to baseline by day 29 for the 30-mg dose, day 43 for the 100-mg dose, and day 64 for the 300- to 800-mg doses. 

There were no deaths or serious adverse events. Treatment-associated adverse events were reported by 62% in the single ascending dose group and by 80% in the multiple ascending dose group; these were mild and transient and included headache, fatigue, and vomiting.  

Muvalaplin had no significant effects on LDL cholesterol, HDL cholesterol, or total cholesterol or apo B100, and did not significantly affect plasminogen levels or activity.

The team is currently conducting the phase 2 KRAKEN trial. They plan to enroll 233 patients aged 40 and older with elevated Lp(a) levels (≥ 175 nmol/L) and high risk for cardiovascular events. The primary outcome is change in Lp(a) levels at 12 weeks, and the estimated primary trial completion is this coming January.
 

OCEAN (a)-DOSE extended study of olpasiran

In a separate presentation, Michelle L. O’Donoghue, MD, MPH, reported findings from an extension of the phase 2 trial of olpasiran in patients with atherosclerotic CVD and elevated Lp(a).

courtesy Brigham and Women's Hospital

Olpasiran is a small interfering RNA (siRNA) molecule directed to the liver that prevents the assembly of Lp(a).

Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School in Boston, presented the main results from the OCEAN(a) DOSE (TIMI 67) study of olpasiran, at the 2022 annual scientific sessions of the American Heart Association, and the trial was simultaneously published online in the New England Journal of Medicine.

The trial included 281 patients with established atherosclerotic CVD and Lp(a) greater than 150 nmol/L (60 mg/dL). Participants were randomly assigned to one of four doses of olpasiran (10 mg, 75 mg, or 225 mg every 12 weeks, or 225 mg every 24 weeks) or matching placebo, administered subcutaneously.

At 36 weeks, doses of 75 mg or more of olpasiran every 12 weeks led to reductions of more than 95% in levels of Lp(a).

The extension study aimed to examine the effects of olpasiran on levels of the oxidized phospholipids on apolipoprotein B100 (OxPL-apoB) and on levels of Lp(a), as well as safety, after the last administered dose.

The minimum extended off-treatment period was 72 weeks from randomization (in 276 patients). Complete follow-up was a median of 86 weeks (50 weeks after the last administered dose).

The study showed that “olpasiran is an siRNA that robustly lowers Lp(a) levels” and “leads to a marked and durable reduction” in proatherogenic OxPL-apoB, Dr. O’Donoghue reported.

Patients on doses of at least 75 mg every 12 weeks “sustained around a 40%-50% placebo-adjusted reduction in Lp(a) levels close to 1 year after the last dose.”

The long-term clinical efficacy and safety of olpasiran are being further evaluated in the ongoing phase 3 OCEAN(a)-Outcomes trial which has as an estimated enrollment of 6000 and projected completion in December 2026.

These are “exciting” results, and “we’re all waiting with bated breath for more news,” said session cochairperson Louise Bowman, MD, University of Oxford (England).

In reply to questions from the audience, Dr. O’Donoghue said that the only adverse events that were imbalanced during the on-treatment phase were injection-site reactions and localized hypersensitivity reactions, which were not reported during the off-treatment period. There was also no evidence of a proinflammatory increase in phospholipids, or of a rebound effect on Lp(a) levels after stopping olpasiran.

The muvalaplin study was funded by Eli Lilly. Dr. Nicholls reported numerous conflicts of interest with various pharmaceutical companies. Dr. O’Donoghue reported receiving research grants from Amgen, AstraZeneca, Merck, and Novartis; consulting with Amgen and Novartis; and serving as a data and safety monitor for AstraZeneca and Janssen.

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

Investigational muvalaplin (Eli Lilly), the first oral therapy being developed to lower lipoprotein (a) levels, was shown to reduce levels in a phase 1 trial, with no safety concerns, researchers report.

In a separate phase 2 study, olpasiran (Amgen), which is given by injection, lowered Lp(a) levels for nearly 1 year after the last dose, also without safety concerns, in a phase 2 trial extension.

