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Emotional support animals help lick symptoms of depression, anxiety in serious mental illness
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of emotional support animals (ESAs) yields quantifiable reductions in depression, anxiety, and loneliness for patients with serious mental illness (SMI) who live alone, early research suggests.
Investigators followed 11 community-dwelling adults with SMI who were paired with a shelter dog or cat for 1 year. Participants’ depression, anxiety, and loneliness were assessed at baseline and 12 months after receipt of their ESAs.
At regular home visits during the study, participants also underwent saliva testing before playing with their pets and after 10 minutes of enjoyable pet interaction to assess levels of oxytocin – a biomarker associated with bonding – as well as cortisol and alpha amylase, which are markers of stress.
Significant reductions in measures of anxiety, depression, and loneliness were found between baseline and 12 months for all participants. Moreover, there was a pattern of an increase in levels of oxytocin and a decrease in levels of cortisol after 10 minutes of ESA interaction, but the degree of change did not reach statistical significance.
“Although this was a small pilot study and the findings are correlational, rather than causal, we can nevertheless say from the self-report of this group of participants and from the data collected that having an emotional support animal was beneficial to their mental health,” lead author Janet Hoy-Gerlach, PhD, professor of social work, University of Toledo (Ohio), said in an interview.
“We feel this data is a strong justification for additional study, and we hope that it will be a catalyst for future research with larger samples and more rigorous methodology,” said Dr. Hoy-Gerlach, author of “Human-Animal Interaction: A Social Work Guide,” published by NASW Press in 2017.
The study was published online May 20 in Human Animal Interaction Bulletin.
Everyday interactions
An ESA is a “companion animal (pet) who helps to reduce disability-related impairment for a particular person through the animal’s presence and everyday interactions,” the authors wrote.
Unlike service animals, which perform specific functions, ESAs “provide benefits that fall along the same dimensions as the benefits of pets – physical, social, emotional, and psychological – and there is research supporting the role that animals can play in each of these arenas,” Dr. Hoy-Gerlach said.
ESAs require no special training. All that is needed is a letter from a medical or mental health professional “that the individual meets the definition of ‘disability’ under the Fair Housing Act and a companion animal is a needed disability-ameliorating accommodation and should be allowed in buildings that don’t ordinarily permit pets,” she noted.
There is currently no peer-reviewed research that focuses explicitly on the impact of ESAs in individuals with SMI. To investigate, the researchers turned to the Hope and Recovery Pet Program (HARP) – a community partnership of the University of Toledo, the Toledo Humane Society, and ProMedica, a large regional nonprofit Toledo-based health care system – that pairs community-living individuals who have depression and/or anxiety with shelter animals that require adoption. The program pays for pet food, supplies, and veterinary care for those unable to afford these.
Participants (n = 11; mean age, 53.67 years; 78% women) were recruited from the HARP program. Participants were required to be psychiatrically stable, have stable housing, live alone, be at risk for social isolation, have low income, be sober, and have no history of violence. Their primary diagnoses were major depressive disorder, bipolar disorder, and schizoaffective disorder (63%, 18%, and 18%, respectively).
Six participants adopted a cat, and five adopted a dog.
Prior to ESA adoption and at 12 months, participants completed the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the UCLA Loneliness Scale Version 3.
Prior to ESA adoption and at 1, 3, 6, 9, and 12 months, saliva samples were collected from participants by researchers at the beginning of a home visit and then after 10 minutes of “focused pleasant interaction” with the ESA. The saliva was tested for oxytocin, alpha amylase, and cortisol.
Motivation, comfort, calm
The researchers found statistically significant decreases in UCLA Loneliness Scale scores from pre-ESA (mean [SD],59.20 [9.47]) to 12 months (49.90 [13.66], P = .004). The eta-squared statistic (.62) indicated a large effect size.
For 18 of the 20 items on the loneliness scale, mean values were lower after the intervention than before the intervention. Of these, four were statistically significant.
A statistically significant decrease in BDI total scores was also seen from pre-ESA to 12 months (21.09 [8.43] to 14.64 [7.03], respectively; P = .03). The eta-squared statistic (.41) indicated a large effect size.
Of the 21 items on the BDI scale, the mean value was lower for 19 after the intervention. Of these, five were statistically significant.
Similarly, a statistically significant decrease in BAI score was found from pre-ESA to 12 months (23.55 [9.81] to 17.73 [11.79], P = .049). The eta-squared statistic (.36) indicated a large effect size, although there were no statistically significant changes in individual item scores.
The researchers found “observable patterns” of decreases in cortisol and increases in oxytocin after the 10-minute enjoyable ESA interactions. The highest oxytocin increase occurred at 12 months; however, these improvements did not reach statistical significance.
Participants offered open-ended statements about the positive impact of their ESA on their mental health, Dr. Hoy-Gerlach said. “For example, they described feeling motivated to take better care of themselves because their ESA needed them. Some described feeling ‘comforted,’ distracted from symptoms, soothed, and calmed.
“There is definitely a place for ESAs, especially with mental health post pandemic, when we need all the resources that we can for those who can benefit,” she added.
Postpandemic mental health
Commenting on the study for this news organization, Christine Crawford, MD, MPH, assistant professor of psychiatry, Boston University, observed that ESAs “are not on the radar for a lot of clinicians, and a lot of clinicians don’t know about the science [supporting their use] or what an emotional support pet entails.
“
The Kenneth A. Scott Charitable Trust provided grant funding. Dr. Hoy-Gerlach, her coauthors, and Dr. Crawford have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Neurologists brace and prepare for long-COVID fallout
“If there’s one universal truth amongst all the patients I’ve interviewed, it’s that they’re often brushed aside, pigeonholed, or, frankly, abandoned,” said Greg Vanichkachorn, MD, MPH, a family physician and founder of Mayo Clinic’s COVID-19 Activity Rehabilitation Program (CARP).
Take a nap. Tough it out. Push through it. Dr. Vanichkachorn describes the frustration voiced by thousands of patients whose lives continue to be disrupted and thrown into upheaval.
Brain fog. Cognitive dysfunction. Headaches. These are just a few of the manifestations of what the National Institutes of Health has termed post-acute sequelae of SARS COVID-2 (PASC), more commonly known as long-COVID.
PASC is loosely defined as symptoms and/or sequelae that persist for several weeks to months after the initial infection has cleared.
A total of 33.6% (95% confidence interval, 11.17-34.07) of patients with COVID-19 experience neurologic sequelae in the first 6 months following resolution of the infection. Almost half of cases (12.8%; 95% CI, 12.36-13.33) represented first-time diagnoses.
