Clinical Psychiatry News

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Amid recent reports of hackers targeting and blackmailing health care systems and even patients, the Federal Bureau of Investigation and other agencies have issued warning of “imminent” cyberattacks on more U.S. hospitals.

Thinkstock compilation

A new report released by the Cybersecurity and Infrastructure Security Agency, part of the Department of Homeland Security, noted that the FBI and the Department of Health & Human Services have “credible information of an increased and imminent cybercrime threat to U.S. hospitals and health care providers.”

The agencies are urging “timely and reasonable precautions” to protect health care networks from these threats.

As reported, hackers accessed patient records at Vastaamo, Finland’s largest private psychotherapy system, and emailed some patients last month demanding €200 in bitcoin or else personal health data would be released online.

In June, the University of California, San Francisco, experienced an information technology (IT) “security incident” that led to the payout of $1.14 million to individuals responsible for a malware attack in exchange for the return of data.

In addition, last week, Sky Lakes Medical Center in Klamath Falls, Ore., released a statement in which it said there had been a ransomware attack on its computer systems. Although “there is no evidence that patient information has been compromised,” some of its systems are still down.

“We’re open for business, it’s just not business as usual,” Tom Hottman, public information officer at Sky Lakes, said in an interview.

Paul S. Appelbaum, MD, Dollard Professor of Psychiatry, Medicine, and Law at Columbia University, New York, said in an interview, “People have known for a long time that there are nefarious actors out there.” He said all health care systems should be prepared to deal with these problems.

“In the face of a warning from the FBI, I’d say that’s even more important now,” Dr. Appelbaum added.
 

‘Malicious cyber actors’

In the new CISA report, the agency noted that it, the FBI, and the HHS have been assessing “malicious cyber actors” targeting health care systems with malware loaders such as TrickBot and BazarLoader, which often lead to data theft, ransomware attacks, and service disruptions.

“The cybercriminal enterprise behind TrickBot, which is likely also the creator of BazarLoader malware, has continued to develop new functionality and tools, increasing the ease, speed, and profitability of victimization,” the report authors wrote.

Phishing campaigns often contain attachments with malware or links to malicious websites. “Loaders start the infection chain by distributing the payload,” the report noted. A backdoor mechanism is then installed on the victim’s device.

In addition to TrickBot and BazarLoader (or BazarBackdoor), the report discussed other malicious tools, including Ryuk and Conti, which are types of ransomware that can infect systems for hackers’ financial gain.

“These issues will be particularly challenging for organizations within the COVID-19 pandemic; therefore, administrators will need to balance this risk when determining their cybersecurity investments,” the agencies wrote.

Dr. Appelbaum said his organization is taking the warning seriously.

“When the report first came out, I received emails from every system that I’m affiliated with warning about it and encouraging me as a member of the medical staff to take the usual prudent precautions,” such as not opening attachments or links from unknown sources, he said.

“The FBI warning has what seems like very reasonable advice, which is that every system should automatically back up their data off site in a separate system that’s differently accessible,” he added.

After a ransomware attack, the most recently entered information may not be backed up and could get lost, but “that’s a lot easier to deal with then losing access to all of your medical records,” said Dr. Appelbaum.

Ipsit Vahia, MD, medical director at the Institute for Technology and Psychiatry at McLean Hospital, Belmont, Mass., noted that, in answer to the FBI warning, he has heard that many centers, including his own, are warning their clinicians not to open any email attachments at this time.
 

Recent attacks

UCSF issued a statement noting that malware detected in early June led to the encryption of “a limited number of servers” in its medical school, making them temporarily inaccessible.

“We do not currently believe patient medical records were exposed,” the university said in the statement.

It added that because the encrypted data were necessary for “some of the academic work” conducted at UCSF, they agreed to pay a portion of the ransom demand – about $1.14 million. The hackers then provided a tool that unlocked the encrypted data.

“We continue to cooperate with law enforcement and we appreciate everyone’s understanding that we are limited in what we can share while we continue our investigation,” the statement reads. UCSF declined a request for further comment.

At Sky Lakes Medical Center, computer systems are still down after its ransomware attack, including use of electronic medical records, but the Oregon-based health care system is still seeing patients.

They are “being interviewed old school,” with the admitting process being conducted on paper, “but patient care goes on,” said Mr. Hottman.

In addition to a teaching hospital, Sky Lakes comprises specialty and primary care clinics, including a cancer treatment center. All remain open to patients at this time.

Diagnostic imaging is also continuing, but “getting the image to a place it can be read” has become more complicated, said Mr. Hottman.

“We have some work-arounds in process, and a plan is being assembled that we think will be in place as early as this weekend so that we can get those images read starting next week,” he said.

In addition, “scheduling is a little clunky,” he reported. However, “we have an awesome staff with a good attitude, so there’s still a whole lot we can do.”

He also noted that his institution has reconfirmed that, as of Nov. 4, no patient data had been compromised.

‘Especially chilling’

Targeting hospitals through cyberattacks isn’t new. In 2017, the WannaCry virus affected more than 200,000 computers in 150 countries, including the operating system of the U.K. National Health Service. The cyberattack locked clinicians out of NHS patient records and other digital tools for 3 days.