Researchers presented these findings in two late breaking science sessions at the recent annual congress of the European Society of Cardiology. The muvalaplin trial was also simultaneously published online as a preliminary communication in JAMA.
 

Phase 1 trial of muvalaplin

Epidemiologic and genetic evidence suggests that Lp(a) has a causal role in cardiovascular disease (CVD) events, Stephen J. Nicholls, MBBS, PhD, and colleagues wrote.

In initial studies, Lp(a) was reduced by approximately 80% with an antisense oligonucleotide (pelacarsen, Ionis) and by up to 98% with RNA interference (olpasiran) – both injectable therapies.

Muvalaplin is a small molecule that disrupts the binding of apolipoprotein(a) to apo B100 that forms Lp(a), said Dr. Nicholls, from Monash University and Victoria Heart Institute, both in Melbourne.

In this first-in-human, phase 1 trial in 114 healthy individuals, Lp(a) levels were reduced up to 65% following daily administration of 100-800 mg of muvalaplin for 14 days, without safety or tolerability concerns or significant effects on plasminogen, a homologous protein, he said in an interview.

Approximately 20% of the population have high LP(a) levels, Dr. Nicholls noted.

“We saw in the PCSK9 [proprotein convertase subtilisin/kexin type 9] inhibitor trials that Lp(a) lowering is associated with benefit, but those agents substantially lower LDL cholesterol,” he said. “Now, here for the first time we have an oral agent” that lowers Lp(a) levels. However, “we will still need to determine if this leads to a reduction in cardiovascular risk,” in longer and larger trials.

The researchers randomly assigned healthy adults aged 18-69 with a BMI of 30 kg/m² or less, into two groups.

The 55 participants in the single ascending dose group were randomly assigned to receive muvalaplin (1 mg, 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 800 mg) or matching placebo daily for 14 days. They had a mean age of 29 years; 64% were female and 91% were White. Their median Lp(a) level was 10.3 mg/dL.

The 59 participants in the multiple ascending dose group, who were required to have Lp(a) of at least 30 mg/dL, were randomly assigned to receive muvalaplin (30 mg, 100 mg, 300 mg, 500 mg, or 800 mg) or placebo daily for 14 days. They had a mean age of 32; 58% were female and 80% were White. Their median Lp(a) level was 58.4 mg/dL.

The maximum placebo-adjusted Lp(a) reduction was 63% to 65%, which occurred on days 14 and 15, in participants who received doses of at least 100 mg.

The levels returned to baseline by day 29 for the 30-mg dose, day 43 for the 100-mg dose, and day 64 for the 300- to 800-mg doses. 

There were no deaths or serious adverse events. Treatment-associated adverse events were reported by 62% in the single ascending dose group and by 80% in the multiple ascending dose group; these were mild and transient and included headache, fatigue, and vomiting.  

Muvalaplin had no significant effects on LDL cholesterol, HDL cholesterol, or total cholesterol or apo B100, and did not significantly affect plasminogen levels or activity.

The team is currently conducting the phase 2 KRAKEN trial. They plan to enroll 233 patients aged 40 and older with elevated Lp(a) levels (≥ 175 nmol/L) and high risk for cardiovascular events. The primary outcome is change in Lp(a) levels at 12 weeks, and the estimated primary trial completion is this coming January.
 

OCEAN (a)-DOSE extended study of olpasiran

In a separate presentation, Michelle L. O’Donoghue, MD, MPH, reported findings from an extension of the phase 2 trial of olpasiran in patients with atherosclerotic CVD and elevated Lp(a).

courtesy Brigham and Women's Hospital

Olpasiran is a small interfering RNA (siRNA) molecule directed to the liver that prevents the assembly of Lp(a).

Dr. O’Donoghue, from Brigham and Women’s Hospital and Harvard Medical School in Boston, presented the main results from the OCEAN(a) DOSE (TIMI 67) study of olpasiran, at the 2022 annual scientific sessions of the American Heart Association, and the trial was simultaneously published online in the New England Journal of Medicine.