“Anecdotally, the longer we go into this, and the more people that, in the past, have been infected with COVID-19, the more patients will be seeing neurologists with some of these complaints,” said Ralph Sacco, MD, professor and Olemberg chair of neurology at University of Miami, and past president of the American Academy of Neurology.
Neurologic detritus
Further complicating the epidemiologic picture is the broad array of clinical and functional symptoms. “What we call long-haul COVID is not a single entity,” explained Michel Toledano, MD, a neurology consultant and a member of the CARP team at the Mayo Clinic in Rochester, Minnesota. Patients present with persistent or emergent polysymptomatic and multisystemic diseases that often include neurologic symptoms, he said. In many circumstances, they had an acute infection with either very mild symptoms or no symptoms at all.
“There’s no doubt that these people are experiencing significant neurologic symptoms, but it remains unclear whether the driving factor is mainly systemic or the nervous system independently of what is happening in the body,” he said.
Like patients with SARS-CoV-1 and Middle Eastern respiratory syndrome (MERS), patients recovering from confirmed or suspected SARS-CoV-2 infections experience a variety of self-reported neurologic symptoms that vary in terms of time frame, duration, and severity.
Take Jacqueline Jolly, for example, a 50-year-old single mother and construction permit contractor living outside of Tampa, Florida. She was diagnosed with COVID-19 in January 2021. Jolly explained that she was never sick enough to be admitted to the hospital and yet is still not close to full recovery. Lingering, debilitating symptoms include executive function challenges, anosmia, headaches, and paresthesia that frequently bring her to the edge of losing consciousness. She has not returned to work, despite multiple attempts.
Vicky Nunally, a 35-year-old single mother and medical office assistant who lives in the suburbs of Atlanta, Georgia, recounted that she landed in the intensive care unit with a severe SARS-CoV-2 infection. Roughly 6 months later, she continues to experience debilitating headaches, brain fog, and cognitive delays. Her endometriosis has flared up. She says that she is depressed, anxious, and has returned to therapy. “It makes you feel crazy,” she said.
Debilitating, pervasive symptoms
Findings from an international survey of 3,762 respondents that was published on April 21 in medRXiv underscore that PASC occurs predominantly in middle-aged women (78.9% were women; 31% were aged 40-49 years; 25.0% were aged 50-59 years). For the most part, it manifests similarly among people with prior confirmed or suspected SARS-CoV-2 infections. In the study, symptoms were reported in both cohorts well past the initial infection; symptoms persisted past 90 days in 96% of patients and for at least 6 months in 65.2%.
Similarly, a recent study showed that 68% of patients who were enrolled in Mayo Clinic’s CARP as of June 2020 were women, middle aged (mean age, 45 ± 14.2 years), and presented roughly 3 months (94.4 ± 65 days) post diagnosis. Of these patients, 75% had not been previously hospitalized.
In both studies, fatigue and cognitive dysfunction were consistently cited as the most debilitating and pervasive manifestations lasting more than 6 months. Others included postexertional (physical or mental) malaise, sensorimotor symptoms, headaches, and memory problems.
Reports of even more severe neurologic first-time diagnoses are emerging. Findings from the Lancet Psychiatry study showed there was a small but clinically relevant risk for a range of conditions that included intracranial hemorrhage (0.14%; 95% CI, 0.10-0.20), ischemic stroke (0.43%; 95% CI, 0.36-0.52), parkinsonism (0.07%; 95% CI, 0.05-0.12), and nerve root/plexus disorders (2.69%; 95% CI, 2.51-2.89).
Dr. Toledano noted that he’s also seen patients who developed autonomic/small-fiber dysfunction. Preliminary data from a retrospective chart review suggest that the most likely diagnosis is orthostatic intolerance without tachycardia or hypotension.
In the study, 63% (17) of the 27 participants who met the inclusion criteria had abnormal results on function testing, but Composite Autonomic Severity Score results indicated mostly mild disease (sudomotor range, 0-3 [median, 0]; cardiovagal, 0-3 [median, 0]; cardiovascular adrenergic, 0-4 [median, 0]).
“The pattern that’s emerging is consistent with deconditioning,” Dr. Toledano said. “However, a small proportion of patients do have evidence of damage to the nervous system, which is something we’ve seen with other viruses.”
Proliferation of long-COVID clinics
A few of these patients with orthostatic intolerance developed postural tachycardia syndrome or experienced exacerbations of preexisting sensory or autonomic small-fiber neuropathies. “These post-viral, autonomic neuropathies tend to be self-limiting, but we’re starting to see different levels of involvement,” Dr. Toledano explained. At present, causality and/or underlying mechanisms are unclear.
Speaking on behalf of the American Academy of Neurology, Dr. Sacco acknowledged the challenges that lie ahead. “Like any neurological symptom that continues to affect a patient’s quality of life, you may need to seek the expertise of a neurologist. The only issue is that some may still not be sure exactly what to do; we don’t have all the data yet,” he said.
On the flip side, he pointed to the lessons of the past year and how quickly health care systems were able to pivot to deal with the pandemic and critically ill patients, then pivot again to disseminate vaccines, and how they are pivoting yet again to address PASC.
Across the nation, numerous hospitals and health care systems and even small private clinics have launched clinics that focus on long-COVID, including Mayo.
The program has a multidisciplinary, collaborative framework and offers both face-to-face and video telemedicine consultations. The latter are geared toward ensuring that under-resourced populations can access needed care and assistance.
“At Mayo, we have a centralized triage system to help target patients’ visits so that appropriate subspecialties and studies can be preordered,” explained Dr. Toledano. During these visits, patients are assessed for underlying conditions and possible signs of decompensation, as well as functional and physical needs and psychosocial challenges. Thereafter, patients enter either CARP, which offers active rehabilitation for up to 3 months after resolution of the acute infection, or the Post-COVID Care Center, which focuses on patients whose condition is not improving or who are demonstrating signs of central sensitization.
An uphill battle
Both programs incorporate individually paced occupational and physical therapy aimed at ameliorating symptoms, restoring function, developing psychosocial coping skills, and, ultimately, facilitating a return to work. “The idea is, if we can meet with these patients sooner than later and help them recover in an appropriate fashion, they will exit the program faster,” Dr. Vanichkachorn said. “We do see a group of patients who tend to get better right around the 4-month period.”
Although telemedicine provides an opportunity for clinicians outside these hospital systems to engage patients, Dr. Vanichkachorn pointed out that almost all the initial treatments can be offered in the local community by a provider who has adequate time and knowledge of the condition.
