Eczema may increase lymphoma risk, cohort studies suggest

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Wed, 06/24/2020 - 14:59

Atopic eczema was linked with a significantly increased risk of lymphoma, and severe eczema was associated with a twofold increase in non-Hodgkin lymphoma (NHL) risk, according to two matched longitudinal cohort studies from England and Denmark.

“In this study, no evidence was found that people with atopic eczema are at increased risk of most cancers. An exception is the observed association between atopic eczema and lymphoma, particularly NHL, [which] increased with eczema severity,” Kathryn E. Mansfield, PhD, wrote in JAMA Dermatology. Adjusted hazard ratios for NHL in the English cohort were 1.06 (99% CI, 0.90-1.25) for mild atopic eczema, 1.24 (99% CI, 1.04-1.48) for moderate eczema, and 2.08 (99% CI, 1.42-3.04) for severe eczema, reported Dr. Mansfield of the London School of Hygiene and Tropical Medicine and associates.

Past studies of a possible link between atopic eczema and cancer have produced conflicting evidence, which might reflect “two competing theories” – that cancer risk falls with greater immune surveillance, and that cancer risk rises with immune stimulation, the researchers wrote. Immunosuppressive treatment and an impaired skin barrier might also increase the risk of cancer, but the evidence is conflicting.



For the study, they analyzed electronic health records linked with hospital admissions and death records in England and national health registry data from Denmark. The English cohort included 471,970 adults with atopic eczema and 2,239,775 adults without atopic eczema. The Danish cohort was composed of individuals of any age, including 44,945 who had eczema and with 445,673 who did not. Participants were matched based on factors such as age, sex, and primary care practice. The researchers excluded individuals with a history of cancer, apart from nonmelanoma skin cancer or keratinocyte cancer. (For analyses of skin cancer risk, they also excluded individuals with a history of nonmelanoma skin cancer.)

Overall, there was “little evidence” for a link between atopic eczema and cancer (adjusted hazard ratio in England, 1.04; 99% CI, 1.02-1.06; aHR in Denmark, 1.05; 99% CI, 0.95-1.16) or for most specific types of cancer, the investigators wrote.

In England, however, eczema was associated with a significantly increased risk for noncutaneous lymphoma, with an adjusted HRs of 1.19 (99% CI, 1.07-1.34) for NHL, and 1.48 (99% CI, 1.07-2.04) for Hodgkin lymphoma. Lymphoma risk was highest among adults with severe eczema, defined as those who had been prescribed a systemic treatment for their disease, who had received phototherapy, or who had been referred to a specialist or admitted to a hospital for atopic eczema. Point estimates in the Danish cohort also revealed a higher risk for lymphoma among individuals with moderate to severe atopic eczema, compared with those with eczema, but the 99% CIs crossed 1.0.

Dr. Shadmehr Demehri
Dr. Shadmehr Demehri

The findings highlight the need to be aware of, screen for, and study the pathogenesis of heightened lymphoma risk among patients with atopic eczema, said Shawn Demehri, MD, PhD, of the department of dermatology and cancer center, at Massachusetts General Hospital, Boston, who was not involved in the study.

“Prospectively collected data from large cohorts of eczema patients is a strength of this study,” he said in an interview. “However, the age range included in the study is suboptimal for assessing cancer as an outcome. The lower incidence of cancer in younger individuals hinders the ability to detect differences in cancer risk between the two groups.” (Approximately 57% of individuals in the English cohort were aged 18-44 years, while approximately 70% of those in the Danish cohort were less than 18 years.)

Understanding how eczema affects the risk of non-Hodgkin lymphoma is an important future direction of research, Dr. Demehri emphasized. “The landscape of atopic eczema therapeutics has dramatically changed in the recent years. It will be very interesting to determine how new biologics impact cancer risk in eczema patients.”

Partial support for the work was provided by the Wellcome Trust, the Royal Society, the Dagmar Marshalls Fund, and the Aase and Ejnar Danielsens Fund. Dr. Mansfield disclosed support from a Wellcome Trust grant. Her coinvestigators disclosed ties to TARGET-DERM, Pfizer, and GlaxoSmithKline, and from the Wellcome Trust, Medical Research Council, the National Institute for Health Research, the British Heart Foundation, Diabetes UK, and IMI Horizon 2020 funding BIOMAP. Dr. Demehri reported having no relevant conflicts of interest.

SOURCE: Mansfield KE et al. JAMA Dermatol. 2020 Jun 24. doi: 10.1001/jamadermatol.2020.1948.

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Atopic eczema was linked with a significantly increased risk of lymphoma, and severe eczema was associated with a twofold increase in non-Hodgkin lymphoma (NHL) risk, according to two matched longitudinal cohort studies from England and Denmark.

“In this study, no evidence was found that people with atopic eczema are at increased risk of most cancers. An exception is the observed association between atopic eczema and lymphoma, particularly NHL, [which] increased with eczema severity,” Kathryn E. Mansfield, PhD, wrote in JAMA Dermatology. Adjusted hazard ratios for NHL in the English cohort were 1.06 (99% CI, 0.90-1.25) for mild atopic eczema, 1.24 (99% CI, 1.04-1.48) for moderate eczema, and 2.08 (99% CI, 1.42-3.04) for severe eczema, reported Dr. Mansfield of the London School of Hygiene and Tropical Medicine and associates.

Past studies of a possible link between atopic eczema and cancer have produced conflicting evidence, which might reflect “two competing theories” – that cancer risk falls with greater immune surveillance, and that cancer risk rises with immune stimulation, the researchers wrote. Immunosuppressive treatment and an impaired skin barrier might also increase the risk of cancer, but the evidence is conflicting.



For the study, they analyzed electronic health records linked with hospital admissions and death records in England and national health registry data from Denmark. The English cohort included 471,970 adults with atopic eczema and 2,239,775 adults without atopic eczema. The Danish cohort was composed of individuals of any age, including 44,945 who had eczema and with 445,673 who did not. Participants were matched based on factors such as age, sex, and primary care practice. The researchers excluded individuals with a history of cancer, apart from nonmelanoma skin cancer or keratinocyte cancer. (For analyses of skin cancer risk, they also excluded individuals with a history of nonmelanoma skin cancer.)

Overall, there was “little evidence” for a link between atopic eczema and cancer (adjusted hazard ratio in England, 1.04; 99% CI, 1.02-1.06; aHR in Denmark, 1.05; 99% CI, 0.95-1.16) or for most specific types of cancer, the investigators wrote.

In England, however, eczema was associated with a significantly increased risk for noncutaneous lymphoma, with an adjusted HRs of 1.19 (99% CI, 1.07-1.34) for NHL, and 1.48 (99% CI, 1.07-2.04) for Hodgkin lymphoma. Lymphoma risk was highest among adults with severe eczema, defined as those who had been prescribed a systemic treatment for their disease, who had received phototherapy, or who had been referred to a specialist or admitted to a hospital for atopic eczema. Point estimates in the Danish cohort also revealed a higher risk for lymphoma among individuals with moderate to severe atopic eczema, compared with those with eczema, but the 99% CIs crossed 1.0.

Dr. Shadmehr Demehri
Dr. Shadmehr Demehri

The findings highlight the need to be aware of, screen for, and study the pathogenesis of heightened lymphoma risk among patients with atopic eczema, said Shawn Demehri, MD, PhD, of the department of dermatology and cancer center, at Massachusetts General Hospital, Boston, who was not involved in the study.

“Prospectively collected data from large cohorts of eczema patients is a strength of this study,” he said in an interview. “However, the age range included in the study is suboptimal for assessing cancer as an outcome. The lower incidence of cancer in younger individuals hinders the ability to detect differences in cancer risk between the two groups.” (Approximately 57% of individuals in the English cohort were aged 18-44 years, while approximately 70% of those in the Danish cohort were less than 18 years.)

Understanding how eczema affects the risk of non-Hodgkin lymphoma is an important future direction of research, Dr. Demehri emphasized. “The landscape of atopic eczema therapeutics has dramatically changed in the recent years. It will be very interesting to determine how new biologics impact cancer risk in eczema patients.”

Partial support for the work was provided by the Wellcome Trust, the Royal Society, the Dagmar Marshalls Fund, and the Aase and Ejnar Danielsens Fund. Dr. Mansfield disclosed support from a Wellcome Trust grant. Her coinvestigators disclosed ties to TARGET-DERM, Pfizer, and GlaxoSmithKline, and from the Wellcome Trust, Medical Research Council, the National Institute for Health Research, the British Heart Foundation, Diabetes UK, and IMI Horizon 2020 funding BIOMAP. Dr. Demehri reported having no relevant conflicts of interest.

SOURCE: Mansfield KE et al. JAMA Dermatol. 2020 Jun 24. doi: 10.1001/jamadermatol.2020.1948.

Atopic eczema was linked with a significantly increased risk of lymphoma, and severe eczema was associated with a twofold increase in non-Hodgkin lymphoma (NHL) risk, according to two matched longitudinal cohort studies from England and Denmark.

“In this study, no evidence was found that people with atopic eczema are at increased risk of most cancers. An exception is the observed association between atopic eczema and lymphoma, particularly NHL, [which] increased with eczema severity,” Kathryn E. Mansfield, PhD, wrote in JAMA Dermatology. Adjusted hazard ratios for NHL in the English cohort were 1.06 (99% CI, 0.90-1.25) for mild atopic eczema, 1.24 (99% CI, 1.04-1.48) for moderate eczema, and 2.08 (99% CI, 1.42-3.04) for severe eczema, reported Dr. Mansfield of the London School of Hygiene and Tropical Medicine and associates.

Past studies of a possible link between atopic eczema and cancer have produced conflicting evidence, which might reflect “two competing theories” – that cancer risk falls with greater immune surveillance, and that cancer risk rises with immune stimulation, the researchers wrote. Immunosuppressive treatment and an impaired skin barrier might also increase the risk of cancer, but the evidence is conflicting.



For the study, they analyzed electronic health records linked with hospital admissions and death records in England and national health registry data from Denmark. The English cohort included 471,970 adults with atopic eczema and 2,239,775 adults without atopic eczema. The Danish cohort was composed of individuals of any age, including 44,945 who had eczema and with 445,673 who did not. Participants were matched based on factors such as age, sex, and primary care practice. The researchers excluded individuals with a history of cancer, apart from nonmelanoma skin cancer or keratinocyte cancer. (For analyses of skin cancer risk, they also excluded individuals with a history of nonmelanoma skin cancer.)

Overall, there was “little evidence” for a link between atopic eczema and cancer (adjusted hazard ratio in England, 1.04; 99% CI, 1.02-1.06; aHR in Denmark, 1.05; 99% CI, 0.95-1.16) or for most specific types of cancer, the investigators wrote.

In England, however, eczema was associated with a significantly increased risk for noncutaneous lymphoma, with an adjusted HRs of 1.19 (99% CI, 1.07-1.34) for NHL, and 1.48 (99% CI, 1.07-2.04) for Hodgkin lymphoma. Lymphoma risk was highest among adults with severe eczema, defined as those who had been prescribed a systemic treatment for their disease, who had received phototherapy, or who had been referred to a specialist or admitted to a hospital for atopic eczema. Point estimates in the Danish cohort also revealed a higher risk for lymphoma among individuals with moderate to severe atopic eczema, compared with those with eczema, but the 99% CIs crossed 1.0.

Dr. Shadmehr Demehri
Dr. Shadmehr Demehri

The findings highlight the need to be aware of, screen for, and study the pathogenesis of heightened lymphoma risk among patients with atopic eczema, said Shawn Demehri, MD, PhD, of the department of dermatology and cancer center, at Massachusetts General Hospital, Boston, who was not involved in the study.

“Prospectively collected data from large cohorts of eczema patients is a strength of this study,” he said in an interview. “However, the age range included in the study is suboptimal for assessing cancer as an outcome. The lower incidence of cancer in younger individuals hinders the ability to detect differences in cancer risk between the two groups.” (Approximately 57% of individuals in the English cohort were aged 18-44 years, while approximately 70% of those in the Danish cohort were less than 18 years.)

Understanding how eczema affects the risk of non-Hodgkin lymphoma is an important future direction of research, Dr. Demehri emphasized. “The landscape of atopic eczema therapeutics has dramatically changed in the recent years. It will be very interesting to determine how new biologics impact cancer risk in eczema patients.”

Partial support for the work was provided by the Wellcome Trust, the Royal Society, the Dagmar Marshalls Fund, and the Aase and Ejnar Danielsens Fund. Dr. Mansfield disclosed support from a Wellcome Trust grant. Her coinvestigators disclosed ties to TARGET-DERM, Pfizer, and GlaxoSmithKline, and from the Wellcome Trust, Medical Research Council, the National Institute for Health Research, the British Heart Foundation, Diabetes UK, and IMI Horizon 2020 funding BIOMAP. Dr. Demehri reported having no relevant conflicts of interest.

SOURCE: Mansfield KE et al. JAMA Dermatol. 2020 Jun 24. doi: 10.1001/jamadermatol.2020.1948.

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Clinical Edge

The merger of personal and professional: A psychologist’s experience with the effects of COVID-19

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Thu, 08/26/2021 - 16:04

The concepts of days, weeks, and months have all but lost their meaning during the times of coronavirus. This became all too clear when I found myself weeks into June before realizing that we were in the second half of 2020. The world has been in the grips of COVID-19 (the disease caused by SARS-CoV-2) for over half a year, and the end is still not in sight. Even more chilling is the fact that the virus’s effects will continue to be felt by humanity for years to come.

Dr. Juliana Tseng

By now, most of us have been affected by COVID-19, whether directly or indirectly. Consequently, we’ve seen that the psychological toll the pandemic takes is as wide ranging as the disease caused by the novel coronavirus itself. Confusion, denial, fear, anxiety, depression/sadness, and emotional dysregulation have become all too common an experience. Many mental health experts have even likened our psychological response to COVID-19 to that of trauma survivors.

In early 2020, when the trickle of news about the coronavirus turned into a steady stream, Chinese Americans began to experience anxiety triggered by two separate but related threats. In addition to concerns regarding COVID-19, we also began to experience fear for our physical safety as anti-Chinese sentiment began to rise across the country and the world. Discrimination and acts of violence toward Chinese people worldwide began to spread almost as rapidly as the virus itself. Anxiety and fear became a common daily experience of countless people, myself included.

In late March, amid coping with existing stressors, my situation became significantly worse when my brother, a New York City firefighter, contracted COVID-19 while working on the front lines. Shortly thereafter, my parents, both aged 60 years and older, with whom my brother shares a home, contracted the virus as well. My anxiety triggers related to the spread of the virus and xenophobia suddenly became a distant memory. I now found myself grappling with the much greater fear of losing my entire family.

At the time, the availability of testing was very limited, even for those working on the front lines. Although not without a short delay, my brother was able to access testing through Fire Department of New York connections. After about 3 weeks in self-isolation at home and with the use of over the counter pain relievers, he made a full recovery and returned to work. My parents, on the other hand, were placed at the end of a weeks-long line for testing, during which time their conditions deteriorated. Nine days following the onset of my mother’s symptoms, her condition had gotten so bad, she required hospitalization. Six days later, my father followed suit.

Being in the epicenter of the COVID-19 outbreak, New York hospitals were severely overwhelmed. Upon admission, my mother was held in the ED and other temporary open spaces in the hospital for nearly 24 hours because there was a lack of available patient rooms. During this time, she was packed into small spaces with dozens of other patients afflicted with the same disease. Four days later, she was transferred to a different hospital 10 miles away to make room for new patients. Decisions needed to be made rapidly and often with limited communication, which made for a roller coaster of emotions that would not relent.

Confusion. One of the few things we know with certainty about coronavirus is how much we don’t know. The Centers for Disease Control and Prevention data indicate that older adults with underlying health conditions have worse outcomes. Yet my mother, who is younger and in better physical health than my father, became much sicker in a drastically shorter period of time. Furthermore, my parents’ symptoms were completely inconsistent with one another’s. Based on their symptoms alone, it appeared as though they were suffering with different conditions entirely. My mother experienced body aches and gastrointestinal symptoms, whereas my father developed the typical cough and fever associated with COVID-19. In addition to confusion regarding their symptoms and, therefore, in determining the best at-home supportive care prior to their hospitalizations, the lack of available testing made the very question of whether they even had COVID-19 an uncertainty.

Denial. When my family members first became symptomatic, I found myself in a state of denial not unlike that of individuals experiencing grief. I frequently engaged in both internal and external dialogues in which I would attempt to convince myself of the reasons why my family did not have COVID-19.

“My brother wears PPE while at work.”

“My father’s cough was mild.”

“My mother does not have a cough or a fever.”

Despite knowing better, I was initially unable to accept that everyone in my family had contracted a disease that had already claimed the lives of tens of thousands globally.

Fear. In order to prevent the spread of infection, many hospitals made changes to their visitor policies, placing greater restrictions on who can come and go. This has meant hospital patients who have died from COVID-19 complications have done so separated from their loved ones. After transporting my mother to the hospital ED, I was politely but firmly asked to leave per the new visitor policy. I felt as though there were cinder blocks attached to my feet as I reluctantly walked away, not knowing if it would be the last time I would see her. I experienced a fear and sadness so intense, it continues to elicit an emotional response today as I think back on that moment.

Anxiety. The difference between fear and anxiety is fear is an emotional response to a known threat or danger, and anxiety is a response to an unknown threat or danger. The days that followed my parents’ hospitalizations were riddled with anxiety that would come in waves. How were they doing? Could they breathe? Do the overwhelmed hospital staff have time to take care of them? What can I do to help? Is there anything I can do to help? The worrisome thoughts and unanswerable questions were incessant and seemed unresponsive to my efforts to quell them.