The trial included 281 patients with established atherosclerotic CVD and Lp(a) greater than 150 nmol/L (60 mg/dL). Participants were randomly assigned to one of four doses of olpasiran (10 mg, 75 mg, or 225 mg every 12 weeks, or 225 mg every 24 weeks) or matching placebo, administered subcutaneously.

At 36 weeks, doses of 75 mg or more of olpasiran every 12 weeks led to reductions of more than 95% in levels of Lp(a).

The extension study aimed to examine the effects of olpasiran on levels of the oxidized phospholipids on apolipoprotein B100 (OxPL-apoB) and on levels of Lp(a), as well as safety, after the last administered dose.

The minimum extended off-treatment period was 72 weeks from randomization (in 276 patients). Complete follow-up was a median of 86 weeks (50 weeks after the last administered dose).

The study showed that “olpasiran is an siRNA that robustly lowers Lp(a) levels” and “leads to a marked and durable reduction” in proatherogenic OxPL-apoB, Dr. O’Donoghue reported.

Patients on doses of at least 75 mg every 12 weeks “sustained around a 40%-50% placebo-adjusted reduction in Lp(a) levels close to 1 year after the last dose.”

The long-term clinical efficacy and safety of olpasiran are being further evaluated in the ongoing phase 3 OCEAN(a)-Outcomes trial which has as an estimated enrollment of 6000 and projected completion in December 2026.

These are “exciting” results, and “we’re all waiting with bated breath for more news,” said session cochairperson Louise Bowman, MD, University of Oxford (England).

In reply to questions from the audience, Dr. O’Donoghue said that the only adverse events that were imbalanced during the on-treatment phase were injection-site reactions and localized hypersensitivity reactions, which were not reported during the off-treatment period. There was also no evidence of a proinflammatory increase in phospholipids, or of a rebound effect on Lp(a) levels after stopping olpasiran.

The muvalaplin study was funded by Eli Lilly. Dr. Nicholls reported numerous conflicts of interest with various pharmaceutical companies. Dr. O’Donoghue reported receiving research grants from Amgen, AstraZeneca, Merck, and Novartis; consulting with Amgen and Novartis; and serving as a data and safety monitor for AstraZeneca and Janssen.

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

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

A newly published scientific statement from the American Heart Association focuses on the impact of aggressive low-density lipoprotein cholesterol (LDL-C) lowering on the risk for dementia and hemorrhagic stroke.

“The brain is the body’s most cholesterol-rich organ, and some have questioned whether aggressive LDL-C lowering induces abnormal structural and functional changes,” the writing group, led by Larry Goldstein, MD, chair, department of neurology, University of Kentucky, Lexington, points out.

The 39-page AHA scientific statement, titled “Aggressive LDL-C Lowering and the Brain: Impact on Risk for Dementia and Hemorrhagic Stroke,” was published online in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

The objective was to evaluate contemporary evidence that either supports or refutes the conclusion that aggressive LDL-C lowering or lipid lowering exerts toxic effects on the brain, leading to cognitive impairment or dementia or hemorrhagic stroke.

The eight-member writing group used literature reviews, references to published clinical and epidemiology studies, clinical and public health guidelines, authoritative statements, and expert opinion to summarize the latest evidence and identify gaps in current knowledge.

They reached four main conclusions:

• First, the available data “consistently” show that LDL-C lowering reduces the risk of atherosclerotic cardiovascular disease-related events in high-risk groups.
• Second, although some older retrospective, case-control, and prospective longitudinal studies suggest that statins and LDL-C lowering are associated with cognitive impairment or dementia, the “preponderance” of observational studies and data from randomized trials do not support this conclusion, at least among trials with median follow-up of up to 6 years. The group says additional studies are needed to ensure cognitive safety over longer periods of time. For now, contemporary guidelines recommending the risk-stratified attainment of lipid-lowering goals are “reasonable,” they conclude.
• Third, the risk for hemorrhagic stroke associated with statin therapy in patients without a history of cerebrovascular disease is “small and consistently nonsignificant.” They found no evidence that PCSK9 inhibitors or ezetimibe (Zetia) increases bleeding risk. Further, there is “no indication” that patients or populations with lifelong low LDL-C have enhanced vulnerability to hemorrhagic stroke, and there is “little evidence” that achieving very low levels of LDL-C increases that risk. What is clear, the writing group says, is that lower LDL-C levels correlate with lower risk of overall stroke and stroke recurrence, mostly related to a reduction in ischemic stroke. “Concern about hemorrhagic stroke risk should not deter a clinician from treating LDL-C to guideline-recommended risk-stratified targets,” the writing group says.
• Fourth, the group notes that data reflecting the risk of hemorrhagic stroke with statin therapy among patients with a history of hemorrhagic stroke are not robust. PCSK9 inhibitors have not been adequately tested in patients with prior intracerebral hemorrhage. Lipid lowering in these populations requires more focused study.

The research had no commercial funding. A list of disclosures for the writing group is available with the original article.

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

SAN DIEGO – In the clinical experience of Mathew M. Avram, MD, JD, fractional lasers work best in combination with other devices and wavelengths when treating signs of photoaging, such as dyspigmentation, wrinkles, and actinic damage.

“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.

The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”

The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.

Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”

Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.

SAN DIEGO – In the clinical experience of Mathew M. Avram, MD, JD, fractional lasers work best in combination with other devices and wavelengths when treating signs of photoaging, such as dyspigmentation, wrinkles, and actinic damage.

“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.

The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”

The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.

Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”

Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.

SAN DIEGO – In the clinical experience of Mathew M. Avram, MD, JD, fractional lasers work best in combination with other devices and wavelengths when treating signs of photoaging, such as dyspigmentation, wrinkles, and actinic damage.

“Using a fractional laser as a solo treatment is missing an opportunity to achieve more dramatic improvement for your patients,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said at the annual Masters of Aesthetics Symposium. Among the laser treatments he performs, “combination fractional treatments, typically using the 1927-nm laser” are associated with the highest patient satisfaction, he said.

The order of device use matters, he noted. First, he recommended, use a pulsed dye laser, KTP, or intense pulsed light (IPL) for erythema and telangiectasias, and/or a Q-switched or picosecond laser for pigment. Second, use an ablative or nonablative fractional laser for resurfacing. “A lot of seborrheic keratoses don’t respond to selective photothermolysis well, so I’ll use liquid nitrogen at the time of treatment and before or after treat with a picosecond laser,” added Dr. Avram. “This combined treatment approach is less painful than ablative fractional treatment. You’re going to have downtime anyway, so why not maximize the results at that one treatment session?”

The fractional 1927 laser delivers hundreds of thousands of microscopic pulses and fosters high water absorption, so it targets superficial skin conditions such as actinic keratoses, lentigines, and ephelides at depths of 200-250 microns. It thermally coagulates 30%-40% of skin, which heals without affecting surrounding skin and leaves no perceptible scar, he said.

Clinicians can also combine devices to treat scars. “For red scars, it’s often best to treat both erythema and scar texture with two lasers at the same session,” Dr. Avram said. Again, the order matters. First, he recommended using the pulse dye laser, IPL, or KTP at low fluence and short pulse duration. Second, treat with an ablative or nonablative fractional laser at a low density. “In my experience the ablative fractional lasers are far more efficacious,” he said. “Then we typically add a little Kenalog and 5-FU via laser-assisted drug delivery.”

Dr. Avram disclosed that he has received consulting fees from Allergan. He also reported holding shareholder interest and intellectual property rights with Cytrellis Biosystems.

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.

The American Academy of Pediatrics recommends against low-carbohydrate diets for most children and adolescents with or at risk for diabetes, according to a new clinical report.

Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.

“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”

Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.

Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.

“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”

They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”

“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”

Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.

“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.

For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
 

Lack of evidence is the problem

David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”

courtesy Boston Children's Hospital

“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”

He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.

For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.

“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”

This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.

This article was updated 9/20/23.