He also acknowledged the potential for an uphill battle, especially among those who cling to the belief that PASC is simply a manifestation of anxiety or depression. “This is something that we’ve seen previously with SARS and MERS, as well as in conjunction with fibromyalgia and chronic fatigue, only now with greater magnitude,” he said. “This is a real condition that has important and huge ramifications on a person’s ability to function.”
The silver lining is that last December, the NIH announced that it was allocating $1.1 billion for research through its NIH PASC Initiative. Like other institutions, Mayo is waiting to hear what it has been awarded. In the meantime, it has developed a biorepository of patient samples to better understand pathophysiologic mechanisms underlying PASC and to identify possible biomarkers that differentiate these patients.
Despite the challenges, Dr. Vanichkachorn is hopeful. “If we can get a concrete understanding of what is occurring on the chemical level and develop diagnostic tests, then the education will follow. Providers won’t be able to ignore it any longer,” he said.
The interviewees have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“If there’s one universal truth amongst all the patients I’ve interviewed, it’s that they’re often brushed aside, pigeonholed, or, frankly, abandoned,” said Greg Vanichkachorn, MD, MPH, a family physician and founder of Mayo Clinic’s COVID-19 Activity Rehabilitation Program (CARP).
Take a nap. Tough it out. Push through it. Dr. Vanichkachorn describes the frustration voiced by thousands of patients whose lives continue to be disrupted and thrown into upheaval.
Brain fog. Cognitive dysfunction. Headaches. These are just a few of the manifestations of what the National Institutes of Health has termed post-acute sequelae of SARS COVID-2 (PASC), more commonly known as long-COVID.
PASC is loosely defined as symptoms and/or sequelae that persist for several weeks to months after the initial infection has cleared.
A total of 33.6% (95% confidence interval, 11.17-34.07) of patients with COVID-19 experience neurologic sequelae in the first 6 months following resolution of the infection. Almost half of cases (12.8%; 95% CI, 12.36-13.33) represented first-time diagnoses.
“Anecdotally, the longer we go into this, and the more people that, in the past, have been infected with COVID-19, the more patients will be seeing neurologists with some of these complaints,” said Ralph Sacco, MD, professor and Olemberg chair of neurology at University of Miami, and past president of the American Academy of Neurology.
Neurologic detritus
Further complicating the epidemiologic picture is the broad array of clinical and functional symptoms. “What we call long-haul COVID is not a single entity,” explained Michel Toledano, MD, a neurology consultant and a member of the CARP team at the Mayo Clinic in Rochester, Minnesota. Patients present with persistent or emergent polysymptomatic and multisystemic diseases that often include neurologic symptoms, he said. In many circumstances, they had an acute infection with either very mild symptoms or no symptoms at all.
“There’s no doubt that these people are experiencing significant neurologic symptoms, but it remains unclear whether the driving factor is mainly systemic or the nervous system independently of what is happening in the body,” he said.
Like patients with SARS-CoV-1 and Middle Eastern respiratory syndrome (MERS), patients recovering from confirmed or suspected SARS-CoV-2 infections experience a variety of self-reported neurologic symptoms that vary in terms of time frame, duration, and severity.
Take Jacqueline Jolly, for example, a 50-year-old single mother and construction permit contractor living outside of Tampa, Florida. She was diagnosed with COVID-19 in January 2021. Jolly explained that she was never sick enough to be admitted to the hospital and yet is still not close to full recovery. Lingering, debilitating symptoms include executive function challenges, anosmia, headaches, and paresthesia that frequently bring her to the edge of losing consciousness. She has not returned to work, despite multiple attempts.
Vicky Nunally, a 35-year-old single mother and medical office assistant who lives in the suburbs of Atlanta, Georgia, recounted that she landed in the intensive care unit with a severe SARS-CoV-2 infection. Roughly 6 months later, she continues to experience debilitating headaches, brain fog, and cognitive delays. Her endometriosis has flared up. She says that she is depressed, anxious, and has returned to therapy. “It makes you feel crazy,” she said.
Debilitating, pervasive symptoms
Findings from an international survey of 3,762 respondents that was published on April 21 in medRXiv underscore that PASC occurs predominantly in middle-aged women (78.9% were women; 31% were aged 40-49 years; 25.0% were aged 50-59 years). For the most part, it manifests similarly among people with prior confirmed or suspected SARS-CoV-2 infections. In the study, symptoms were reported in both cohorts well past the initial infection; symptoms persisted past 90 days in 96% of patients and for at least 6 months in 65.2%.
Similarly, a recent study showed that 68% of patients who were enrolled in Mayo Clinic’s CARP as of June 2020 were women, middle aged (mean age, 45 ± 14.2 years), and presented roughly 3 months (94.4 ± 65 days) post diagnosis. Of these patients, 75% had not been previously hospitalized.
In both studies, fatigue and cognitive dysfunction were consistently cited as the most debilitating and pervasive manifestations lasting more than 6 months. Others included postexertional (physical or mental) malaise, sensorimotor symptoms, headaches, and memory problems.
Reports of even more severe neurologic first-time diagnoses are emerging. Findings from the Lancet Psychiatry study showed there was a small but clinically relevant risk for a range of conditions that included intracranial hemorrhage (0.14%; 95% CI, 0.10-0.20), ischemic stroke (0.43%; 95% CI, 0.36-0.52), parkinsonism (0.07%; 95% CI, 0.05-0.12), and nerve root/plexus disorders (2.69%; 95% CI, 2.51-2.89).
Dr. Toledano noted that he’s also seen patients who developed autonomic/small-fiber dysfunction. Preliminary data from a retrospective chart review suggest that the most likely diagnosis is orthostatic intolerance without tachycardia or hypotension.
In the study, 63% (17) of the 27 participants who met the inclusion criteria had abnormal results on function testing, but Composite Autonomic Severity Score results indicated mostly mild disease (sudomotor range, 0-3 [median, 0]; cardiovagal, 0-3 [median, 0]; cardiovascular adrenergic, 0-4 [median, 0]).
“The pattern that’s emerging is consistent with deconditioning,” Dr. Toledano said. “However, a small proportion of patients do have evidence of damage to the nervous system, which is something we’ve seen with other viruses.”
Proliferation of long-COVID clinics
A few of these patients with orthostatic intolerance developed postural tachycardia syndrome or experienced exacerbations of preexisting sensory or autonomic small-fiber neuropathies. “These post-viral, autonomic neuropathies tend to be self-limiting, but we’re starting to see different levels of involvement,” Dr. Toledano explained. At present, causality and/or underlying mechanisms are unclear.