Dr. Appelbaum noted that, as hospital systems become more dependent on the Internet and on electronic communications, they become more vulnerable to data breaches.

“I think it’s clear that there have been concerted efforts lately to undertake attacks on health care IT systems to either hold them hostage, as in a ransomware attack, or to download files and use that information for profit,” he said.

Still, Dr. Vahia noted that contacting patients directly, which occurred in the Finland data breach and blackmail scheme, is something new. It is “especially chilling” that individual psychiatric patients were targeted.

“It is difficult to even fathom the kind of damage that can be done by compromised mental health records. It’s difficult to overstate how big a deal this is, and we should be treating it with the appropriate level of urgency,” he said in an interview.

“It shows how badly things can go wrong when security is compromised; and it should make us take a step back and survey the world of digital health to gain recognition of how much risk there might be that we haven’t really understood before,” Dr. Vahia said.
 

Clinical tips

Asked whether he had any tips to share with clinicians, Mr. Hottman noted that the best time to have a plan is before something dire happens.

“I would make [the possibility of cyberattacks] part of the emergency preparedness program. What if you don’t have access to computers? What do you do?” It’s important to answer those questions prior to systems going down, he said.

Mr. Hottman reported that after a mechanical failure last year put their computer systems offline for a day, “we started putting all critical information on paper and in a binder,” including phone numbers for the state police.

Dr. Vahia noted that another important step for clinicians “is to just pause and take stock of how digitally dependent” health care is becoming. He also warned that precautions should be taken regarding wearables and apps, as well as for electronic medical records. He noted the importance of strong passwords and two-step verification processes.

Even with the risks, digital technology has had a major impact on health care efficiency. “It’s not perfect, the work is ongoing, and there are big questions that need to be addressed, but in the end, the ability of technology when used right and securely” leads to better patient care, he said.

John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, agreed that digital health care is and will remain very important; but at the same time, security issues need proper attention.

“When you look back at medical hacks that have happened, there’s often a human error behind it. It’s rare for someone to break encryption. I think we have pretty darn good security, but we need to realize that sometimes errors will happen,” he said in an interview.

As an example, Dr. Torous, who is also chair of the American Psychiatric Association’s Health and Technology Committee, cited phishing emails, which depend on a user clicking a link that can cause a virus to be downloaded into their network.

“You can be cautious, but it takes just one person to download an attachment with a virus in it” to cause disruptions, Dr. Torous said.
 

Telehealth implications

After its data breach, Vastaamo posted on its website a notice that video is never recorded during the centers’ telehealth sessions, and so patients need not worry that any videos could be leaked online.

Asked whether video is commonly recorded during telehealth sessions in the United States, Dr. Vahia said that he was not aware of sessions being recorded, especially because the amount of the data would be too great to store indefinitely.

Dr. Appelbaum agreed and said that, to his knowledge, no clinicians at Columbia University are recording telehealth sessions. He said that it would represent a privacy threat, and he noted that most health care providers “don’t have the time to go back and watch videos of their interactions with patients.”

In the case of recordings for research purposes, he emphasized that it would be important to get consent and then store the health information offline.

As for other telehealth security risks, Dr. Vahia noted that it is possible that if a computer or device is compromised, an individual could hack into a camera and observe the session. In addition to microphones, “these pose some especially high vulnerabilities,” he said. “Clinicians need to pay attention as to whether the cameras they’re using for telecare are on or if they’re covered when not in use. And they should pay attention to security settings on smartphones and ensure microphones are not turned on as the default.”

Dr. Appelbaum said the HIPAA requires that telehealth sessions be conducted on secure systems, so clinicians need to ascertain whether the system they’re using complies with that rule.

“Particularly people who are not part of larger systems and would not usually take on that responsibility, maybe they’re in private practice or a small group, they really need to check on the security level and on HIPAA compliance and not just assume that it is adequately secure,” he said.

Dr. Appelbaum, who is also a past president of the APA and director of the Center for Law, Ethics, and Psychiatry at Columbia University, noted that the major risk for hospitals after a cyberattack is probably not liability to individual patients.

“It’s much more likely that they would face fines from HIPAA if it’s found that they failed to live up to HIPAA requirements,” he said.

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

Amid recent reports of hackers targeting and blackmailing health care systems and even patients, the Federal Bureau of Investigation and other agencies have issued warning of “imminent” cyberattacks on more U.S. hospitals.

Thinkstock compilation

A new report released by the Cybersecurity and Infrastructure Security Agency, part of the Department of Homeland Security, noted that the FBI and the Department of Health & Human Services have “credible information of an increased and imminent cybercrime threat to U.S. hospitals and health care providers.”

The agencies are urging “timely and reasonable precautions” to protect health care networks from these threats.

As reported, hackers accessed patient records at Vastaamo, Finland’s largest private psychotherapy system, and emailed some patients last month demanding €200 in bitcoin or else personal health data would be released online.

In June, the University of California, San Francisco, experienced an information technology (IT) “security incident” that led to the payout of $1.14 million to individuals responsible for a malware attack in exchange for the return of data.