Sadness. To feel sadness is to be human. In my work as a psychologist, I emphasize the value in experiencing this emotion when therapeutically beneficial. This technique is used as part of acceptance and commitment therapy (ACT), which emphasizes the value of being present or in touch with one’s thoughts and emotions, instead of working to eliminate them. During these scary times, I leaned into this notion more than ever. I gave myself permission to not feel okay, to cry more than I had in a long time, and to be unapologetically sad. I flip-flopped between states of near-despair and hopeful, with the switch usually following a call from a member of the hospital care team with updates on my parents’ conditions.

My parents’ road to recovery extended far beyond their discharge from the hospital and was not without incident, but with support and appropriate follow-up care, they have since made full recoveries from COVID-19. Although the relief and happiness this brings me is immeasurable, the experience has left a lasting impression on me as both a person and a psychologist. Speaking as a person, I cannot overstate the value of relying on one’s social support network while coping with stressors related to COVID-19. Whether you are directly or indirectly affected by the disease, the emotional effects can feel equally intense. As in times of happiness and celebration, times of sadness can and should be shared by those who are equipped to provide support. This can be tricky in an era during which isolation is prescribed for our safety, but we have more options today for connecting virtually with others than ever before, including video conferencing, email, and that old friend, the telephone. Furthermore, identify and assert your boundaries. Sometimes, saying no to others is the best way to say yes to yourself. Certain work, chores, and social obligations that can wait, should wait.

As a psychologist, my experience has given me a renewed appreciation for the power of the therapeutic use of self in psychotherapy. The factor with the greatest effects on psychotherapy outcomes is the quality of the therapeutic alliance, a concept introduced by Sigmund Freud in 1912. I believe a therapist’s willingness to show that we, too, experience life’s ups and downs strengthens our ability to demonstrate empathy and further promote a sense of alliance. Therapists are not immune to the effects of COVID-19, and to acknowledge this fact allows us to relate to our patients on a basic human level, which is more important now than ever.

Dr. Tseng, a licensed clinical psychologist, is in private practice in New York. She disclosed no relevant financial relationships.

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The concepts of days, weeks, and months have all but lost their meaning during the times of coronavirus. This became all too clear when I found myself weeks into June before realizing that we were in the second half of 2020. The world has been in the grips of COVID-19 (the disease caused by SARS-CoV-2) for over half a year, and the end is still not in sight. Even more chilling is the fact that the virus’s effects will continue to be felt by humanity for years to come.

Dr. Juliana Tseng

By now, most of us have been affected by COVID-19, whether directly or indirectly. Consequently, we’ve seen that the psychological toll the pandemic takes is as wide ranging as the disease caused by the novel coronavirus itself. Confusion, denial, fear, anxiety, depression/sadness, and emotional dysregulation have become all too common an experience. Many mental health experts have even likened our psychological response to COVID-19 to that of trauma survivors.

In early 2020, when the trickle of news about the coronavirus turned into a steady stream, Chinese Americans began to experience anxiety triggered by two separate but related threats. In addition to concerns regarding COVID-19, we also began to experience fear for our physical safety as anti-Chinese sentiment began to rise across the country and the world. Discrimination and acts of violence toward Chinese people worldwide began to spread almost as rapidly as the virus itself. Anxiety and fear became a common daily experience of countless people, myself included.

In late March, amid coping with existing stressors, my situation became significantly worse when my brother, a New York City firefighter, contracted COVID-19 while working on the front lines. Shortly thereafter, my parents, both aged 60 years and older, with whom my brother shares a home, contracted the virus as well. My anxiety triggers related to the spread of the virus and xenophobia suddenly became a distant memory. I now found myself grappling with the much greater fear of losing my entire family.

At the time, the availability of testing was very limited, even for those working on the front lines. Although not without a short delay, my brother was able to access testing through Fire Department of New York connections. After about 3 weeks in self-isolation at home and with the use of over the counter pain relievers, he made a full recovery and returned to work. My parents, on the other hand, were placed at the end of a weeks-long line for testing, during which time their conditions deteriorated. Nine days following the onset of my mother’s symptoms, her condition had gotten so bad, she required hospitalization. Six days later, my father followed suit.

Being in the epicenter of the COVID-19 outbreak, New York hospitals were severely overwhelmed. Upon admission, my mother was held in the ED and other temporary open spaces in the hospital for nearly 24 hours because there was a lack of available patient rooms. During this time, she was packed into small spaces with dozens of other patients afflicted with the same disease. Four days later, she was transferred to a different hospital 10 miles away to make room for new patients. Decisions needed to be made rapidly and often with limited communication, which made for a roller coaster of emotions that would not relent.

Confusion. One of the few things we know with certainty about coronavirus is how much we don’t know. The Centers for Disease Control and Prevention data indicate that older adults with underlying health conditions have worse outcomes. Yet my mother, who is younger and in better physical health than my father, became much sicker in a drastically shorter period of time. Furthermore, my parents’ symptoms were completely inconsistent with one another’s. Based on their symptoms alone, it appeared as though they were suffering with different conditions entirely. My mother experienced body aches and gastrointestinal symptoms, whereas my father developed the typical cough and fever associated with COVID-19. In addition to confusion regarding their symptoms and, therefore, in determining the best at-home supportive care prior to their hospitalizations, the lack of available testing made the very question of whether they even had COVID-19 an uncertainty.

Denial. When my family members first became symptomatic, I found myself in a state of denial not unlike that of individuals experiencing grief. I frequently engaged in both internal and external dialogues in which I would attempt to convince myself of the reasons why my family did not have COVID-19.

“My brother wears PPE while at work.”

“My father’s cough was mild.”

“My mother does not have a cough or a fever.”

Despite knowing better, I was initially unable to accept that everyone in my family had contracted a disease that had already claimed the lives of tens of thousands globally.

Fear. In order to prevent the spread of infection, many hospitals made changes to their visitor policies, placing greater restrictions on who can come and go. This has meant hospital patients who have died from COVID-19 complications have done so separated from their loved ones. After transporting my mother to the hospital ED, I was politely but firmly asked to leave per the new visitor policy. I felt as though there were cinder blocks attached to my feet as I reluctantly walked away, not knowing if it would be the last time I would see her. I experienced a fear and sadness so intense, it continues to elicit an emotional response today as I think back on that moment.

Anxiety. The difference between fear and anxiety is fear is an emotional response to a known threat or danger, and anxiety is a response to an unknown threat or danger. The days that followed my parents’ hospitalizations were riddled with anxiety that would come in waves. How were they doing? Could they breathe? Do the overwhelmed hospital staff have time to take care of them? What can I do to help? Is there anything I can do to help? The worrisome thoughts and unanswerable questions were incessant and seemed unresponsive to my efforts to quell them.

Sadness. To feel sadness is to be human. In my work as a psychologist, I emphasize the value in experiencing this emotion when therapeutically beneficial. This technique is used as part of acceptance and commitment therapy (ACT), which emphasizes the value of being present or in touch with one’s thoughts and emotions, instead of working to eliminate them. During these scary times, I leaned into this notion more than ever. I gave myself permission to not feel okay, to cry more than I had in a long time, and to be unapologetically sad. I flip-flopped between states of near-despair and hopeful, with the switch usually following a call from a member of the hospital care team with updates on my parents’ conditions.

My parents’ road to recovery extended far beyond their discharge from the hospital and was not without incident, but with support and appropriate follow-up care, they have since made full recoveries from COVID-19. Although the relief and happiness this brings me is immeasurable, the experience has left a lasting impression on me as both a person and a psychologist. Speaking as a person, I cannot overstate the value of relying on one’s social support network while coping with stressors related to COVID-19. Whether you are directly or indirectly affected by the disease, the emotional effects can feel equally intense. As in times of happiness and celebration, times of sadness can and should be shared by those who are equipped to provide support. This can be tricky in an era during which isolation is prescribed for our safety, but we have more options today for connecting virtually with others than ever before, including video conferencing, email, and that old friend, the telephone. Furthermore, identify and assert your boundaries. Sometimes, saying no to others is the best way to say yes to yourself. Certain work, chores, and social obligations that can wait, should wait.

As a psychologist, my experience has given me a renewed appreciation for the power of the therapeutic use of self in psychotherapy. The factor with the greatest effects on psychotherapy outcomes is the quality of the therapeutic alliance, a concept introduced by Sigmund Freud in 1912. I believe a therapist’s willingness to show that we, too, experience life’s ups and downs strengthens our ability to demonstrate empathy and further promote a sense of alliance. Therapists are not immune to the effects of COVID-19, and to acknowledge this fact allows us to relate to our patients on a basic human level, which is more important now than ever.

Dr. Tseng, a licensed clinical psychologist, is in private practice in New York. She disclosed no relevant financial relationships.

The concepts of days, weeks, and months have all but lost their meaning during the times of coronavirus. This became all too clear when I found myself weeks into June before realizing that we were in the second half of 2020. The world has been in the grips of COVID-19 (the disease caused by SARS-CoV-2) for over half a year, and the end is still not in sight. Even more chilling is the fact that the virus’s effects will continue to be felt by humanity for years to come.

Dr. Juliana Tseng

By now, most of us have been affected by COVID-19, whether directly or indirectly. Consequently, we’ve seen that the psychological toll the pandemic takes is as wide ranging as the disease caused by the novel coronavirus itself. Confusion, denial, fear, anxiety, depression/sadness, and emotional dysregulation have become all too common an experience. Many mental health experts have even likened our psychological response to COVID-19 to that of trauma survivors.

In early 2020, when the trickle of news about the coronavirus turned into a steady stream, Chinese Americans began to experience anxiety triggered by two separate but related threats. In addition to concerns regarding COVID-19, we also began to experience fear for our physical safety as anti-Chinese sentiment began to rise across the country and the world. Discrimination and acts of violence toward Chinese people worldwide began to spread almost as rapidly as the virus itself. Anxiety and fear became a common daily experience of countless people, myself included.

In late March, amid coping with existing stressors, my situation became significantly worse when my brother, a New York City firefighter, contracted COVID-19 while working on the front lines. Shortly thereafter, my parents, both aged 60 years and older, with whom my brother shares a home, contracted the virus as well. My anxiety triggers related to the spread of the virus and xenophobia suddenly became a distant memory. I now found myself grappling with the much greater fear of losing my entire family.

At the time, the availability of testing was very limited, even for those working on the front lines. Although not without a short delay, my brother was able to access testing through Fire Department of New York connections. After about 3 weeks in self-isolation at home and with the use of over the counter pain relievers, he made a full recovery and returned to work. My parents, on the other hand, were placed at the end of a weeks-long line for testing, during which time their conditions deteriorated. Nine days following the onset of my mother’s symptoms, her condition had gotten so bad, she required hospitalization. Six days later, my father followed suit.

Being in the epicenter of the COVID-19 outbreak, New York hospitals were severely overwhelmed. Upon admission, my mother was held in the ED and other temporary open spaces in the hospital for nearly 24 hours because there was a lack of available patient rooms. During this time, she was packed into small spaces with dozens of other patients afflicted with the same disease. Four days later, she was transferred to a different hospital 10 miles away to make room for new patients. Decisions needed to be made rapidly and often with limited communication, which made for a roller coaster of emotions that would not relent.

Confusion. One of the few things we know with certainty about coronavirus is how much we don’t know. The Centers for Disease Control and Prevention data indicate that older adults with underlying health conditions have worse outcomes. Yet my mother, who is younger and in better physical health than my father, became much sicker in a drastically shorter period of time. Furthermore, my parents’ symptoms were completely inconsistent with one another’s. Based on their symptoms alone, it appeared as though they were suffering with different conditions entirely. My mother experienced body aches and gastrointestinal symptoms, whereas my father developed the typical cough and fever associated with COVID-19. In addition to confusion regarding their symptoms and, therefore, in determining the best at-home supportive care prior to their hospitalizations, the lack of available testing made the very question of whether they even had COVID-19 an uncertainty.

Denial. When my family members first became symptomatic, I found myself in a state of denial not unlike that of individuals experiencing grief. I frequently engaged in both internal and external dialogues in which I would attempt to convince myself of the reasons why my family did not have COVID-19.

“My brother wears PPE while at work.”

“My father’s cough was mild.”

“My mother does not have a cough or a fever.”

Despite knowing better, I was initially unable to accept that everyone in my family had contracted a disease that had already claimed the lives of tens of thousands globally.

Fear. In order to prevent the spread of infection, many hospitals made changes to their visitor policies, placing greater restrictions on who can come and go. This has meant hospital patients who have died from COVID-19 complications have done so separated from their loved ones. After transporting my mother to the hospital ED, I was politely but firmly asked to leave per the new visitor policy. I felt as though there were cinder blocks attached to my feet as I reluctantly walked away, not knowing if it would be the last time I would see her. I experienced a fear and sadness so intense, it continues to elicit an emotional response today as I think back on that moment.

Anxiety. The difference between fear and anxiety is fear is an emotional response to a known threat or danger, and anxiety is a response to an unknown threat or danger. The days that followed my parents’ hospitalizations were riddled with anxiety that would come in waves. How were they doing? Could they breathe? Do the overwhelmed hospital staff have time to take care of them? What can I do to help? Is there anything I can do to help? The worrisome thoughts and unanswerable questions were incessant and seemed unresponsive to my efforts to quell them.

Sadness. To feel sadness is to be human. In my work as a psychologist, I emphasize the value in experiencing this emotion when therapeutically beneficial. This technique is used as part of acceptance and commitment therapy (ACT), which emphasizes the value of being present or in touch with one’s thoughts and emotions, instead of working to eliminate them. During these scary times, I leaned into this notion more than ever. I gave myself permission to not feel okay, to cry more than I had in a long time, and to be unapologetically sad. I flip-flopped between states of near-despair and hopeful, with the switch usually following a call from a member of the hospital care team with updates on my parents’ conditions.

My parents’ road to recovery extended far beyond their discharge from the hospital and was not without incident, but with support and appropriate follow-up care, they have since made full recoveries from COVID-19. Although the relief and happiness this brings me is immeasurable, the experience has left a lasting impression on me as both a person and a psychologist. Speaking as a person, I cannot overstate the value of relying on one’s social support network while coping with stressors related to COVID-19. Whether you are directly or indirectly affected by the disease, the emotional effects can feel equally intense. As in times of happiness and celebration, times of sadness can and should be shared by those who are equipped to provide support. This can be tricky in an era during which isolation is prescribed for our safety, but we have more options today for connecting virtually with others than ever before, including video conferencing, email, and that old friend, the telephone. Furthermore, identify and assert your boundaries. Sometimes, saying no to others is the best way to say yes to yourself. Certain work, chores, and social obligations that can wait, should wait.

As a psychologist, my experience has given me a renewed appreciation for the power of the therapeutic use of self in psychotherapy. The factor with the greatest effects on psychotherapy outcomes is the quality of the therapeutic alliance, a concept introduced by Sigmund Freud in 1912. I believe a therapist’s willingness to show that we, too, experience life’s ups and downs strengthens our ability to demonstrate empathy and further promote a sense of alliance. Therapists are not immune to the effects of COVID-19, and to acknowledge this fact allows us to relate to our patients on a basic human level, which is more important now than ever.

Dr. Tseng, a licensed clinical psychologist, is in private practice in New York. She disclosed no relevant financial relationships.

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HSCT may be best option for therapy-related ALL

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Wed, 06/24/2020 - 13:00

Therapy-related acute lymphoblastic leukemia (tALL) is less common and less well known than therapy-related acute myeloid leukemia, but tALL also appears to be associated with poor-prognosis features, compared with de novo ALL, investigators said.

“Currently, this condition is not fully recognized by the [World Health Organization] classification, but it has emerged as a relevant and increasingly common form of ALL. There is no standardized therapy for tALL at this time due to the rarity of the condition. Therefore, more information regarding characteristics, prognosis, and treatment is needed,” wrote Brayan Merchán, MD, and colleagues at Princess Margaret Hospital in Toronto.

At their center, the median overall survival (OS) among 58 patients with tALL who received front line induction therapy was 13 months, although patients who were able to undergo hematopoietic stem cell transplant had a 400% longer OS than patients who did not receive HSCT, they reported in an electronic poster presented as part of the virtual annual congress of the European Hematology Association.

A hematologist-oncologist who has studied tALL agreed that it appears to be a distinct clinical entity from de novo ALL.

“It is distinct from the other ALL because the age [at diagnosis] is different, the cytogenetic and molecular profiles are different, and while responses are the same, it seems that survival is lower in cases who don’t go through bone marrow transplant as consolidation,” said Ibrahim Aldoss, MD, from City of Hope Medical Center in Duarte, Calif.

Dr. Aldoss, who was not involved in the study, was the lead author of a study published in 2018 which found that, “[a]lthough survival of therapy-related acute lymphoblastic leukemia was inferior to de novo cases, allogeneic hematopoietic cell transplantation outcomes were comparable for the two entities” (Haematologica. 2018 Oct; 103[10]:1662-8).

He noted that induction regimen options for patients with tALL may be limited because some patients may had previous exposures to cytotoxic chemotherapy agents – such as anthracyclines used in standard regimens for breast cancer – that have cumulative toxicities and lifetime dose limits.

In addition, “these patients tend to be older, because they went through another cancer and then developed therapy-related ALL, and usually they’re not eligible for pediatric-inspired regimens that we use more frequently in younger patients,” he said.
 

Retrospective study

Dr. Merchán and colleagues conducted a retrospective study of all consecutive adults with ALL treated at their center from 1999 to 2019 and followed until January 2020. Of this group, they identified 59 patients who had been exposed to chemotherapy or radiation for other diseases prior to their ALL diagnosis.

The mean age of the 59 patients (31 women and 28 men) was 54.7 years. In all, 34 had solid cancers and 25 had hematologic malignancies before their ALL diagnosis. The most common diagnosis was breast cancer in 15 patients, followed by multiple myeloma in 11, lymphoma in 7, and AML in 5. Other prior diagnoses were not specified.

Prior therapies included chemotherapy alone in 18 patients, radiotherapy alone in 19, and 20 had both treatment modalities (information about 2 remaining patients was not presented).