Speaking on behalf of the American Academy of Neurology, Dr. Sacco acknowledged the challenges that lie ahead. “Like any neurological symptom that continues to affect a patient’s quality of life, you may need to seek the expertise of a neurologist. The only issue is that some may still not be sure exactly what to do; we don’t have all the data yet,” he said.
On the flip side, he pointed to the lessons of the past year and how quickly health care systems were able to pivot to deal with the pandemic and critically ill patients, then pivot again to disseminate vaccines, and how they are pivoting yet again to address PASC.
Across the nation, numerous hospitals and health care systems and even small private clinics have launched clinics that focus on long-COVID, including Mayo.
The program has a multidisciplinary, collaborative framework and offers both face-to-face and video telemedicine consultations. The latter are geared toward ensuring that under-resourced populations can access needed care and assistance.
“At Mayo, we have a centralized triage system to help target patients’ visits so that appropriate subspecialties and studies can be preordered,” explained Dr. Toledano. During these visits, patients are assessed for underlying conditions and possible signs of decompensation, as well as functional and physical needs and psychosocial challenges. Thereafter, patients enter either CARP, which offers active rehabilitation for up to 3 months after resolution of the acute infection, or the Post-COVID Care Center, which focuses on patients whose condition is not improving or who are demonstrating signs of central sensitization.
An uphill battle
Both programs incorporate individually paced occupational and physical therapy aimed at ameliorating symptoms, restoring function, developing psychosocial coping skills, and, ultimately, facilitating a return to work. “The idea is, if we can meet with these patients sooner than later and help them recover in an appropriate fashion, they will exit the program faster,” Dr. Vanichkachorn said. “We do see a group of patients who tend to get better right around the 4-month period.”
Although telemedicine provides an opportunity for clinicians outside these hospital systems to engage patients, Dr. Vanichkachorn pointed out that almost all the initial treatments can be offered in the local community by a provider who has adequate time and knowledge of the condition.
He also acknowledged the potential for an uphill battle, especially among those who cling to the belief that PASC is simply a manifestation of anxiety or depression. “This is something that we’ve seen previously with SARS and MERS, as well as in conjunction with fibromyalgia and chronic fatigue, only now with greater magnitude,” he said. “This is a real condition that has important and huge ramifications on a person’s ability to function.”
The silver lining is that last December, the NIH announced that it was allocating $1.1 billion for research through its NIH PASC Initiative. Like other institutions, Mayo is waiting to hear what it has been awarded. In the meantime, it has developed a biorepository of patient samples to better understand pathophysiologic mechanisms underlying PASC and to identify possible biomarkers that differentiate these patients.
Despite the challenges, Dr. Vanichkachorn is hopeful. “If we can get a concrete understanding of what is occurring on the chemical level and develop diagnostic tests, then the education will follow. Providers won’t be able to ignore it any longer,” he said.
The interviewees have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“If there’s one universal truth amongst all the patients I’ve interviewed, it’s that they’re often brushed aside, pigeonholed, or, frankly, abandoned,” said Greg Vanichkachorn, MD, MPH, a family physician and founder of Mayo Clinic’s COVID-19 Activity Rehabilitation Program (CARP).
Take a nap. Tough it out. Push through it. Dr. Vanichkachorn describes the frustration voiced by thousands of patients whose lives continue to be disrupted and thrown into upheaval.
Brain fog. Cognitive dysfunction. Headaches. These are just a few of the manifestations of what the National Institutes of Health has termed post-acute sequelae of SARS COVID-2 (PASC), more commonly known as long-COVID.
PASC is loosely defined as symptoms and/or sequelae that persist for several weeks to months after the initial infection has cleared.
A total of 33.6% (95% confidence interval, 11.17-34.07) of patients with COVID-19 experience neurologic sequelae in the first 6 months following resolution of the infection. Almost half of cases (12.8%; 95% CI, 12.36-13.33) represented first-time diagnoses.
“Anecdotally, the longer we go into this, and the more people that, in the past, have been infected with COVID-19, the more patients will be seeing neurologists with some of these complaints,” said Ralph Sacco, MD, professor and Olemberg chair of neurology at University of Miami, and past president of the American Academy of Neurology.
Neurologic detritus
Further complicating the epidemiologic picture is the broad array of clinical and functional symptoms. “What we call long-haul COVID is not a single entity,” explained Michel Toledano, MD, a neurology consultant and a member of the CARP team at the Mayo Clinic in Rochester, Minnesota. Patients present with persistent or emergent polysymptomatic and multisystemic diseases that often include neurologic symptoms, he said. In many circumstances, they had an acute infection with either very mild symptoms or no symptoms at all.
“There’s no doubt that these people are experiencing significant neurologic symptoms, but it remains unclear whether the driving factor is mainly systemic or the nervous system independently of what is happening in the body,” he said.
Like patients with SARS-CoV-1 and Middle Eastern respiratory syndrome (MERS), patients recovering from confirmed or suspected SARS-CoV-2 infections experience a variety of self-reported neurologic symptoms that vary in terms of time frame, duration, and severity.
Take Jacqueline Jolly, for example, a 50-year-old single mother and construction permit contractor living outside of Tampa, Florida. She was diagnosed with COVID-19 in January 2021. Jolly explained that she was never sick enough to be admitted to the hospital and yet is still not close to full recovery. Lingering, debilitating symptoms include executive function challenges, anosmia, headaches, and paresthesia that frequently bring her to the edge of losing consciousness. She has not returned to work, despite multiple attempts.
Vicky Nunally, a 35-year-old single mother and medical office assistant who lives in the suburbs of Atlanta, Georgia, recounted that she landed in the intensive care unit with a severe SARS-CoV-2 infection. Roughly 6 months later, she continues to experience debilitating headaches, brain fog, and cognitive delays. Her endometriosis has flared up. She says that she is depressed, anxious, and has returned to therapy. “It makes you feel crazy,” she said.
Debilitating, pervasive symptoms
Findings from an international survey of 3,762 respondents that was published on April 21 in medRXiv underscore that PASC occurs predominantly in middle-aged women (78.9% were women; 31% were aged 40-49 years; 25.0% were aged 50-59 years). For the most part, it manifests similarly among people with prior confirmed or suspected SARS-CoV-2 infections. In the study, symptoms were reported in both cohorts well past the initial infection; symptoms persisted past 90 days in 96% of patients and for at least 6 months in 65.2%.
Similarly, a recent study showed that 68% of patients who were enrolled in Mayo Clinic’s CARP as of June 2020 were women, middle aged (mean age, 45 ± 14.2 years), and presented roughly 3 months (94.4 ± 65 days) post diagnosis. Of these patients, 75% had not been previously hospitalized.
