Jennifer Lubell

Difficulties associated with treating borderline personality disorder (BPD) make for an uneasy alliance between patient and clinician. Deep-seated anxiety and trust issues often lead to patients skipping visits or raging at those who treat them, leaving clinicians frustrated and ready to give up or relying on a pill to make the patient better.

John M. Oldham, MD, MS, recalls one patient he almost lost, a woman who was struggling with aggressive behavior. Initially cooperative and punctual, the patient gradually became distrustful, grilling Dr. Oldham on his training and credentials. “As the questions continued, she slipped from being very cooperative to being enraged and attacking me,” said Dr. Oldham, Distinguished Emeritus Professor in the Menninger department of psychiatry and behavioral sciences at Baylor College in Houston.

Dr. Oldham eventually drew her back in by earning her trust. “There’s no magic to this,” he acknowledged. “You try to be as alert and informed and vigilant for anything you say that produces a negative or concerning reaction in the patient.”

This interactive approach to BPD treatment has been gaining traction in a profession that often looks to medications to alleviate specific symptoms. It’s so effective that it sometimes even surprises the patient, Dr. Oldham noted. “When you approach them like this, they can begin to settle down,” which was the case with the female patient he once treated.

About 1.4% of the U.S. population has BPD, according to the National Institute of Mental Health. Conceptualized by the late John G. Gunderson, MD, BPD initially was seen as floating on the borderline between psychosis and neurosis. Clinicians now understand that this isn’t the case. The patients need, as Dr. Gunderson once pointed out, constant vigilance because of attachment issues and childhood trauma.

A stable therapeutic alliance between patient and physician, sometimes in combination with evidence-based therapies, is a formula for success, some experts say.
 

A misunderstood condition

Although there is some degree of heritable risk, BPD patients are often the product of an invalidating environment in childhood. “As kids, we’re guided and nurtured by caring adults to provide models of reasonable, trustworthy behavior. If those role models are missing or just so inconsistent and unpredictable, the patient doesn’t end up with a sturdy self-image. Instead, they’re adrift, trying to figure out who will be helpful and be a meaningful, trustworthy companion and adviser,” Dr. Oldham said.

Emotional or affective instability and impulsivity, sometimes impulsive aggression, often characterize their condition. “Brain-imaging studies have revealed that certain nerve pathways that are necessary to regulate emotions are impoverished in patients with BPD,” Dr. Oldham said.

An analogy is a car going too fast, with a runaway engine that’s running too hot – and the brakes don’t work, he added.

“People think these patients are trying to create big drama, that they’re putting on a big show. That’s not accurate,” he continued. These patients don’t have the ability to stop the trigger that leads to their emotional storms. They also don’t have the ability to regulate themselves. “We may say, it’s a beautiful day outside, but I still have to go to work. Someone with BPD may say: It’s a beautiful day; I’m going to the beach,” Dr. Oldham explained.

A person with BPD might sound coherent when arguing with someone else. But their words are driven by the storm they can’t turn off.

This can lead to their own efforts to turn off the intensity. They might become self-injurious or push other people away. It’s one of the ironies of this condition because BPD patients desperately want to trust others but are scared to do so. “They look for any little signal – that someone else will hurt, disappoint, or leave them. Eventually their relationships unravel,” Dr. Oldham saod.

For some, suicide is sometimes a final solution.

Those traits make it difficult for a therapist to connect with a patient. “This is a very difficult group of people to treat and to establish treatment,” said Michael A. Cummings, MD, of the department of psychiatry at University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD patients tend to idealize people who are attempting to help them. When they become frustrated or disappointed in some way, “they then devalue the caregiver or the treatment and not infrequently, fall out of treatment,” Dr. Cummings said. It can be a very taxing experience, particularly for younger, less experienced therapists.
 

Medication only goes so far

Psychiatrists tend to look at BPD patients as receptor sites for molecules, assessing symptoms they can prescribe for, Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass., said in an interview.

Yet, BPD is not a molecular problem, principally. It’s an interpersonal disorder. When BPD is a co-occurring disorder, as is often the case, the depressive, anxiety, or other disorder can mask the BPD, he added, citing his 2018 paper on tensions in psychiatry between the biomedical and biopsychosocial models (Psychiatr Clin North Am. 2018 Jun;41[2]:237-48).

In one longitudinal study (J Pers Disord. 2005 Oct;19[5]:487-504), the presence of BPD strongly predicted the persistence of depression. BPD comorbid with depression is often a recipe for treatment-resistant depression, which results in higher costs, more utilization of resources, and higher suicide rates. Too often, psychiatrists diagnose the depression but miss the BPD. They keep trying molecular approaches with prescription drugs – even though it’s really the interpersonal issues of BPD that need to be addressed, said Dr. Plakun, who is a member of the Group for the Advancement of Psychiatry’s Psychotherapy Committee, and founder and past leader of the American Psychiatric Association’s Psychotherapy Caucus.

Medication can be helpful as a short-term adjunctive therapy. Long term, it’s not a sustainable approach, said Dr. Oldham. “If a patient is in a particularly stressful period, in the middle of a stormy breakup or having a depressive episode or talking about suicide, a time-limited course of an antidepressant may be helpful,” he said. They could also benefit from an anxiety-related drug or medication to help them sleep.

What you don’t want is for the patient to start relying on medications to help them feel better. The problem is, many are suffering so much that they’ll go to their primary care doctor and say, “I’m suffering from anxiety,” and get an antianxiety drug. Or they’re depressed or in pain and end up with a cocktail of medications. “And that’s just going to make matters worse,” Dr. Oldham said.
 

Psychotherapy as a first-line approach

APA practice guidelines and others worldwide have all come to the same conclusion about BPD. The primary or core treatment for this condition is psychotherapy, said Dr. Oldham, who chaired an APA committee that developed an evidence-based practice guideline for patients with BPD.

Psychotherapy keeps the patient from firing you, he asserted. “Because of the lack of trust, they push away. They’re very scared, and this fear also applies to therapist. The goal is to help the patient learn to trust you. To do that, you need to develop a strong therapeutic alliance.”

In crafting the APA’s practice guideline, Dr. Oldham and his colleagues studied a variety of approaches, including mentalization-based therapy (MBT) and dialectical behavior therapy (DBT), which was developed by Marsha Linehan, PhD. Since then, other approaches have demonstrated efficacy in randomized clinical trials, including schema-based therapy (SBT), cognitive-behavioral therapy (CBT), and transference-focused psychotherapy (TFP).

Those treatments might complement the broader goal of establishing a strong alliance with the patient, Dr. Oldham said. Manualized approaches can help prepackage a program that allows clinicians and patients to look at their problems in an objective, nonpejorative way, Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute at McLean Hospital in Belmont, Mass., said in an interview. DBT, for example, focuses on emotion dysregulation. MBT addresses how the patient sees themselves through others and their interactions with others. “It destigmatizes a problem as a clinical entity rather than an interpersonal problem between the patient and the clinician,” Dr. Choi-Kain said.

The choice of approach depends on several factors: the patient’s needs and preferences, and the therapist’s skills and experience, said Dr. Oldham. Some patients don’t do well with DBT because it involves a lot of homework and didactic work. Others do better with TFP because they want to understand what drives their behavior.

Dr. Cummings recalled how one of his patients used TFP to look inward and heal.

He first met the patient when she was in her early 30s. “She had made some progress, but I remember she was still struggling mightily with relationship issues and with identifying her role in relationships,” he said. The patient was becoming increasingly aware that she was going to end up alone and didn’t want that as an outcome.

Adapting to a TFP model, “she worked very hard trying to understand herself as she related to other people, understanding her own emotional volatility, and some of her proneness to behavioral problems,” Dr. Cummings said. The patient also had to learn how to negotiate her relationships to the point where she didn’t end up destroying them and alienating people.
 

Customizing the treatment

Physicians can choose from one of these manualized forms of treatment to see what’s appropriate and what works for the patient. “You can individualize the treatment, borrowing from these approaches and shaping it based on what your patient needs,” Dr. Oldham recommended.

Recently, the field of psychiatry has seen the benefits of combining manualized, evidence-based approaches with general psychiatric management (GPM), a method conceived by Dr. Gunderson. GPM “reflects a sensitive understanding of mental illness, offering ‘non attacking’ or collaborative work with the patient and a sensitive recognition of appropriate interventions or corrections to help the patient stay in treatment,” said Dr. Oldham.

It aims to conceptualize BPD in a clinically objective way, medicalizing the disorder so it’s something that the patient has, rather than something he or she is, explained Dr. Choi-Kain, who worked with Dr. Gunderson to train clinicians on using this approach. Using a framework that’s compatible with good medical practices, the clinician tries to define the problem together with the patient, “really assessing whether or not the treatment works, setting goals, managing safety, and trying to promote functioning, something we need to pay more attention to with BPD,” she said.

For these patients, the goal is to have positive, corrective experiences in the real world, reinforcing their hopes and what they’re capable of, and an interface with the world that makes them feel like contributors, she said.

Cycle of rupture and repair

Many people with BPD struggle with the desire to find and feel love, but also deal with their rage and hate. Hence, therapists must prepare themselves for the experience of sometimes being hated, said Dr. Plakun. The patient needs to feel they’re in a safe enough space to express those feelings, activating a cycle of “rupture and repair,” he continued.

The key in working with these patients is to avoid any language that will make them feel attacked or criticized, said Dr. Oldham.

A patient may get furious and say “I don’t know what you’re talking about. I didn’t say that.” When in truth, the psychiatrist is flat accurate about what the patient said. Instead of arguing with the patient, a physician can back up and say: “Help me understand what you’re feeling right now. What did I say that made you feel that you couldn’t trust me? Help me understand you. I may have made a mistake,” he advised.

Trust is a key ingredient in an alliance-based intervention for suicidal patients with BPD that Dr. Plakun has frequently written about. A bond he had with a deeply suicidal patient helped her overcome her grief and come to terms with an abusive childhood.

“She had a horrible history of abuse and had BPD and bipolar disorder. Even controlled with medications her life was still awful. She contemplated suicide relentlessly.” Working through her history of sexual abuse, the patient discovered that much of what she and clinicians thought of as a depressive illness was in fact intense grief about the irreparable damage that had taken place during childhood.

Through their work she was able to mourn, and her depression and BPD improved.

Developing a trusting relationship with the patient isn’t a starting point; it’s the goal, he emphasized.

“You don’t prescribe trust to someone. It’s earned.” Through the shared journey of therapy, as the patient suffers from inevitable injuries and ruptures and as the therapist reveals his or her imperfections, opportunities arise to nonjudgmentally examine and repair ruptures. This lead to gains in trust, he said.
 

It’s not just about genes

Many in the psychiatric and psychological communities tend to develop a very nihilistic view of BPD patients, observed Dr. Cummings. “They’ll say: ‘Oh, well, it’s hopeless. There’s nothing that can be done.’ That isn’t true,” he said.

Epidemiologic studies of these individuals have shown that many of these patients no longer meet the diagnostic criteria for BPD by the time they reach middle age. This means they get better over time, noted Dr. Cummings.

Dr. Plakun’s hope is that the field will evolve in a direction that recognizes the importance of psychosocial treatments like psychotherapy, in addition to biomedical treatments. The drive to medicate still exists, which can contribute to underdiagnosis and undertreatment of BPD, he said. “Although there are manualized, evidence-based treatments, few clinicians learn even one of these for BPD, not to mention those for other disorders.”

In 1996, Francis S. Collins, MD, PhD, the current director of the National Institutes of Health, predicted that the decoding of the human genome would transform treatment of medical and mental disorders [and] “that we would discover the ways in which genes equal disease,” said Dr. Plakun. What the science has since shown, is genes by environmental interaction lead to disease and health.

Nature and nurture both matter. “And I don’t think we’re paying enough attention to the nurture side,” Dr. Plakun said.

The solution is a return to a biopsychosocial model, recognizing that psychotherapy is an essential part of treatment of BPD and other conditions, and an essential clinician skill, he said.

Dr. Oldham is coeditor of the “Textbook of Personality Disorders”, 3rd edition (Washington: American Psychiatric Association Publishing, 2021).Dr. Choi-Kain is coeditor with Dr. Gunderson of “Applications of Good Psychiatric Management for Borderline Personality Disorder: A Practical Guide” (Washington: American Psychiatric Association Publishing, 2019).

Dr. Cummings and Dr. Plakun had no disclosures.

Difficulties associated with treating borderline personality disorder (BPD) make for an uneasy alliance between patient and clinician. Deep-seated anxiety and trust issues often lead to patients skipping visits or raging at those who treat them, leaving clinicians frustrated and ready to give up or relying on a pill to make the patient better.

John M. Oldham, MD, MS, recalls one patient he almost lost, a woman who was struggling with aggressive behavior. Initially cooperative and punctual, the patient gradually became distrustful, grilling Dr. Oldham on his training and credentials. “As the questions continued, she slipped from being very cooperative to being enraged and attacking me,” said Dr. Oldham, Distinguished Emeritus Professor in the Menninger department of psychiatry and behavioral sciences at Baylor College in Houston.

Dr. Oldham eventually drew her back in by earning her trust. “There’s no magic to this,” he acknowledged. “You try to be as alert and informed and vigilant for anything you say that produces a negative or concerning reaction in the patient.”

This interactive approach to BPD treatment has been gaining traction in a profession that often looks to medications to alleviate specific symptoms. It’s so effective that it sometimes even surprises the patient, Dr. Oldham noted. “When you approach them like this, they can begin to settle down,” which was the case with the female patient he once treated.

About 1.4% of the U.S. population has BPD, according to the National Institute of Mental Health. Conceptualized by the late John G. Gunderson, MD, BPD initially was seen as floating on the borderline between psychosis and neurosis. Clinicians now understand that this isn’t the case. The patients need, as Dr. Gunderson once pointed out, constant vigilance because of attachment issues and childhood trauma.

A stable therapeutic alliance between patient and physician, sometimes in combination with evidence-based therapies, is a formula for success, some experts say.
 

A misunderstood condition

Although there is some degree of heritable risk, BPD patients are often the product of an invalidating environment in childhood. “As kids, we’re guided and nurtured by caring adults to provide models of reasonable, trustworthy behavior. If those role models are missing or just so inconsistent and unpredictable, the patient doesn’t end up with a sturdy self-image. Instead, they’re adrift, trying to figure out who will be helpful and be a meaningful, trustworthy companion and adviser,” Dr. Oldham said.

Emotional or affective instability and impulsivity, sometimes impulsive aggression, often characterize their condition. “Brain-imaging studies have revealed that certain nerve pathways that are necessary to regulate emotions are impoverished in patients with BPD,” Dr. Oldham said.

An analogy is a car going too fast, with a runaway engine that’s running too hot – and the brakes don’t work, he added.

“People think these patients are trying to create big drama, that they’re putting on a big show. That’s not accurate,” he continued. These patients don’t have the ability to stop the trigger that leads to their emotional storms. They also don’t have the ability to regulate themselves. “We may say, it’s a beautiful day outside, but I still have to go to work. Someone with BPD may say: It’s a beautiful day; I’m going to the beach,” Dr. Oldham explained.

A person with BPD might sound coherent when arguing with someone else. But their words are driven by the storm they can’t turn off.

This can lead to their own efforts to turn off the intensity. They might become self-injurious or push other people away. It’s one of the ironies of this condition because BPD patients desperately want to trust others but are scared to do so. “They look for any little signal – that someone else will hurt, disappoint, or leave them. Eventually their relationships unravel,” Dr. Oldham saod.

For some, suicide is sometimes a final solution.

Those traits make it difficult for a therapist to connect with a patient. “This is a very difficult group of people to treat and to establish treatment,” said Michael A. Cummings, MD, of the department of psychiatry at University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD patients tend to idealize people who are attempting to help them. When they become frustrated or disappointed in some way, “they then devalue the caregiver or the treatment and not infrequently, fall out of treatment,” Dr. Cummings said. It can be a very taxing experience, particularly for younger, less experienced therapists.
 

Medication only goes so far

Psychiatrists tend to look at BPD patients as receptor sites for molecules, assessing symptoms they can prescribe for, Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass., said in an interview.

Yet, BPD is not a molecular problem, principally. It’s an interpersonal disorder. When BPD is a co-occurring disorder, as is often the case, the depressive, anxiety, or other disorder can mask the BPD, he added, citing his 2018 paper on tensions in psychiatry between the biomedical and biopsychosocial models (Psychiatr Clin North Am. 2018 Jun;41[2]:237-48).