For the overall population the median time to tALL diagnosis was 5 years, but for 9 patients with the poor-prognosis MLL gene rearrangement the median time to tALL was just 21 months. The disease latency period was 21 months for patients who received chemotherapy, compared with 117 months for patients treated with radiotherapy.

The majority of patients (53) had B-phenotype ALL. Of the 49 for whom cytogenetic data were available, 41 had cytogenetic abnormalities, including the MLL rearrangement in 9, and complex karyotype in 7. Of all 59 patients, 12 had translocation t(9;22).

One patient did not undergo induction therapy for ALL because of poor performance status. All of the other patients received induction therapy, either a Dana-Farber Cancer Institute protocol in 44 patients, hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) in 5, or blinatumomab in 3.

A complete response was seen in 41 patients (70%); 7 patients died during induction from causes attributed to therapy.

The mean follow-up for all patients was 27 months, and median overall survival was 13 months.

Median overall survival was 98 months for patients who underwent allogeneic HSCT versus a median of 19 months for patients who did not undergo transplant. This difference was not statistically significant, however, likely because of the small sample size.

Causes of death in 11 patients after transplant included relapse in 4 and graft-versus-host disease in 2 (other causes were not specified). Among the 34 patients who did not undergo HSCT following induction, 15 died from disease progression.

“From our results, tALL patients who were able to receive HSCT had better OS. Our data also supports the notion that tALL may be distinct entity with poor prognosis features compared to de novo ALL,” the investigators concluded.

The authors did not disclose a funding source. Dr. Merchán and Dr. Aldoss reported no relevant disclosures.

SOURCE: Merchán B et al. EHA25, Abstract EP391.

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Therapy-related acute lymphoblastic leukemia (tALL) is less common and less well known than therapy-related acute myeloid leukemia, but tALL also appears to be associated with poor-prognosis features, compared with de novo ALL, investigators said.

“Currently, this condition is not fully recognized by the [World Health Organization] classification, but it has emerged as a relevant and increasingly common form of ALL. There is no standardized therapy for tALL at this time due to the rarity of the condition. Therefore, more information regarding characteristics, prognosis, and treatment is needed,” wrote Brayan Merchán, MD, and colleagues at Princess Margaret Hospital in Toronto.

At their center, the median overall survival (OS) among 58 patients with tALL who received front line induction therapy was 13 months, although patients who were able to undergo hematopoietic stem cell transplant had a 400% longer OS than patients who did not receive HSCT, they reported in an electronic poster presented as part of the virtual annual congress of the European Hematology Association.

A hematologist-oncologist who has studied tALL agreed that it appears to be a distinct clinical entity from de novo ALL.

“It is distinct from the other ALL because the age [at diagnosis] is different, the cytogenetic and molecular profiles are different, and while responses are the same, it seems that survival is lower in cases who don’t go through bone marrow transplant as consolidation,” said Ibrahim Aldoss, MD, from City of Hope Medical Center in Duarte, Calif.

Dr. Aldoss, who was not involved in the study, was the lead author of a study published in 2018 which found that, “[a]lthough survival of therapy-related acute lymphoblastic leukemia was inferior to de novo cases, allogeneic hematopoietic cell transplantation outcomes were comparable for the two entities” (Haematologica. 2018 Oct; 103[10]:1662-8).

He noted that induction regimen options for patients with tALL may be limited because some patients may had previous exposures to cytotoxic chemotherapy agents – such as anthracyclines used in standard regimens for breast cancer – that have cumulative toxicities and lifetime dose limits.

In addition, “these patients tend to be older, because they went through another cancer and then developed therapy-related ALL, and usually they’re not eligible for pediatric-inspired regimens that we use more frequently in younger patients,” he said.
 

Retrospective study

Dr. Merchán and colleagues conducted a retrospective study of all consecutive adults with ALL treated at their center from 1999 to 2019 and followed until January 2020. Of this group, they identified 59 patients who had been exposed to chemotherapy or radiation for other diseases prior to their ALL diagnosis.

The mean age of the 59 patients (31 women and 28 men) was 54.7 years. In all, 34 had solid cancers and 25 had hematologic malignancies before their ALL diagnosis. The most common diagnosis was breast cancer in 15 patients, followed by multiple myeloma in 11, lymphoma in 7, and AML in 5. Other prior diagnoses were not specified.

Prior therapies included chemotherapy alone in 18 patients, radiotherapy alone in 19, and 20 had both treatment modalities (information about 2 remaining patients was not presented).

For the overall population the median time to tALL diagnosis was 5 years, but for 9 patients with the poor-prognosis MLL gene rearrangement the median time to tALL was just 21 months. The disease latency period was 21 months for patients who received chemotherapy, compared with 117 months for patients treated with radiotherapy.

The majority of patients (53) had B-phenotype ALL. Of the 49 for whom cytogenetic data were available, 41 had cytogenetic abnormalities, including the MLL rearrangement in 9, and complex karyotype in 7. Of all 59 patients, 12 had translocation t(9;22).

One patient did not undergo induction therapy for ALL because of poor performance status. All of the other patients received induction therapy, either a Dana-Farber Cancer Institute protocol in 44 patients, hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) in 5, or blinatumomab in 3.

A complete response was seen in 41 patients (70%); 7 patients died during induction from causes attributed to therapy.

The mean follow-up for all patients was 27 months, and median overall survival was 13 months.

Median overall survival was 98 months for patients who underwent allogeneic HSCT versus a median of 19 months for patients who did not undergo transplant. This difference was not statistically significant, however, likely because of the small sample size.

Causes of death in 11 patients after transplant included relapse in 4 and graft-versus-host disease in 2 (other causes were not specified). Among the 34 patients who did not undergo HSCT following induction, 15 died from disease progression.

“From our results, tALL patients who were able to receive HSCT had better OS. Our data also supports the notion that tALL may be distinct entity with poor prognosis features compared to de novo ALL,” the investigators concluded.

The authors did not disclose a funding source. Dr. Merchán and Dr. Aldoss reported no relevant disclosures.

SOURCE: Merchán B et al. EHA25, Abstract EP391.

Therapy-related acute lymphoblastic leukemia (tALL) is less common and less well known than therapy-related acute myeloid leukemia, but tALL also appears to be associated with poor-prognosis features, compared with de novo ALL, investigators said.

“Currently, this condition is not fully recognized by the [World Health Organization] classification, but it has emerged as a relevant and increasingly common form of ALL. There is no standardized therapy for tALL at this time due to the rarity of the condition. Therefore, more information regarding characteristics, prognosis, and treatment is needed,” wrote Brayan Merchán, MD, and colleagues at Princess Margaret Hospital in Toronto.

At their center, the median overall survival (OS) among 58 patients with tALL who received front line induction therapy was 13 months, although patients who were able to undergo hematopoietic stem cell transplant had a 400% longer OS than patients who did not receive HSCT, they reported in an electronic poster presented as part of the virtual annual congress of the European Hematology Association.

A hematologist-oncologist who has studied tALL agreed that it appears to be a distinct clinical entity from de novo ALL.

“It is distinct from the other ALL because the age [at diagnosis] is different, the cytogenetic and molecular profiles are different, and while responses are the same, it seems that survival is lower in cases who don’t go through bone marrow transplant as consolidation,” said Ibrahim Aldoss, MD, from City of Hope Medical Center in Duarte, Calif.

Dr. Aldoss, who was not involved in the study, was the lead author of a study published in 2018 which found that, “[a]lthough survival of therapy-related acute lymphoblastic leukemia was inferior to de novo cases, allogeneic hematopoietic cell transplantation outcomes were comparable for the two entities” (Haematologica. 2018 Oct; 103[10]:1662-8).

He noted that induction regimen options for patients with tALL may be limited because some patients may had previous exposures to cytotoxic chemotherapy agents – such as anthracyclines used in standard regimens for breast cancer – that have cumulative toxicities and lifetime dose limits.

In addition, “these patients tend to be older, because they went through another cancer and then developed therapy-related ALL, and usually they’re not eligible for pediatric-inspired regimens that we use more frequently in younger patients,” he said.
 

Retrospective study

Dr. Merchán and colleagues conducted a retrospective study of all consecutive adults with ALL treated at their center from 1999 to 2019 and followed until January 2020. Of this group, they identified 59 patients who had been exposed to chemotherapy or radiation for other diseases prior to their ALL diagnosis.

The mean age of the 59 patients (31 women and 28 men) was 54.7 years. In all, 34 had solid cancers and 25 had hematologic malignancies before their ALL diagnosis. The most common diagnosis was breast cancer in 15 patients, followed by multiple myeloma in 11, lymphoma in 7, and AML in 5. Other prior diagnoses were not specified.

Prior therapies included chemotherapy alone in 18 patients, radiotherapy alone in 19, and 20 had both treatment modalities (information about 2 remaining patients was not presented).

For the overall population the median time to tALL diagnosis was 5 years, but for 9 patients with the poor-prognosis MLL gene rearrangement the median time to tALL was just 21 months. The disease latency period was 21 months for patients who received chemotherapy, compared with 117 months for patients treated with radiotherapy.

The majority of patients (53) had B-phenotype ALL. Of the 49 for whom cytogenetic data were available, 41 had cytogenetic abnormalities, including the MLL rearrangement in 9, and complex karyotype in 7. Of all 59 patients, 12 had translocation t(9;22).

One patient did not undergo induction therapy for ALL because of poor performance status. All of the other patients received induction therapy, either a Dana-Farber Cancer Institute protocol in 44 patients, hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) in 5, or blinatumomab in 3.

A complete response was seen in 41 patients (70%); 7 patients died during induction from causes attributed to therapy.

The mean follow-up for all patients was 27 months, and median overall survival was 13 months.

Median overall survival was 98 months for patients who underwent allogeneic HSCT versus a median of 19 months for patients who did not undergo transplant. This difference was not statistically significant, however, likely because of the small sample size.

Causes of death in 11 patients after transplant included relapse in 4 and graft-versus-host disease in 2 (other causes were not specified). Among the 34 patients who did not undergo HSCT following induction, 15 died from disease progression.

“From our results, tALL patients who were able to receive HSCT had better OS. Our data also supports the notion that tALL may be distinct entity with poor prognosis features compared to de novo ALL,” the investigators concluded.

The authors did not disclose a funding source. Dr. Merchán and Dr. Aldoss reported no relevant disclosures.

SOURCE: Merchán B et al. EHA25, Abstract EP391.

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George Floyd, race, and psychiatry: How to talk to patients

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Thu, 10/29/2020 - 12:42

Editor’s Note: This transcript from the June 5 special episode of the Psychcast has been edited for clarity.

Nick Andrews: This is the Psychcast, the official podcast of MDedge Psychiatry. I am the voice of the MDedge podcasts, Nick Andrews. We are bringing this special edition of the Psychcast from MDedge in response to all of the unrest, peaceful or otherwise, in the United States in the aftermath of the shocking murder of George Floyd in late May of 2020.

Dr. Lorenzo Norris agreed to have this “after hours” discussion, believing the most appropriate response would be for us to have a real conversation about it. So welcome aboard.

Lorenzo Norris, MD: I’m happy to be here, Nick, and I’m so pleased to be talking with our guest, Dr. Brandon Newsome, a young black male psychiatrist. Dr. Newsome, sir, tell us a little about yourself and where you’re coming from.

Brandon Newsome, MD: I’m a 4th-year psychiatry resident at Boston Medical Center, so I’m about to graduate and to become a first-year fellow, as of July, at Children’s National Medical Center in Washington, D.C. I was born and raised in the South so I can talk about those experiences, and now I’ve been in the Northeast for the past 4 years.

Dr. Norris: Let’s get right into it. This is a time in our country that we’ve not seen – I shouldn’t say we, because depending on where you live in America, you have seen this and you’ve seen this multiple times.

I see a lot of myself in Dr. Newsome right now, and I am struggling with this: I’m talking to you about the same stuff I was talking about when I was a 4th-year resident. I’m talking to you about the same stuff I was talking about when I was a college student. I’m still talking about the same stuff I was talking about when I was a medical student. I’m still talking about the same things that were the impetus for the hip-hop generation regarding police brutality and violence.

We are still talking about the use of lethal force and abuse of power, particularly by police or law enforcement officers, and how that is perpetrated against African American men in particular, and the unfortunate and tragic murder of Mr. George Floyd. Dr. Newsome, tell me how you’re thinking about this. Before we even get into how our patients or our colleagues are doing, how are you doing with this?

Dr. Newsome: It’s been difficult. Like you, I’ve heard this story time and time again. I was just on a panel, having a conversation about race and policing, and I realized we had the same conversation during my first or second year of residency because there had been another death. But even though all of these unfortunate deaths are triggering us, this one is a little different for me for a few reasons. As you know, this is happening with the backdrop of the COVID-19 crisis and we’re already seeing so many people, especially from black and brown communities, dying from that.

 

 

And then I’m witnessing what happened, watching that video and thinking about all the interventions we’ve already tried. We tried body cameras, and the dude was wearing a body camera. We tried to get our police officers to be engaged, to try to check their roles, but people were there, witnessing everything, and nothing happened. An upstander was there, a white upstander, a firefighter who was telling them to check his pulse. Still nothing happened; it didn’t stop them.

I believe the backdrop of the COVID-19 crisis makes it a whole lot more painful for me and many others. I am part of a black physician email group and it’s been triggering for all of us because we all imagine that this could be me one day, especially when you think about the Amy Coopers of the world, among other things.

Dr. Norris: I completely agree. We’re dealing with loss of life due to a virus, including, [personally speaking] that of my departed grandmother Why am I bringing this up? I bring it up because, regardless of one’s socioeconomic strata or title or whatnot, particularly in the black community, this is the kind of mess we’re dealing with. We’re dealing with the stress of COVID-19 that is disproportionately affecting African Americans. We’re dealing with social isolation, we’re dealing with the economic recession and the collapse that everyone else is dealing with, and on top of that we are now dealing with another murder. But this particular murder resonates very differently because, as you said, it seemed like every single thing that could have been done was done.

You will read reports that Mr. Floyd was resisting arrest. But you look at this video; this is not a man resisting arrest. This is a man trying to say, please, you are killing me. These are other people saying the same thing. These are police officers not acting right. This is so many different things going on, and when you hear this and look at this video, you can come to no other conclusion than it is murder.

As psychiatrists, we frequently have to restrain people, and it is always understood that restraint can turn into assault extremely quickly. But in this particular case, there was no thought or concern about this man’s life or his health. There are many good police officers that do think of that, and so this was shocking. It was jarring. It was another thing piled on an already taxed black America. I was talking with my black male colleagues about this, and I think a lot of people don’t actually realize that, while there are black male psychiatrists, there are only a few of us.

Dr. Newsome: True that.

Dr. Norris: There are only so many black male physicians, period, and black male psychiatrists in particular. At different points in time we are called on to take leadership roles, and to talk, to speak on things and be a voice. Well, I have to tell you, after a while, this is pretty goddamn tiring for us to contain our disappointment, our anger, and our rage and still stay hopeful, optimistic, and still be a voice for those who are not able to speak.

Dr. Newsome: I agree that sometimes it can be tiring to have to take leadership roles and continue to talk about all these things, but I also feel that, at least for me, it gives me some sort of route to address the angst and do something with it. I believe all of us are just figuring out how to deal with these feelings that we shouldn’t have to feel because of a murder that was televised.

Dr. Norris: Thank you. For a murder that was televised; that was tweeted; that was broadbanded; that was streamed.

 

 

Now we’ve laid the framework, in terms of what we’re feeling. Let’s move on to why you and I are in this profession, and that’s our patients. What are you seeing on the front lines? What are you seeing with our patients?

Dr. Newsome: I was speaking with one of my black male patients, and he was fearful. He had been perfectly fine, even in the COVID crisis, he was doing well. But when you get this milieu of police violence, now he’s feeling this intense fear. Should I be walking alone at night? What happens if I am the one who is at the wrong place at the wrong time?

I also find that some of my nonminority patients sometimes find difficulty making sense of it. Minority individuals already know these things are happening. But some of the nonminorities are wondering how or why would something like this happen in America? This is just how America is for the black folks.

Dr. Norris: Could you elaborate on that? I always found that to be a very interesting dynamic for those who are not minorities or people of color. I will have folks in a psychotherapy session who are just bewildered by events like this. It is not the America they think they know – they are shocked that this is actually what’s going on.

Dr. Newsome: It’s all about experiences. If you didn’t grow up around a lot of minorities, you haven’t necessarily had these conversations. Even speaking for myself, sometimes I don’t want to discuss these things; you never know what you’re going to get. You might find an ally, or you might find someone who isn’t at all supportive. I think the surprise is from lack of exposure. If you don’t have to live through racism, you can most certainly have blinders on and not notice.

Dr. Norris: Can you comment on the fear you’re seeing in some folks? Can it get to the point of reactivating PTSD?

Dr. Newsome: I notice it more with black individuals, a fear that they might be the ones who may die; or with black mothers, wondering, what about my child? Is this what they are going to have to live with for the rest of their lives? Older people would say that we fought already and it’s still going on. What are the fruits of the labor we put in?

Dr. Norris: I agree with you completely. What are the fruits? You’re going to see those strong reactions. You’re going to see fear, you’re going to see anger, and you’re also going to see guilt that they could not stop this. I’m speaking particularly about some of my nonminority patients. It goes along with that confusion. This manifests in a desperate need to do something.

But here’s the problem: You don’t really know what to do because no one is educated on it. And as you said before, race is a very polarized subject. No one even likes to talk about racism because it’s so, oh my goodness. We’ve run away from it so much to the point that we can’t deal with it. Racism, whether or not you witness it, whether or not you participate in it, whether or not you are the subject of it, affects and hurts us all. We all have to start to own that. You can’t just stay siloed, because eventually, it’s going to come back and affect you.

I could easily be Mr. Floyd, but at the same time, due to my station and things of that nature, I have a certain level of privilege and autonomy. There could be a tendency to put your head under the sand, you know, look at how far we’ve come, Barack Obama. But you’ve got to say, no, we still have enormous amounts of work to do.