In both studies, fatigue and cognitive dysfunction were consistently cited as the most debilitating and pervasive manifestations lasting more than 6 months. Others included postexertional (physical or mental) malaise, sensorimotor symptoms, headaches, and memory problems.
Reports of even more severe neurologic first-time diagnoses are emerging. Findings from the Lancet Psychiatry study showed there was a small but clinically relevant risk for a range of conditions that included intracranial hemorrhage (0.14%; 95% CI, 0.10-0.20), ischemic stroke (0.43%; 95% CI, 0.36-0.52), parkinsonism (0.07%; 95% CI, 0.05-0.12), and nerve root/plexus disorders (2.69%; 95% CI, 2.51-2.89).
Dr. Toledano noted that he’s also seen patients who developed autonomic/small-fiber dysfunction. Preliminary data from a retrospective chart review suggest that the most likely diagnosis is orthostatic intolerance without tachycardia or hypotension.
In the study, 63% (17) of the 27 participants who met the inclusion criteria had abnormal results on function testing, but Composite Autonomic Severity Score results indicated mostly mild disease (sudomotor range, 0-3 [median, 0]; cardiovagal, 0-3 [median, 0]; cardiovascular adrenergic, 0-4 [median, 0]).
“The pattern that’s emerging is consistent with deconditioning,” Dr. Toledano said. “However, a small proportion of patients do have evidence of damage to the nervous system, which is something we’ve seen with other viruses.”
Proliferation of long-COVID clinics
A few of these patients with orthostatic intolerance developed postural tachycardia syndrome or experienced exacerbations of preexisting sensory or autonomic small-fiber neuropathies. “These post-viral, autonomic neuropathies tend to be self-limiting, but we’re starting to see different levels of involvement,” Dr. Toledano explained. At present, causality and/or underlying mechanisms are unclear.
Speaking on behalf of the American Academy of Neurology, Dr. Sacco acknowledged the challenges that lie ahead. “Like any neurological symptom that continues to affect a patient’s quality of life, you may need to seek the expertise of a neurologist. The only issue is that some may still not be sure exactly what to do; we don’t have all the data yet,” he said.
On the flip side, he pointed to the lessons of the past year and how quickly health care systems were able to pivot to deal with the pandemic and critically ill patients, then pivot again to disseminate vaccines, and how they are pivoting yet again to address PASC.
Across the nation, numerous hospitals and health care systems and even small private clinics have launched clinics that focus on long-COVID, including Mayo.
The program has a multidisciplinary, collaborative framework and offers both face-to-face and video telemedicine consultations. The latter are geared toward ensuring that under-resourced populations can access needed care and assistance.
“At Mayo, we have a centralized triage system to help target patients’ visits so that appropriate subspecialties and studies can be preordered,” explained Dr. Toledano. During these visits, patients are assessed for underlying conditions and possible signs of decompensation, as well as functional and physical needs and psychosocial challenges. Thereafter, patients enter either CARP, which offers active rehabilitation for up to 3 months after resolution of the acute infection, or the Post-COVID Care Center, which focuses on patients whose condition is not improving or who are demonstrating signs of central sensitization.
An uphill battle
Both programs incorporate individually paced occupational and physical therapy aimed at ameliorating symptoms, restoring function, developing psychosocial coping skills, and, ultimately, facilitating a return to work. “The idea is, if we can meet with these patients sooner than later and help them recover in an appropriate fashion, they will exit the program faster,” Dr. Vanichkachorn said. “We do see a group of patients who tend to get better right around the 4-month period.”
Although telemedicine provides an opportunity for clinicians outside these hospital systems to engage patients, Dr. Vanichkachorn pointed out that almost all the initial treatments can be offered in the local community by a provider who has adequate time and knowledge of the condition.
He also acknowledged the potential for an uphill battle, especially among those who cling to the belief that PASC is simply a manifestation of anxiety or depression. “This is something that we’ve seen previously with SARS and MERS, as well as in conjunction with fibromyalgia and chronic fatigue, only now with greater magnitude,” he said. “This is a real condition that has important and huge ramifications on a person’s ability to function.”
The silver lining is that last December, the NIH announced that it was allocating $1.1 billion for research through its NIH PASC Initiative. Like other institutions, Mayo is waiting to hear what it has been awarded. In the meantime, it has developed a biorepository of patient samples to better understand pathophysiologic mechanisms underlying PASC and to identify possible biomarkers that differentiate these patients.
Despite the challenges, Dr. Vanichkachorn is hopeful. “If we can get a concrete understanding of what is occurring on the chemical level and develop diagnostic tests, then the education will follow. Providers won’t be able to ignore it any longer,” he said.
The interviewees have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Novel text-messaging program boosts ADHD treatment adherence
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Naomi Osaka withdraws from the French Open: When athletes struggle
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
In 2018, when Naomi Osaka won the U.S. Open by defeating Serena Williams, the trophy ceremony was painful to watch.
Ms. Williams had argued with an umpire over a controversial call, and the ceremony began with the crowd booing. Ms. Osaka, the victor, cried while Ms. Williams comforted her and quietly assured Ms. Osaka that the crowd was not booing at her. When asked how her dream of playing against Ms. Williams compared with the reality, the new champion, looking anything but victorious, responded: “Umm, I’m gonna sort of defer from your question, I’m sorry. I know that everyone was cheering for her, and I’m sorry it had to end like this.”
It was hardly the joyous moment it should have been in this young tennis player’s life.
Ms. Osaka, now 23, entered this year’s French Open as the Women’s Tennis Association’s second-ranked player and as the highest-paid female athlete of all time. She is known for her support of Black Lives Matter. Ms. Osaka announced that she would not be attending press conferences in an Instagram post days before the competition began. “If the organizations think they can keep saying, ‘do press or you’re going to get fined,’ and continue to ignore the mental health of the athletes that are the centerpiece of their cooperation then I just gotta laugh,” Ms. Osaka posted.
She was fined $15,000 on Sunday, May 30, when she did not appear at a press conference after winning her first match. Officials noted that she would be subjected to higher fines and expulsion from the tournament if she did not attend the mandatory media briefings. On June 1, Ms. Osaka withdrew from the French Open and explained her reasons on Instagram in a post where she announced that she has been struggling with depression and social anxiety and did not mean to become a distraction for the competition.
Psychiatrists weigh in
Sue Kim, MD, a psychiatrist who both plays and watches tennis, brought up Ms. Osaka’s resignation for discussion on the Maryland Psychiatric Society’s listserv. “[Ms.] Osaka put out on social media her depression and wanted to have rules reviewed and revised by the governing body of tennis, for future occasions. I feel it is so unfortunate and unfair and I am interested in hearing your opinions.”