In one longitudinal study (J Pers Disord. 2005 Oct;19[5]:487-504), the presence of BPD strongly predicted the persistence of depression. BPD comorbid with depression is often a recipe for treatment-resistant depression, which results in higher costs, more utilization of resources, and higher suicide rates. Too often, psychiatrists diagnose the depression but miss the BPD. They keep trying molecular approaches with prescription drugs – even though it’s really the interpersonal issues of BPD that need to be addressed, said Dr. Plakun, who is a member of the Group for the Advancement of Psychiatry’s Psychotherapy Committee, and founder and past leader of the American Psychiatric Association’s Psychotherapy Caucus.

Medication can be helpful as a short-term adjunctive therapy. Long term, it’s not a sustainable approach, said Dr. Oldham. “If a patient is in a particularly stressful period, in the middle of a stormy breakup or having a depressive episode or talking about suicide, a time-limited course of an antidepressant may be helpful,” he said. They could also benefit from an anxiety-related drug or medication to help them sleep.

What you don’t want is for the patient to start relying on medications to help them feel better. The problem is, many are suffering so much that they’ll go to their primary care doctor and say, “I’m suffering from anxiety,” and get an antianxiety drug. Or they’re depressed or in pain and end up with a cocktail of medications. “And that’s just going to make matters worse,” Dr. Oldham said.
 

Psychotherapy as a first-line approach

APA practice guidelines and others worldwide have all come to the same conclusion about BPD. The primary or core treatment for this condition is psychotherapy, said Dr. Oldham, who chaired an APA committee that developed an evidence-based practice guideline for patients with BPD.

Psychotherapy keeps the patient from firing you, he asserted. “Because of the lack of trust, they push away. They’re very scared, and this fear also applies to therapist. The goal is to help the patient learn to trust you. To do that, you need to develop a strong therapeutic alliance.”

In crafting the APA’s practice guideline, Dr. Oldham and his colleagues studied a variety of approaches, including mentalization-based therapy (MBT) and dialectical behavior therapy (DBT), which was developed by Marsha Linehan, PhD. Since then, other approaches have demonstrated efficacy in randomized clinical trials, including schema-based therapy (SBT), cognitive-behavioral therapy (CBT), and transference-focused psychotherapy (TFP).

Those treatments might complement the broader goal of establishing a strong alliance with the patient, Dr. Oldham said. Manualized approaches can help prepackage a program that allows clinicians and patients to look at their problems in an objective, nonpejorative way, Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute at McLean Hospital in Belmont, Mass., said in an interview. DBT, for example, focuses on emotion dysregulation. MBT addresses how the patient sees themselves through others and their interactions with others. “It destigmatizes a problem as a clinical entity rather than an interpersonal problem between the patient and the clinician,” Dr. Choi-Kain said.

The choice of approach depends on several factors: the patient’s needs and preferences, and the therapist’s skills and experience, said Dr. Oldham. Some patients don’t do well with DBT because it involves a lot of homework and didactic work. Others do better with TFP because they want to understand what drives their behavior.

Dr. Cummings recalled how one of his patients used TFP to look inward and heal.

He first met the patient when she was in her early 30s. “She had made some progress, but I remember she was still struggling mightily with relationship issues and with identifying her role in relationships,” he said. The patient was becoming increasingly aware that she was going to end up alone and didn’t want that as an outcome.

Adapting to a TFP model, “she worked very hard trying to understand herself as she related to other people, understanding her own emotional volatility, and some of her proneness to behavioral problems,” Dr. Cummings said. The patient also had to learn how to negotiate her relationships to the point where she didn’t end up destroying them and alienating people.
 

Customizing the treatment

Physicians can choose from one of these manualized forms of treatment to see what’s appropriate and what works for the patient. “You can individualize the treatment, borrowing from these approaches and shaping it based on what your patient needs,” Dr. Oldham recommended.

Recently, the field of psychiatry has seen the benefits of combining manualized, evidence-based approaches with general psychiatric management (GPM), a method conceived by Dr. Gunderson. GPM “reflects a sensitive understanding of mental illness, offering ‘non attacking’ or collaborative work with the patient and a sensitive recognition of appropriate interventions or corrections to help the patient stay in treatment,” said Dr. Oldham.

It aims to conceptualize BPD in a clinically objective way, medicalizing the disorder so it’s something that the patient has, rather than something he or she is, explained Dr. Choi-Kain, who worked with Dr. Gunderson to train clinicians on using this approach. Using a framework that’s compatible with good medical practices, the clinician tries to define the problem together with the patient, “really assessing whether or not the treatment works, setting goals, managing safety, and trying to promote functioning, something we need to pay more attention to with BPD,” she said.

For these patients, the goal is to have positive, corrective experiences in the real world, reinforcing their hopes and what they’re capable of, and an interface with the world that makes them feel like contributors, she said.

Cycle of rupture and repair

Many people with BPD struggle with the desire to find and feel love, but also deal with their rage and hate. Hence, therapists must prepare themselves for the experience of sometimes being hated, said Dr. Plakun. The patient needs to feel they’re in a safe enough space to express those feelings, activating a cycle of “rupture and repair,” he continued.

The key in working with these patients is to avoid any language that will make them feel attacked or criticized, said Dr. Oldham.

A patient may get furious and say “I don’t know what you’re talking about. I didn’t say that.” When in truth, the psychiatrist is flat accurate about what the patient said. Instead of arguing with the patient, a physician can back up and say: “Help me understand what you’re feeling right now. What did I say that made you feel that you couldn’t trust me? Help me understand you. I may have made a mistake,” he advised.

Trust is a key ingredient in an alliance-based intervention for suicidal patients with BPD that Dr. Plakun has frequently written about. A bond he had with a deeply suicidal patient helped her overcome her grief and come to terms with an abusive childhood.

“She had a horrible history of abuse and had BPD and bipolar disorder. Even controlled with medications her life was still awful. She contemplated suicide relentlessly.” Working through her history of sexual abuse, the patient discovered that much of what she and clinicians thought of as a depressive illness was in fact intense grief about the irreparable damage that had taken place during childhood.

Through their work she was able to mourn, and her depression and BPD improved.

Developing a trusting relationship with the patient isn’t a starting point; it’s the goal, he emphasized.

“You don’t prescribe trust to someone. It’s earned.” Through the shared journey of therapy, as the patient suffers from inevitable injuries and ruptures and as the therapist reveals his or her imperfections, opportunities arise to nonjudgmentally examine and repair ruptures. This lead to gains in trust, he said.
 

It’s not just about genes

Many in the psychiatric and psychological communities tend to develop a very nihilistic view of BPD patients, observed Dr. Cummings. “They’ll say: ‘Oh, well, it’s hopeless. There’s nothing that can be done.’ That isn’t true,” he said.

Epidemiologic studies of these individuals have shown that many of these patients no longer meet the diagnostic criteria for BPD by the time they reach middle age. This means they get better over time, noted Dr. Cummings.

Dr. Plakun’s hope is that the field will evolve in a direction that recognizes the importance of psychosocial treatments like psychotherapy, in addition to biomedical treatments. The drive to medicate still exists, which can contribute to underdiagnosis and undertreatment of BPD, he said. “Although there are manualized, evidence-based treatments, few clinicians learn even one of these for BPD, not to mention those for other disorders.”

In 1996, Francis S. Collins, MD, PhD, the current director of the National Institutes of Health, predicted that the decoding of the human genome would transform treatment of medical and mental disorders [and] “that we would discover the ways in which genes equal disease,” said Dr. Plakun. What the science has since shown, is genes by environmental interaction lead to disease and health.

Nature and nurture both matter. “And I don’t think we’re paying enough attention to the nurture side,” Dr. Plakun said.

The solution is a return to a biopsychosocial model, recognizing that psychotherapy is an essential part of treatment of BPD and other conditions, and an essential clinician skill, he said.

Dr. Oldham is coeditor of the “Textbook of Personality Disorders”, 3rd edition (Washington: American Psychiatric Association Publishing, 2021).Dr. Choi-Kain is coeditor with Dr. Gunderson of “Applications of Good Psychiatric Management for Borderline Personality Disorder: A Practical Guide” (Washington: American Psychiatric Association Publishing, 2019).

Dr. Cummings and Dr. Plakun had no disclosures.

Difficulties associated with treating borderline personality disorder (BPD) make for an uneasy alliance between patient and clinician. Deep-seated anxiety and trust issues often lead to patients skipping visits or raging at those who treat them, leaving clinicians frustrated and ready to give up or relying on a pill to make the patient better.

John M. Oldham, MD, MS, recalls one patient he almost lost, a woman who was struggling with aggressive behavior. Initially cooperative and punctual, the patient gradually became distrustful, grilling Dr. Oldham on his training and credentials. “As the questions continued, she slipped from being very cooperative to being enraged and attacking me,” said Dr. Oldham, Distinguished Emeritus Professor in the Menninger department of psychiatry and behavioral sciences at Baylor College in Houston.

Dr. Oldham eventually drew her back in by earning her trust. “There’s no magic to this,” he acknowledged. “You try to be as alert and informed and vigilant for anything you say that produces a negative or concerning reaction in the patient.”

This interactive approach to BPD treatment has been gaining traction in a profession that often looks to medications to alleviate specific symptoms. It’s so effective that it sometimes even surprises the patient, Dr. Oldham noted. “When you approach them like this, they can begin to settle down,” which was the case with the female patient he once treated.

About 1.4% of the U.S. population has BPD, according to the National Institute of Mental Health. Conceptualized by the late John G. Gunderson, MD, BPD initially was seen as floating on the borderline between psychosis and neurosis. Clinicians now understand that this isn’t the case. The patients need, as Dr. Gunderson once pointed out, constant vigilance because of attachment issues and childhood trauma.

A stable therapeutic alliance between patient and physician, sometimes in combination with evidence-based therapies, is a formula for success, some experts say.
 

A misunderstood condition

Although there is some degree of heritable risk, BPD patients are often the product of an invalidating environment in childhood. “As kids, we’re guided and nurtured by caring adults to provide models of reasonable, trustworthy behavior. If those role models are missing or just so inconsistent and unpredictable, the patient doesn’t end up with a sturdy self-image. Instead, they’re adrift, trying to figure out who will be helpful and be a meaningful, trustworthy companion and adviser,” Dr. Oldham said.

Emotional or affective instability and impulsivity, sometimes impulsive aggression, often characterize their condition. “Brain-imaging studies have revealed that certain nerve pathways that are necessary to regulate emotions are impoverished in patients with BPD,” Dr. Oldham said.

An analogy is a car going too fast, with a runaway engine that’s running too hot – and the brakes don’t work, he added.

“People think these patients are trying to create big drama, that they’re putting on a big show. That’s not accurate,” he continued. These patients don’t have the ability to stop the trigger that leads to their emotional storms. They also don’t have the ability to regulate themselves. “We may say, it’s a beautiful day outside, but I still have to go to work. Someone with BPD may say: It’s a beautiful day; I’m going to the beach,” Dr. Oldham explained.

A person with BPD might sound coherent when arguing with someone else. But their words are driven by the storm they can’t turn off.

This can lead to their own efforts to turn off the intensity. They might become self-injurious or push other people away. It’s one of the ironies of this condition because BPD patients desperately want to trust others but are scared to do so. “They look for any little signal – that someone else will hurt, disappoint, or leave them. Eventually their relationships unravel,” Dr. Oldham saod.

For some, suicide is sometimes a final solution.

Those traits make it difficult for a therapist to connect with a patient. “This is a very difficult group of people to treat and to establish treatment,” said Michael A. Cummings, MD, of the department of psychiatry at University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD patients tend to idealize people who are attempting to help them. When they become frustrated or disappointed in some way, “they then devalue the caregiver or the treatment and not infrequently, fall out of treatment,” Dr. Cummings said. It can be a very taxing experience, particularly for younger, less experienced therapists.
 

Medication only goes so far

Psychiatrists tend to look at BPD patients as receptor sites for molecules, assessing symptoms they can prescribe for, Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass., said in an interview.

Yet, BPD is not a molecular problem, principally. It’s an interpersonal disorder. When BPD is a co-occurring disorder, as is often the case, the depressive, anxiety, or other disorder can mask the BPD, he added, citing his 2018 paper on tensions in psychiatry between the biomedical and biopsychosocial models (Psychiatr Clin North Am. 2018 Jun;41[2]:237-48).

In one longitudinal study (J Pers Disord. 2005 Oct;19[5]:487-504), the presence of BPD strongly predicted the persistence of depression. BPD comorbid with depression is often a recipe for treatment-resistant depression, which results in higher costs, more utilization of resources, and higher suicide rates. Too often, psychiatrists diagnose the depression but miss the BPD. They keep trying molecular approaches with prescription drugs – even though it’s really the interpersonal issues of BPD that need to be addressed, said Dr. Plakun, who is a member of the Group for the Advancement of Psychiatry’s Psychotherapy Committee, and founder and past leader of the American Psychiatric Association’s Psychotherapy Caucus.

Medication can be helpful as a short-term adjunctive therapy. Long term, it’s not a sustainable approach, said Dr. Oldham. “If a patient is in a particularly stressful period, in the middle of a stormy breakup or having a depressive episode or talking about suicide, a time-limited course of an antidepressant may be helpful,” he said. They could also benefit from an anxiety-related drug or medication to help them sleep.

What you don’t want is for the patient to start relying on medications to help them feel better. The problem is, many are suffering so much that they’ll go to their primary care doctor and say, “I’m suffering from anxiety,” and get an antianxiety drug. Or they’re depressed or in pain and end up with a cocktail of medications. “And that’s just going to make matters worse,” Dr. Oldham said.
 

Psychotherapy as a first-line approach

APA practice guidelines and others worldwide have all come to the same conclusion about BPD. The primary or core treatment for this condition is psychotherapy, said Dr. Oldham, who chaired an APA committee that developed an evidence-based practice guideline for patients with BPD.

Psychotherapy keeps the patient from firing you, he asserted. “Because of the lack of trust, they push away. They’re very scared, and this fear also applies to therapist. The goal is to help the patient learn to trust you. To do that, you need to develop a strong therapeutic alliance.”

In crafting the APA’s practice guideline, Dr. Oldham and his colleagues studied a variety of approaches, including mentalization-based therapy (MBT) and dialectical behavior therapy (DBT), which was developed by Marsha Linehan, PhD. Since then, other approaches have demonstrated efficacy in randomized clinical trials, including schema-based therapy (SBT), cognitive-behavioral therapy (CBT), and transference-focused psychotherapy (TFP).

Those treatments might complement the broader goal of establishing a strong alliance with the patient, Dr. Oldham said. Manualized approaches can help prepackage a program that allows clinicians and patients to look at their problems in an objective, nonpejorative way, Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute at McLean Hospital in Belmont, Mass., said in an interview. DBT, for example, focuses on emotion dysregulation. MBT addresses how the patient sees themselves through others and their interactions with others. “It destigmatizes a problem as a clinical entity rather than an interpersonal problem between the patient and the clinician,” Dr. Choi-Kain said.

The choice of approach depends on several factors: the patient’s needs and preferences, and the therapist’s skills and experience, said Dr. Oldham. Some patients don’t do well with DBT because it involves a lot of homework and didactic work. Others do better with TFP because they want to understand what drives their behavior.

Dr. Cummings recalled how one of his patients used TFP to look inward and heal.

He first met the patient when she was in her early 30s. “She had made some progress, but I remember she was still struggling mightily with relationship issues and with identifying her role in relationships,” he said. The patient was becoming increasingly aware that she was going to end up alone and didn’t want that as an outcome.

Adapting to a TFP model, “she worked very hard trying to understand herself as she related to other people, understanding her own emotional volatility, and some of her proneness to behavioral problems,” Dr. Cummings said. The patient also had to learn how to negotiate her relationships to the point where she didn’t end up destroying them and alienating people.
 

Customizing the treatment

Physicians can choose from one of these manualized forms of treatment to see what’s appropriate and what works for the patient. “You can individualize the treatment, borrowing from these approaches and shaping it based on what your patient needs,” Dr. Oldham recommended.

Recently, the field of psychiatry has seen the benefits of combining manualized, evidence-based approaches with general psychiatric management (GPM), a method conceived by Dr. Gunderson. GPM “reflects a sensitive understanding of mental illness, offering ‘non attacking’ or collaborative work with the patient and a sensitive recognition of appropriate interventions or corrections to help the patient stay in treatment,” said Dr. Oldham.