We’ve been talking about the patients. What have you noticed in your colleagues and how they’ve been feeling about this?

Dr. Newsome: Again, I see them feeling saddened by the events. One of the other things I’ve noticed is that some people are in environments where they have program directors and chairs who will directly condemn certain behaviors and say, “This is racist, this shouldn’t happen.” But then there are other programs that have been more silent. I’ve had people say that this is the first time that they have felt isolated in a long while.

We all participate in these physician WhatsApp groups, and according to some of the comments, people are realizing that these folks that they were just on the front lines with, fighting COVID, are perhaps not the allies that they originally thought they were, based on the things these people are saying.

Dr. Norris: Wow. It’s good that we’re talking about this from the viewpoint of two different generations. You’ve got the WhatsApp group and Google Hangouts and all that kind of good stuff, and I’m still with pagers and such. That’s interesting – the reality that folks you thought were your allies turn out not to be, because you’re bringing up difficult conversations that we don’t normally talk about.

I have noticed that some people around me have been silent because they don’t know what to say. They’re so concerned that I’m going to be offended or they’re going to hurt me or say the wrong thing, so they stay quiet. As I reflect now, this is the wrong thing to do. Own your concern. I’ve been in two large meetings now, and I’ve had multiple people whom I consider friends say, I wanted to email or text you right then and ask you how you’re doing, but I didn’t because I didn’t know what to say. I have entered meetings recently, and the meeting felt tense, and I’m thinking, what’s going on? And now I realize they did not know what to say or how to approach it.

That’s been a very interesting dynamic and tells us where we are with this. Today, for example, I was pleased to have the support of my dean’s group. I felt I had to speak out, I just had to straight out tell them. Do you want to know what I’m feeling? I’m feeling rage. I’m feeling rage. And you all have to understand that, because I have to speak for those who aren’t necessarily going to be able to express themselves. More importantly, I have to speak for myself and I’m feeling rage.

How our colleagues are processing this and how they’re thinking about this runs the gamut. But I think about people not necessarily knowing what to say or how to approach it. I absolutely agree that with the leadership, you’re going to get many different responses, and sometimes you’re left to wonder, do I have to watch what I say? But I’m definitely supported at my institution.

What else are you seeing out there in terms of your colleagues or how people think about it?

 

 

Dr. Newsome: This also spurs some folks to activism. Some have been participating in protests. There will be White Coats for Black Lives protests, among other things. So it’s spurred folks to action, and it’s also spurred folks to try to be part of a community. Of course, with the whole COVID crisis, we can’t necessarily come together, so we’ve been doing Zoom gatherings more than anything else. But it has encouraged folks to want to do that more, too, because they want to check in on their brother or their sister to make sure they are doing well, and also to be able to express what’s going on with them in a community where they know they can get validation.

The mission of White Coats for Black Lives is to "dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color."
Courtesy George Washington University Hospital Internal Medicine, Instagram @gtwon_medres
The mission of White Coats for Black Lives is to 'dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color.'

Dr. Norris: I’m going to push you a bit because I detect in your tone something similar to what I’m feeling. I just got the email, the White Coats For Black Lives email. But I think your feeling is similar to mine – I’ve done this before. I’ve done White Coats for Black Lives. You all may have protested. But this display in Washington, D.C., of the use of military and law enforcement to clear a public square of peaceful protesters is above and beyond the pale of anything I’ve ever seen in my life. We have to label that for the danger it is, for the threat to everything this country and the people that bled for this country stand for.

So while I’m going to participate in White Coats for Black Lives and many other things, I am looking for what is actually going to move the needle. I think the protests are great, but at this point in time I want institutions, I want money, I want lawyers, I want a systematic approach.

Dr. Newsome: I most certainly agree. Of course, the protests are really important, but depending on where you are, you have a different lens. As physicians, especially as black physicians, since there are so few of us, we have a unique opportunity to leverage that, whether that means communicating through op-eds or calling your senators and talking with them to try to move things forward.

Physicians are mobilizing. In the last few days, a physician created a Zoom event and hundreds of physicians joined to try to figure out how we can structurally fix this problem. So I most certainly believe that in this effort to address racism, we physicians will need to lend our voices and our privilege to move the needle as best we can.

Dr. Norris: Some of our colleagues in Black Psychiatrists of America have put out a press release on racism in which they propose some actions that should be taken immediately. I think this is a useful thing to talk about.

The first action: “Declare racism a public health problem and establish national goals for addressing this as a health equity issue. Give priority to addressing the issues of health care disparities, including the mental health needs of historically marginalized communities across the U.S.”

 

 

What do you think about that?

Dr. Newsome: Those are two extremely important steps. The question is: How do you make that happen?

Dr. Norris: You’re reading my mind. I love that our colleagues put that out there, but that was my next question.

Dr. Newsome: There is going to be a town hall about this and I’m hoping that we can plan how we envision this happening. I can imagine that 20 or 30 years ago there was also a fear in society that there would be episodes of police brutality. I can imagine that there were similar ideals and hopes. But I think we need to put all of our minds together and ask: How are we going to accomplish this? Is this going to be something we’re going to put our money into? Is this going to be something we’re going to get senators and legislatures onboard with to make policy?

Dr. Norris: Let me read off some of the other action points they put out. There are six of them.

“Establish a governmental multidisciplinary and ethnically diverse commission with representatives from the major health care professional associations in medicine, nursing, psychiatry, public health, psychology, social work, etc., and the faith-based community to provide recommendations to Congress regarding policies on how to best improve the health and well-being of our nation’s black citizens.”

That’s a very solid overall recommendation. My question is, doesn’t that, in some way, shape, or form already exist? Could we not put up policy statements from all of these folks regarding racism and things of that nature? I agree with what they’re saying, but part of me wonders why certain things in the current system aren’t working. That becomes the question. Are we not integrated enough? Do we not have enough cross talk? Do we not have enough money behind it? So I agree with that goal, but I would be curious if that doesn’t already exist. What are your thoughts about that, Dr. Newsome?

Dr. Newsome: I would imagine that the National Institute on Minority Mental Health and Health Disparities would have something similar. I believe one of the things you mentioned is really important. In addition to making these recommendations, we need to be looking at where these leaks are occurring that keep them from working. What is the current structure and why is it the way it is with regard to the governance?

Dr. Norris: Here is another of their action statements: “Declare ‘civic mental health’ a national priority and incorporate it into the educational curriculum from K through college, as well as in the training of local, state, and national officials, law enforcement, and the criminal justice system.”

Let me be clear, I like every single one of these action statements. I encourage everyone to participate in dialogue and discussion. You may agree with some of these, and some of them you may not, but if there is one you agree with, that you really are motivated about, that’s one that you need to explore and dig into a bit more, because it’s too big for us to handle on our own, just like racism and equality.

 

 

I’m going to tell you, I like this statement. I do like this. Obviously these are broad points, but I do like the idea of training law enforcement officers about “civic mental health.” For example, Dr. Michael Compton, who has done a lot of great work in the area of mental health and prevention, has worked with police officers to help them interact with those with mental health conditions by modulating their own emotional response. I’m very interested in these types of recommendations that particularly target law enforcement officers, and helping with that ”emotional quotient.” I’m interested in seeing how far that can spread in the country. What do you think, Dr. Newsome?

Dr. Newsome: Educating police officers about how to interact would be quite important. I believe the National Alliance on Mental Illness does some of that work, partnering with law enforcement agencies, talking about mental health and cues to look at. There also are some programs where people ride along with mental health clinicians and police officers, which I find to be really helpful. But clearly, what’s going on right now isn’t working. So I would be open to any reasonable idea.

Dr. Norris: Here’s one last action point: “Establish police community review boards with power to take action in areas of police misconduct pending formal review by the appropriate authorities. This will offer a level of empowerment when communities feel they have a voice that can be heard.”

This is where I want my focus to be, as I move forward to try to do something sustainable. To deal with police brutality and abuse of power in general, but specifically as it relates to African American men and the lethal use of force. We need to work on policies that will enable African American men to make it to court, so that every encounter with a police officer is not literally viewed as a potentially lethal encounter.

A lot of people aren’t going to like me saying that, but it’s the absolute truth. You have to think like that, as an African American male, regardless of your station, regardless of where you live, this is the reality. There are many, many good police officers out there. I have a few friends who are law enforcement officers. I work with security at the George Washington Hospital constantly. But that still does not change the fact that if I get pulled over at a traffic stop, I know precisely certain things I need to do and not do, or the encounter could end badly. By that I mean loss of life.

So I encourage anything where we can start to take a systematic look at law enforcement and empower communities to look at who is doing it right and who is doing it wrong. Information is coming out now about the man who murdered Mr. Floyd, and this was not the first time he was involved in misconduct. There were red flags; we have to start to confront this. We have to learn from every single one of these situations and grow because another one is going to happen next week, it’s just whether or not you hear about it. That’s the reality of the state of America. You may not like to hear it, but that’s just a fact.


To hear the entire conversation, go to mdedge.com/podcasts or listen wherever you find your podcasts.
 

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Editor’s Note: This transcript from the June 5 special episode of the Psychcast has been edited for clarity.

Nick Andrews: This is the Psychcast, the official podcast of MDedge Psychiatry. I am the voice of the MDedge podcasts, Nick Andrews. We are bringing this special edition of the Psychcast from MDedge in response to all of the unrest, peaceful or otherwise, in the United States in the aftermath of the shocking murder of George Floyd in late May of 2020.

Dr. Lorenzo Norris agreed to have this “after hours” discussion, believing the most appropriate response would be for us to have a real conversation about it. So welcome aboard.

Lorenzo Norris, MD: I’m happy to be here, Nick, and I’m so pleased to be talking with our guest, Dr. Brandon Newsome, a young black male psychiatrist. Dr. Newsome, sir, tell us a little about yourself and where you’re coming from.

Brandon Newsome, MD: I’m a 4th-year psychiatry resident at Boston Medical Center, so I’m about to graduate and to become a first-year fellow, as of July, at Children’s National Medical Center in Washington, D.C. I was born and raised in the South so I can talk about those experiences, and now I’ve been in the Northeast for the past 4 years.

Dr. Norris: Let’s get right into it. This is a time in our country that we’ve not seen – I shouldn’t say we, because depending on where you live in America, you have seen this and you’ve seen this multiple times.

I see a lot of myself in Dr. Newsome right now, and I am struggling with this: I’m talking to you about the same stuff I was talking about when I was a 4th-year resident. I’m talking to you about the same stuff I was talking about when I was a college student. I’m still talking about the same stuff I was talking about when I was a medical student. I’m still talking about the same things that were the impetus for the hip-hop generation regarding police brutality and violence.

We are still talking about the use of lethal force and abuse of power, particularly by police or law enforcement officers, and how that is perpetrated against African American men in particular, and the unfortunate and tragic murder of Mr. George Floyd. Dr. Newsome, tell me how you’re thinking about this. Before we even get into how our patients or our colleagues are doing, how are you doing with this?

Dr. Newsome: It’s been difficult. Like you, I’ve heard this story time and time again. I was just on a panel, having a conversation about race and policing, and I realized we had the same conversation during my first or second year of residency because there had been another death. But even though all of these unfortunate deaths are triggering us, this one is a little different for me for a few reasons. As you know, this is happening with the backdrop of the COVID-19 crisis and we’re already seeing so many people, especially from black and brown communities, dying from that.

 

 

And then I’m witnessing what happened, watching that video and thinking about all the interventions we’ve already tried. We tried body cameras, and the dude was wearing a body camera. We tried to get our police officers to be engaged, to try to check their roles, but people were there, witnessing everything, and nothing happened. An upstander was there, a white upstander, a firefighter who was telling them to check his pulse. Still nothing happened; it didn’t stop them.

I believe the backdrop of the COVID-19 crisis makes it a whole lot more painful for me and many others. I am part of a black physician email group and it’s been triggering for all of us because we all imagine that this could be me one day, especially when you think about the Amy Coopers of the world, among other things.

Dr. Norris: I completely agree. We’re dealing with loss of life due to a virus, including, [personally speaking] that of my departed grandmother Why am I bringing this up? I bring it up because, regardless of one’s socioeconomic strata or title or whatnot, particularly in the black community, this is the kind of mess we’re dealing with. We’re dealing with the stress of COVID-19 that is disproportionately affecting African Americans. We’re dealing with social isolation, we’re dealing with the economic recession and the collapse that everyone else is dealing with, and on top of that we are now dealing with another murder. But this particular murder resonates very differently because, as you said, it seemed like every single thing that could have been done was done.

You will read reports that Mr. Floyd was resisting arrest. But you look at this video; this is not a man resisting arrest. This is a man trying to say, please, you are killing me. These are other people saying the same thing. These are police officers not acting right. This is so many different things going on, and when you hear this and look at this video, you can come to no other conclusion than it is murder.

As psychiatrists, we frequently have to restrain people, and it is always understood that restraint can turn into assault extremely quickly. But in this particular case, there was no thought or concern about this man’s life or his health. There are many good police officers that do think of that, and so this was shocking. It was jarring. It was another thing piled on an already taxed black America. I was talking with my black male colleagues about this, and I think a lot of people don’t actually realize that, while there are black male psychiatrists, there are only a few of us.

Dr. Newsome: True that.

Dr. Norris: There are only so many black male physicians, period, and black male psychiatrists in particular. At different points in time we are called on to take leadership roles, and to talk, to speak on things and be a voice. Well, I have to tell you, after a while, this is pretty goddamn tiring for us to contain our disappointment, our anger, and our rage and still stay hopeful, optimistic, and still be a voice for those who are not able to speak.

Dr. Newsome: I agree that sometimes it can be tiring to have to take leadership roles and continue to talk about all these things, but I also feel that, at least for me, it gives me some sort of route to address the angst and do something with it. I believe all of us are just figuring out how to deal with these feelings that we shouldn’t have to feel because of a murder that was televised.

Dr. Norris: Thank you. For a murder that was televised; that was tweeted; that was broadbanded; that was streamed.

 

 

Now we’ve laid the framework, in terms of what we’re feeling. Let’s move on to why you and I are in this profession, and that’s our patients. What are you seeing on the front lines? What are you seeing with our patients?

Dr. Newsome: I was speaking with one of my black male patients, and he was fearful. He had been perfectly fine, even in the COVID crisis, he was doing well. But when you get this milieu of police violence, now he’s feeling this intense fear. Should I be walking alone at night? What happens if I am the one who is at the wrong place at the wrong time?

I also find that some of my nonminority patients sometimes find difficulty making sense of it. Minority individuals already know these things are happening. But some of the nonminorities are wondering how or why would something like this happen in America? This is just how America is for the black folks.

Dr. Norris: Could you elaborate on that? I always found that to be a very interesting dynamic for those who are not minorities or people of color. I will have folks in a psychotherapy session who are just bewildered by events like this. It is not the America they think they know – they are shocked that this is actually what’s going on.

Dr. Newsome: It’s all about experiences. If you didn’t grow up around a lot of minorities, you haven’t necessarily had these conversations. Even speaking for myself, sometimes I don’t want to discuss these things; you never know what you’re going to get. You might find an ally, or you might find someone who isn’t at all supportive. I think the surprise is from lack of exposure. If you don’t have to live through racism, you can most certainly have blinders on and not notice.

Dr. Norris: Can you comment on the fear you’re seeing in some folks? Can it get to the point of reactivating PTSD?

Dr. Newsome: I notice it more with black individuals, a fear that they might be the ones who may die; or with black mothers, wondering, what about my child? Is this what they are going to have to live with for the rest of their lives? Older people would say that we fought already and it’s still going on. What are the fruits of the labor we put in?

Dr. Norris: I agree with you completely. What are the fruits? You’re going to see those strong reactions. You’re going to see fear, you’re going to see anger, and you’re also going to see guilt that they could not stop this. I’m speaking particularly about some of my nonminority patients. It goes along with that confusion. This manifests in a desperate need to do something.

But here’s the problem: You don’t really know what to do because no one is educated on it. And as you said before, race is a very polarized subject. No one even likes to talk about racism because it’s so, oh my goodness. We’ve run away from it so much to the point that we can’t deal with it. Racism, whether or not you witness it, whether or not you participate in it, whether or not you are the subject of it, affects and hurts us all. We all have to start to own that. You can’t just stay siloed, because eventually, it’s going to come back and affect you.

I could easily be Mr. Floyd, but at the same time, due to my station and things of that nature, I have a certain level of privilege and autonomy. There could be a tendency to put your head under the sand, you know, look at how far we’ve come, Barack Obama. But you’ve got to say, no, we still have enormous amounts of work to do.

We’ve been talking about the patients. What have you noticed in your colleagues and how they’ve been feeling about this?

Dr. Newsome: Again, I see them feeling saddened by the events. One of the other things I’ve noticed is that some people are in environments where they have program directors and chairs who will directly condemn certain behaviors and say, “This is racist, this shouldn’t happen.” But then there are other programs that have been more silent. I’ve had people say that this is the first time that they have felt isolated in a long while.

We all participate in these physician WhatsApp groups, and according to some of the comments, people are realizing that these folks that they were just on the front lines with, fighting COVID, are perhaps not the allies that they originally thought they were, based on the things these people are saying.

Dr. Norris: Wow. It’s good that we’re talking about this from the viewpoint of two different generations. You’ve got the WhatsApp group and Google Hangouts and all that kind of good stuff, and I’m still with pagers and such. That’s interesting – the reality that folks you thought were your allies turn out not to be, because you’re bringing up difficult conversations that we don’t normally talk about.

I have noticed that some people around me have been silent because they don’t know what to say. They’re so concerned that I’m going to be offended or they’re going to hurt me or say the wrong thing, so they stay quiet. As I reflect now, this is the wrong thing to do. Own your concern. I’ve been in two large meetings now, and I’ve had multiple people whom I consider friends say, I wanted to email or text you right then and ask you how you’re doing, but I didn’t because I didn’t know what to say. I have entered meetings recently, and the meeting felt tense, and I’m thinking, what’s going on? And now I realize they did not know what to say or how to approach it.