Yusuke Sagawa, MD, a psychiatrist and tennis fan, wrote in: “During the COVID-19 pandemic, I rekindled my interest in tennis and I followed what transpired this past weekend. Naomi Osaka is an exceptionally shy and introverted person. I have noted that her speech is somewhat akin to (for lack of a better term) ‘Valley Girl’ talk, and from reading comments on tennis-related blogs, it appears she has garnered a significant amount of hatred as a result. Most of it is along the lines of people feeling her shyness and modesty is simply a masquerade.
“I have also seen YouTube videos of her signing autographs for fans. She is cooperative and pleasant, but clearly uncomfortable around large groups of people.
“Having seen many press conferences after a match,” Dr. Sagawa continued, “tennis journalists have a penchant for asking questions that are either personal or seemingly an attempt to stir up acrimony amongst players. Whatever the case, I truly do believe that this is not some sort of ruse on her part, and I hope that people come to her defense. It is disturbing to hear the comments already coming out from the ‘big names’ in the sport that have mostly been nonsupportive. Fortunately, there have also been a number of her contemporaries who have expressed this support for her.”
In the days following Ms. Osaka’s departure from the French Open, the situation has become more complex. as it is used in these types of communications.
Maryland psychiatrist Erik Roskes, MD, wrote: “I have followed this story from a distance and what strikes me is the intermixing of athleticism – which is presumably why we watch sports – and entertainment, the money-making part of it. The athletes are both athletes and entertainers, and [Ms.] Osaka seems to be unable to fully fulfill the latter part due to her unique traits. But like many, I wonder what if this had been Michael Phelps? Is there a gender issue at play?”
Stephanie Durruthy, MD, added: “[Ms.] Osaka brings complexity to the mental health conversations. There is no one answer to her current plight, but her being a person of color cannot be minimized. She magnified the race conversation in tennis to a higher level.
“When she was new to the Grand Slam scene, her Haitian, Japanese, and Black heritage became an issue with unending curiosity.
“[Ms.] Osaka used her platform during the 2020 U.S. Open to single-handedly highlight Black Lives Matter,” Dr. Durruthy continued. “Afterward, the tennis fans could not avoid seeing her face mask. In each match, she displayed another mask depicting the name of those killed. She described on social media her fears of being a Black person in America. The biases of gender and race are well described in the sports world.”
Lindsay Crouse wrote June 1 in the New York Times: “When Naomi Osaka dropped out of the French Open, after declining to attend media interviews that she said could trigger her anxiety, she wasn’t just protecting her mental health. She was sending a message to the establishment of one of the world’s most elite sports: I will not be controlled. This was a power move – and it packed more punch coming from a young woman of color. When the system hasn’t historically stood for you, why sacrifice yourself to uphold it? Especially when you have the power to change it instead.”
Professional sports are grueling on athletes, both physically and mentally. People will speculate about Ms. Osaka’s motives for refusing to participate in the media briefings that are mandated by her contract. Some will see it as manipulative, others as the desire of a young woman struggling with anxiety and depression to push back against a system that makes few allowances for those who suffer. As psychiatrists, we see how crippling these illnesses can be and admire those who achieve at these superhuman levels, often at the expense of their own well-being.
Dr. Kim, who started the MPS listserv discussion, ended it with: “I feel bad if Naomi Osaka needs to play a mental ‘illness’ card, as opposed to mental ‘wellness’ card.”
Let’s hope that Ms. Osaka’s withdrawal from the French Open sparks more conversation about how to accommodate athletes as they endeavor to meet both the demands of their contracts and when it might be more appropriate to be flexible for those with individual struggles.
Dr. Miller is coauthor of “ Committed: The Battle Over Involuntary Psychiatric Care ” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
DOJ charges 14 with COVID-19–related fraud nearing $150M
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
FDA okays new drug option for schizophrenia, bipolar I disorder
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.
The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.
An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.
“Schizophrenia and bipolar I disorder are complex, chronic diseases, and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients’ treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal,” René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, department of psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York, said in a company press release.
In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone and the FDA’s findings of the safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community, and we applaud the FDA for considering the experiences of individuals living with these conditions.”
A version of this article first appeared on Medscape.com.
Psychiatric fallout from long-COVID: How to prepare
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that
lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that
lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
As mounting evidence points to a significant psychiatric component of COVID-19, experts are concerned about an influx of survivors presenting with persistent mental health problems and how best to prepare.
Clinicians should be aware that patients who have had COVID frequently develop psychiatric symptoms, Silvia S. Martins, MD, PhD, associate professor of epidemiology, Columbia University, New York, said in an interview.
“There should be more screening of all patients recovering from a COVID infection for anxiety, posttraumatic stress disorder, and depression, as well as referral to services, including psychotherapy, and medication as needed,” said Dr. Martins, who, along with colleagues, uncovered a high rate of these symptoms in patients who had the disease.
The COVID-19 pandemic has taken an enormous social, emotional, and public health toll. It has disrupted lives and caused stress, fear, and uncertainty about loss of health and income, not to mention forced isolation.
In addition, a significant number of patients who contract COVID-19 continue to have symptoms after the acute phase of the illness. This post-COVID, or “long-haul,” syndrome isn’t well defined; experts cite a range of symptoms that persist for weeks or months.
These ongoing symptoms can include cough, fatigue, and chronic pain, as well as psychiatric complaints. As reported by this news organization, an observational study of more than 230,000 U.S. patient health records revealed that one in three COVID-19 survivors received a psychiatric or neurologic diagnosis within 6 months of contracting the virus.
The most common psychiatric diagnoses were anxiety disorders, mood disorders, substance misuse disorders, and insomnia.
Significant symptoms even in mild cases
Another study showed that even those with mild COVID-19 may experience psychiatric symptoms independently of previous psychiatric diagnoses. Results revealed that 26% of the sample of almost 900 patients reported depression, 22% reported anxiety, and 17% reported symptoms of posttraumatic stress 2 months after testing positive for the virus. This finding is important because the majority of individuals who contract COVID-19 have a mild case.
“We saw very high levels of clinically significant depression, anxiety, and posttraumatic stress symptoms in people who had mild disease,” study investigator João Mauricio Castaldelli-Maia, MD, PhD, postdoctoral fellow, department of epidemiology, Columbia University, said in an interview.
He attributed these symptoms in part to long periods of isolation, even from relatives in the same household, in cramped spaces typical of large cities such as São Paulo.