It aims to conceptualize BPD in a clinically objective way, medicalizing the disorder so it’s something that the patient has, rather than something he or she is, explained Dr. Choi-Kain, who worked with Dr. Gunderson to train clinicians on using this approach. Using a framework that’s compatible with good medical practices, the clinician tries to define the problem together with the patient, “really assessing whether or not the treatment works, setting goals, managing safety, and trying to promote functioning, something we need to pay more attention to with BPD,” she said.

For these patients, the goal is to have positive, corrective experiences in the real world, reinforcing their hopes and what they’re capable of, and an interface with the world that makes them feel like contributors, she said.

Cycle of rupture and repair

Many people with BPD struggle with the desire to find and feel love, but also deal with their rage and hate. Hence, therapists must prepare themselves for the experience of sometimes being hated, said Dr. Plakun. The patient needs to feel they’re in a safe enough space to express those feelings, activating a cycle of “rupture and repair,” he continued.

The key in working with these patients is to avoid any language that will make them feel attacked or criticized, said Dr. Oldham.

A patient may get furious and say “I don’t know what you’re talking about. I didn’t say that.” When in truth, the psychiatrist is flat accurate about what the patient said. Instead of arguing with the patient, a physician can back up and say: “Help me understand what you’re feeling right now. What did I say that made you feel that you couldn’t trust me? Help me understand you. I may have made a mistake,” he advised.

Trust is a key ingredient in an alliance-based intervention for suicidal patients with BPD that Dr. Plakun has frequently written about. A bond he had with a deeply suicidal patient helped her overcome her grief and come to terms with an abusive childhood.

“She had a horrible history of abuse and had BPD and bipolar disorder. Even controlled with medications her life was still awful. She contemplated suicide relentlessly.” Working through her history of sexual abuse, the patient discovered that much of what she and clinicians thought of as a depressive illness was in fact intense grief about the irreparable damage that had taken place during childhood.

Through their work she was able to mourn, and her depression and BPD improved.

Developing a trusting relationship with the patient isn’t a starting point; it’s the goal, he emphasized.

“You don’t prescribe trust to someone. It’s earned.” Through the shared journey of therapy, as the patient suffers from inevitable injuries and ruptures and as the therapist reveals his or her imperfections, opportunities arise to nonjudgmentally examine and repair ruptures. This lead to gains in trust, he said.
 

It’s not just about genes

Many in the psychiatric and psychological communities tend to develop a very nihilistic view of BPD patients, observed Dr. Cummings. “They’ll say: ‘Oh, well, it’s hopeless. There’s nothing that can be done.’ That isn’t true,” he said.

Epidemiologic studies of these individuals have shown that many of these patients no longer meet the diagnostic criteria for BPD by the time they reach middle age. This means they get better over time, noted Dr. Cummings.

Dr. Plakun’s hope is that the field will evolve in a direction that recognizes the importance of psychosocial treatments like psychotherapy, in addition to biomedical treatments. The drive to medicate still exists, which can contribute to underdiagnosis and undertreatment of BPD, he said. “Although there are manualized, evidence-based treatments, few clinicians learn even one of these for BPD, not to mention those for other disorders.”

In 1996, Francis S. Collins, MD, PhD, the current director of the National Institutes of Health, predicted that the decoding of the human genome would transform treatment of medical and mental disorders [and] “that we would discover the ways in which genes equal disease,” said Dr. Plakun. What the science has since shown, is genes by environmental interaction lead to disease and health.

Nature and nurture both matter. “And I don’t think we’re paying enough attention to the nurture side,” Dr. Plakun said.

The solution is a return to a biopsychosocial model, recognizing that psychotherapy is an essential part of treatment of BPD and other conditions, and an essential clinician skill, he said.

Dr. Oldham is coeditor of the “Textbook of Personality Disorders”, 3rd edition (Washington: American Psychiatric Association Publishing, 2021).Dr. Choi-Kain is coeditor with Dr. Gunderson of “Applications of Good Psychiatric Management for Borderline Personality Disorder: A Practical Guide” (Washington: American Psychiatric Association Publishing, 2019).

Dr. Cummings and Dr. Plakun had no disclosures.

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

The arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) poses an increased risk of serious cardiac events such as heart attack or stroke, cancer, blood clots, and death, the Food and Drug Administration announced Sept 1.

Manufacturers of this drug along with other Janus kinase (JAK) inhibitors baricitinib (Olumiant) and upadacitinib (Rinvoq) must update their boxed warnings to include information about these health risks. The FDA made the determination after new study data from Pfizer, which manufacturers Xeljanz, found an association between a lower dose of Xeljanz and increased risk of blood clots and death.

“Recommendations for healthcare professionals will include consideration of the benefits and risks for the individual patient prior to initiating or continuing therapy,” the agency stated.

The FDA is limiting all approved uses of these three medications to patients who have not responded well to tumor necrosis factor (TNF) blockers to ensure their benefits outweigh their risks. Tofacitinib is indicated for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. Baricitinib and upadacitinib are approved only for RA. The FDA included baricitinib and upadacitinib in the warning because of the similar properties they share with tofacitinib, even though they haven’t been studied as extensively.

“We believe this update will bring important clarity for healthcare plans on the risk/benefit profile of Xeljanz, which is a medicine informed by more clinical data than any other JAK inhibitor,” Pfizer said in a statement.

Investigators for the ORAL Surveillance trial compared two doses of tofacitinib (5 mg twice daily and 10 mg twice daily) with TNF blockers in patients with rheumatoid arthritis who were aged 50 years or older with at least one additional cardiovascular risk factor.

For both dose regimens of tofacitinib, they found an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death compared with the TNF blocker regimen. In addition, rates of lung cancers and lymphomas were higher with tofacitinib. In trial data released earlier this year, Pfizer revealed that the tofacitinib group had a much higher incidence of adjudicated malignancies compared with the TNF blocker group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09).

Impact on clinical practice

Physicians treating patients who have rheumatoid arthritis with tofacitinib may initially decrease prescriptions following the FDA’s drug safety communication, said Daniel E. Furst, MD, professor of medicine (emeritus) at the University of California, Los Angeles, adjunct professor at the University of Washington, Seattle, and a research professor at the University of Florence (Italy) – particularly those with a principal mechanism of action slightly different from that of tofacitinib, he added.

“Tofacitinib is principally a JAK 1,3 inhibitor at usual concentrations, whereas upadacitinib and baricitinib are JAK 1,2 inhibitors. Thus, I speculate that the tofacitinib prescriptions will go down more than the upadacitinib and baricitinib prescriptions,” he said in an interview.

Some patients may also be worried about taking tofacitinib, particularly those with previous events or predisposing conditions, Dr. Furst noted.

“First and foremost, I think we need to actually look at the data in a publication rather than just an FDA statement before making huge changes in our practice,” he advised.

“I am looking forward to the data finally being published ... It’s interesting that the full data still isn’t really out there beyond the press releases and an abstract. I think there’s a lot more to learn about how these drugs work and who is really at risk for harmful events,” said Alexis R. Ogdie, MD, MSCE, associate professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia.

Pfizer’s data also may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

“I think many rheumatologists have already taken this information in, and begun to incorporate it into their discussions with their patients” since it has been over a year since the first public release of information about the ORAL Surveillance trial, said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego. “I don’t know that it will affect the approvals, but it will impact their labels.”

Wariness to prescribing tofacitinib may be lower for patients younger than those in the ORAL Surveillance trial without additional cardiovascular risk factors who are taking tofacitinib for non-RA indications, said gastroenterologist Miguel Regueiro, MD.

“The JAK inhibitor warning by the FDA is an important consideration for any prescriber or patient. The risk of cardiovascular disease and venous thromboembolism with this class of medicine appears higher in older rheumatoid arthritis patients with underlying cardiovascular disease. While the warning applies to all JAK inhibitors and likely the newer selective JAK inhibitors to come, we need to weigh the risk and benefit based on the indication for prescribing,” said Dr. Regueiro, chair of the Digestive Disease and Surgery Institute and of the department of gastroenterology, hepatology and nutrition at the Cleveland Clinic in Ohio.

“I do think that there will be a heightened awareness and wariness for older RA patients and for the prescribers. However, for inflammatory bowel disease (and other non-RA indications), it does not appear that the risk for cardiovascular disease and VTE are significantly increased. To that end, in my own practice, I still use tofacitinib for ulcerative colitis and will do the same for the selective JAK inhibitors to come for IBD. Of course, as with any medication, we need to have discussions with our patients, alert them to potential side effects and have an open line of communication for any questions or concerns.”

Gastroenterologist Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, thought that while patients with RA have many other treatment options besides JAK inhibitors, fewer options available to patients with IBD “may motivate the use of oral [sphingosine-1-phosphate receptor modulator] agents such as ozanimod, although IBD patients are younger and [have fewer] MACE risk factors than RA patients, so absolute risk is very small in the ulcerative colitis population.”

Pfizer’s data may be affecting FDA approvals of other JAK inhibitors. This past summer, AbbVie and Eli Lilly stated that the FDA’s ongoing assessment of the safety trial was delaying the agency’s decisions about expanding use of their respective drugs upadacitinib and baricitinib.

The agency’s decision corroborates an earlier 2019 warning about the increased risk of blood clots and of death in patients with ulcerative colitis taking 10 mg tofacitinib twice daily.

The FDA said that two other JAK inhibitors, ruxolitinib (Jakafi) and fedratinib (Inrebic), are not indicated for the treatment of arthritis and other inflammatory conditions, and so are not a part of the updates being required.

Baricitinib, abrocitinib, and upadacitinib are currently under FDA review for treating atopic dermatitis (AD); a topical formulation of the JAK1/2 inhibitor ruxolitinib is under review for treating AD. Reviews for all 4 have been extended. In September 2020, baricitinib was approved for treating moderate to severe AD in Europe, at a dose of 4 mg once a day, with recommendations that the dose can be reduced to 2 mg once a day when the disease is under control, and that the dose may need to be reduced in patients with impaired kidney function, those with an increased risk of infections, and those older than aged 75 years.

In an interview, Jacob Thyssen, MD, PhD, professor of dermatology at the University of Copenhagen, said that in the EU, there has been “extensive education” about cardiovascular risks with baricitinib “and it is my impression that payers and dermatologists in Europe are confident that it is safe to use in AD.” In addition, there has been an emphasis on the differences in cardiovascular risk factors between RA and AD patients, “given that the latter group is generally young and lean.” In the United States, he added, it will be interesting to see which doses of the JAK inhibitors will be approved for AD.

Dr. Thyssen disclosed that he is a speaker, advisory board member and/or investigator for Regeneron, Sanofi-Genzyme, Eli Lilly, Pfizer, LEO Pharma, AbbVie, and Almirall.
 

*This story was updated 9/3/21 and 9/6/2021.

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

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

Mark Nelson, PharmD, recalls the anguish when a major pharmacy benefit manager (PBM) moved all veteran patients with prostate cancer at his facility from an effective medication to a pricier alternative therapy. “All of these patients were stable on their therapy and were extremely distraught about their medications being changed,” said Dr. Nelson, CEO of Northwest Medical Specialties in Washington State. While there was no clinical reason to change the medication, “our oncologists had no choice other than to comply,” he said.

Niyazz/ThinkStock

It’s unclear why a PBM would switch to a more expensive medication that has no additional clinical benefit, he continued. “Why upset so many veterans? For what reason? We were not given a reason despite our very vocal protest.”

Angus B. Worthing, MD, sees these scenarios unfold every day in his rheumatology practice in the Washington, D.C., area. “In my clinic with 25 doctors, we have three full-time people that only handle PBMs,” he said in an interview. He and others in the medical community, as well as many states, have been pushing back on what they see as efforts by PBMs to raise drug prices and collect the profits at the expense of patients.

PCMA’s challenges against PBM law

The Pharmaceutical Care Management Association (PCMA), a trade group that represents PBMs, has sued at least a half dozen states on their ability to regulate PBMs. However, a landmark case in late 2020 (Pharmaceutical Care Management Association v. Rutledge) set a new precedent. Reversing a lower appeals court decision, the Supreme Court unanimously ruled in favor of allowing states to put in place fair regulation of these entities.

Dr. Worthing and others hope that the medical community and states can leverage this ruling in another lawsuit PCMA brought against North Dakota (PCMA v. Wehbi). PCMA filed this lawsuit in 2017, which challenges two statutes on PBM regulation. The group has issued similar legal challenges in Maine, the District of Columbia, Iowa, Oklahoma, and Arkansas with the Rutledge case.

“PBMs have become massive profit centers while (ironically) increasing patients’ out-of-pocket costs, interfering with doctor-patient relationships, and impairing patient access to appropriate treatment,” according to an amicus brief filed by The Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American Pharmacies, supporting North Dakota in the Wehbi case.

This is to ensure the case represents the voices of physicians, patients, nurses, and other stakeholders, and underscores PBM abuses, said Dr. Worthing, vice president of ATAP. He also serves as the American College of Rheumatology’s representative on ATAP’s Executive Committee.

PCMA did not respond to requests for comment. Its CEO and president, J.C. Scott, emphasizes that PBMs have a long track record of reducing drug costs for patients and plan sponsors. In 2021, PCMA released 21 policy solutions, a set of industry principles and a three-part policy platform, all with an aim to bring down costs and increase access to pharmaceutical care, according to the organization.

PCMA estimates that the strategies in its platform (updating Medicare Part D, accelerating value-based care, and eliminating anticompetitive ‘pay for delay’ agreements) would save the federal government a maximum of $398.7 billion over 10 years.

According to Wendy Hemmen, senior director with Texas Oncology in Dallas, PBMs do their own unique calculations to arrive at their cost reductions. “Essentially in a PBM, they use things that make their story. Numbers reported to plan sponsors and to the public are not audited and are usually in terms of percentages or a per member per month. Data points are moved around, dropped, or reclassified to make the story that the PBM needs to tell,” Ms. Hemmen said.


 

Amicus briefs dispute ERISA connection

North Dakota legislation prohibits PBMs from charging copays to patients that exceed the cost of a drug. It also prohibits gag clause provisions that restrict what pharmacists may discuss with patients. PBMs may charge fees based on performance metrics, but they must use nationally recognized metrics. Fees must be disclosed at the point of sale.

In its legal challenges, PCMA has asserted that state laws violate the preemption clause in the Employee Retirement Income Security Act (ERISA). “Federal preemption allows employers flexibility to administer innovative benefit plans in an environment of increasing health care costs. The court’s decision in Rutledge v. PCMA will either uphold or threaten these federal protections,” PCMA asserted in a statement issued in March 2020.

ATAP’s amicus brief, and another one filed by 34 attorneys general that supports the North Dakota statute to regulate PBMs, counter that this isn’t the case.

“First, PBM regulation (in its common and standard form) does not reference ERISA itself. These laws leave all plans on equal footing; they do not single out ERISA plans for preferred or disfavored coverage, and they do not change the playing field for ERISA plans alone ... Second, PBM regulation does not have any prohibited connection with ERISA plans,” noted authors in the ATAP brief.

PCMA has also included Medicare preemption in its arguments against PBM regulation. This is meritless, wrote the state attorneys general. “Medicare preempts state laws only if a Medicare ‘standard’ particularly addresses the subject of state regulation. Because the challenged North Dakota laws do not dictate plan benefits or conflict with a Medicare standard, they are not preempted.”

The auctioning of medications

PBMs in theory could use their market power to drive down costs by extracting discounts from drug makers and pharmacies. In reality, they retain any price concessions and discounts for themselves, ATAP’s brief continued.

A system that PBMs have put into place, called step therapy, is essentially an auction for the preferred spot that will be authorized and covered, Dr. Worthing explained.

PBMs create formularies through this auction. The highest rebate to the PBM earns the top spot in the auction and becomes the preferred drug. “That highest bid gets paid for by passing the cost along to patients and insurance plans, and PBMs pocket the profits. This provides an incentive for pharmaceutical manufacturers to raise prices,” he said.

Dr. Worthing has seen these practices trickle down and affect his patients. “Frequently, the medication I prescribe based on what’s best for the patient based on their disease activity, values, and medical history is often not covered because a different drug or portfolio of drugs has earned the top spot in step therapy. This is an extremely frustrating and cumbersome process that not only delays access to treatments but also provides an incentive for higher drug prices,” he said.

There are other ways in which PBMs get in the way of care, said Ms. Hemmen, whose facility serves complex-care oncology patients.