That’s been a very interesting dynamic and tells us where we are with this. Today, for example, I was pleased to have the support of my dean’s group. I felt I had to speak out, I just had to straight out tell them. Do you want to know what I’m feeling? I’m feeling rage. I’m feeling rage. And you all have to understand that, because I have to speak for those who aren’t necessarily going to be able to express themselves. More importantly, I have to speak for myself and I’m feeling rage.

How our colleagues are processing this and how they’re thinking about this runs the gamut. But I think about people not necessarily knowing what to say or how to approach it. I absolutely agree that with the leadership, you’re going to get many different responses, and sometimes you’re left to wonder, do I have to watch what I say? But I’m definitely supported at my institution.

What else are you seeing out there in terms of your colleagues or how people think about it?

 

 

Dr. Newsome: This also spurs some folks to activism. Some have been participating in protests. There will be White Coats for Black Lives protests, among other things. So it’s spurred folks to action, and it’s also spurred folks to try to be part of a community. Of course, with the whole COVID crisis, we can’t necessarily come together, so we’ve been doing Zoom gatherings more than anything else. But it has encouraged folks to want to do that more, too, because they want to check in on their brother or their sister to make sure they are doing well, and also to be able to express what’s going on with them in a community where they know they can get validation.

The mission of White Coats for Black Lives is to "dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color."
Courtesy George Washington University Hospital Internal Medicine, Instagram @gtwon_medres
The mission of White Coats for Black Lives is to 'dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color.'

Dr. Norris: I’m going to push you a bit because I detect in your tone something similar to what I’m feeling. I just got the email, the White Coats For Black Lives email. But I think your feeling is similar to mine – I’ve done this before. I’ve done White Coats for Black Lives. You all may have protested. But this display in Washington, D.C., of the use of military and law enforcement to clear a public square of peaceful protesters is above and beyond the pale of anything I’ve ever seen in my life. We have to label that for the danger it is, for the threat to everything this country and the people that bled for this country stand for.

So while I’m going to participate in White Coats for Black Lives and many other things, I am looking for what is actually going to move the needle. I think the protests are great, but at this point in time I want institutions, I want money, I want lawyers, I want a systematic approach.

Dr. Newsome: I most certainly agree. Of course, the protests are really important, but depending on where you are, you have a different lens. As physicians, especially as black physicians, since there are so few of us, we have a unique opportunity to leverage that, whether that means communicating through op-eds or calling your senators and talking with them to try to move things forward.

Physicians are mobilizing. In the last few days, a physician created a Zoom event and hundreds of physicians joined to try to figure out how we can structurally fix this problem. So I most certainly believe that in this effort to address racism, we physicians will need to lend our voices and our privilege to move the needle as best we can.

Dr. Norris: Some of our colleagues in Black Psychiatrists of America have put out a press release on racism in which they propose some actions that should be taken immediately. I think this is a useful thing to talk about.

The first action: “Declare racism a public health problem and establish national goals for addressing this as a health equity issue. Give priority to addressing the issues of health care disparities, including the mental health needs of historically marginalized communities across the U.S.”

 

 

What do you think about that?

Dr. Newsome: Those are two extremely important steps. The question is: How do you make that happen?

Dr. Norris: You’re reading my mind. I love that our colleagues put that out there, but that was my next question.

Dr. Newsome: There is going to be a town hall about this and I’m hoping that we can plan how we envision this happening. I can imagine that 20 or 30 years ago there was also a fear in society that there would be episodes of police brutality. I can imagine that there were similar ideals and hopes. But I think we need to put all of our minds together and ask: How are we going to accomplish this? Is this going to be something we’re going to put our money into? Is this going to be something we’re going to get senators and legislatures onboard with to make policy?

Dr. Norris: Let me read off some of the other action points they put out. There are six of them.

“Establish a governmental multidisciplinary and ethnically diverse commission with representatives from the major health care professional associations in medicine, nursing, psychiatry, public health, psychology, social work, etc., and the faith-based community to provide recommendations to Congress regarding policies on how to best improve the health and well-being of our nation’s black citizens.”

That’s a very solid overall recommendation. My question is, doesn’t that, in some way, shape, or form already exist? Could we not put up policy statements from all of these folks regarding racism and things of that nature? I agree with what they’re saying, but part of me wonders why certain things in the current system aren’t working. That becomes the question. Are we not integrated enough? Do we not have enough cross talk? Do we not have enough money behind it? So I agree with that goal, but I would be curious if that doesn’t already exist. What are your thoughts about that, Dr. Newsome?

Dr. Newsome: I would imagine that the National Institute on Minority Mental Health and Health Disparities would have something similar. I believe one of the things you mentioned is really important. In addition to making these recommendations, we need to be looking at where these leaks are occurring that keep them from working. What is the current structure and why is it the way it is with regard to the governance?

Dr. Norris: Here is another of their action statements: “Declare ‘civic mental health’ a national priority and incorporate it into the educational curriculum from K through college, as well as in the training of local, state, and national officials, law enforcement, and the criminal justice system.”

Let me be clear, I like every single one of these action statements. I encourage everyone to participate in dialogue and discussion. You may agree with some of these, and some of them you may not, but if there is one you agree with, that you really are motivated about, that’s one that you need to explore and dig into a bit more, because it’s too big for us to handle on our own, just like racism and equality.

 

 

I’m going to tell you, I like this statement. I do like this. Obviously these are broad points, but I do like the idea of training law enforcement officers about “civic mental health.” For example, Dr. Michael Compton, who has done a lot of great work in the area of mental health and prevention, has worked with police officers to help them interact with those with mental health conditions by modulating their own emotional response. I’m very interested in these types of recommendations that particularly target law enforcement officers, and helping with that ”emotional quotient.” I’m interested in seeing how far that can spread in the country. What do you think, Dr. Newsome?

Dr. Newsome: Educating police officers about how to interact would be quite important. I believe the National Alliance on Mental Illness does some of that work, partnering with law enforcement agencies, talking about mental health and cues to look at. There also are some programs where people ride along with mental health clinicians and police officers, which I find to be really helpful. But clearly, what’s going on right now isn’t working. So I would be open to any reasonable idea.

Dr. Norris: Here’s one last action point: “Establish police community review boards with power to take action in areas of police misconduct pending formal review by the appropriate authorities. This will offer a level of empowerment when communities feel they have a voice that can be heard.”

This is where I want my focus to be, as I move forward to try to do something sustainable. To deal with police brutality and abuse of power in general, but specifically as it relates to African American men and the lethal use of force. We need to work on policies that will enable African American men to make it to court, so that every encounter with a police officer is not literally viewed as a potentially lethal encounter.

A lot of people aren’t going to like me saying that, but it’s the absolute truth. You have to think like that, as an African American male, regardless of your station, regardless of where you live, this is the reality. There are many, many good police officers out there. I have a few friends who are law enforcement officers. I work with security at the George Washington Hospital constantly. But that still does not change the fact that if I get pulled over at a traffic stop, I know precisely certain things I need to do and not do, or the encounter could end badly. By that I mean loss of life.

So I encourage anything where we can start to take a systematic look at law enforcement and empower communities to look at who is doing it right and who is doing it wrong. Information is coming out now about the man who murdered Mr. Floyd, and this was not the first time he was involved in misconduct. There were red flags; we have to start to confront this. We have to learn from every single one of these situations and grow because another one is going to happen next week, it’s just whether or not you hear about it. That’s the reality of the state of America. You may not like to hear it, but that’s just a fact.


To hear the entire conversation, go to mdedge.com/podcasts or listen wherever you find your podcasts.
 

Editor’s Note: This transcript from the June 5 special episode of the Psychcast has been edited for clarity.

Nick Andrews: This is the Psychcast, the official podcast of MDedge Psychiatry. I am the voice of the MDedge podcasts, Nick Andrews. We are bringing this special edition of the Psychcast from MDedge in response to all of the unrest, peaceful or otherwise, in the United States in the aftermath of the shocking murder of George Floyd in late May of 2020.

Dr. Lorenzo Norris agreed to have this “after hours” discussion, believing the most appropriate response would be for us to have a real conversation about it. So welcome aboard.

Lorenzo Norris, MD: I’m happy to be here, Nick, and I’m so pleased to be talking with our guest, Dr. Brandon Newsome, a young black male psychiatrist. Dr. Newsome, sir, tell us a little about yourself and where you’re coming from.

Brandon Newsome, MD: I’m a 4th-year psychiatry resident at Boston Medical Center, so I’m about to graduate and to become a first-year fellow, as of July, at Children’s National Medical Center in Washington, D.C. I was born and raised in the South so I can talk about those experiences, and now I’ve been in the Northeast for the past 4 years.

Dr. Norris: Let’s get right into it. This is a time in our country that we’ve not seen – I shouldn’t say we, because depending on where you live in America, you have seen this and you’ve seen this multiple times.

I see a lot of myself in Dr. Newsome right now, and I am struggling with this: I’m talking to you about the same stuff I was talking about when I was a 4th-year resident. I’m talking to you about the same stuff I was talking about when I was a college student. I’m still talking about the same stuff I was talking about when I was a medical student. I’m still talking about the same things that were the impetus for the hip-hop generation regarding police brutality and violence.

We are still talking about the use of lethal force and abuse of power, particularly by police or law enforcement officers, and how that is perpetrated against African American men in particular, and the unfortunate and tragic murder of Mr. George Floyd. Dr. Newsome, tell me how you’re thinking about this. Before we even get into how our patients or our colleagues are doing, how are you doing with this?

Dr. Newsome: It’s been difficult. Like you, I’ve heard this story time and time again. I was just on a panel, having a conversation about race and policing, and I realized we had the same conversation during my first or second year of residency because there had been another death. But even though all of these unfortunate deaths are triggering us, this one is a little different for me for a few reasons. As you know, this is happening with the backdrop of the COVID-19 crisis and we’re already seeing so many people, especially from black and brown communities, dying from that.

 

 

And then I’m witnessing what happened, watching that video and thinking about all the interventions we’ve already tried. We tried body cameras, and the dude was wearing a body camera. We tried to get our police officers to be engaged, to try to check their roles, but people were there, witnessing everything, and nothing happened. An upstander was there, a white upstander, a firefighter who was telling them to check his pulse. Still nothing happened; it didn’t stop them.

I believe the backdrop of the COVID-19 crisis makes it a whole lot more painful for me and many others. I am part of a black physician email group and it’s been triggering for all of us because we all imagine that this could be me one day, especially when you think about the Amy Coopers of the world, among other things.

Dr. Norris: I completely agree. We’re dealing with loss of life due to a virus, including, [personally speaking] that of my departed grandmother Why am I bringing this up? I bring it up because, regardless of one’s socioeconomic strata or title or whatnot, particularly in the black community, this is the kind of mess we’re dealing with. We’re dealing with the stress of COVID-19 that is disproportionately affecting African Americans. We’re dealing with social isolation, we’re dealing with the economic recession and the collapse that everyone else is dealing with, and on top of that we are now dealing with another murder. But this particular murder resonates very differently because, as you said, it seemed like every single thing that could have been done was done.

You will read reports that Mr. Floyd was resisting arrest. But you look at this video; this is not a man resisting arrest. This is a man trying to say, please, you are killing me. These are other people saying the same thing. These are police officers not acting right. This is so many different things going on, and when you hear this and look at this video, you can come to no other conclusion than it is murder.

As psychiatrists, we frequently have to restrain people, and it is always understood that restraint can turn into assault extremely quickly. But in this particular case, there was no thought or concern about this man’s life or his health. There are many good police officers that do think of that, and so this was shocking. It was jarring. It was another thing piled on an already taxed black America. I was talking with my black male colleagues about this, and I think a lot of people don’t actually realize that, while there are black male psychiatrists, there are only a few of us.

Dr. Newsome: True that.

Dr. Norris: There are only so many black male physicians, period, and black male psychiatrists in particular. At different points in time we are called on to take leadership roles, and to talk, to speak on things and be a voice. Well, I have to tell you, after a while, this is pretty goddamn tiring for us to contain our disappointment, our anger, and our rage and still stay hopeful, optimistic, and still be a voice for those who are not able to speak.

Dr. Newsome: I agree that sometimes it can be tiring to have to take leadership roles and continue to talk about all these things, but I also feel that, at least for me, it gives me some sort of route to address the angst and do something with it. I believe all of us are just figuring out how to deal with these feelings that we shouldn’t have to feel because of a murder that was televised.

Dr. Norris: Thank you. For a murder that was televised; that was tweeted; that was broadbanded; that was streamed.

 

 

Now we’ve laid the framework, in terms of what we’re feeling. Let’s move on to why you and I are in this profession, and that’s our patients. What are you seeing on the front lines? What are you seeing with our patients?

Dr. Newsome: I was speaking with one of my black male patients, and he was fearful. He had been perfectly fine, even in the COVID crisis, he was doing well. But when you get this milieu of police violence, now he’s feeling this intense fear. Should I be walking alone at night? What happens if I am the one who is at the wrong place at the wrong time?

I also find that some of my nonminority patients sometimes find difficulty making sense of it. Minority individuals already know these things are happening. But some of the nonminorities are wondering how or why would something like this happen in America? This is just how America is for the black folks.

Dr. Norris: Could you elaborate on that? I always found that to be a very interesting dynamic for those who are not minorities or people of color. I will have folks in a psychotherapy session who are just bewildered by events like this. It is not the America they think they know – they are shocked that this is actually what’s going on.

Dr. Newsome: It’s all about experiences. If you didn’t grow up around a lot of minorities, you haven’t necessarily had these conversations. Even speaking for myself, sometimes I don’t want to discuss these things; you never know what you’re going to get. You might find an ally, or you might find someone who isn’t at all supportive. I think the surprise is from lack of exposure. If you don’t have to live through racism, you can most certainly have blinders on and not notice.

Dr. Norris: Can you comment on the fear you’re seeing in some folks? Can it get to the point of reactivating PTSD?

Dr. Newsome: I notice it more with black individuals, a fear that they might be the ones who may die; or with black mothers, wondering, what about my child? Is this what they are going to have to live with for the rest of their lives? Older people would say that we fought already and it’s still going on. What are the fruits of the labor we put in?

Dr. Norris: I agree with you completely. What are the fruits? You’re going to see those strong reactions. You’re going to see fear, you’re going to see anger, and you’re also going to see guilt that they could not stop this. I’m speaking particularly about some of my nonminority patients. It goes along with that confusion. This manifests in a desperate need to do something.

But here’s the problem: You don’t really know what to do because no one is educated on it. And as you said before, race is a very polarized subject. No one even likes to talk about racism because it’s so, oh my goodness. We’ve run away from it so much to the point that we can’t deal with it. Racism, whether or not you witness it, whether or not you participate in it, whether or not you are the subject of it, affects and hurts us all. We all have to start to own that. You can’t just stay siloed, because eventually, it’s going to come back and affect you.

I could easily be Mr. Floyd, but at the same time, due to my station and things of that nature, I have a certain level of privilege and autonomy. There could be a tendency to put your head under the sand, you know, look at how far we’ve come, Barack Obama. But you’ve got to say, no, we still have enormous amounts of work to do.

We’ve been talking about the patients. What have you noticed in your colleagues and how they’ve been feeling about this?

Dr. Newsome: Again, I see them feeling saddened by the events. One of the other things I’ve noticed is that some people are in environments where they have program directors and chairs who will directly condemn certain behaviors and say, “This is racist, this shouldn’t happen.” But then there are other programs that have been more silent. I’ve had people say that this is the first time that they have felt isolated in a long while.

We all participate in these physician WhatsApp groups, and according to some of the comments, people are realizing that these folks that they were just on the front lines with, fighting COVID, are perhaps not the allies that they originally thought they were, based on the things these people are saying.

Dr. Norris: Wow. It’s good that we’re talking about this from the viewpoint of two different generations. You’ve got the WhatsApp group and Google Hangouts and all that kind of good stuff, and I’m still with pagers and such. That’s interesting – the reality that folks you thought were your allies turn out not to be, because you’re bringing up difficult conversations that we don’t normally talk about.

I have noticed that some people around me have been silent because they don’t know what to say. They’re so concerned that I’m going to be offended or they’re going to hurt me or say the wrong thing, so they stay quiet. As I reflect now, this is the wrong thing to do. Own your concern. I’ve been in two large meetings now, and I’ve had multiple people whom I consider friends say, I wanted to email or text you right then and ask you how you’re doing, but I didn’t because I didn’t know what to say. I have entered meetings recently, and the meeting felt tense, and I’m thinking, what’s going on? And now I realize they did not know what to say or how to approach it.

That’s been a very interesting dynamic and tells us where we are with this. Today, for example, I was pleased to have the support of my dean’s group. I felt I had to speak out, I just had to straight out tell them. Do you want to know what I’m feeling? I’m feeling rage. I’m feeling rage. And you all have to understand that, because I have to speak for those who aren’t necessarily going to be able to express themselves. More importantly, I have to speak for myself and I’m feeling rage.

How our colleagues are processing this and how they’re thinking about this runs the gamut. But I think about people not necessarily knowing what to say or how to approach it. I absolutely agree that with the leadership, you’re going to get many different responses, and sometimes you’re left to wonder, do I have to watch what I say? But I’m definitely supported at my institution.

What else are you seeing out there in terms of your colleagues or how people think about it?

 

 

Dr. Newsome: This also spurs some folks to activism. Some have been participating in protests. There will be White Coats for Black Lives protests, among other things. So it’s spurred folks to action, and it’s also spurred folks to try to be part of a community. Of course, with the whole COVID crisis, we can’t necessarily come together, so we’ve been doing Zoom gatherings more than anything else. But it has encouraged folks to want to do that more, too, because they want to check in on their brother or their sister to make sure they are doing well, and also to be able to express what’s going on with them in a community where they know they can get validation.