Social isolation can have a huge impact on persons who depend on social connections and relationships, Vivian Pender, MD, president of the American Psychiatric Association and clinical professor of psychiatry, Weill Cornell Medical Center, New York, said in an interview.
“The fact that we have not been able to see our colleagues, our friends, our family, and in the case of psychiatrists, even our patients has taken a toll on everyone, and that leads to more stress, more anxiety,” she said.
National surveys show that psychiatric symptoms occur after acute COVID. One survey revealed that over 50% of 3,900 respondents who had COVID reported having at least moderate symptoms of major depression.
Unique depression subtype?
Another survey, slated for publication later this year, shows that
lead investigator Roy Perlis, MD, professor of psychiatry, Harvard Medical School, Boston, said in an interview.This might suggest a neurobiological element. Researchers are speculating as to whether lingering psychiatric problems that occur after having COVID are linked to the psychosocial impact of the disease or to pathological processes, such as inflammation, that affect the brain.
Although rates of post-COVID psychiatric symptoms vary from study to study, “they seem to be pretty enduring,” noted Faith Gunning, PhD, vice chair of research, department of psychology, Weill Cornell Medicine, who specializes in clinical neuropsychology.
“So they’re not just a brief response” to getting sick, a fact that points to the possible need for treatment, she told this news organization. “In some of the work that’s starting to emerge, it does appear that the symptoms persist, at least for a relatively large subset of individuals.”
Although depression typically affects twice as many women as men, these new surveys show that, after COVID, “that difference is not so distinct,” said Dr. Gunning.
It’s unclear why this is, but it could be cause by financial stresses that may affect men to a greater extent, she added. “There is so much we’re still learning.”
Increased suicide risk?
Other researchers, including Leo Sher, MD, professor of psychiatry, Icahn School of Medicine at Mount Sinai, and director of inpatient psychiatry, James J. Peters Veterans Affairs Medical Center, both in New York, are concerned that higher rates of psychiatric symptoms among patients with long-haul COVID raise the risk for suicidal ideation and behavior.
Studies of suicidality in COVID-19 survivors “are urgently needed,” said Dr. Sher in an article published in the Monthly Journal of the Association of Physicians.
“We need to study what factors may increase suicide risk among the COVID-19 survivors during and after the recovery. We also need to investigate whether there is a long-term increased suicide risk among COVID-19 survivors,” Dr. Sher said.
COVID-19 is not unique among viral respiratory diseases in being associated with long-term mental health problems. Research shows that survivors of the 2003 outbreak of severe acute respiratory syndrome experienced increased psychological distress that persisted for at least a year, as did patients who in 2015 had Middle East respiratory syndrome coronavirus (MERS-CoV).
Some experts believe clinicians should screen patients for mental health symptoms after the acute phase of COVID and offer early and prolonged care.
“Early mental health intervention such as psychotherapy and supportive groups could play an important role in preventing incident mental health problems for post-COVID sufferers,” said Dr. Castaldelli-Maia.
A version of this article first appeared on Medscape.com.
FDA fast tracks testing of schizophrenia drug for impaired cognition
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).
The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.
The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.
In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.
Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.
“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.
The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.
The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.
The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.
The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.
“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.
A version of this article first appeared on Medscape.com.
Bill seeks to streamline prior authorization in Medicare Advantage plans
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
What brought me back from the brink of suicide: A physician’s story
William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.
In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”
By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.
“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
A way to heal
For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.
Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.
Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.
Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.
He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.
A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.
The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”
For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
Why physicians die by suicide
Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”
Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.
Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.
A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.
The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.
The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.
Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
Every story is different
It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.
Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started.
Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.
After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.
The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.
Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.
Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.
His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.
Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
A real gift
Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.
“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”
Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.
Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.
A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.
Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.
In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”
Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.
“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
A version of this article first appeared on Medscape.com.
William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.
In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”
By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.
“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
A way to heal
For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.
Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.
Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.
Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.
He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.
A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.
The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”
For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
Why physicians die by suicide
Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”
Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.
Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.
A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.
The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.
The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.
Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
Every story is different
It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.
Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started.
Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.
After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.
The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.
Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.
Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.
His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.
Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
A real gift
Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.
“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”
Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.
Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.
A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.
Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.
In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”
Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.
“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
A version of this article first appeared on Medscape.com.
William Lynes, MD, had a flourishing medical practice and a fulfilling family life with three children when he first attempted suicide in 1999 at age 45. By 2003, depression and two more suicide attempts led to his early retirement.
In a session at the recent virtual American Psychiatric Association (APA) 2021 annual meeting, Dr. Lynes talked about the challenges of dealing with depression while managing the stresses of a career in medicine. The session in which he spoke was called, “The Suicidal Physician: Narratives From a Physician Who Survived and the Physician Widow of One Who Did Not.”
By writing and speaking about his experiences, he says, he has been able to retain his identity as a physician and avoid obsessive thoughts about suicide. He hopes conversations like these help other physicians feel less alone and enable them to push past stigmas to get the help they need. He suspects they do. More than 600 people joined the APA session, and Dr. Lynes received dozens of thankful messages afterward.
“I love medicine, but intrinsically, the practice of medicine is stressful, and you can’t get away,” said Dr. Lynes, a retired urologist in Temecula, Calif. “As far as feedback, it made me feel like it’s something I should continue to do.”
A way to heal
For Dr. Lynes, his “downward spiral into darkness” began with a series of catastrophic medical events starting in 1998, when he came home from a family vacation in Mexico feeling unwell. He didn’t bother to do anything about it – typical of a physician, he says. Then one night he woke up shaking with chills and fever. Soon he was in the hospital with respiratory failure from septic shock.
Dr. Lynes spent 6 weeks in the intensive care unit, including 4 weeks on a ventilator. He underwent a tracheostomy. He lost 40 pounds and experienced ICU-related delirium. It was a terrifying time, he said. When he tried to return to work 10 months later, he didn’t feel as though he could function normally.
Having once been a driven doctor who worked long hours, he now doubted himself and dreaded giving patients bad news. Spontaneously, he tried to take his own life.
Afterward, he concealed what had happened from everyone except his wife and managed to resume his practice. However, he was unable to regain the enthusiasm he had once had for his work. Although he had experienced depression before, this time it was unrelenting.
He sought help from a psychiatrist, received a diagnosis of bipolar disorder, and began taking medication. Still, he struggled to fulfill his responsibilities. Then in April 2002, he had a snowboarding accident that caused multiple facial fractures and required five operations. When he returned to work this time, he felt like a failure but resisted asking colleagues for help.