“PBMs force scripts out of higher-quality pharmacies that preserve unfragmented care. They incentivize plan sponsors to put programs into place that take away patient choice, fragment care, and drive scripts to their own owned pharmacies,” she said.
 

Rutledge case sets precedent

In the Rutledge case, PCMA had challenged an Arkansas law that forbid PBMs from paying local pharmacies at a lower rate than what the pharmacies were reimbursed to fill prescriptions. Although the 8th Circuit Court of Appeals agreed with PCMA, the Supreme Court ruled in favor of Arkansas in late 2020.

The appeals court also backed PCMA in PCMA v. Wehbi. However, the Supreme Court vacated this decision and remanded it back to the appeals court, asking for a reconsideration in wake of the outcome in Rutledge v. PCMA.

PCMA has argued that Rutledge was a narrow decision, limited to state laws that regulate PBM reimbursements, and that Rutledge has no bearing on North Dakota law.

While it’s unfortunate that PCMA is trying to delay implementation of sensible regulations, “a lot of us are happy that this issue is coming to light,” Dr. Worthing said. “As a rheumatologist and health policy advocate, exposing drug middlemen is the most important bipartisan issue in the country today because it gets at the core of making sure that sick people get access to the medications they need and reducing the budget of insurance carriers, hospitals, and the federal budget.”

The ATAP brief noted that 28 state attorneys general have filed suit against PBMs, “securing settlements compelling PBMs to correct deceptive trade practices.”

Many people at the state and local level were waiting for the Supreme Court to decide on Rutledge before enacting legislation and sensible regulations, and now they can go ahead and do it, said Dr. Worthing. “I expect to see this across the country as states look at budgets, and as patients bring personal stories to light. We look forward to states passing these kinds of laws to regulate PBMs.”

The ACR doesn’t anticipate a ruling in the Wehbi case until the spring of 2022.

Recent laws passed around PBMs and the pharmacy benefit are a good first step in holding PBMs accountable for quality of care and honoring patient choice, Ms. Hemmen said. The laws also begin to address the fiscal manipulations PBMs use to gain advantage and direct scripts to their own coffers, she added. However, this may not have enough teeth. “These state laws are coming from a provider perspective, and they don’t anticipate what PBMs will do in response. The PBMs are going to work around it.”

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

COVID-19’s ever-changing trajectory has led to a notable rise in anxiety-related disorders in the United States. The average share of U.S. adults reporting symptoms of anxiety and or depressive disorder rose from 11% in 2019 to more than 41% in January 2021, according to a report from the Kaiser Family Foundation.

With the arrival of vaccines, Elspeth Cameron Ritchie, MD, MPH, chair of psychiatry at Medstar Washington (D.C.) Hospital Center, has noticed a shift in patients’ fears and concerns. In an interview, she explained how anxiety in patients has evolved along with the pandemic. She also offered strategies for gaining control, engaging with community, and managing anxiety.
 

Question: When you see patients at this point in the pandemic, what do you ask them?

Answer: I ask them how the pandemic has affected them. Responses have changed over time. In the beginning, I saw a lot of fear, dread of the unknown, a lot of frustration about being in lockdown. As the vaccines have come in and taken hold, there is both a sense of relief, but still a lot of anxiety. Part of that is we’re getting different messages and very much changing messages over time. One day, we were still in a lockdown mode, and then a week later, we were told: If you’re vaccinated, take off your masks and do whatever you want to do. Then there’s the people who are unvaccinated, and we’re also seeing the Delta variant taking hold in the rest of the world. There’s a lot of anxiety, fear, and some depression, although that’s gotten better with the vaccine.

Q: How do we distinguish between reasonable or rational anxiety and excessive or irrational anxiety?

A: There’s not a bright line between them. What’s rational for one person is not rational for another. What we’ve seen is a spectrum. A rational anxiety is: “I’m not ready to go to a party.” Irrational represents all these crazy theories that are made up, such as putting a microchip into your arm with the vaccine so that the government can track you.

Q: How do you talk to these people thinking irrational thoughts?

A: You must listen to them and not just shut them down. Work with them. Many people with irrational thoughts, or believe in conspiracy theories, may not want to go near a psychiatrist. But there’s also the patients in the psychiatric ward who believe COVID doesn’t exist and there’s government plots. Like any other delusional material, we work with this by talking to these patients and using medication as appropriate.

Q: Do you support prescribing medication for those patients who continue to experience anxiety that is irrational?

A: Patients based in inpatient psychiatry are usually delusional. The medication we usually prescribe for these patients is antipsychotics. If it’s an outpatient who’s anxious about COVID, but has rational anxiety, we usually use antidepressants or antianxiety agents such as Zoloft, Paxil, or Lexapro.

Q: What other strategies can psychiatrists share with patients?

A: What I’ve seen throughout COVID is often an overwhelming sense of dread and inability to control the situation. I tell patients to do things they can control. You can go out and get exercise. Especially during the winter, I recommend that people take a walk and get some sunshine.

It also helps with anxiety to reach out and help someone else. Is there a neighbor you’re concerned about? By and large, this is something many communities have done well. The challenge is we’ve been avoiding each other physically for a long time. So, some of the standard ways of helping each other out, like volunteering at a food bank, have been a little problematic. But there are ways to have minimal people on staff to reduce exposure.

One thing I recommend with any type of anxiety is to learn how to control your breathing. Take breaths through the nose several times a day and teach yourself how to slow down. Another thing that helps many people is contact with animals – especially horses, dogs, and cats. You may not be able to adopt an animal, but you could work at a rescue shelter or other facilities. People can benefit from the nonverbal cues of an animal. A friend of mine got a shelter cat. It sleeps with her and licks her when she feels anxious.

Meditation and yoga are also useful. This is not for everyone, but it’s a way to turn down the level of “buzz” or anxiety. Don’t overdo it on caffeine or other things that increase anxiety. I would stay away from illicit drugs, as they increase anxiety.
 

Q: What do you say to patients to give them a sense of hope?

A: A lot of people aren’t ready to return to normal; they want to keep the social isolation, the masks, the working from home. We need to show patients what they have control over to minimize their own risk. For example, if they want to wear a mask, then they should wear one. Patients also really like the option of telehealth appointments.

Another way to cope is to identify what’s better about the way things are now and concentrate on those improvements. Here in Maryland, the traffic is so much better in the morning than it once was. There are things I don’t miss, like going to the airport and waiting 5 hours for a flight.
 

Q: What advice can you give psychiatrists who are experiencing anxiety?

A: We must manage our own anxiety so we can help our patients. Strategies I’ve mentioned are also helpful to psychiatrists or other health care professionals (such as) taking a walk, getting exercise, controlling what you can control. For me, it’s getting dressed, going to work, seeing patients. Having a daily structure, a routine, is important. Many people struggled with this at first. They were working from home and didn’t get much done; they did too much videogaming. It helps to set regular appointments if you’re working from home.

Pre-COVID, many of us got a lot out of our professional meetings. We saw friends there. Now they’re either canceled or we’re doing them virtually, which isn’t the same thing. I think our profession could do a better job of reaching out to each other. We’re used to seeing each other once or twice a year at conventions. I’ve since found it hard to reach out to my colleagues via email. And everyone is tired of Zoom.

If they’re local, ask them to do a safe outdoor activity, a happy hour, a walk. If they’re not, maybe engage with them through a postcard or a phone call.

My colleagues and I go for walks at lunch. There’s a fishpond nearby and we talk to the fish and get a little silly. We sometimes take fish nets with us. People ask what the fish nets are for and we’ll say, “we’re chasing COVID away.”

Dr. Ritchie reported no conflicts of interest.

A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.

In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.

The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.

“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.

The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.

Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.

Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.

Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
 

Two cohorts, alternating regimens

The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.

“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.

For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.

Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.

Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.

In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
 

SCT alone was not studied

The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.

“We can’t say definitively that patients without SCT would respond to a stimulant. That’s a subject for future study,” he said.

Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.

The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
 

SCT as a ‘flavor’ of ADHD

The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.

Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.

“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.

James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.

The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.

A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.

In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.

The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.

“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.

The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.

Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.

Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.

Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
 

Two cohorts, alternating regimens

The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.

“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.

For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.

Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.

Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.

In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
 

SCT alone was not studied

The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.

“We can’t say definitively that patients without SCT would respond to a stimulant. That’s a subject for future study,” he said.

Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.

The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
 

SCT as a ‘flavor’ of ADHD

The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.

Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.

“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.

James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.

The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.

A stimulant used in patients with attention-deficit/hyperactivity disorder might prove useful for other comorbid symptoms, results of a randomized, crossover trial suggest.

In the trial, the investigators reported that lisdexamfetamine (Vyvanse) reduced self-reported symptoms of sluggish cognitive tempo (SCT) by 30%, in addition to lowering ADHD symptoms by more than 40%.

The drug also corrected deficits in executive brain function. Patients had fewer episodes of procrastination, were better able to prioritize, and showed improvements in keeping things in mind.

“These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD,” Lenard A. Adler, MD, the lead author, said in a press release. The results were published June 29, 2021, in the Journal of Clinical Psychiatry.

The trial is groundbreaking because it is the first treatment study for ADHD with SCT in adults, Dr. Adler, director of the adult ADHD program at New York University Langone Health, said in an interview. He said that Russell A. Barkley, PhD, a clinical professor of psychiatry at Virginia Commonwealth University, Richmond, defines SCT as having nine cardinal symptoms: prone to daydreaming, easy boredom, trouble staying awake, feeling foggy, spaciness, lethargy, underachieving, less energy, and not processing information quickly or accurately.

Dr. Barkley, who studied more than 1,200 individuals with SCT, discovered that nearly half also had ADHD, Dr. Adler said. Those with the comorbid symptoms also had more impairment.

Whether or not the symptom set of SCT is a distinct disorder or a cotraveling symptom set that goes along with ADHD has been an area of investigation, said Dr. Adler, also a professor in the departments of psychiatry and child and adolescent psychiatry at New York University. Other known comorbid symptoms include executive function deficits and trouble with emotional control.

Stimulants to date have only shown success in children, as far as improving SCT. The goal of this study was to determine the efficacy of lisdexamfetamine on the nature and severity of ADHD symptoms and SCT behavioral indicators in adults with ADHD and SCT.
 

Two cohorts, alternating regimens

The investigators enrolled 38 adults with DSM-5 ADHD and SCT. Patients were recruited from two academic centers, New York University and the Icahn School of Medicine at Mount Sinai. The randomized 10-week crossover trial included two double-blind treatment periods, each 4 weeks long, with an intervening 2-week, single-blind placebo washout period.

“In crossover design, patients act as their own control, because they receive both treatments,” Dr. Adler said. Recruiting a smaller number of subjects helps to achieve significance in results.

For the first 4 weeks, participants received daily doses of either lisdexamfetamine (30-70 mg/day; mean, 59.1 mg/day) or a placebo sugar pill (mean, 66.6 mg/day). Researchers used standardized tests for SCT signs and symptoms, ADHD, and other measures of brain function to track psychiatric health on a weekly basis. After a month, the two cohorts switched regimens – those taking the placebo started the daily doses of lisdexamfetamine, and the other half stopped the drug and started taking the placebo.

Primary outcomes included the ADHD Rating Scale and Barkley Adult ADHD Rating Scale-IV SCT subscale.

Compared with placebo, adults with ADHD and comorbid SCT showed significant improvement after taking lisdexamfetamine in ratings of SCT and total ADHD symptoms. This was also true of other comorbid symptoms, such as executive function deficits.

In the crossover design, patients who received the drug first hadn’t gone fully back to baseline by the time the investigators crossed them over into the placebo group. “So, we couldn’t combine the two treatment epochs,” Dr. Adler said. However, the effect of the drug versus placebo was comparable in both study arms.
 

SCT alone was not studied

The trial had some limitations, mainly that it was an initial study with a modest sample size, Dr. Adler said. It also did not examine SCT alone, “so we can’t really say whether the stimulant medicine would improve SCT in patients who don’t have ADHD. What’s notable is when you look at how much of the improvement in SCT was due to improvement in ADHD, it was just 25%.” This means the effects occurring on SCT symptoms were not solely caused by effects on ADHD.

“We can’t say definitively that patients without SCT would respond to a stimulant. That’s a subject for future study,” he said.

Dr. Adler would like to see treatment studies of adults with ADHD and SCT in a larger sample, potentially with other stimulants. In addition, future trials could examine the effects of stimulants on adults with SCT that do not have ADHD.

The results of this trial underscore the importance of evaluating adults with ADHD for comorbid symptoms, such as executive function and emotional control, he continued. “Impairing SCT symptoms may very well fall under that umbrella,” Dr. Adler said. “If you don’t identify them, you can’t track them in terms of treatment.”
 

SCT as a ‘flavor’ of ADHD

The outcome of this study demonstrates that lisdexamfetamine significantly improves both ADHD symptoms and SCT symptoms, said David W. Goodman MD, LFAPA, an assistant professor in the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore.

Dr. Goodman, who was not involved in the study, agreed that clinicians should be aware of SCT when assessing adults with ADHD and conceptualize SCT as a “flavor” of ADHD. “SCT is not widely recognized by clinicians outside of the research arena but will likely become an important characteristic of ADHD presentation,” he said in an interview.

“Future studies in adult ADHD should further clarify the prevalence of SCT in the ADHD population and address more specific effective treatment options,” he said.

James M. Swanson, PhD, who also was not involved with the study, agreed in an interview that it documents the clear short-term benefit of stimulants on symptoms of SCT. The study “may be very timely, since adults who were affected by COVID-19 often have residual sequelae manifested as ‘brain fog,’ which resemble SCT,” said Dr. Swanson, professor of pediatrics at the University of California, Irvine.

The study was funded by Takeda Pharmaceutical, manufacturer of lisdexamfetamine. Dr. Adler has received grant/research support and has served as a consultant from Shire/Takeda and other companies. Dr. Goodman is a scientific consultant to Takeda and other pharmaceutical companies in the ADHD arena. Dr. Swanson had no disclosures.

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Courtesy Dr. Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Two widely used rotavirus vaccines performed comparably in a meta-analysis, reducing risk of rotavirus gastroenteritis (RVGE) by more than 60% in young children. While the findings evidence a high protection level and low-risk safety profile, investigators of the study called for additional head-to-head comparisons to assess risks and benefits.

RVGE, which accounts for 28.8% of all deaths from diarrhea worldwide, is the leading cause of diarrhea in children under age 5. More than 100 countries include rotavirus vaccines in their immunization programs. Among six types of vaccines currently in use, two live-attenuated oral vaccines: the two-dose monovalent Rotarix (RV1) and three-dose pentavalent RotaTeq (RV5]) are in use worldwide.

Not much is known about their interchangeability, although a previous meta-analysis reported similarities in effectiveness of Rotarix (83%), RotaTeq (85%), and Rotarix and RotaTeq mixed series (86%) in low-mortality countries. RVGE morbidity and mortality have declined since the introduction of these vaccines, but concerns persist about their safety, Zi-Wei Sun, MSc, of Nanjing (China) Medical University and colleagues wrote in JAMA Pediatrics.

Their systematic review and meta-analysis of randomized clinical trials, case-control, and cohort studies compared benefit, risk, and immunogenicity of these vaccines and their effectiveness in reducing RVGE. Combing through databases Embase, PubMed, the Cochrane Library, and Web of Science using search terms “rotavirus” and “vaccine,” they chose 121 randomized clinical trials and cohort and case-control studies that included more than 100 children younger than 5 years. Thirty-eight of the randomized clinical trials had related data that examined the vaccines’ protection against RVGE hospitalization, study coauthor Hemant Goyal, MD, FACP, explained in an interview.

All of the studies reported on the safety and effectiveness or immunogenicity of rotavirus vaccines. The investigators used a random-effects model to calculate relative risks, odds ratios, risk differences, and 95% confidence intervals. They also stratified studies by economic development of countries, given that vaccine efficacy is often higher in middle- and high-income countries, compared with low-income countries. An adjusted indirect treatment comparison evaluated differences in vaccine protection among different subgroups, adopting P < .05 as the level of statistical significance.

Primary outcomes included RVGE, severe RVGE, and RVGE hospitalization and safety-associated outcomes such as serious adverse events, intussusception, and mortality.