The mission of White Coats for Black Lives is to "dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color."
Courtesy George Washington University Hospital Internal Medicine, Instagram @gtwon_medres
The mission of White Coats for Black Lives is to 'dismantle racism in medicine and promote the health, well-being, and self-determination of black and Indigenous people, and other people of color.'

Dr. Norris: I’m going to push you a bit because I detect in your tone something similar to what I’m feeling. I just got the email, the White Coats For Black Lives email. But I think your feeling is similar to mine – I’ve done this before. I’ve done White Coats for Black Lives. You all may have protested. But this display in Washington, D.C., of the use of military and law enforcement to clear a public square of peaceful protesters is above and beyond the pale of anything I’ve ever seen in my life. We have to label that for the danger it is, for the threat to everything this country and the people that bled for this country stand for.

So while I’m going to participate in White Coats for Black Lives and many other things, I am looking for what is actually going to move the needle. I think the protests are great, but at this point in time I want institutions, I want money, I want lawyers, I want a systematic approach.

Dr. Newsome: I most certainly agree. Of course, the protests are really important, but depending on where you are, you have a different lens. As physicians, especially as black physicians, since there are so few of us, we have a unique opportunity to leverage that, whether that means communicating through op-eds or calling your senators and talking with them to try to move things forward.

Physicians are mobilizing. In the last few days, a physician created a Zoom event and hundreds of physicians joined to try to figure out how we can structurally fix this problem. So I most certainly believe that in this effort to address racism, we physicians will need to lend our voices and our privilege to move the needle as best we can.

Dr. Norris: Some of our colleagues in Black Psychiatrists of America have put out a press release on racism in which they propose some actions that should be taken immediately. I think this is a useful thing to talk about.

The first action: “Declare racism a public health problem and establish national goals for addressing this as a health equity issue. Give priority to addressing the issues of health care disparities, including the mental health needs of historically marginalized communities across the U.S.”

 

 

What do you think about that?

Dr. Newsome: Those are two extremely important steps. The question is: How do you make that happen?

Dr. Norris: You’re reading my mind. I love that our colleagues put that out there, but that was my next question.

Dr. Newsome: There is going to be a town hall about this and I’m hoping that we can plan how we envision this happening. I can imagine that 20 or 30 years ago there was also a fear in society that there would be episodes of police brutality. I can imagine that there were similar ideals and hopes. But I think we need to put all of our minds together and ask: How are we going to accomplish this? Is this going to be something we’re going to put our money into? Is this going to be something we’re going to get senators and legislatures onboard with to make policy?

Dr. Norris: Let me read off some of the other action points they put out. There are six of them.

“Establish a governmental multidisciplinary and ethnically diverse commission with representatives from the major health care professional associations in medicine, nursing, psychiatry, public health, psychology, social work, etc., and the faith-based community to provide recommendations to Congress regarding policies on how to best improve the health and well-being of our nation’s black citizens.”

That’s a very solid overall recommendation. My question is, doesn’t that, in some way, shape, or form already exist? Could we not put up policy statements from all of these folks regarding racism and things of that nature? I agree with what they’re saying, but part of me wonders why certain things in the current system aren’t working. That becomes the question. Are we not integrated enough? Do we not have enough cross talk? Do we not have enough money behind it? So I agree with that goal, but I would be curious if that doesn’t already exist. What are your thoughts about that, Dr. Newsome?

Dr. Newsome: I would imagine that the National Institute on Minority Mental Health and Health Disparities would have something similar. I believe one of the things you mentioned is really important. In addition to making these recommendations, we need to be looking at where these leaks are occurring that keep them from working. What is the current structure and why is it the way it is with regard to the governance?

Dr. Norris: Here is another of their action statements: “Declare ‘civic mental health’ a national priority and incorporate it into the educational curriculum from K through college, as well as in the training of local, state, and national officials, law enforcement, and the criminal justice system.”

Let me be clear, I like every single one of these action statements. I encourage everyone to participate in dialogue and discussion. You may agree with some of these, and some of them you may not, but if there is one you agree with, that you really are motivated about, that’s one that you need to explore and dig into a bit more, because it’s too big for us to handle on our own, just like racism and equality.

 

 

I’m going to tell you, I like this statement. I do like this. Obviously these are broad points, but I do like the idea of training law enforcement officers about “civic mental health.” For example, Dr. Michael Compton, who has done a lot of great work in the area of mental health and prevention, has worked with police officers to help them interact with those with mental health conditions by modulating their own emotional response. I’m very interested in these types of recommendations that particularly target law enforcement officers, and helping with that ”emotional quotient.” I’m interested in seeing how far that can spread in the country. What do you think, Dr. Newsome?

Dr. Newsome: Educating police officers about how to interact would be quite important. I believe the National Alliance on Mental Illness does some of that work, partnering with law enforcement agencies, talking about mental health and cues to look at. There also are some programs where people ride along with mental health clinicians and police officers, which I find to be really helpful. But clearly, what’s going on right now isn’t working. So I would be open to any reasonable idea.

Dr. Norris: Here’s one last action point: “Establish police community review boards with power to take action in areas of police misconduct pending formal review by the appropriate authorities. This will offer a level of empowerment when communities feel they have a voice that can be heard.”

This is where I want my focus to be, as I move forward to try to do something sustainable. To deal with police brutality and abuse of power in general, but specifically as it relates to African American men and the lethal use of force. We need to work on policies that will enable African American men to make it to court, so that every encounter with a police officer is not literally viewed as a potentially lethal encounter.

A lot of people aren’t going to like me saying that, but it’s the absolute truth. You have to think like that, as an African American male, regardless of your station, regardless of where you live, this is the reality. There are many, many good police officers out there. I have a few friends who are law enforcement officers. I work with security at the George Washington Hospital constantly. But that still does not change the fact that if I get pulled over at a traffic stop, I know precisely certain things I need to do and not do, or the encounter could end badly. By that I mean loss of life.

So I encourage anything where we can start to take a systematic look at law enforcement and empower communities to look at who is doing it right and who is doing it wrong. Information is coming out now about the man who murdered Mr. Floyd, and this was not the first time he was involved in misconduct. There were red flags; we have to start to confront this. We have to learn from every single one of these situations and grow because another one is going to happen next week, it’s just whether or not you hear about it. That’s the reality of the state of America. You may not like to hear it, but that’s just a fact.


To hear the entire conversation, go to mdedge.com/podcasts or listen wherever you find your podcasts.
 

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What COVID-19 has taught us about senior care

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Thu, 08/26/2021 - 16:04

Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

Dr. Madhukar Kasarla hospitalist with Apogee Physicians at Parkway Surgical and Cardiovascular Hospital in Fort Worth, Texas.
Dr. Madhukar Kasarla

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

  • Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
  • Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
  • Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

Dr. Jaisheel Devireddy, a family physician at Positive Health Medical Center, Kingston, Jamaica
Dr. Jaisheel Devireddy

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

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Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

Dr. Madhukar Kasarla hospitalist with Apogee Physicians at Parkway Surgical and Cardiovascular Hospital in Fort Worth, Texas.
Dr. Madhukar Kasarla

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

  • Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
  • Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
  • Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

Dr. Jaisheel Devireddy, a family physician at Positive Health Medical Center, Kingston, Jamaica
Dr. Jaisheel Devireddy

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

Across the globe, there are marked differences in how countries responded to the COVID-19 outbreak, with varying degrees of success in limiting the spread of the virus. Some countries learned important lessons from previous outbreaks, including SARS and MERS, and put policies in place that contributed to lower infection and death rates from COVID-19 in these countries. Others struggled to respond appropriately to the outbreak.

Dr. Madhukar Kasarla hospitalist with Apogee Physicians at Parkway Surgical and Cardiovascular Hospital in Fort Worth, Texas.
Dr. Madhukar Kasarla

The United States and most of the world was not affected significantly by SARS and MERS. Hence there is a need for different perspectives and observations on lessons that can be learned from this outbreak to help develop effective strategies and policies for the future. It also makes sense to focus intently on the demographic most affected by COVID-19 – the elderly.

Medical care, for the most part, is governed by protocols that clearly detail processes to be followed for the prevention and treatment of disease. Caring for older patients requires going above and beyond the protocols. That is one of the lessons learned from the COVID-19 pandemic – a wake-up call for a more proactive approach for at-risk patients, in this case everyone over the age of 60 years.

In this context, it is important for medical outreach to continue with the senior population long after the pandemic has run its course. Many seniors, particularly those susceptible to other illnesses or exhibiting ongoing issues, would benefit from a consistent and preplanned pattern of contacts by medical professionals and agencies that work with the aging population. These proactive follow-ups can facilitate prevention and treatment and, at the same time, reduce costs that would otherwise increase when health care is reactive.
 

Lessons in infectious disease containment

As COVID-19 spread globally, there were contrasting responses from individual countries in their efforts to contain the disease. Unfortunately, Italy suffered from its decision to lock down only specific regions of the country initially. The leadership in Italy may have ignored the advice of medical experts and been caught off guard by the intensity of the spread of COVID-19. In fact, they might not have taken strict actions right away because they did not want their responses to be viewed as an overreaction to the disease.

The government decided to shut down areas where the infection rates were high (“red zones”) rather than implement restrictions nationally. This may have inadvertently increased the spread as Italians vacated those “red zones” for other areas of the country not yet affected by COVID-19. Italy’s decentralized health care system also played a part in the effects of the disease, with some regions demonstrating more success in slowing the reach of the disease. According to an article in the Harvard Business Review, the neighboring regions of Lombardy and Veneto applied similar approaches to social distancing and retail closures. Veneto was more proactive, and its response to the outbreak was multipronged, including putting a “strong emphasis on home diagnosis and care” and “specific efforts to monitor and protect health care and other essential workers.” These measures most likely contributed to a slowdown of the spread of the disease in Veneto’s health care facilities, which lessened the load on medical providers.1

Conversely, Taiwan implemented proactive measures swiftly after learning about COVID-19. Taiwan was impacted adversely by the SARS outbreak in 2003 and, afterward, revised their medical policies and procedures to respond quickly to future infectious disease crises. In the beginning, little was known about COVID-19 or how it spread. However, Taiwan’s swift public health response to COVID-19 included early travel restrictions, patient screening, and quarantining of symptomatic patients. The government emphasized education and created real-time digital updates and alerts sent to their citizens, as well as partnering with media to broadcast crucial proactive health information and quickly disproving false information related to COVID-19. They coordinated with organizations throughout the country to increase supplies of personal protective equipment (PPE).2

Although countries and even cities within a country differ in terms of population demographics, health resources, government policies, and cultural practices, initial success stories have some similarities, including the following:

  • Early travel restrictions from countries with positive cases, with some circumstances requiring compulsory quarantine periods and testing before entry.
  • Extensive testing and proactive tracing of symptomatic cases early. Contacts of people testing positive were also tested, irrespective of being symptomatic or asymptomatic. If testing kits were unavailable, the contacts were self-quarantined.
  • Emphasis on avoiding overburdening hospitals by having the public health infrastructure to divert people exhibiting symptoms, including using public health hotlines to send patients to dedicated testing sites and drive-through testing, rather than have patients presenting to emergency rooms and hospitals. This approach protected medical staff from exposure and allowed the focus to remain on treating severe symptomatic patients.

Dr. Jaisheel Devireddy, a family physician at Positive Health Medical Center, Kingston, Jamaica
Dr. Jaisheel Devireddy

The vastly different response to the COVID-19 outbreak in these two countries illuminates the need for better preparation in the United States. At the onset of this outbreak, emergency room medical professionals, hospitalists, and outpatient primary care providers did not know how to screen for or treat this virus. Additionally, there was limited information on the most effective contact protocols for medical professionals, patients, and visitors. Finally, the lack of PPE and COVID-19 test kits hindered the U.S. response. Once the country is on the road to recovery from COVID-19, it is imperative to set the groundwork to prepare for future outbreaks and create mechanisms to quickly identify vulnerable populations when outbreaks occur.
 

Senior care in future infectious disease outbreaks

How can medical providers translate lessons learned from this outbreak into improving the quality of care for seniors? The National Institute on Aging (NIA) maintains a website with information about healthy aging. Seniors and their caregivers can use this website to learn more about chronic diseases, lifestyle modifications, disease prevention, and mental health.

In times of a pandemic, this website provides consistent and accurate information and education. One recommendation for reaching the elderly population during future outbreaks is for NIA to develop and implement strategies to increase the use of the website, including adding more audio and visual interfaces and developing a mobile app. Other recommendations for improving the quality of care for seniors include the following:

1. Identify which populations may be most affected when future outbreaks occur.

2. Consider nontraditional platforms, including social media, for communicating with the general population and for medical providers worldwide to learn from each other about new diseases, including the signs, symptoms, and treatment plans. Some medical professionals created specific WhatsApp groups to communicate, and the World Health Organization sent updated information about COVID-19 to anyone who texted them via WhatsApp.3

3. Create a checklist of signs and symptoms related to current infectious diseases and assess every vulnerable patient.

4. Share these guidelines with medical facilities that treat these populations, such as senior care, assisted living and rehabilitation facilities, hospitals, and outpatient treatment centers. Teach the staff at these medical facilities how to screen patients for signs and symptoms of the disease.

5. Implement social isolation strategies, travel and visitor restrictions, and testing and screening as soon as possible at these medical facilities.

6. Recognize that these strategies may affect the psychological and emotional well-being of seniors, increasing their risk for depression and anxiety and negatively affecting their immunity and mental health. Additionally, the use of PPE, either by the medical providers or the patient, may cause anxiety in seniors and those with mild cognitive impairment.

7. Encourage these medical facilities to improve coping strategies with older patients, such as incorporating communication technology that helps seniors stay connected with their families, and participating in physical and mental exercise, as well as religious activities.

8. Ask these medical facilities to create isolation or quarantine rooms for infected seniors.

9. Work with family members to proactively report to medical professionals any symptoms noticed in their senior relatives. Educate seniors to report symptoms earlier.

10. Offer incentives for medical professionals to conduct on-site testing in primary care offices or senior care facilities instead of sending patients to hospital emergency rooms for evaluation. This will only be effective if there are enough test kits available.

11. Urge insurance companies and Medicare to allow additional medical visits for screening vulnerable populations. Encourage the use of telemedicine in place of in-office visits (preferably billed at the same rate as an in-office visit) where appropriate, especially with nonambulatory patients or those with transportation issues. Many insurance companies, including Medicare, approved COVID-19–related coverage of telemedicine in place of office visits to limit the spread of the disease.

12. Provide community health care and integration and better coordination of local, state, and national health care.

13. Hold regular epidemic and pandemic preparedness exercises in every hospital, nursing home, and assisted living facility.

Proactive health care outreach

It is easier to identify the signs and symptoms of already identified infectious diseases as opposed to a novel one like COVID-19. The United States faced a steep learning curve with COVID-19. Hospitalists and other medical professionals were not able to learn about COVID-19 in a journal. At first, they did not know how to screen patients coming into the ER, how to protect staff, or what the treatment plan was for this new disease. As a result, the medical system experienced disorder and confusion. Investing in community health care and better coordination of local, state, and national health care resources is a priority.

The senior citizen population appears to be most vulnerable to this virus and may be just as vulnerable in future outbreaks. Yet the insights gained from this pandemic can lead to a more comprehensive outreach to senior patients and increased screenings for comorbidities and future contagious diseases. An emphasis on proactive health care and outreach for seniors, with a focus on identifying and treating comorbid conditions, improves the medical care system overall and may prevent or slow future community outbreaks.
 

Dr. Kasarla is a hospitalist with APOGEE Physicians at Wise Surgical at Parkway in Fort Worth, Tex. He did his internal medicine residency at Mercy Hospital & Medical Center, Chicago. Readers can contact him at madhukarreddy.kasarla@apogeephysicians.com. Dr. Devireddy is a family physician at Positive Health Medical Center, Kingston, Jamaica. Contact him at drjaisheel@gmail.com.

References

1. Pisano GP et al. Lessons from Italy’s response to coronavirus. Harvard Business Review. 2020 Mar 27. https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus.

2. Tu C. Lessons from Taiwan’s experience with COVID-19. New Atlanticist. 2020 Apr 7. https://atlanticcouncil.org/blogs/new-atlanticist/lessons-from-taiwans-experience-with-covid-19/.

3. Newman LH. WhatsApp is at the center of coronavirus response. WIRED. 2020 Mar 20. https://www.wired.com/story/whatsapp-coronavirus-who-information-app/.

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Marijuana for migraine? Some tentative evidence

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Thu, 07/30/2020 - 12:49

Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

Claire Ceriani, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Claire Ceriani

Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.

Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.

The study was part of the virtual annual meeting of the American Headache Society.
 

An effective abortive therapy?

The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.

The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).

A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.

Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).

Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
 

 

 

Several concerns

The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.

He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.

“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.

Angela Hou, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Angela Hou

The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.

Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.

The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.

SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.

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Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

Claire Ceriani, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Claire Ceriani

Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.

Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.

The study was part of the virtual annual meeting of the American Headache Society.
 

An effective abortive therapy?

The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.

The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).

A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.

Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).

Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
 

 

 

Several concerns

The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.

He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.

“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.

Angela Hou, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Angela Hou

The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.

Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.

The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.

SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.

Medical marijuana may have promise for managing headache pain, according to results from a small study conducted at the Jefferson Headache Center at Thomas Jefferson University. The researchers found general satisfaction with medical marijuana, more frequent use as an abortive medication rather than a preventative, and more than two-thirds using the inhaled form rather than oral.

Claire Ceriani, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Claire Ceriani

Many patients ask about medical marijuana, but there is relatively little data on its effects on headache. Studies are generally retrospective, and often focus on marijuana use for general pain, with subset analyses looking at headache, according to coauthor Claire Ceriani, MD, who is a headache fellow at Jefferson. “A lot of patients are interested in medical marijuana but don’t know how to integrate it into the therapy plan they already have – whether it should be just to treat bad headaches when they happen, or is it meant to be a preventive medicine they use every day? We have some data out there that it can be helpful, but not a lot of specific information to guide your recommendations,” said Dr. Ceriani in an interview.