A few months later, Dr. Lynes again attempted suicide, which led to another stay in the ICU and more time on a ventilator. Doctors told his family they didn’t think he would survive. When he recovered, he spent time as an inpatient in a psychiatric ward, where he received the first of a series of electroconvulsive therapy sessions. Compounding his anxiety and depression was the inability to come to terms with his life if he were not able to practice medicine.
The next fall, in September 2003, his third suicide attempt took place in his office on a weekend when no one was around. After locking the door, he looked at his reflection in the frame of his medical school diploma. The glass was cracked. “It was dark, it was black, it was cold,” he said. “I can remember seeing my reflection and thinking how disgusted I was.”
For years after that, Dr. Lynes struggled with his sense of self-worth. He hid from the medical system and dreaded doctors’ appointments. Finally in 2016, he found new meaning at a writing conference, where he met a fellow physician whose story was similar to his. She encouraged him to write about his experience. His essay was published in Annals of Internal Medicine that year. “Then I started speaking, and I feel like I’m a physician again,” he said. “That has really healed me quite a bit.”
Why physicians die by suicide
Working in health care can be extremely stressful, even in the best of times, said Michael Myers, MD, a psychiatrist at State University of New York, Brooklyn, and author of the book, “Why Physicians Die By Suicide: Lessons Learned From Their Families and Others Who Cared.”
Years of school and training culminate in a career in which demands are relentless. Societal expectations are high. Many doctors are perfectionists by nature, and physicians tend to feel intense pressure to compete for coveted positions.
Stress starts early in a medical career. A 2016 systematic review and meta-analysis of 183 studies from 43 countries showed that nearly 30% of medical students experienced symptoms of depression and that 11% reported suicidal thoughts, but only 15% sought help.
A 2015 review of 31 studies that involved residents showed that rates of depression remained close to 30% and that about three-quarters of trainees meet criteria for burnout, a type of emotional exhaustion and sense of inadequacy that can result from chronic stress at work.
The stress of medical training appears to be a direct cause of mental health struggles. Rates of depression are higher among those working to become physicians than among their peers of the same age, research shows. In addition, symptoms become more prevalent as people progress through their training.
The COVID-19 pandemic has added stress to an already stressful job. Of more than 2,300 physicians surveyed in August 2020 by the Physicians Foundation, a physicians advocacy organization, 50% indicated that they experienced excessive anger, tearfulness, or anxiety because of the way the pandemic affected their work; 30% felt hopeless or lacking purpose; and 8% had thoughts of self-harm related to the pandemic. Rates of burnout had risen from 40% in 2018 to 58%.
Those problems might be even more acute in places experiencing other types of crises. A 2020 study of 154 emergency department (ED) physicians in Libya, which is in the midst of a civil war, found that 65% were experiencing anxiety, 73% were showing signs of depression, and 68% felt emotionally exhausted.
Every story is different
It is unclear how common suicide is among physicians. One often-repeated estimate is that 300-400 physicians die by suicide each year, but no one is certain how that number was determined, said Dr. Myers, who organized the APA panel.
Studies on suicide are inconsistent, and trends are hard to pinpoint. Anecdotally, he has received just as many calls about physician suicides in the past year as he did before the pandemic started.
Every person is different, and so is every death. Sometimes, career problems have nothing to do with a physician’s suicide, Dr. Myers said. When job stress does play a role, factors are often varied and complex.
After a 35-year career as a double board certified ED physician, Matthew Seaman, MD, retired in January 2017. The same month, a patient filed a complaint against him with the Washington State medical board, which led to an investigation and a lawsuit.
The case was hard on Dr. Seaman, who had continued to work night shifts throughout his career and had won a Hero Award from the American Board of Emergency Medicine, said his wife, Linda Seaman, MD, a family practitioner in Yakima, Wash., who also spoke on the APA panel.
Dr. Seaman said that 2 years after the investigation started, her husband was growing increasingly depressed. In 2019, he testified in a deposition. She said the plaintiff’s attorney “tried every way he could to shame Matt, humiliate Matt, make him believe he was a very bad doctor.” Three days later, he died by suicide at age 62.
Looking back at the year leading up to her husband’s death, Dr. Seaman recognizes multiple obstacles that interfered with her husband’s ability to get help, including frustrating interactions with psychiatrists and the couple’s insurance company.
His identity and experience as a physician also played a role. A couple of months before he died, she tried unsuccessfully to reach his psychiatrist, whose office suggested he go to the ED. However, because he worked as an ED doctor in their small town, he wouldn’t go. Dr. Seaman suspects he was wary of the stigma.
Burnout likely set him up to cave in after decades of work on the front lines, she added. Working in the ED exposes providers to horrific, traumatic cases every day, she said. Physicians learn to suppress their own emotions to deal with what they encounter. Stuffing their feelings can lead to posttraumatic stress. “You just perform,” she said. “You learn to do that.”
A real gift
Whenever Dr. Myers hears stories about doctors who died by suicide or who have written about their mental health struggles to help others, he contacts them. One goal of his own writing and of the conference sessions he organizes is to make it easier for others to share their own stories.
“I tell them, first of all, their courage and honesty is a real gift, and they’re saving lives,” he said. “There are so many suffering doctors out there who think that they’re the only one.”
Public conversations such as those that occurred in the APA session also offer opportunities to share advice, including Dr. Myers’ recommendation that doctors be sure they have a primary care physician of their own.
Many don’t, he says, because they say they are too busy, they can treat their own symptoms, or they can self-refer to specialists when needed. But physicians don’t always recognize symptoms of depression in themselves, and when mental health problems arise, they may not seek help or treat themselves appropriately.
A primary care physician can be the first person to recognize a mental health problem and refer a patient for mental health care, said Dr. Myers, whose latest book, “Becoming a Doctors’ Doctor: A Memoir,” explores his experiences treating doctors with burnout and other mental health problems.
Whether they have a primary care doctor or not, he suggests that physicians talk to anyone they trust – a social worker, a religious leader, or a family member who can then help them find the right sort of care.
In the United States, around-the-clock help is available through the National Suicide Prevention Lifeline at 800-273-8255. A psychiatrist-run hotline specifically for physicians is available at 888-409-0141. “Reach out and get some help,” Dr. Myers said. “Just don’t do it alone.”
Dr. Lynes advocates setting boundaries between life and work. He has also benefited from writing about his experiences. A blog or a diary can help physicians process their feelings, he said. His 2016 essay marked a major turning point in his life, giving his life meaning in helping others.
“Since I wrote that article, I can’t tell you how much better I am,” he said. “Now, I’m not embarrassed to be around physicians. I actually consider myself a physician. I didn’t for many, many years. So, I’m doing pretty well.”
A version of this article first appeared on Medscape.com.