Rotarix and RotaTeq reduced RVGE in children younger than 5 years by 68.4% and 63.6%, respectively. Dr. Goyal and colleagues confirmed these results in case-control studies (65.3% and 72.8%, respectively). Both vaccines significantly reduced RVGE and RVGE hospitalization risk and demonstrated higher protection against severe RVGE. In adjusted indirect comparisons, the two vaccines showed no significant differences in protection. They also found a positive correlation between immunogenicity and vaccine protection.

“RotaTeq seems to show lower protection in low-income countries, compared with Rotarix, but these estimates should be interpreted with caution as there was only one study for low-income countries and indirect comparison," said Dr. Goyal, a second-year gastroenterology fellow at the Wright Center for Graduate Medical Education, Scranton, Penn.

None of the vaccines demonstrated risk of serious adverse events. However, an Australian study in 2013 did report a small increased risk of intussusception after RV1 and RV5 vaccination. “Therefore, continuous surveillance of the benefits and adverse effects of rotavirus vaccines is required after vaccination,” the investigators noted.

Analyzing newer, less widely distributed vaccines, Rotavac, Rotasiil, and Lanzhou lamb rotavirus vaccine also showed moderate effectiveness in reducing RVGE risk.
 

Immunity wanes over time

Protection against rotavirus diseases seems to wane over time after vaccination. “Although our results indicated that rotavirus vaccines can provide substantial protection against RVGE during the first 2 years of life, more studies following up the vaccine efficacy for more than 2 years are required,” the investigators recommended.

Declining vaccine-induced antibodies, RVGE-acquired protection from the vaccine’s indirect effects, or exposure to unvaccinated populations may explain gradual loss of immunity.

Monitoring of rotavirus strains following vaccination should take place “to avoid population-based selection of so-called escape strains, especially fully heterotypic strains and new strains, because of the long-term pressure of vaccine immunity,” they recommended.

The findings emphasize the importance of introducing vaccines worldwide to reduce infection, summarized Dr. Goyal and colleagues. Given how challenging it is to treat the wide varieties of rotavirus, “It encouraging that RV1 and RV5 work well against heterotypic strains,” they added. Similar performance between Rotarix and RotaTeq also makes it easier for clinicians to choose a vaccine.

Increasing the availability and efficacy of these vaccines in low-income countries with high mortality rates is a high priority,

David I. Bernstein, MD, MA, wrote in a related editorial: “A clear gradient in vaccine protections was noted by country income level in the analysis presented, and much effort has been spent to understand this discrepancy.”

Overall, the study confirmed the efficacy of these two vaccines and their equivalence, noted Dr. Bernstein.

The study’s literature search process had some limitations. “Especially in stratified analyses, sparse data in some subgroups limit generalizability. ... The most accurate method, head-to-head comparisons, to evaluate the comparative efficacy of different vaccines is required in further studies,” the study investigators wrote.

Such studies would directly compare Rotarix and RotaTeq from multiple perspectives: efficacy, cost-effectiveness, strain-specific protection, the duration of protection, safety, and immunogenicity, said Dr. Goyal.

*This story was updated on May 24, 2021.

Most patients will not make a full recovery from attention-deficit/hyperactivity disorder in adulthood. This late-breaking finding headlined the World Congress on ADHD – Virtual Event. Held under the specter of SARS-CoV-2, the virtual program delved into the latest research on ADHD pathophysiology, imaging, genetics, and issues on medical and psychiatric comorbidities.

However, one of the conference’s highlights was a piece of unpublished work on remission patterns by Margaret Sibley, PhD, associate professor of psychiatry and behavioral sciences at the University of Washington, Seattle.

Anywhere from 65% to 67% of young adults have desistant ADHD – meaning that they no longer meet criteria. Only up to 23% experience full remission, said Dr. Sibley during a special late-breaking session. All research on remission and most on persistence consider just one endpoint – nothing is known about longitudinal fluctuations in remission status over time.

Her research sought to answer a key question: Do people fully recover from ADHD?

Using data from the Multimodal Treatment of Attention Deficit Hyperactivity Disorder (MTA) Study, Dr. Sibley prospectively followed over 550 children aged 7-9.9 years with DSM-IV combined-type ADHD over 14 years, until 16 years after baseline, using interviews, questionnaires, and rating scales to track symptoms, impairment, and treatment history.

The researchers also came up with a “winning” definition for full remission, which included three or fewer symptoms of inattention and hyperactive impulsivity from all available reporters, negligible ADHD-related impairment based on preestablished impairment rating thresholds, and discontinuation of medication and behavioral treatments for at least a month prior to assessment.

In the longitudinal results, Dr. Sibley and colleagues reported that the majority (63.8%) demonstrated fluctuations between full or partial remission and ADHD recurrence. Only 9.1% sustained full remission over the course of the study. From these findings, ADHD appears to be a fluctuating disorder. While it continues into adulthood for most people, there may also be periods of remission or “good functioning.”

Most desistance from ADHD represents partial, not full remission, said Dr. Sibley. The results also show that recovery by young adulthood is very rare – most patients with remitted ADHD have recurrences.

These are important findings, said Luis Augusto Rohde, MD, PhD, who co-organized the congress’ scientific program committee with Manfred Gerlach, PhD. It shows that a patient’s ADHD may sometimes be more definitive and at other times, no clear phenotype expression emerges.

COVID’s influence

COVID-19 greatly influenced this year’s program’s agenda, said Dr. Rohde. “There’s a lot of evidence that ADHD patients are at greater risk for COVID-19, which is not a surprise,” said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry in Porto Alegre, Brazil.

ADHD is a combination of genetic liability and the demands of the environment. “In times like we are living in right now, if you have increasing demands and stress from the environment, you trigger symptoms in those even with lower genetic liability,” he said. ADHD’s pathophysiology involves attention and executive deficit disorder, which means these patients may not follow strategies to avoid infection.

This shows why COVID was so important to the discussion of program topics, he said.

Two experts addressed this subject head on in a point-counterpoint debate, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?” James Swanson, PhD, professor of pediatrics at the University of California, Irvine, projected that biological coeffects of COVID-19 will lead to ADHD symptoms, generating potentially 5 million new ADHD cases.

David Coghill, MBChB, MD, a professor of child adolescent mental health at the University of Melbourne, countered that not enough data are available yet to back this hypothesis. “Researchers are asking this question, but clinically we don’t know enough.”

While the COVID virus might not directly lead to more cases of ADHD, this could potentially happen indirectly through environmental agents of the pandemic, offered Dr. Rohde. “We’ve clearly seen in our appointments with families and children that they can’t face the amount of schooling and working from home,” he said.

 

Novel treatments

The conference also addressed new treatments and nonpharmacologic interventions in the pipeline for ADHD. “We had a chance to discuss the possibilities about new medications that address the problems in the current market and to show the potential usefulness of nonpharma interventions such as neuromodulations in ADHD,” said Dr. Rohde. Speakers discussed strategies ranging from family-based mindfulness interventions to oligoantigenic diets in children with ADHD.

Other researchers are looking at novel digital tools to help patients manage and treat ADHD. Adherence is a major problem in chronic disorders like hypertension, diabetes, epilepsy, and ADHD, said Dr. Rohde. “Due to ADHD symptomatology including inattention, novelty-seeking, executive deficits, and difficulties in persistence, it is an even bigger problem in this disorder.”

Speakers at the “ADHD in the digital age – From pitfalls to challenges” session discussed video game strategies to reduce ADHD impairment, and a texting app to improve adherence. Dr. Rohde talked about the FOCUS app, which fosters collaboration between patients, families, and caregivers to efficiently track ADHD symptoms and help customize treatments.

Studies suggest these tools can significantly improve adherence. They’re also well accepted by patients, said Dr. Rohde. While the expectations are high, digital interventions are not a substitute for medication. “More data is needed to include them as part of the clinical interventions for ADHD.”

Dr. Sibley received book royalties from Guilford Press. Dr. Rohde has received grant or research support from, served as a consultant to, and served on the speakers’ bureau of Bial, Medice, Novartis/Sandoz, Pfizer, and Shire/Takeda in the last 3 years. The ADHD and Juvenile Bipolar Disorder Outpatient Programs chaired by Dr. Rohde have received unrestricted educational and research support from the following pharmaceutical companies in the last 3 years: Novartis/Sandoz and Shire/Takeda. Dr. Rohde has received authorship royalties from Oxford Press and ArtMed and travel grants from Shire to take part in the 2018 APA annual meeting. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth of infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). He has received travel support from Medice and has done legal review for NLS. Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to the session debate on the pandemic.

Most patients will not make a full recovery from attention-deficit/hyperactivity disorder in adulthood. This late-breaking finding headlined the World Congress on ADHD – Virtual Event. Held under the specter of SARS-CoV-2, the virtual program delved into the latest research on ADHD pathophysiology, imaging, genetics, and issues on medical and psychiatric comorbidities.

However, one of the conference’s highlights was a piece of unpublished work on remission patterns by Margaret Sibley, PhD, associate professor of psychiatry and behavioral sciences at the University of Washington, Seattle.

Anywhere from 65% to 67% of young adults have desistant ADHD – meaning that they no longer meet criteria. Only up to 23% experience full remission, said Dr. Sibley during a special late-breaking session. All research on remission and most on persistence consider just one endpoint – nothing is known about longitudinal fluctuations in remission status over time.

Her research sought to answer a key question: Do people fully recover from ADHD?

Using data from the Multimodal Treatment of Attention Deficit Hyperactivity Disorder (MTA) Study, Dr. Sibley prospectively followed over 550 children aged 7-9.9 years with DSM-IV combined-type ADHD over 14 years, until 16 years after baseline, using interviews, questionnaires, and rating scales to track symptoms, impairment, and treatment history.

The researchers also came up with a “winning” definition for full remission, which included three or fewer symptoms of inattention and hyperactive impulsivity from all available reporters, negligible ADHD-related impairment based on preestablished impairment rating thresholds, and discontinuation of medication and behavioral treatments for at least a month prior to assessment.

In the longitudinal results, Dr. Sibley and colleagues reported that the majority (63.8%) demonstrated fluctuations between full or partial remission and ADHD recurrence. Only 9.1% sustained full remission over the course of the study. From these findings, ADHD appears to be a fluctuating disorder. While it continues into adulthood for most people, there may also be periods of remission or “good functioning.”

Most desistance from ADHD represents partial, not full remission, said Dr. Sibley. The results also show that recovery by young adulthood is very rare – most patients with remitted ADHD have recurrences.

These are important findings, said Luis Augusto Rohde, MD, PhD, who co-organized the congress’ scientific program committee with Manfred Gerlach, PhD. It shows that a patient’s ADHD may sometimes be more definitive and at other times, no clear phenotype expression emerges.

COVID’s influence

COVID-19 greatly influenced this year’s program’s agenda, said Dr. Rohde. “There’s a lot of evidence that ADHD patients are at greater risk for COVID-19, which is not a surprise,” said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry in Porto Alegre, Brazil.

ADHD is a combination of genetic liability and the demands of the environment. “In times like we are living in right now, if you have increasing demands and stress from the environment, you trigger symptoms in those even with lower genetic liability,” he said. ADHD’s pathophysiology involves attention and executive deficit disorder, which means these patients may not follow strategies to avoid infection.

This shows why COVID was so important to the discussion of program topics, he said.

Two experts addressed this subject head on in a point-counterpoint debate, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?” James Swanson, PhD, professor of pediatrics at the University of California, Irvine, projected that biological coeffects of COVID-19 will lead to ADHD symptoms, generating potentially 5 million new ADHD cases.

David Coghill, MBChB, MD, a professor of child adolescent mental health at the University of Melbourne, countered that not enough data are available yet to back this hypothesis. “Researchers are asking this question, but clinically we don’t know enough.”

While the COVID virus might not directly lead to more cases of ADHD, this could potentially happen indirectly through environmental agents of the pandemic, offered Dr. Rohde. “We’ve clearly seen in our appointments with families and children that they can’t face the amount of schooling and working from home,” he said.

 

Novel treatments

The conference also addressed new treatments and nonpharmacologic interventions in the pipeline for ADHD. “We had a chance to discuss the possibilities about new medications that address the problems in the current market and to show the potential usefulness of nonpharma interventions such as neuromodulations in ADHD,” said Dr. Rohde. Speakers discussed strategies ranging from family-based mindfulness interventions to oligoantigenic diets in children with ADHD.

Other researchers are looking at novel digital tools to help patients manage and treat ADHD. Adherence is a major problem in chronic disorders like hypertension, diabetes, epilepsy, and ADHD, said Dr. Rohde. “Due to ADHD symptomatology including inattention, novelty-seeking, executive deficits, and difficulties in persistence, it is an even bigger problem in this disorder.”

Speakers at the “ADHD in the digital age – From pitfalls to challenges” session discussed video game strategies to reduce ADHD impairment, and a texting app to improve adherence. Dr. Rohde talked about the FOCUS app, which fosters collaboration between patients, families, and caregivers to efficiently track ADHD symptoms and help customize treatments.

Studies suggest these tools can significantly improve adherence. They’re also well accepted by patients, said Dr. Rohde. While the expectations are high, digital interventions are not a substitute for medication. “More data is needed to include them as part of the clinical interventions for ADHD.”

Dr. Sibley received book royalties from Guilford Press. Dr. Rohde has received grant or research support from, served as a consultant to, and served on the speakers’ bureau of Bial, Medice, Novartis/Sandoz, Pfizer, and Shire/Takeda in the last 3 years. The ADHD and Juvenile Bipolar Disorder Outpatient Programs chaired by Dr. Rohde have received unrestricted educational and research support from the following pharmaceutical companies in the last 3 years: Novartis/Sandoz and Shire/Takeda. Dr. Rohde has received authorship royalties from Oxford Press and ArtMed and travel grants from Shire to take part in the 2018 APA annual meeting. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth of infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). He has received travel support from Medice and has done legal review for NLS. Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to the session debate on the pandemic.

Most patients will not make a full recovery from attention-deficit/hyperactivity disorder in adulthood. This late-breaking finding headlined the World Congress on ADHD – Virtual Event. Held under the specter of SARS-CoV-2, the virtual program delved into the latest research on ADHD pathophysiology, imaging, genetics, and issues on medical and psychiatric comorbidities.

However, one of the conference’s highlights was a piece of unpublished work on remission patterns by Margaret Sibley, PhD, associate professor of psychiatry and behavioral sciences at the University of Washington, Seattle.

Anywhere from 65% to 67% of young adults have desistant ADHD – meaning that they no longer meet criteria. Only up to 23% experience full remission, said Dr. Sibley during a special late-breaking session. All research on remission and most on persistence consider just one endpoint – nothing is known about longitudinal fluctuations in remission status over time.

Her research sought to answer a key question: Do people fully recover from ADHD?

Using data from the Multimodal Treatment of Attention Deficit Hyperactivity Disorder (MTA) Study, Dr. Sibley prospectively followed over 550 children aged 7-9.9 years with DSM-IV combined-type ADHD over 14 years, until 16 years after baseline, using interviews, questionnaires, and rating scales to track symptoms, impairment, and treatment history.

The researchers also came up with a “winning” definition for full remission, which included three or fewer symptoms of inattention and hyperactive impulsivity from all available reporters, negligible ADHD-related impairment based on preestablished impairment rating thresholds, and discontinuation of medication and behavioral treatments for at least a month prior to assessment.

In the longitudinal results, Dr. Sibley and colleagues reported that the majority (63.8%) demonstrated fluctuations between full or partial remission and ADHD recurrence. Only 9.1% sustained full remission over the course of the study. From these findings, ADHD appears to be a fluctuating disorder. While it continues into adulthood for most people, there may also be periods of remission or “good functioning.”

Most desistance from ADHD represents partial, not full remission, said Dr. Sibley. The results also show that recovery by young adulthood is very rare – most patients with remitted ADHD have recurrences.

These are important findings, said Luis Augusto Rohde, MD, PhD, who co-organized the congress’ scientific program committee with Manfred Gerlach, PhD. It shows that a patient’s ADHD may sometimes be more definitive and at other times, no clear phenotype expression emerges.

COVID’s influence

COVID-19 greatly influenced this year’s program’s agenda, said Dr. Rohde. “There’s a lot of evidence that ADHD patients are at greater risk for COVID-19, which is not a surprise,” said Dr. Rohde, professor of child and adolescent psychiatry at the Federal University of Rio Grande do Sul’s department of psychiatry in Porto Alegre, Brazil.

ADHD is a combination of genetic liability and the demands of the environment. “In times like we are living in right now, if you have increasing demands and stress from the environment, you trigger symptoms in those even with lower genetic liability,” he said. ADHD’s pathophysiology involves attention and executive deficit disorder, which means these patients may not follow strategies to avoid infection.