Although the research is far from a final word on the subject, it did have some take-home messages, said Dr. Ceriani. “Most people seem to find it effective as an abortive medication that might be able to take the place of some of the prescription medications that they were previously using,” she said.

The study was part of the virtual annual meeting of the American Headache Society.
 

An effective abortive therapy?

The study began shortly after the Jefferson Headache Center became certified to offer medical marijuana around the beginning of 2019. “We wanted to start keeping track of these patients from the get-go so we’d be able to learn as much as possible from them and help guide the recommendations we give to patients in the future,” said Dr. Ceriani.

The study included 48 patients with migraine or other types of chronic headache who received medical marijuana treatment between January and September 2019. After collecting baseline information from medical records and questionnaires filled out at marijuana treatment initiation, the researchers followed up periodically with telephone questionnaires to assess treatment response and side effects. About half of the participants (56.3%) reported daily headache. 14.6% had posttraumatic headache, 10.4% new daily persistent headache, and 4.2% tension-type headache. Additional symptoms were common, including anxiety (72.9%) and insomnia (62.5%).

A total of 28 subjects completed a follow-up questionnaire over the phone. Out of the 28 participants , 3 had stopped using marijuana. Of 25 subjects who continued use, 71.4% used it two or more times per week, and 25.0% used it every day. Among participants, 50% used a THC-dominant strain of marijuana. Overall, 71.4% used an inhaled form.

Side effects included dry mouth/throat (46.4%), dry/red eyes (35.7%), fatigue/lethargy (35.7%), and increased appetite (35.7%).

Before starting on marijuana, 46.4% of the subjects used abortive medications at least 10 days per month. After starting marijuana treatment, the rate dropped to 25.0%. Marijuana use was associated with improvements in anxiety: 57.1% who had anxiety reported improvement with marijuana use, as did 78.6% with insomnia. On a scale of 10, the average rating of marijuana’s usefulness was 5.9, and 17.9% rated it as 10.
 

 

 

Several concerns

The study has numerous limitations. It has a small sample size, it is from a single center, and the patient population had relatively severe symptoms. Such studies are “fraught with possible bias,” said Andrew Charles, MD, professor of neurology and director of the UCLA Goldberg Migraine Program, when asked to comment.

He pointed out that one key concern for marijuana is concerns over worsening of the condition or refractoriness caused by medication overuse. The cannabinoid receptors it acts on bear some similarity to opioid receptors, and opioid overuse headache is well known. The recent changes in marijuana laws makes it an important issue, one that patients often asked about. But prospective clinical trials face a range of roadblocks: Marijuana remains a controlled substance, it would be difficult to create a placebo control, and no large companies are likely to sponsor such a trial.

“But I think it’s important to keep talking about and developing evidence as much as we can and addressing not just the benefits but also being keenly aware of the possible adverse effects, especially medication overuse,” said Dr. Charles.

Angela Hou, MD, a headache fellow at Thomas Jefferson University in Philadelphia.
Dr. Angela Hou

The authors also acknowledged the study’s limitations, “but I think there is value, because there are definitely specific patterns we were able to find in terms of what’s helpful for patients, and we also found that a lot of patients also have other disorders in addition to headache, like anxiety and insomnia. And we found that those patients in particular seemed to have more benefit than most with medical marijuana,” said coauthor Angela Hou, MD, who is also a headache fellow at Jefferson.

Dr. Hou and Dr. Ceriani cautioned against use of marijuana in any patient with a substance use disorder, as well as the inhaled form in patients with chronic lung conditions.

The study received no funding. Dr. Ceriani and Dr. Hou had no relevant financial disclosures. Dr. Charles has consulted for Amgen, Biohaven, Eli Lilly, Novartis, and Lundbeck.

SOURCE: Marmura MJ et al. AHS 2020, Abstract 842679.

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Surge in colonoscopies postponed by COVID-19 expected

Offer alternative CRC screening methods now
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Wed, 06/24/2020 - 11:31

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Prof. Massuti and Prof. Martinez are with Hospital General Universitario in Alicante, Spain; Dr. Aslam is with University Hospitals of Coventry and Warwickshire, England
Webinar presenters clockwise from top right: Dr. Imran Aslam, Dr. Bartomeu Massuti, Dr. Rodrigo Jover Martinez

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

Body

Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.

Dr. David Lieberman, Oregon Health and Science University, Portland

David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts. 

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Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.

Dr. David Lieberman, Oregon Health and Science University, Portland

David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts. 

Body

Medical issues, deferred or neglected during the pandemic, can result in adverse outcomes, and this applies to colorectal cancer (CRC) screening and surveillance. There is a real risk of increased rates of CRC and discovery of CRC at an advanced stage if individuals go unscreened. While colonoscopy remains an important screening option, capacity has been limited during the pandemic. I believe it is important to offer patients screening choices like fecal immunochemical test, and then prioritize patients with positive fecal immunochemical test results for colonoscopy since these patients have a higher risk of CRC, compared with those with negative tests. Patients with a prior history of high-risk adenomas should be prioritized for surveillance colonoscopy.

Dr. David Lieberman, Oregon Health and Science University, Portland

David Lieberman, MD, past president of the American Gastroenterological Association, professor of medicine and chief of division of gastroenterology and hepatology at Oregon Health and Science University, Portland. He has no conflicts. 

Title
Offer alternative CRC screening methods now
Offer alternative CRC screening methods now

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Prof. Massuti and Prof. Martinez are with Hospital General Universitario in Alicante, Spain; Dr. Aslam is with University Hospitals of Coventry and Warwickshire, England
Webinar presenters clockwise from top right: Dr. Imran Aslam, Dr. Bartomeu Massuti, Dr. Rodrigo Jover Martinez

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

An expected surge in the number of people seeking colonoscopy after the peak of the COVID-19 pandemic passes could cause physicians to rethink patient prioritization, could create a strain on endoscopy capacity, and might raise the specter of detecting colorectal cancer in more patients at a later stage of disease.

Prof. Massuti and Prof. Martinez are with Hospital General Universitario in Alicante, Spain; Dr. Aslam is with University Hospitals of Coventry and Warwickshire, England
Webinar presenters clockwise from top right: Dr. Imran Aslam, Dr. Bartomeu Massuti, Dr. Rodrigo Jover Martinez

Furthermore, months of delay in diagnosis of colorectal cancer (CRC) could shorten survival, although more data is needed, according to expert analysis from a gastroenterologist, a medical oncologist, and a colorectal surgeon.

“It has been a big decrease in the number of colonoscopies performed at our hospital in Alicante, Spain,” Rodrigo Jover Martinez, MD, PhD, said during a COVID-19 and Digestive Health webinar presented by United European Gastroenterology (UEG). He estimated colonoscopy procedures are down 60%-90%, and the number of CRC surgeries has dropped by 60%. “As you know, the COVID-19 pandemic is hitting Europe hard.”

When patients do return, “the backlog will be huge ... in already exhausted endoscopy units,” predicted Dr. Martinez, a gastroenterologist at Hospital General Universitario in Alicante.
 

Multiple risks

Not knowing which patients with CRC will develop severe COVID-19 infection is another challenge, Bartomeu Massuti, MD, of the medical oncology service at the Hospital General Universitario de Alicante, said during the webinar.

Caution is warranted because “we know cancer patients have an increased risk of infection.” However, he added, most evidence supports an elevated risk for bacterial infections, not viral infections.

Therefore, physicians must continue to balance the risks associated with potential COVID-19 exposure against the risks associated with postponed treatment, Dr. Massuti said. “The goal of oncology care is to try to maintain the preplanned treatment and follow-up. We need mainly to avoid stopping or delaying treatment ... because we will lose efficacy in oncology disease outcomes.”

Imran Aslam, MD, PhD, a colorectal surgeon who moderated and presented during the webinar, agreed: “By delaying the treatment, we might do harm to our patients.”

Dr. Aslam cited data about clinical costs of delaying CRC surgery. A 2019 population-based study in PLOS ONE evaluated different times from diagnosis to treatment. The researchers found a delay of more than 150 days “significantly reduced survival, even during stage I, II, and III disease,” he said. The stage I hazard ratio was 2.66, compared with a reference HR of 1.00 for 90 days or fewer. They also reported elevated risk for people with stage II CRC (HR, 2.80), stage III CRC (HR, 2.70), and stage IV CRC (HR, 1.36).

“This could become more and more abysmal if the pandemic continues,” added Dr. Aslam, consultant colorectal surgeon at University Hospitals of Coventry and Warwickshire, England.
 

Prioritizing patients

Restarting endoscopy with prioritization strategies and increasing patient capacity are possible solutions. Dr. Martinez suggested a four-quadrant matrix in which physicians place patients into “now,” “next,” “delayed,” or “never” categories based on clinical indicators. The priority 1 “now” patients, for example, will be those with suspected CRC based on physical examination, imaging results, and/or an abnormal fecal immunochemical test result.

He suggested, furthermore, that more widespread CRC screening can resume once “endoscopy units have been alleviated of priority 1, symptomatic patients.”

Dr. Massuti concurred with Dr. Martinez’s call to prioritize patients carefully. He suggested a green, yellow, and red classification system based on treatment priority recommendations from the European Society for Medical Oncology. The green group, for example, should receive priority for intervention based on a condition that is immediately clinically unstable or life threatening.

“The main goal is to preserve the continuum of care,” he added.

Another concern – although data are limited – is that treatment might also increase risk of mortality among cancer patients with COVID-19, according to a cohort study of nearly 1,000 such patients reported May 2020 in The Lancet. Dr. Massuti, who was not affiliated with the research, noted that 12% of the patients had GI tumors. In addition to increased risk associated with male sex (odds ratio, 1.63), cytotoxic cancer treatment in the prior 4 weeks increased risk (OR, 1.47), as did surgery in the same time frame (OR, 1.52).

“This means patients on treatment have an increased risk of mortality,” Dr. Massuti said.
 

Moving forward

Implementing telehealth information and communication technologies will continue to grow in importance, Dr. Massuti said. Dr. Aslam noted that video consultation with patients before surgery is already replacing face-to-face interaction, and most follow-up care at his hospital is now done by telephone.

Postoperative care is just as essential in the COVID-19 era, if not more so. “We need to be very vigilant to manage postoperative complications – any symptoms of pyrexia or sepsis, or any sign of COVID,” Dr. Aslam said, including postoperative fever. “If there is any doubt, do a chest CT scan.”

Dr. Aslam predicted the time to perform endoscopy or surgery for each patient will be longer, “so the number of patients done in 1 day will be less than 4 months ago.” In addition, elective surgery patients at his institution undergo COVID-19 testing twice, 3 days apart, prior to intervention.

“This disease will continue in the community for a while, so we have to continue what we’ve done well, like social distancing,” Dr. Aslam said. “We’ve gone through a storm and we are awaiting a tsunami. That tsunami of patients will overwhelm us in the coming months.”

Dr. Martinez, Dr. Massuti, and Dr. Aslam had no relevant disclosures.

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Endoscopic myotomy for achalasia

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Mon, 08/31/2020 - 17:48

Dear colleagues and friends,

Dr. Charles J. Kahi of Indiana University, Indianapolis
Dr. Charles J. Kahi

In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.

Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
 

Endoscopic myotomy for achalasia is ready for prime time

BY MOUEN A. KHASHAB, MD

When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.

Dr. Mouen A. Kashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore
Dr. Mouen A. Kashab

One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1

Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2

I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.

POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.

LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.

A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2

In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4

Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3

It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5

In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
 

References

1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.

2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.

3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.

4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.

5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.

Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.

 

 

Heller myotomy is still the gold standard

BY ROBERT M. SIWIEC, MD

Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.

Dr. Robert Siwiec is a gastroenterologist at Indiana University Health Methodist Hospital
Dr. Robert Siwiec

Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.

During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.

PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4

Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5

Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).

Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
 

References

1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.

2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.

3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.

4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.

5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.

6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.

Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.

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Dear colleagues and friends,

Dr. Charles J. Kahi of Indiana University, Indianapolis
Dr. Charles J. Kahi

In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.

Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
 

Endoscopic myotomy for achalasia is ready for prime time

BY MOUEN A. KHASHAB, MD

When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.

Dr. Mouen A. Kashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore
Dr. Mouen A. Kashab

One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1

Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2

I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.

POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.

LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.

A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2

In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4

Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3

It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5

In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
 

References

1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.

2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.

3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.

4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.

5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.

Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.

 

 

Heller myotomy is still the gold standard

BY ROBERT M. SIWIEC, MD

Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.

Dr. Robert Siwiec is a gastroenterologist at Indiana University Health Methodist Hospital
Dr. Robert Siwiec

Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.

During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.

PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4

Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5

Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).

Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
 

References

1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.

2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.

3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.

4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.

5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.

6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.

Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.

Dear colleagues and friends,

Dr. Charles J. Kahi of Indiana University, Indianapolis
Dr. Charles J. Kahi

In this edition of Perspectives, Dr. Mouen Khashab and Dr. Robert Siwiec tackle an exciting and constantly evolving topic, which is the optimal approach to myotomy for patients with achalasia. Dr. Khashab makes the case for endoscopic myotomy, while Dr. Siwiec argues that surgical myotomy remains the gold standard. I hope that you will find this debate as useful and thought provoking as I did. As always, I welcome your comments and suggestions for future topics at ginews@gastro.org.

Charles Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is also an associate editor for GI & Hepatology News.
 

Endoscopic myotomy for achalasia is ready for prime time

BY MOUEN A. KHASHAB, MD

When I encounter a symptomatic patient with manometrically confirmed achalasia, I discuss three effective treatment modalities: pneumatic dilation (PD), peroral endoscopic myotomy (POEM), and laparoscopic Heller myotomy (LHM). I recommend against botulinum toxin injection and reserve it for patients who are not candidates for the aforementioned definitive therapies. I also present to the patient the current level I evidence from randomized, controlled trials (RCTs) comparing achalasia treatment modalities.

Dr. Mouen A. Kashab, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore
Dr. Mouen A. Kashab

One landmark RCT reported comparative outcomes at 2 years following POEM and PD and found higher treatment success at the 2-year follow-up in the POEM group (92% vs. 54%; P < .001).1 Reflux esophagitis was observed significantly more frequently in patients treated with POEM (41% in the POEM group, of whom 35% were assigned Los Angeles grade A-B and 6% were assigned LA grade C versus 7% in the PD group, all of whom were assigned LA grade A; P = .002).1

Another milestone RCT included 221 patients and compared outcomes of POEM and LHM plus Dor fundoplication.2 Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group, and was noninferior to the LHM group (81.7%). Serious adverse events occurred in 2.7% of patients in the POEM group and in 7.3% of patients in the LHM group. Although 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis as assessed by endoscopy at 3 months, the corresponding proportions were 44% and 29% at 24 months. Importantly, the rate of severe esophagitis was not different between both groups (6% vs. 3% at 3 months, and 5% vs. 6% at 24 months).2

I summarize these results by stating that POEM seems to be superior to PD and equivalent to LHM in terms of clinical success. Nonetheless, POEM also seems to be associated with increased risk of early gastroesophageal reflux disease.

POEM is now a ubiquitous procedure performed worldwide and is endorsed as a primary achalasia treatment by multiple society guidelines.3 It is a minimally invasive, effective, and safe therapeutic option for patients with all types of achalasia and is considered the treatment of choice for achalasia type III. POEM has also been shown to be effective in the treatment of spastic esophageal disorders (e.g. Jackhammer esophagus, diffuse esophageal spasm) and esophagogastric junction outflow obstruction. It can be performed in the endoscopy unit or operating theater either by experienced therapeutic endoscopists or surgical endoscopists in less than an hour. The procedure can be performed on an outpatient basis in appropriate individuals and allows tailoring the myotomy length to specific clinical scenarios. For example, patients with type III achalasia (and those with spastic esophageal disorders) typically require a long myotomy and that can be readily accomplished during POEM as opposed to LHM. POEM has also proven effective in children; octogenarians; and patients with sigmoid esophagus, epiphrenic diverticula, and those who had undergone prior interventions for achalasia, including LHM and PD. In experienced hands, the rate of adverse events is low and serious events are rare and occur in 0.5% of cases. Perforations/leakage are also uncommon and occur in 0.7% of patients. It is an incisionless procedure that eliminates the risk of wound infection and shortens postprocedural recovery. Patients are typically admitted for an overnight observation postprocedure, discharged home the following day, and back to activities of daily living (including work) within a few days. Postprocedural pain is minimal in most patients and narcotics are rarely needed. Resumption of a soft diet is carried out on the first postoperative day and normal diet 1 week later.

LHM is an established procedure with proven long-term efficacy in the treatment of achalasia. Nonetheless, it is invasive and requires placement of multiple trocars. The procedure is more time consuming than POEM and length of hospital stay can also be longer. This results in possibly higher cost than POEM. Importantly, recovery of dysphagia and resumption of normal diet is significantly delayed and is likely the result of the partial concomitant fundoplication procedure. Finally, LHM is not appropriate for the treatment of spastic esophageal disorders, including type III achalasia.

A major advantage of LHM plus partial fundoplication over POEM is the diminished risk of gastroesophageal reflux disease (GERD). However, this advantage seems short lived as the risk of GERD increases over time after surgery, likely because of the loosening of the wrap over time. From the New England Journal of Medicine paper mentioned earlier, it seems that the increased risk of GERD after POEM as compared with LHM diminishes over time.2 Importantly, it also appears that the rate of significant esophagitis (LA grade C-D) is similar between both procedures.2

In an effort to assess the long-term antireflux efficacy of surgical partial fundoplication, one study noted that 12% of 182 patients who had surgical myotomy with partial fundoplication continued to have occasional or continuous heartburn symptoms at a median of 18 years after surgery. Esophagitis and Barrett’s esophagus were found in 14.5% and 0.8% of patients, respectively. De novo esophageal adenocarcinoma has been reported after both POEM and LHM.4

Therefore, GERD and its complications can occur after any procedure that disrupts the lower esophageal sphincter (POEM, LHM, and PD) and postprocedural management of patients should include long-term testing and management of possible GERD. Different strategies have been proposed and include objective periodic testing for esophageal acid exposure, long-term and possible lifelong proton pump inhibitor use, and surveillance for long-term consequences of GER via periodic upper endoscopy.3

It is important to acknowledge that the lack of symptoms or the absence of endoscopic evidence of GER on initial endoscopy does not necessarily rule out GER. Approximately a third of post-POEM patients with clinically successful outcome and absence of reflux esophagitis on their first surveillance endoscopy eventually develop esophagitis at subsequent surveillance endoscopy.5

In summary, POEM has deservingly taken a prime time spot in the management of patients with achalasia. It is an efficient, efficacious and safe treatment modality that results in rapid resolution of achalasia symptoms in the majority of patients. Research should focus on technical modifications (e.g., short gastric myotomy; addition of endoscopic fundoplication) that reduce the incidence of postprocedural GERD.
 

References

1. Ponds FA et al. Effect of peroral endoscopic myotomy versus pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: A randomized clinical trial. JAMA. 2019;322:134-44.

2. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381:2219-29.

3. Khashab MA et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91:213-27 e6.

4. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-110.

5. Werner YB et al. Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years. Gut. 2016;65:899-906.

Dr. Khashab is associate professor of medicine, director of therapeutic endoscopy, division of gastroenterology and hepatology, Johns Hopkins Hospital, Baltimore. He is a consultant for BSCI, Olympus, and Medtronic.

 

 

Heller myotomy is still the gold standard

BY ROBERT M. SIWIEC, MD

Achalasia is a rare, primary esophageal motor disorder characterized by ineffective relaxation of the lower esophageal sphincter (LES) and concomitant loss of esophageal peristalsis. High-resolution esophageal manometry has allowed for the diagnosis and classification of achalasia into relevant clinical subtypes which become important when discussing and considering treatment options. Confirmatory studies (e.g., timed barium esophagram) and provocative manometric maneuvers (e.g., upright swallows, rapid swallow sequence, and/or rapid drink challenge) can be helpful when distinguishing between true achalasia versus achalasia variants and esophagogastric junction outflow obstruction.

Dr. Robert Siwiec is a gastroenterologist at Indiana University Health Methodist Hospital
Dr. Robert Siwiec

Treatment options only provide palliation by eliminating outflow obstruction caused by a nonrelaxing and often times hypertensive LES. Pharmacotherapy (e.g., oral nitrates, 5-phosphodiesterase inhibitors, anticholinergics) is the least effective option because of medication side effects and short-acting duration. I only consider it for patients who are either unwilling or unable to tolerate invasive therapies. Botulinum toxin injection into the LES can be considered in patients who are not good candidates for more definitive therapy with PD or myotomy (endoscopic or surgical). Although the success rates with botulinum toxin are comparable with PD and surgical myotomy, patients treated with botulinum toxin require retreatment. Furthermore, continued botulinum toxin injections can compromise tissue planes making myotomy complex and challenging.

During the 1970s and 1980s, PD was the primary treatment modality for achalasia. Surgical myotomy was reserved for patients who suffered a perforation during PD or developed recurrent symptoms after multiple dilations. Minimally invasive surgery (left thoracoscopic approach) for achalasia was first introduced in the early 1990s and was shown to be a feasible, safe, and effective procedure, becoming the primary treatment approach in most centers. Patients fared well; however, it was soon discovered that >50% had pathological reflux based on pH monitoring. A few centers then began to perform a Heller myotomy through a laparoscopic approach with the addition of a fundoplication resulting in significant reductions in pathological reflux by pH monitoring. Eventually, a seminal RCT confirmed the importance of fundoplication with laparoscopic Heller myotomy (LHM) – resolution of dysphagia was unaffected and pathological reflux was avoided in most patients.1 Overall, clinical success rates for LHM with fundoplication are typically >90% and reflux incidence rates <10% with the overall complication rate being about 5% with reported mortality <0.1%.

PD remains appealing in that it is cost effective and less invasive, compared with POEM and LHM. Initial success rates and short-term efficacy are comparable with LHM but unfortunately PD’s efficacy significantly wanes over time. POEM, introduced by Inoue et al. in 2010, is a novel endoscopic technique with an excellent safety profile that provides good symptom relief while avoiding abdominal wall scars for patients. It has been shown to have a distinct advantage in patients with type III achalasia by nature of the longer myotomy not achievable by LHM.2 POEM has seen increasing enthusiasm and acceptance as a standard treatment option for achalasia largely because of the fact that its safety and efficacy have been shown to be comparable and in most cases equal with LHM. However, in 2020, direct comparison with LHM is challenging given that the follow-up in the majority of studies is either short or incomplete. The most recent multicenter, randomized trial comparing POEM with LHM plus Dor fundoplication showed POEM’s noninferiority in controlling symptoms of achalasia, but only after a 24 month follow-up.3 A recent report included one of the largest cohorts of post-POEM patients (500), but the 36-month data were based on the follow-up of only 61 patients (about 12%).4

Once the muscle fibers of the LES are disrupted, reflux will occur in the majority of patients. Unlike LHM, no concomitant fundoplication is performed during POEM and this increases the incidence of GERD and its long-term sequelae including peptic strictures, Barrett’s esophagus, and adenocarcinoma. A meta-analysis from 2018 looked at published series of POEM and LHM with fundoplication and found that GERD symptoms were present in 19% of POEM patients, compared with 8.8% of LHM patients. Worse yet, esophagitis was seen in 29.4% of the POEM group and 7.6% of the LHM group, with more individuals in the POEM group also having abnormal acid exposure based on ambulatory pH monitoring (39.0% vs. 16.8%).5

Proponents of POEM will argue that proton pump inhibitors (PPIs) are the panacea for post-POEM GERD. Unfortunately, this approach has its own problems. PPIs are very effective at reducing acid secretion by parietal cells, but do not block reflux through an iatrogenically incompetent LES. The drumbeat of publications on potential complications from chronic PPI use has greatly contributed to patients’ reluctance to commit to long-term PPI use. Lastly, the first case of early Barrett’s cancer was recently reported in a patient 4 years post-POEM despite adherence to an aggressive antisecretory regimen (b.i.d. PPI and H2 blocker at bedtime).6 LHM with fundoplication significantly reduces the risk of pathological GERD and spares patients from committing to lifelong PPI therapy and routine endoscopic surveillance (appropriate interval yet to be determined) and needing to consider additional procedures (i.e., endoscopic or surgical fundoplication).

Despite POEM’s well established efficacy and safety, the development of post-POEM GERD is a major concern that has yet to be adequately addressed. A significant number of post-POEM patients with pathological reflux have asymptomatic and unrecognized GERD and current management and monitoring strategies for post-POEM GERD are anemic and poorly established. Without question, there are individual patients who are clearly better served with POEM (type III achalasia and other spastic esophageal disorders). However, as we continue to learn more about post-POEM GERD and how to better prevent, manage, and monitor it, LHM with fundoplication for the time being remains the tried-and-tested treatment option for patients with non–type III achalasia.
 

References

1. Richards WO et al. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: A prospective randomized double-blind clinical trial. Ann Surg. 2004;240:405-12.

2. Podboy AJ et al. Long-term outcomes of peroral endoscopic myotomy compared to laparoscopic Heller myotomy for achalasia: A single-center experience. Surg Endosc. 2020. doi: 10.1007/s00464-020-07450-6.

3. Werner YB et al. Endoscopic or surgical myotomy in patients with idiopathic achalasia. N Engl J Med. 2019;381(23):2219-29.

4. Inoue H et al. Peroral endoscopic myotomy: A series of 500 patients. J Am Coll Surg. 2015;221:256-64.

5. Repici A et al. GERD after peroral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: A systematic review with meta-analysis. Gastrointest Endosc. 2018;87(4):934-43.

6. Ichkhanian Y et al. Case of early Barrett cancer following peroral endoscopic myotomy. Gut. 2019;68:2107-10.

Dr. Siwiec is assistant professor of clinical medicine, division of gastroenterology and hepatology, GI motility and neurogastroenterology unit, Indiana University, Indianapolis. He has no conflicts of interest.

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A tribute to Edward Ross Ritvo, MD, 1930-2020

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Thu, 08/26/2021 - 16:04

Reflections on loss amid COVID-19

I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.

Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.

My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.

June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”

Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.

Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.

He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.

Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.

Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.

Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.

Dr. Eva Ritvo, a psychiatrist who practices in Miami Beach, Fla.
Dr. Eva Ritvo

As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are now left to carry the torch and ensure that our field continues to move forward in an integrative fashion. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.

I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.

I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

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Reflections on loss amid COVID-19

Reflections on loss amid COVID-19

I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.

Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.

My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.

June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”

Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.

Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.

He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.

Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.

Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.

Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.

Dr. Eva Ritvo, a psychiatrist who practices in Miami Beach, Fla.
Dr. Eva Ritvo

As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are now left to carry the torch and ensure that our field continues to move forward in an integrative fashion. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.

I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.

I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

I sit here on Father’s Day during a global pandemic and can’t help but think of Mark Twain’s quote, “Truth is stranger than fiction.” Isn’t that what calls us to our profession? When friends ask if I have watched a particular movie or TV show, I almost always say no. Why would I? Day after day at “work” I am hearing the most remarkable stories – many unfolding right before my eyes.

Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo shares a light moment with his daughter, Eva, and their dogs, circa 1963.

My Dad’s story is no less remarkable. As he was a pioneer in our field, I hope you will allow me to share a few recollections.

June 10, just 10 days after turning 90, Dad died peacefully in his home. His obituary, written by James McCracken, MD, says: “He was an internationally known child psychiatrist who, with colleagues, formed the vanguard of UCLA researchers establishing the biomedical basis of autism in the 1960s despite the prevailing psychological theories of the day ... who would later break new ground in identifying the role of genetics, sleep, and neurophysiological differences, perinatal risk factors, and biomarkers relating to autism and autism risk.”

Dad had extensive training in psychoanalysis and worked hard to maintain expertise in both the psychological and biological arenas. While he helped established autism as a neurologic disease and advocated for DSM criteria changes, he continued teaching Psychodynamic Theory of Personality to the UCLA medical students and maintained a clinical practice based in psychotherapeutic techniques. He was practicing biopsychosocial medicine long before the concept was articulated.

Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.
Courtesy Dr. Eva Ritvo
Dr. Edward Ross Ritvo, who was a pilot in his younger days, copiloted this flight from Connecticut to Florida.

He conducted the first epidemiologic survey of autism in the state of Utah. He chose Utah because the Mormons keep perfect genealogical records. He identified multiple families with more than one child affected as well as examining, pre-, peri-, and postnatal factors affecting these families. Being a maverick has its challenges. One paper about parents with mild autism was rejected from publication seven times before a watered-down version of clinical vignettes finally got accepted. In collaboration with his wife, Riva Ariella Ritvo, he developed the Ritvo Autism Asperger Diagnostic Scale–Revised, (RAADS-R) still in use today.

Dad’s career was complicated by medical issues beginning in his 40s when he had a near-fatal heart attack at the top of Mammoth Mountain while skiing. After struggling for 20 years, he ultimately had a heart transplant at Cedars-Sinai Medical Center at 69 years old. Months after the transplant, he was back at work. He was unstoppable and maintained his optimism and great sense of humor throughout this complicated ordeal. He always remembered his commitment to his donor and his new heart, and worked out every day. Living to 90 was against all the odds.

Dad also persevered throughout his youngest son’s 10-year battle with Ewing’s sarcoma. Despite losing Max in 2016, Dad was active in research and clinical practice until the very end. He was doing telepsychiatry with patients in prisons and rehabilitation hospitals the last few years because he was too weak to travel to an office. He continued his research, and his last paper on eye movement responses as a possible biological marker of autism was published in February 2020.

Although Dad did not have COVID-19, the social isolation and stress of the last few months hastened his decline. The last week in the hospital with no visitors was too much for such a social man, and he died days after he was discharged. Always a trailblazer, Dad’s Zoom funeral was watched across the country by his children, grandchildren, extended family, and friends. Choosing to honor his wish to be cautious in this pandemic, we remained sheltering in place.

Dr. Eva Ritvo, a psychiatrist who practices in Miami Beach, Fla.
Dr. Eva Ritvo

As Dad was the ultimate professor, I know he would want us to learn from his life and his passing. We are now left to carry the torch and ensure that our field continues to move forward in an integrative fashion. We are in an accelerated growth phase now as our lives and the lives of our patients are radically altered.

I hope, like Dad, we can choose to feel nourished by our meaningful work as we travel through life’s ups and downs. We must learn new ways to care for ourselves, our families, and our patients during these challenging times. We must find ways to mourn and celebrate those lost during the pandemic.

I know Dad would love synchronicity that I spent Father’s Day writing about him for Clinical Psychiatry News! Thank you for giving me this gift of reflection on this special day.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

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Isa-Kd improves PFS in relapsed/refractory multiple myeloma

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The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).

After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.

“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.

Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
 

A ‘me too’ agent?

It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.

“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.

Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.

Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
 

Study details

In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.

Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.

At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.

An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.

Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).

Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.

Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.

The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.

The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.

SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.

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The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).

After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.

“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.

Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
 

A ‘me too’ agent?

It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.

“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.

Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.

Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
 

Study details

In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.

Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.

At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.

An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.

Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).

Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.

Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.

The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.

The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.

SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.

 

The risk of progression or death for patients with relapsed or refractory multiple myeloma was nearly halved with the addition of isatuximab to carfilzomib and dexamethasone, according to an interim analysis of the phase 3 IKEMA trial (NCT03275285).

After a median follow-up of 20.7 months, the median progression-free survival had not been reached for 179 patients treated with isatuximab (Sarclisa), carfilzomib (Kyprolis), and dexamethasone (together, known as Isa-Kd), compared with 19.5 months for 123 patients treated with carfilzomib and dexamethasone alone (Kd). The hazard ratio for progression free survival with the triple combination was 0.531 (P = .0007), reported coprincipal investigator Phillipe Moreau, MD, from the University Hospital Hôtel-Dieu in Nantes, France.

“The benefit of the triplet combination was observed across subgroups, including patients difficult to treat, such as [those with] high-risk cytogenetics or elderly patients,” he said in a late-breaking abstract presentation during the virtual annual congress of the European Hematology Association.

Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of another anti-CD38 antibody, daratumumab (Darzalex). Isatuximab is approved in the United States and Europe in combination with pomalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma after at least two prior lines of therapy.
 

A ‘me too’ agent?

It’s unclear, however, whether isatuximab offers any additional benefit over daratumumab, an agent approved for use both in front line therapy combinations and for patients with relapsed/refractory disease, said Brea C. Lipe, MD, a multiple myeloma specialist at the University of Rochester (N.Y.) Wilmot Cancer Institute, who was not involved in the study.

“Every time we get a new drug it’s nice to have another option, but it doesn’t really add anything different from daratumumab at this point,” she said in an interview.

Dr. Lipe noted the IKEMA results are similar to those seen in the phase 3 CANDOR trial, comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib/dexamethasone alone in patients with relapsed/refractory myeloma. In addition, it’s unknown whether patients with disease that is refractory to daratumumab could benefit from isatuximab, she said.

Although isatuximab has been touted as offering more rapid and more convenient dosing than daratumumab, the introduction of rapid infusion and subcutaneous administration of daratumumab has negated any theoretical advantage of the newcomer, Dr. Lipe added.
 

Study details

In the IKEMA trial, 302 patients with relapsed/refractory multiple myeloma who’d received one to three prior lines of therapy were stratified by the number of prior lines and by revised Multiple Myeloma International Staging System (R-ISS) and were then randomized on a 3:2 basis to treatment with carfilzomib 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of cycle 1 and 56 mg/m2 on the corresponding days of each subsequent cycle plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle, with or without isatuximab. The antibody was dosed 10 mg/kg on days 1, 8, 15, and 22 in cycle 1 then every 2 weeks thereafter.

Treatments were continued until disease progression, unacceptable toxicity, or patient choice intervened.

At a prespecified interim analysis, the trial met its primary endpoint of a minimum 41% risk reduction in the hazard rate for progression free survival (PFS), with an actual risk reduction of 47%.

An analysis of PFS by subgroup showed significant benefits with the triple combination for patients aged 65 years and older, those with baseline estimated glomerular filtration rates below 60 mL/min per 1.73 m2, those with more than one prior line of therapy, those who had not previously received a proteasome inhibitor (e.g., bortezomib) or immunomodulatory agent (e.g., lenalidomide), those with high-risk cytogenetic status, and those with R-ISS stage II at study entry.

Overall response rates were similar between the study arms, at 86.6% with Isa-Kd and 82.9% with Kd, but the rate of very good partial responses or better was significantly higher with the triplet, at 72.6% versus 56.1% (P = .0011). The rate of minimal residual disease negativity was also significantly lower with Isa-Kd in the intent-to-treat population, at 29.6% versus 13%, respectively (P = .0004).

Overall survival data were not mature at the time of data cutoff and will be reported later, Dr. Moreau said.

Grade 3 or greater treatment-emergent adverse events (TEAEs) occurred in 76.8% of patients on the triplet and 67.2% of those on Kd. The incidences of death, serious TEAEs, or adverse events leading to discontinuation of therapy did not differ markedly between the treatment arms, however. Grade 3 or greater cardiac failure occurred in seven patients treated with the triplet (4%) and five treated with Kd (4.1%); respective rates of grade 3 or greater hematologic abnormalities included anemia in 22% and 19.7%, neutropenia in 19.2% and 7.4%, and thrombocytopenia in 29.9% and 23.8%.

The primary completion date for the trial is estimated to occur in November 2020, with final results in November 2023.

The study was sponsored by Sanofi. Dr. Moreau disclosed honoraria and a consulting or advisory role with several companies, not including Sanofi. Dr. Lipe disclosed impending advisory board activity for Janssen.

SOURCE: Moreau P et al. EHA Congress, Abstract LB2603.

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