This shows why COVID was so important to the discussion of program topics, he said.

Two experts addressed this subject head on in a point-counterpoint debate, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?” James Swanson, PhD, professor of pediatrics at the University of California, Irvine, projected that biological coeffects of COVID-19 will lead to ADHD symptoms, generating potentially 5 million new ADHD cases.

David Coghill, MBChB, MD, a professor of child adolescent mental health at the University of Melbourne, countered that not enough data are available yet to back this hypothesis. “Researchers are asking this question, but clinically we don’t know enough.”

While the COVID virus might not directly lead to more cases of ADHD, this could potentially happen indirectly through environmental agents of the pandemic, offered Dr. Rohde. “We’ve clearly seen in our appointments with families and children that they can’t face the amount of schooling and working from home,” he said.

 

Novel treatments

The conference also addressed new treatments and nonpharmacologic interventions in the pipeline for ADHD. “We had a chance to discuss the possibilities about new medications that address the problems in the current market and to show the potential usefulness of nonpharma interventions such as neuromodulations in ADHD,” said Dr. Rohde. Speakers discussed strategies ranging from family-based mindfulness interventions to oligoantigenic diets in children with ADHD.

Other researchers are looking at novel digital tools to help patients manage and treat ADHD. Adherence is a major problem in chronic disorders like hypertension, diabetes, epilepsy, and ADHD, said Dr. Rohde. “Due to ADHD symptomatology including inattention, novelty-seeking, executive deficits, and difficulties in persistence, it is an even bigger problem in this disorder.”

Speakers at the “ADHD in the digital age – From pitfalls to challenges” session discussed video game strategies to reduce ADHD impairment, and a texting app to improve adherence. Dr. Rohde talked about the FOCUS app, which fosters collaboration between patients, families, and caregivers to efficiently track ADHD symptoms and help customize treatments.

Studies suggest these tools can significantly improve adherence. They’re also well accepted by patients, said Dr. Rohde. While the expectations are high, digital interventions are not a substitute for medication. “More data is needed to include them as part of the clinical interventions for ADHD.”

Dr. Sibley received book royalties from Guilford Press. Dr. Rohde has received grant or research support from, served as a consultant to, and served on the speakers’ bureau of Bial, Medice, Novartis/Sandoz, Pfizer, and Shire/Takeda in the last 3 years. The ADHD and Juvenile Bipolar Disorder Outpatient Programs chaired by Dr. Rohde have received unrestricted educational and research support from the following pharmaceutical companies in the last 3 years: Novartis/Sandoz and Shire/Takeda. Dr. Rohde has received authorship royalties from Oxford Press and ArtMed and travel grants from Shire to take part in the 2018 APA annual meeting. Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth of infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). He has received travel support from Medice and has done legal review for NLS. Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to the session debate on the pandemic.

Attention-deficit/hyperactivity disorder and autism spectrum disorder (ASD) often coexist in children and adults, but the range of cognitive abilities can vary widely in these patients. Researchers from around the world are leveraging symptom, cognitive assessment, and neurobiological measures to gain insights on how individuals with ADHD/ASD approach and solve problems.

Several experts discussed the progress of their research during the session, “Overlap and differences of ADHD and autism – new findings of functional imaging and cognition studies” at the World Congress on ADHD – Virtual Event.

“The overlap of these two disorders is a critical issue for our field,” said Sarah Karalunas, PhD, assistant professor of clinical psychology at Purdue University, West Lafayette, Ind., who moderated the session. Clinicians are often asked to make differential diagnoses between these two disorders. Only recently has the DSM-5 allowed their codiagnosis. “There’s increasing recognition that there may be shared cognitive and physiological features that reflect their shared risk and account for the high levels of symptom overlap,” said Dr. Karalunas.
 

Shared cognitive markers

Under the DSM’s change, “it’s now recognized that an estimated 20%-60% of children with ASD have comorbidities with ADHD, and around 20%-40% of children with ADHD have ASD symptoms,” said Beth Johnson, PhD, a research fellow with the Turner Institute for Brain and Mental Health at Monash University, Melbourne.

The shared overlap on genetic traits and comorbidities such as intellectual disability, anxiety, depression, and oppositional defiant disorder, make it difficult for clinicians to predict clinical outcomes, noted Dr. Johnson.

“We’re now understanding that they’re likely to be multiple autisms and ADHDs, that these symptoms exist on a spectrum of severity or ability,” she said. Dr. Johnson discussed a data-driven subtyping approach based on neurocognitive and symptom profiles in children with ADHD. The aim was to better understand how symptoms are managed across ADHD, ASD and comorbid ASD-ADHD.

As part of this research, her team recruited 295 controls and 117 children with ADHD who underwent clinical phenotyping and also completed working memory tasks, stop signal, and sustained attention tasks.

The researchers divided the children into four stable clusters based on the ADHD rating scale and autism questionnaire data: high ASD/ADHD traits, high ADHD/low ASD, low ADHD/moderate ASD, and low ADHD/ASD. Approximately half of the children with ADHD showed moderate to high ASD symptoms. Looking at neurocognition across the tasks, unsurprisingly, performance was lowest among the high-ASD/ADHD children, with performance on the stop signal being the most pronounced. “Notably, performance on the working memory task worsened with increasing ADHD symptoms,” she reported.
 

Drift model identifies information processing

Dr. Karalunas has also compared subgroups of ADHD and ASD children. “Our analysis examined whether cognitive impairments in ASD reflect a shared risk mechanism or co-occurring ADHD symptoms and why we see an overlap in these types of impairments,” she said.

Her study included 509 children with ADHD, 97 with ASD, and 301 controls (typical development). All three groups underwent a full cognitive assessment battery that measured attention arousal, basic processing speed, and working memory. Those tasks were collapsed into a series of variables as well as a set of tasks measuring response inhibition, switching, interference control, reward discounting, and measure of reaction time variability.

Four cognitive profiles emerged: a typically developing group, an ADHD group, an ASD group with low levels of ADHD symptoms and an ASD group with high levels of ADHD symptoms.

The ADHD group did worse on many of the tasks than the control group, and the ASD group with low ADHD levels also did poorly relative to the typically developing sample. This shows that autism – even in absence of co-occurring ADHD – demonstrates more cognitive impairment than typically developing kids. The ADHD group with high levels of autism did the most poorly across all of the tasks.

The findings also revealed a symptom severity pattern: the group with fewer symptoms did the best and the group with the most symptoms did the worst. “Overall, this reflects severity of impairment,” said Dr. Karalunas.

To identify measures more specific to either ADHD or autism, Dr. Karalunas and colleagues did a follow-up analysis to characterize cognitive performance. To accomplish this, they applied a drift-diffusion model to the same four cognitive profiles. The model assessed three parameters: drift rate, which relates to the speed or efficiency of information processing, boundary separation or speed accuracy trade-offs (impulsivity), and nondecision time such as motor preparation.

Using the same four cognitive profiles, they found that the ADHD group had slower drift rate relative to the control, although the two groups did not differ on boundary separation, which meant there were no differences on waiting to need to respond. The ADHD group had faster nondecision times. “This is a classic pattern, shown in the literature,” said Dr. Karalunas.
 

In other results, an interesting pattern began to evolve

Both ASD groups, for example, had much wider boundary separations, which meant they were waiting to be sure before they responded than the ADHD or typically developing groups. In contrast, the two ADHD groups had much faster non-decision times, whereas the two non-ADHD groups had similar nondecisions times.

Unlike the previous analysis, which saw a symptom severity pattern develop, “we’re getting two parameters that seem to track much more specifically to specific symptom domains,” observed Dr. Karalunas.

The results suggest there’s a substantial overlap in cognitive impairments in ADHD/ASD. “But we have pretty strong evidence at this point that these similarities are not accounted for by symptom overlap, especially for things like response and inhibition, working memory and processing speed. These seem to be independently related to ADHD and autism, regardless of the level of comorbid ADHD symptoms in the autism group,” said Dr. Karalunas.

The hope is to expand on these types of analyses to address the interaction of cognition-emotion and social cognition, and empirically define groups based on cognitive performance, she said.
 

Neurocognitive studies

Researchers have also been studying neural networks to assess ASD and ADHD. Roselyne Chauvin, PhD, a postdoctoral associate at Washington University, St. Louis, discussed the concept of “a task generic connectome,” in which researchers look for a common network between targeted task paradigms to get closer to a common alteration across impairments.

In her research, Dr. Chauvin and colleagues looked at connectivity modulations across three tasks: working memory, reward processing tasks, and stop signal tasks, comparing ADHD patients to siblings and controls. The ADHD group showed reduced sensitivity or a smaller number of connections modulated in the tasks compared with the other groups. Researchers wondered where those missed connections were located.

Dividing the cohorts into task generic and task specific groups, Dr. Chauvin and colleagues found that the ADHD group lacked common processing skills. They were also able to identify reproducible missing circuits in the ADHD participants. Among the cohorts, there was a higher modulation of task-specific edges in the ADHD group.

The ADHD patients seemed to be using more task-tailored alternative strategies that were more challenging and suboptimal.

She also previewed her ongoing work with the EU-AIMS Longitudinal European Autism Project (LEAP) database to study ASD-ADHD comorbidity. In this project, she and her colleagues looked at several tasks: probing emotion processing, inhibitory control, theory of mind, and reward anticipation. Comparing ASD groups with or without ADHD comorbidity or a shared connection, she and her team were able to devise a functional profile predictive of ADHD severity. As an example, “for the connection only used by the ASD with ADHD comorbidity, the more they were using those connections of higher amplitude in the modulation, inside this subset of connection, the higher they would have ADHD severity,” said Dr. Chauvin.

Neural correlates of different behavioral and cognitive profiles haven’t been widely studied, according to Charlotte Tye, PhD, who’s based at the Institute of Psychiatry, Psychology & Neuroscience, King’s College, London. Electroencephalography is a useful technique for understanding the neural correlates of cognitive impairments and teasing apart different models of co-occurrence in ASD and ADHD. 

Dr. Tye and colleagues tested this approach in a cohort of boys aged 8-13 years diagnosed with ASD and/or ADHD, measuring EEG while the children did various continuous performance tasks to assess changes in brain activity. Examining P3 amplitude (event-related potential components) they found that children with ADHD or ADHD+ASD showed an attenuated amplitude of the P3, compared with typically developing children and those with ASD.

“This suggests children with an ADHD diagnosis exhibited reduced inhibitory control,” said Dr. Tye. In contrast, children with ASD showed reduced conflict monitoring as indexed by altered N2 amplitude across task conditions.

These, and other studies conducted by Dr. Tye and colleagues indicate that children with ADHD show reduced neural responses during attentional processing, whereas autistic children show typical neural responses, supporting specific profiles.

“Autistic children with a diagnosis of ADHD appear to show the unique patterns of neural responses of autism and ADHD, supporting an additive co-occurrence rather than a distinct condition. This contributes to identification of transdiagnostic subgroups within neurodevelopmental conditions for targeting of personalized intervention, and suggests that children with co-occurring autism and ADHD require support for both conditions,” said Dr. Tye.

An important takeaway from all of these findings is “we can’t look just at how someone does overall on a single test,” said Dr. Karalunas in an interview. “There is a tremendous amount of variability between people who have the same diagnosis, and our research really needs to account for this.”

Attention-deficit/hyperactivity disorder and autism spectrum disorder (ASD) often coexist in children and adults, but the range of cognitive abilities can vary widely in these patients. Researchers from around the world are leveraging symptom, cognitive assessment, and neurobiological measures to gain insights on how individuals with ADHD/ASD approach and solve problems.

Several experts discussed the progress of their research during the session, “Overlap and differences of ADHD and autism – new findings of functional imaging and cognition studies” at the World Congress on ADHD – Virtual Event.

“The overlap of these two disorders is a critical issue for our field,” said Sarah Karalunas, PhD, assistant professor of clinical psychology at Purdue University, West Lafayette, Ind., who moderated the session. Clinicians are often asked to make differential diagnoses between these two disorders. Only recently has the DSM-5 allowed their codiagnosis. “There’s increasing recognition that there may be shared cognitive and physiological features that reflect their shared risk and account for the high levels of symptom overlap,” said Dr. Karalunas.
 

Shared cognitive markers

Under the DSM’s change, “it’s now recognized that an estimated 20%-60% of children with ASD have comorbidities with ADHD, and around 20%-40% of children with ADHD have ASD symptoms,” said Beth Johnson, PhD, a research fellow with the Turner Institute for Brain and Mental Health at Monash University, Melbourne.

The shared overlap on genetic traits and comorbidities such as intellectual disability, anxiety, depression, and oppositional defiant disorder, make it difficult for clinicians to predict clinical outcomes, noted Dr. Johnson.

“We’re now understanding that they’re likely to be multiple autisms and ADHDs, that these symptoms exist on a spectrum of severity or ability,” she said. Dr. Johnson discussed a data-driven subtyping approach based on neurocognitive and symptom profiles in children with ADHD. The aim was to better understand how symptoms are managed across ADHD, ASD and comorbid ASD-ADHD.

As part of this research, her team recruited 295 controls and 117 children with ADHD who underwent clinical phenotyping and also completed working memory tasks, stop signal, and sustained attention tasks.

The researchers divided the children into four stable clusters based on the ADHD rating scale and autism questionnaire data: high ASD/ADHD traits, high ADHD/low ASD, low ADHD/moderate ASD, and low ADHD/ASD. Approximately half of the children with ADHD showed moderate to high ASD symptoms. Looking at neurocognition across the tasks, unsurprisingly, performance was lowest among the high-ASD/ADHD children, with performance on the stop signal being the most pronounced. “Notably, performance on the working memory task worsened with increasing ADHD symptoms,” she reported.
 

Drift model identifies information processing

Dr. Karalunas has also compared subgroups of ADHD and ASD children. “Our analysis examined whether cognitive impairments in ASD reflect a shared risk mechanism or co-occurring ADHD symptoms and why we see an overlap in these types of impairments,” she said.

Her study included 509 children with ADHD, 97 with ASD, and 301 controls (typical development). All three groups underwent a full cognitive assessment battery that measured attention arousal, basic processing speed, and working memory. Those tasks were collapsed into a series of variables as well as a set of tasks measuring response inhibition, switching, interference control, reward discounting, and measure of reaction time variability.

Four cognitive profiles emerged: a typically developing group, an ADHD group, an ASD group with low levels of ADHD symptoms and an ASD group with high levels of ADHD symptoms.

The ADHD group did worse on many of the tasks than the control group, and the ASD group with low ADHD levels also did poorly relative to the typically developing sample. This shows that autism – even in absence of co-occurring ADHD – demonstrates more cognitive impairment than typically developing kids. The ADHD group with high levels of autism did the most poorly across all of the tasks.

The findings also revealed a symptom severity pattern: the group with fewer symptoms did the best and the group with the most symptoms did the worst. “Overall, this reflects severity of impairment,” said Dr. Karalunas.

To identify measures more specific to either ADHD or autism, Dr. Karalunas and colleagues did a follow-up analysis to characterize cognitive performance. To accomplish this, they applied a drift-diffusion model to the same four cognitive profiles. The model assessed three parameters: drift rate, which relates to the speed or efficiency of information processing, boundary separation or speed accuracy trade-offs (impulsivity), and nondecision time such as motor preparation.

Using the same four cognitive profiles, they found that the ADHD group had slower drift rate relative to the control, although the two groups did not differ on boundary separation, which meant there were no differences on waiting to need to respond. The ADHD group had faster nondecision times. “This is a classic pattern, shown in the literature,” said Dr. Karalunas.
 

In other results, an interesting pattern began to evolve

Both ASD groups, for example, had much wider boundary separations, which meant they were waiting to be sure before they responded than the ADHD or typically developing groups. In contrast, the two ADHD groups had much faster non-decision times, whereas the two non-ADHD groups had similar nondecisions times.

Unlike the previous analysis, which saw a symptom severity pattern develop, “we’re getting two parameters that seem to track much more specifically to specific symptom domains,” observed Dr. Karalunas.

The results suggest there’s a substantial overlap in cognitive impairments in ADHD/ASD. “But we have pretty strong evidence at this point that these similarities are not accounted for by symptom overlap, especially for things like response and inhibition, working memory and processing speed. These seem to be independently related to ADHD and autism, regardless of the level of comorbid ADHD symptoms in the autism group,” said Dr. Karalunas.

The hope is to expand on these types of analyses to address the interaction of cognition-emotion and social cognition, and empirically define groups based on cognitive performance, she said.
 

Neurocognitive studies

Researchers have also been studying neural networks to assess ASD and ADHD. Roselyne Chauvin, PhD, a postdoctoral associate at Washington University, St. Louis, discussed the concept of “a task generic connectome,” in which researchers look for a common network between targeted task paradigms to get closer to a common alteration across impairments.

In her research, Dr. Chauvin and colleagues looked at connectivity modulations across three tasks: working memory, reward processing tasks, and stop signal tasks, comparing ADHD patients to siblings and controls. The ADHD group showed reduced sensitivity or a smaller number of connections modulated in the tasks compared with the other groups. Researchers wondered where those missed connections were located.

Dividing the cohorts into task generic and task specific groups, Dr. Chauvin and colleagues found that the ADHD group lacked common processing skills. They were also able to identify reproducible missing circuits in the ADHD participants. Among the cohorts, there was a higher modulation of task-specific edges in the ADHD group.

The ADHD patients seemed to be using more task-tailored alternative strategies that were more challenging and suboptimal.

She also previewed her ongoing work with the EU-AIMS Longitudinal European Autism Project (LEAP) database to study ASD-ADHD comorbidity. In this project, she and her colleagues looked at several tasks: probing emotion processing, inhibitory control, theory of mind, and reward anticipation. Comparing ASD groups with or without ADHD comorbidity or a shared connection, she and her team were able to devise a functional profile predictive of ADHD severity. As an example, “for the connection only used by the ASD with ADHD comorbidity, the more they were using those connections of higher amplitude in the modulation, inside this subset of connection, the higher they would have ADHD severity,” said Dr. Chauvin.

Neural correlates of different behavioral and cognitive profiles haven’t been widely studied, according to Charlotte Tye, PhD, who’s based at the Institute of Psychiatry, Psychology & Neuroscience, King’s College, London. Electroencephalography is a useful technique for understanding the neural correlates of cognitive impairments and teasing apart different models of co-occurrence in ASD and ADHD. 

Dr. Tye and colleagues tested this approach in a cohort of boys aged 8-13 years diagnosed with ASD and/or ADHD, measuring EEG while the children did various continuous performance tasks to assess changes in brain activity. Examining P3 amplitude (event-related potential components) they found that children with ADHD or ADHD+ASD showed an attenuated amplitude of the P3, compared with typically developing children and those with ASD.

“This suggests children with an ADHD diagnosis exhibited reduced inhibitory control,” said Dr. Tye. In contrast, children with ASD showed reduced conflict monitoring as indexed by altered N2 amplitude across task conditions.

These, and other studies conducted by Dr. Tye and colleagues indicate that children with ADHD show reduced neural responses during attentional processing, whereas autistic children show typical neural responses, supporting specific profiles.

“Autistic children with a diagnosis of ADHD appear to show the unique patterns of neural responses of autism and ADHD, supporting an additive co-occurrence rather than a distinct condition. This contributes to identification of transdiagnostic subgroups within neurodevelopmental conditions for targeting of personalized intervention, and suggests that children with co-occurring autism and ADHD require support for both conditions,” said Dr. Tye.

An important takeaway from all of these findings is “we can’t look just at how someone does overall on a single test,” said Dr. Karalunas in an interview. “There is a tremendous amount of variability between people who have the same diagnosis, and our research really needs to account for this.”

Attention-deficit/hyperactivity disorder and autism spectrum disorder (ASD) often coexist in children and adults, but the range of cognitive abilities can vary widely in these patients. Researchers from around the world are leveraging symptom, cognitive assessment, and neurobiological measures to gain insights on how individuals with ADHD/ASD approach and solve problems.

Several experts discussed the progress of their research during the session, “Overlap and differences of ADHD and autism – new findings of functional imaging and cognition studies” at the World Congress on ADHD – Virtual Event.

“The overlap of these two disorders is a critical issue for our field,” said Sarah Karalunas, PhD, assistant professor of clinical psychology at Purdue University, West Lafayette, Ind., who moderated the session. Clinicians are often asked to make differential diagnoses between these two disorders. Only recently has the DSM-5 allowed their codiagnosis. “There’s increasing recognition that there may be shared cognitive and physiological features that reflect their shared risk and account for the high levels of symptom overlap,” said Dr. Karalunas.
 

Shared cognitive markers

Under the DSM’s change, “it’s now recognized that an estimated 20%-60% of children with ASD have comorbidities with ADHD, and around 20%-40% of children with ADHD have ASD symptoms,” said Beth Johnson, PhD, a research fellow with the Turner Institute for Brain and Mental Health at Monash University, Melbourne.

The shared overlap on genetic traits and comorbidities such as intellectual disability, anxiety, depression, and oppositional defiant disorder, make it difficult for clinicians to predict clinical outcomes, noted Dr. Johnson.

“We’re now understanding that they’re likely to be multiple autisms and ADHDs, that these symptoms exist on a spectrum of severity or ability,” she said. Dr. Johnson discussed a data-driven subtyping approach based on neurocognitive and symptom profiles in children with ADHD. The aim was to better understand how symptoms are managed across ADHD, ASD and comorbid ASD-ADHD.

As part of this research, her team recruited 295 controls and 117 children with ADHD who underwent clinical phenotyping and also completed working memory tasks, stop signal, and sustained attention tasks.

The researchers divided the children into four stable clusters based on the ADHD rating scale and autism questionnaire data: high ASD/ADHD traits, high ADHD/low ASD, low ADHD/moderate ASD, and low ADHD/ASD. Approximately half of the children with ADHD showed moderate to high ASD symptoms. Looking at neurocognition across the tasks, unsurprisingly, performance was lowest among the high-ASD/ADHD children, with performance on the stop signal being the most pronounced. “Notably, performance on the working memory task worsened with increasing ADHD symptoms,” she reported.
 

Drift model identifies information processing

Dr. Karalunas has also compared subgroups of ADHD and ASD children. “Our analysis examined whether cognitive impairments in ASD reflect a shared risk mechanism or co-occurring ADHD symptoms and why we see an overlap in these types of impairments,” she said.

Her study included 509 children with ADHD, 97 with ASD, and 301 controls (typical development). All three groups underwent a full cognitive assessment battery that measured attention arousal, basic processing speed, and working memory. Those tasks were collapsed into a series of variables as well as a set of tasks measuring response inhibition, switching, interference control, reward discounting, and measure of reaction time variability.

Four cognitive profiles emerged: a typically developing group, an ADHD group, an ASD group with low levels of ADHD symptoms and an ASD group with high levels of ADHD symptoms.

The ADHD group did worse on many of the tasks than the control group, and the ASD group with low ADHD levels also did poorly relative to the typically developing sample. This shows that autism – even in absence of co-occurring ADHD – demonstrates more cognitive impairment than typically developing kids. The ADHD group with high levels of autism did the most poorly across all of the tasks.

The findings also revealed a symptom severity pattern: the group with fewer symptoms did the best and the group with the most symptoms did the worst. “Overall, this reflects severity of impairment,” said Dr. Karalunas.

To identify measures more specific to either ADHD or autism, Dr. Karalunas and colleagues did a follow-up analysis to characterize cognitive performance. To accomplish this, they applied a drift-diffusion model to the same four cognitive profiles. The model assessed three parameters: drift rate, which relates to the speed or efficiency of information processing, boundary separation or speed accuracy trade-offs (impulsivity), and nondecision time such as motor preparation.

Using the same four cognitive profiles, they found that the ADHD group had slower drift rate relative to the control, although the two groups did not differ on boundary separation, which meant there were no differences on waiting to need to respond. The ADHD group had faster nondecision times. “This is a classic pattern, shown in the literature,” said Dr. Karalunas.
 

In other results, an interesting pattern began to evolve

Both ASD groups, for example, had much wider boundary separations, which meant they were waiting to be sure before they responded than the ADHD or typically developing groups. In contrast, the two ADHD groups had much faster non-decision times, whereas the two non-ADHD groups had similar nondecisions times.

Unlike the previous analysis, which saw a symptom severity pattern develop, “we’re getting two parameters that seem to track much more specifically to specific symptom domains,” observed Dr. Karalunas.

The results suggest there’s a substantial overlap in cognitive impairments in ADHD/ASD. “But we have pretty strong evidence at this point that these similarities are not accounted for by symptom overlap, especially for things like response and inhibition, working memory and processing speed. These seem to be independently related to ADHD and autism, regardless of the level of comorbid ADHD symptoms in the autism group,” said Dr. Karalunas.

The hope is to expand on these types of analyses to address the interaction of cognition-emotion and social cognition, and empirically define groups based on cognitive performance, she said.
 

Neurocognitive studies

Researchers have also been studying neural networks to assess ASD and ADHD. Roselyne Chauvin, PhD, a postdoctoral associate at Washington University, St. Louis, discussed the concept of “a task generic connectome,” in which researchers look for a common network between targeted task paradigms to get closer to a common alteration across impairments.

In her research, Dr. Chauvin and colleagues looked at connectivity modulations across three tasks: working memory, reward processing tasks, and stop signal tasks, comparing ADHD patients to siblings and controls. The ADHD group showed reduced sensitivity or a smaller number of connections modulated in the tasks compared with the other groups. Researchers wondered where those missed connections were located.

Dividing the cohorts into task generic and task specific groups, Dr. Chauvin and colleagues found that the ADHD group lacked common processing skills. They were also able to identify reproducible missing circuits in the ADHD participants. Among the cohorts, there was a higher modulation of task-specific edges in the ADHD group.

The ADHD patients seemed to be using more task-tailored alternative strategies that were more challenging and suboptimal.

She also previewed her ongoing work with the EU-AIMS Longitudinal European Autism Project (LEAP) database to study ASD-ADHD comorbidity. In this project, she and her colleagues looked at several tasks: probing emotion processing, inhibitory control, theory of mind, and reward anticipation. Comparing ASD groups with or without ADHD comorbidity or a shared connection, she and her team were able to devise a functional profile predictive of ADHD severity. As an example, “for the connection only used by the ASD with ADHD comorbidity, the more they were using those connections of higher amplitude in the modulation, inside this subset of connection, the higher they would have ADHD severity,” said Dr. Chauvin.

Neural correlates of different behavioral and cognitive profiles haven’t been widely studied, according to Charlotte Tye, PhD, who’s based at the Institute of Psychiatry, Psychology & Neuroscience, King’s College, London. Electroencephalography is a useful technique for understanding the neural correlates of cognitive impairments and teasing apart different models of co-occurrence in ASD and ADHD. 

Dr. Tye and colleagues tested this approach in a cohort of boys aged 8-13 years diagnosed with ASD and/or ADHD, measuring EEG while the children did various continuous performance tasks to assess changes in brain activity. Examining P3 amplitude (event-related potential components) they found that children with ADHD or ADHD+ASD showed an attenuated amplitude of the P3, compared with typically developing children and those with ASD.

“This suggests children with an ADHD diagnosis exhibited reduced inhibitory control,” said Dr. Tye. In contrast, children with ASD showed reduced conflict monitoring as indexed by altered N2 amplitude across task conditions.

These, and other studies conducted by Dr. Tye and colleagues indicate that children with ADHD show reduced neural responses during attentional processing, whereas autistic children show typical neural responses, supporting specific profiles.

“Autistic children with a diagnosis of ADHD appear to show the unique patterns of neural responses of autism and ADHD, supporting an additive co-occurrence rather than a distinct condition. This contributes to identification of transdiagnostic subgroups within neurodevelopmental conditions for targeting of personalized intervention, and suggests that children with co-occurring autism and ADHD require support for both conditions,” said Dr. Tye.

An important takeaway from all of these findings is “we can’t look just at how someone does overall on a single test,” said Dr. Karalunas in an interview. “There is a tremendous amount of variability between people who have the same diagnosis, and our research really needs to account for this.”

While it’s possible that residual effects of SARS-CoV-2 could lead to an eruption of attention-deficit/hyperactivity disorder (ADHD) cases, a debate at the World Congress on ADHD – Virtual Event underscored the fact that this is still a hypothesis. The bottom line is there needs to be more data, said Luis Augusto Rohde, MD, PhD, cochair of the congress’ scientific program committee and moderator of the session, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?”

Considering the current pattern of the pandemic, there is not enough evidence for this to be a concern, Dr. Rohde said in an interview.

James Swanson, PhD, professor of pediatrics at the University of California, Irvine, opined that biological co-effects of COVID-19 are likely to have selective effects in children that may produce symptoms representative of ADHD. Using the 1918 Spanish flu pandemic as a historical reference, he estimated that COVID-19 would produce 5 million individuals with new-onset symptoms related to ADHD. “If these cases meet DSM-5 or ICD-11 criteria, there will be lots of new ADHD cases,” he predicted.

David Coghill, MD, a professor of child adolescent mental health at the University of Melbourne, observed that the sums Dr. Swanson presented “are based on maxing out the potential rather than looking at the sums more realistically.”
 

Could the 1918 pandemic offer clues?

In a commentary, Dr. Swanson and Nora D. Volkow, MD, wrote about “lessons learned” from the 1918 pandemic, and how residual sequelae in that era led to a condition labeled hyperkinetic syndrome in children. “It may be worthwhile to consider the hypothesis that the COVID-19 pandemic may result in a novel etiologic subtype of ADHD that clinicians may recognize in patients in the future,” wrote the commentators. 

In survivors of the 1918 pandemic, brain inflammation or encephalitis sometimes emerged as residual sequelae, said Dr. Swanson. In some adult cases, these symptoms were diagnosed as “encephalitis lethargica” (EL) and were associated with Parkinson’s disease. In 1930, based on patients evaluated after 1918, researchers Franz Kramer and Hans Pollnow at Charité Hospital in Berlin described the behavioral manifestation of EL in children as hyperkinetic syndrome, a condition that was characterized by symptoms similar to the properties of ADHD: lack of concentration, insufficient goal orientation, and increased distractibility. “They even reported on autopsy cases that described brain regions that we now know are associated with ADHD from decades of brain imaging studies,” said Dr. Swanson.

COVID-19 rarely results in severe respiratory problems in children but the absolute number requiring hospitalization has accumulated and is now relatively large, said Dr. Swanson. One study of 1,695 severe COVID-19 cases in children and adolescents used MRI and detected neural effects in specific brain regions such as basal ganglia and frontal lobes that previous research had associated with ADHD. Approximately 22% of these rare but severe cases had documented neurologic involvement, and studies of affected children with mild or none of the initial respiratory symptoms of COVID-19 also detected similar selective effects in these brain regions.

A recent survey of medical records of 80 million people that identified 240,000 COVID cases (mostly adults) revealed that a third had neurological and psychiatric sequelae. Dr. Swanson also mentioned an article he wrote more than a decade ago on environmental as well as genetic factors that resulted in etiologic subtypes of ADHD, which provided a model for the impact of COVID-19 on specific brain regions that are associated with ADHD.

So far, the COVID-19 pandemic has produced 150 million cases worldwide and there are about 100 million survivors, setting an estimate of a maximum number of cases with residual sequelae. “I think that severe COVID-19 will probably be related to severe residual sequelae, and that mild or asymptomatic COVID-19 may be associated with less severe residual sequelae, which may resemble ADHD” said Dr. Swanson. If one-third of the cases manifest in some neurologic or psychiatric systems, this means 27 million would have residual sequelae. If 20% have impaired concentration or brain fog, this could result in about 5 million ADHD cases, he said. 
 

Estimates aren’t evidence

The Swanson/Volkow commentary contains a lot of references to “might, could, and may,” said Dr. Coghill. While it’s true that COVID-19 could produce a novel etiologic subtype of ADHD, “the point here is at the moment, all of this is based on hypotheses,” he said.

The Spanish flu did produce mental health consequences – survivors reported depression, sleep disturbances, mental distraction, dizziness, and difficulties coping at work. In the United States, flu death rates from 1918 to 1920 were directly attributed to suicide rates. Unfortunately, these impacts weren’t widely researched, said Dr. Coghill.

It also seems clear that the 1918 Spanish flu outbreak was associated with significant neurological consequences, said Dr. Coghill. By 1919 and 1920, physicians and researchers in the United Kingdom were reporting increases in a variety of symptoms among some patients recovering from flu, such as neuropathy, neurasthenia, meningitis, degenerative changes in nerve cells, and a decline in visual acuity.

The EL cases Dr. Swanson mentioned did coincide with and reach epidemic proportions alongside the Spanish flu. “But still, a causal relationship is far from proven,” said Dr. Coghill.

Sol Levy, MD, described a “disease of criminals” following the 1918 pandemic, in which patients exhibited a high degree of general hyperkinesis, a difficulty in maintaining quiet attitudes, abruptness and clumsiness, and “explosive motor release of all voluntarily inhibited activities.”

However, these impairments suggest a much broader presentation typically seen in ADHD, noted Dr. Coghill.

Neurological complications occur more commonly than initially thought in severe COVID-19, with estimates ranging from 36% to 84%. But in a systematic review of neuropsychiatric complications of severe coronavirus infection, researchers found few psychiatric sequelae of these infections. While they did mention impaired concentration and difficulties with emotional ability, it’s very important to remember that these conditions “are cardinal symptoms of a wide range of psychiatric disorders,” said Dr. Coghill.

Overall, more neurological and neuropsychiatric symptoms largely confine to those with severe COVID-19, meaning they’re much less likely to occur in children and young adults, he said.

If there are severe effects of COVID-19, Dr. Swanson countered that “they might have more ADHD than the complex residual effects [Dr. Coghill] described. I hope that he’s right, but I do think there will be biological co-effects of COVID-19 that will produce symptoms that are more ADHD than other neurological disorders.”
 

Epigenetic effects

Researchers are now seeing transgenerational and intergenerational effects of potential infection. “So I certainly back high-quality studies looking at the effects of maternal and paternal infection on offspring,” said Dr. Coghill. Establishing clinical cohort studies to follow up on this population would be essential in understanding the risks of SARS-CoV-2. “That might be one way we’ll see an increase in ADHD,” said Dr. Coghill.

The reality is COVID-19 hasn’t been around for that long, and current knowledge about it is limited, he said. Rapid publications, cross-sectional or retrospective data, and poor methodological quality and rigor make generalizability difficult. In addition, limited testing and detection probably underestimate prevalence of neurological and neuropsychiatric complications.

“If history teaches us anything, it is that we should always be measured in how we glean lessons from the past. So let’s not get ahead of ourselves,” he cautioned.

An informal, post-discussion survey of session participants revealed that a slight majority – 55%-60% – expected residual effects of COVID-19 to lead to more ADHD, compared to 40%-45% who didn’t think this would happen.

Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to this debate.

While it’s possible that residual effects of SARS-CoV-2 could lead to an eruption of attention-deficit/hyperactivity disorder (ADHD) cases, a debate at the World Congress on ADHD – Virtual Event underscored the fact that this is still a hypothesis. The bottom line is there needs to be more data, said Luis Augusto Rohde, MD, PhD, cochair of the congress’ scientific program committee and moderator of the session, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?”

Considering the current pattern of the pandemic, there is not enough evidence for this to be a concern, Dr. Rohde said in an interview.

James Swanson, PhD, professor of pediatrics at the University of California, Irvine, opined that biological co-effects of COVID-19 are likely to have selective effects in children that may produce symptoms representative of ADHD. Using the 1918 Spanish flu pandemic as a historical reference, he estimated that COVID-19 would produce 5 million individuals with new-onset symptoms related to ADHD. “If these cases meet DSM-5 or ICD-11 criteria, there will be lots of new ADHD cases,” he predicted.

David Coghill, MD, a professor of child adolescent mental health at the University of Melbourne, observed that the sums Dr. Swanson presented “are based on maxing out the potential rather than looking at the sums more realistically.”
 

Could the 1918 pandemic offer clues?

In a commentary, Dr. Swanson and Nora D. Volkow, MD, wrote about “lessons learned” from the 1918 pandemic, and how residual sequelae in that era led to a condition labeled hyperkinetic syndrome in children. “It may be worthwhile to consider the hypothesis that the COVID-19 pandemic may result in a novel etiologic subtype of ADHD that clinicians may recognize in patients in the future,” wrote the commentators. 

In survivors of the 1918 pandemic, brain inflammation or encephalitis sometimes emerged as residual sequelae, said Dr. Swanson. In some adult cases, these symptoms were diagnosed as “encephalitis lethargica” (EL) and were associated with Parkinson’s disease. In 1930, based on patients evaluated after 1918, researchers Franz Kramer and Hans Pollnow at Charité Hospital in Berlin described the behavioral manifestation of EL in children as hyperkinetic syndrome, a condition that was characterized by symptoms similar to the properties of ADHD: lack of concentration, insufficient goal orientation, and increased distractibility. “They even reported on autopsy cases that described brain regions that we now know are associated with ADHD from decades of brain imaging studies,” said Dr. Swanson.

COVID-19 rarely results in severe respiratory problems in children but the absolute number requiring hospitalization has accumulated and is now relatively large, said Dr. Swanson. One study of 1,695 severe COVID-19 cases in children and adolescents used MRI and detected neural effects in specific brain regions such as basal ganglia and frontal lobes that previous research had associated with ADHD. Approximately 22% of these rare but severe cases had documented neurologic involvement, and studies of affected children with mild or none of the initial respiratory symptoms of COVID-19 also detected similar selective effects in these brain regions.

A recent survey of medical records of 80 million people that identified 240,000 COVID cases (mostly adults) revealed that a third had neurological and psychiatric sequelae. Dr. Swanson also mentioned an article he wrote more than a decade ago on environmental as well as genetic factors that resulted in etiologic subtypes of ADHD, which provided a model for the impact of COVID-19 on specific brain regions that are associated with ADHD.

So far, the COVID-19 pandemic has produced 150 million cases worldwide and there are about 100 million survivors, setting an estimate of a maximum number of cases with residual sequelae. “I think that severe COVID-19 will probably be related to severe residual sequelae, and that mild or asymptomatic COVID-19 may be associated with less severe residual sequelae, which may resemble ADHD” said Dr. Swanson. If one-third of the cases manifest in some neurologic or psychiatric systems, this means 27 million would have residual sequelae. If 20% have impaired concentration or brain fog, this could result in about 5 million ADHD cases, he said. 
 

Estimates aren’t evidence

The Swanson/Volkow commentary contains a lot of references to “might, could, and may,” said Dr. Coghill. While it’s true that COVID-19 could produce a novel etiologic subtype of ADHD, “the point here is at the moment, all of this is based on hypotheses,” he said.

The Spanish flu did produce mental health consequences – survivors reported depression, sleep disturbances, mental distraction, dizziness, and difficulties coping at work. In the United States, flu death rates from 1918 to 1920 were directly attributed to suicide rates. Unfortunately, these impacts weren’t widely researched, said Dr. Coghill.

It also seems clear that the 1918 Spanish flu outbreak was associated with significant neurological consequences, said Dr. Coghill. By 1919 and 1920, physicians and researchers in the United Kingdom were reporting increases in a variety of symptoms among some patients recovering from flu, such as neuropathy, neurasthenia, meningitis, degenerative changes in nerve cells, and a decline in visual acuity.

The EL cases Dr. Swanson mentioned did coincide with and reach epidemic proportions alongside the Spanish flu. “But still, a causal relationship is far from proven,” said Dr. Coghill.

Sol Levy, MD, described a “disease of criminals” following the 1918 pandemic, in which patients exhibited a high degree of general hyperkinesis, a difficulty in maintaining quiet attitudes, abruptness and clumsiness, and “explosive motor release of all voluntarily inhibited activities.”

However, these impairments suggest a much broader presentation typically seen in ADHD, noted Dr. Coghill.

Neurological complications occur more commonly than initially thought in severe COVID-19, with estimates ranging from 36% to 84%. But in a systematic review of neuropsychiatric complications of severe coronavirus infection, researchers found few psychiatric sequelae of these infections. While they did mention impaired concentration and difficulties with emotional ability, it’s very important to remember that these conditions “are cardinal symptoms of a wide range of psychiatric disorders,” said Dr. Coghill.

Overall, more neurological and neuropsychiatric symptoms largely confine to those with severe COVID-19, meaning they’re much less likely to occur in children and young adults, he said.

If there are severe effects of COVID-19, Dr. Swanson countered that “they might have more ADHD than the complex residual effects [Dr. Coghill] described. I hope that he’s right, but I do think there will be biological co-effects of COVID-19 that will produce symptoms that are more ADHD than other neurological disorders.”
 

Epigenetic effects

Researchers are now seeing transgenerational and intergenerational effects of potential infection. “So I certainly back high-quality studies looking at the effects of maternal and paternal infection on offspring,” said Dr. Coghill. Establishing clinical cohort studies to follow up on this population would be essential in understanding the risks of SARS-CoV-2. “That might be one way we’ll see an increase in ADHD,” said Dr. Coghill.

The reality is COVID-19 hasn’t been around for that long, and current knowledge about it is limited, he said. Rapid publications, cross-sectional or retrospective data, and poor methodological quality and rigor make generalizability difficult. In addition, limited testing and detection probably underestimate prevalence of neurological and neuropsychiatric complications.

“If history teaches us anything, it is that we should always be measured in how we glean lessons from the past. So let’s not get ahead of ourselves,” he cautioned.

An informal, post-discussion survey of session participants revealed that a slight majority – 55%-60% – expected residual effects of COVID-19 to lead to more ADHD, compared to 40%-45% who didn’t think this would happen.

Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to this debate.

While it’s possible that residual effects of SARS-CoV-2 could lead to an eruption of attention-deficit/hyperactivity disorder (ADHD) cases, a debate at the World Congress on ADHD – Virtual Event underscored the fact that this is still a hypothesis. The bottom line is there needs to be more data, said Luis Augusto Rohde, MD, PhD, cochair of the congress’ scientific program committee and moderator of the session, “Residual effects of the 2019 pandemic will mirror the 1918 pandemic: Will we have lots of new ADHD cases?”

Considering the current pattern of the pandemic, there is not enough evidence for this to be a concern, Dr. Rohde said in an interview.

James Swanson, PhD, professor of pediatrics at the University of California, Irvine, opined that biological co-effects of COVID-19 are likely to have selective effects in children that may produce symptoms representative of ADHD. Using the 1918 Spanish flu pandemic as a historical reference, he estimated that COVID-19 would produce 5 million individuals with new-onset symptoms related to ADHD. “If these cases meet DSM-5 or ICD-11 criteria, there will be lots of new ADHD cases,” he predicted.

David Coghill, MD, a professor of child adolescent mental health at the University of Melbourne, observed that the sums Dr. Swanson presented “are based on maxing out the potential rather than looking at the sums more realistically.”
 

Could the 1918 pandemic offer clues?

In a commentary, Dr. Swanson and Nora D. Volkow, MD, wrote about “lessons learned” from the 1918 pandemic, and how residual sequelae in that era led to a condition labeled hyperkinetic syndrome in children. “It may be worthwhile to consider the hypothesis that the COVID-19 pandemic may result in a novel etiologic subtype of ADHD that clinicians may recognize in patients in the future,” wrote the commentators. 

In survivors of the 1918 pandemic, brain inflammation or encephalitis sometimes emerged as residual sequelae, said Dr. Swanson. In some adult cases, these symptoms were diagnosed as “encephalitis lethargica” (EL) and were associated with Parkinson’s disease. In 1930, based on patients evaluated after 1918, researchers Franz Kramer and Hans Pollnow at Charité Hospital in Berlin described the behavioral manifestation of EL in children as hyperkinetic syndrome, a condition that was characterized by symptoms similar to the properties of ADHD: lack of concentration, insufficient goal orientation, and increased distractibility. “They even reported on autopsy cases that described brain regions that we now know are associated with ADHD from decades of brain imaging studies,” said Dr. Swanson.

COVID-19 rarely results in severe respiratory problems in children but the absolute number requiring hospitalization has accumulated and is now relatively large, said Dr. Swanson. One study of 1,695 severe COVID-19 cases in children and adolescents used MRI and detected neural effects in specific brain regions such as basal ganglia and frontal lobes that previous research had associated with ADHD. Approximately 22% of these rare but severe cases had documented neurologic involvement, and studies of affected children with mild or none of the initial respiratory symptoms of COVID-19 also detected similar selective effects in these brain regions.

A recent survey of medical records of 80 million people that identified 240,000 COVID cases (mostly adults) revealed that a third had neurological and psychiatric sequelae. Dr. Swanson also mentioned an article he wrote more than a decade ago on environmental as well as genetic factors that resulted in etiologic subtypes of ADHD, which provided a model for the impact of COVID-19 on specific brain regions that are associated with ADHD.

So far, the COVID-19 pandemic has produced 150 million cases worldwide and there are about 100 million survivors, setting an estimate of a maximum number of cases with residual sequelae. “I think that severe COVID-19 will probably be related to severe residual sequelae, and that mild or asymptomatic COVID-19 may be associated with less severe residual sequelae, which may resemble ADHD” said Dr. Swanson. If one-third of the cases manifest in some neurologic or psychiatric systems, this means 27 million would have residual sequelae. If 20% have impaired concentration or brain fog, this could result in about 5 million ADHD cases, he said. 
 

Estimates aren’t evidence

The Swanson/Volkow commentary contains a lot of references to “might, could, and may,” said Dr. Coghill. While it’s true that COVID-19 could produce a novel etiologic subtype of ADHD, “the point here is at the moment, all of this is based on hypotheses,” he said.

The Spanish flu did produce mental health consequences – survivors reported depression, sleep disturbances, mental distraction, dizziness, and difficulties coping at work. In the United States, flu death rates from 1918 to 1920 were directly attributed to suicide rates. Unfortunately, these impacts weren’t widely researched, said Dr. Coghill.

It also seems clear that the 1918 Spanish flu outbreak was associated with significant neurological consequences, said Dr. Coghill. By 1919 and 1920, physicians and researchers in the United Kingdom were reporting increases in a variety of symptoms among some patients recovering from flu, such as neuropathy, neurasthenia, meningitis, degenerative changes in nerve cells, and a decline in visual acuity.

The EL cases Dr. Swanson mentioned did coincide with and reach epidemic proportions alongside the Spanish flu. “But still, a causal relationship is far from proven,” said Dr. Coghill.

Sol Levy, MD, described a “disease of criminals” following the 1918 pandemic, in which patients exhibited a high degree of general hyperkinesis, a difficulty in maintaining quiet attitudes, abruptness and clumsiness, and “explosive motor release of all voluntarily inhibited activities.”

However, these impairments suggest a much broader presentation typically seen in ADHD, noted Dr. Coghill.

Neurological complications occur more commonly than initially thought in severe COVID-19, with estimates ranging from 36% to 84%. But in a systematic review of neuropsychiatric complications of severe coronavirus infection, researchers found few psychiatric sequelae of these infections. While they did mention impaired concentration and difficulties with emotional ability, it’s very important to remember that these conditions “are cardinal symptoms of a wide range of psychiatric disorders,” said Dr. Coghill.

Overall, more neurological and neuropsychiatric symptoms largely confine to those with severe COVID-19, meaning they’re much less likely to occur in children and young adults, he said.

If there are severe effects of COVID-19, Dr. Swanson countered that “they might have more ADHD than the complex residual effects [Dr. Coghill] described. I hope that he’s right, but I do think there will be biological co-effects of COVID-19 that will produce symptoms that are more ADHD than other neurological disorders.”
 

Epigenetic effects

Researchers are now seeing transgenerational and intergenerational effects of potential infection. “So I certainly back high-quality studies looking at the effects of maternal and paternal infection on offspring,” said Dr. Coghill. Establishing clinical cohort studies to follow up on this population would be essential in understanding the risks of SARS-CoV-2. “That might be one way we’ll see an increase in ADHD,” said Dr. Coghill.

The reality is COVID-19 hasn’t been around for that long, and current knowledge about it is limited, he said. Rapid publications, cross-sectional or retrospective data, and poor methodological quality and rigor make generalizability difficult. In addition, limited testing and detection probably underestimate prevalence of neurological and neuropsychiatric complications.

“If history teaches us anything, it is that we should always be measured in how we glean lessons from the past. So let’s not get ahead of ourselves,” he cautioned.

An informal, post-discussion survey of session participants revealed that a slight majority – 55%-60% – expected residual effects of COVID-19 to lead to more ADHD, compared to 40%-45% who didn’t think this would happen.

Dr. Swanson has two patents: (PIXA4), which uses a “time-of-flight” camera to measure growth on infants, and a provisional patent on the mechanism of tolerance to stimulant medication (PATSMTA). Dr. Coghill worked for several pharmaceutical companies but had no disclosures relevant to this debate.