In addition, last week, Sky Lakes Medical Center in Klamath Falls, Ore., released a statement in which it said there had been a ransomware attack on its computer systems. Although “there is no evidence that patient information has been compromised,” some of its systems are still down.

“We’re open for business, it’s just not business as usual,” Tom Hottman, public information officer at Sky Lakes, said in an interview.

Paul S. Appelbaum, MD, Dollard Professor of Psychiatry, Medicine, and Law at Columbia University, New York, said in an interview, “People have known for a long time that there are nefarious actors out there.” He said all health care systems should be prepared to deal with these problems.

“In the face of a warning from the FBI, I’d say that’s even more important now,” Dr. Appelbaum added.
 

‘Malicious cyber actors’

In the new CISA report, the agency noted that it, the FBI, and the HHS have been assessing “malicious cyber actors” targeting health care systems with malware loaders such as TrickBot and BazarLoader, which often lead to data theft, ransomware attacks, and service disruptions.

“The cybercriminal enterprise behind TrickBot, which is likely also the creator of BazarLoader malware, has continued to develop new functionality and tools, increasing the ease, speed, and profitability of victimization,” the report authors wrote.

Phishing campaigns often contain attachments with malware or links to malicious websites. “Loaders start the infection chain by distributing the payload,” the report noted. A backdoor mechanism is then installed on the victim’s device.

In addition to TrickBot and BazarLoader (or BazarBackdoor), the report discussed other malicious tools, including Ryuk and Conti, which are types of ransomware that can infect systems for hackers’ financial gain.

“These issues will be particularly challenging for organizations within the COVID-19 pandemic; therefore, administrators will need to balance this risk when determining their cybersecurity investments,” the agencies wrote.

Dr. Appelbaum said his organization is taking the warning seriously.

“When the report first came out, I received emails from every system that I’m affiliated with warning about it and encouraging me as a member of the medical staff to take the usual prudent precautions,” such as not opening attachments or links from unknown sources, he said.

“The FBI warning has what seems like very reasonable advice, which is that every system should automatically back up their data off site in a separate system that’s differently accessible,” he added.

After a ransomware attack, the most recently entered information may not be backed up and could get lost, but “that’s a lot easier to deal with then losing access to all of your medical records,” said Dr. Appelbaum.

Ipsit Vahia, MD, medical director at the Institute for Technology and Psychiatry at McLean Hospital, Belmont, Mass., noted that, in answer to the FBI warning, he has heard that many centers, including his own, are warning their clinicians not to open any email attachments at this time.
 

Recent attacks

UCSF issued a statement noting that malware detected in early June led to the encryption of “a limited number of servers” in its medical school, making them temporarily inaccessible.

“We do not currently believe patient medical records were exposed,” the university said in the statement.

It added that because the encrypted data were necessary for “some of the academic work” conducted at UCSF, they agreed to pay a portion of the ransom demand – about $1.14 million. The hackers then provided a tool that unlocked the encrypted data.

“We continue to cooperate with law enforcement and we appreciate everyone’s understanding that we are limited in what we can share while we continue our investigation,” the statement reads. UCSF declined a request for further comment.

At Sky Lakes Medical Center, computer systems are still down after its ransomware attack, including use of electronic medical records, but the Oregon-based health care system is still seeing patients.

They are “being interviewed old school,” with the admitting process being conducted on paper, “but patient care goes on,” said Mr. Hottman.

In addition to a teaching hospital, Sky Lakes comprises specialty and primary care clinics, including a cancer treatment center. All remain open to patients at this time.

Diagnostic imaging is also continuing, but “getting the image to a place it can be read” has become more complicated, said Mr. Hottman.

“We have some work-arounds in process, and a plan is being assembled that we think will be in place as early as this weekend so that we can get those images read starting next week,” he said.

In addition, “scheduling is a little clunky,” he reported. However, “we have an awesome staff with a good attitude, so there’s still a whole lot we can do.”

He also noted that his institution has reconfirmed that, as of Nov. 4, no patient data had been compromised.

‘Especially chilling’

Targeting hospitals through cyberattacks isn’t new. In 2017, the WannaCry virus affected more than 200,000 computers in 150 countries, including the operating system of the U.K. National Health Service. The cyberattack locked clinicians out of NHS patient records and other digital tools for 3 days.

Dr. Appelbaum noted that, as hospital systems become more dependent on the Internet and on electronic communications, they become more vulnerable to data breaches.

“I think it’s clear that there have been concerted efforts lately to undertake attacks on health care IT systems to either hold them hostage, as in a ransomware attack, or to download files and use that information for profit,” he said.

Still, Dr. Vahia noted that contacting patients directly, which occurred in the Finland data breach and blackmail scheme, is something new. It is “especially chilling” that individual psychiatric patients were targeted.

“It is difficult to even fathom the kind of damage that can be done by compromised mental health records. It’s difficult to overstate how big a deal this is, and we should be treating it with the appropriate level of urgency,” he said in an interview.

“It shows how badly things can go wrong when security is compromised; and it should make us take a step back and survey the world of digital health to gain recognition of how much risk there might be that we haven’t really understood before,” Dr. Vahia said.
 

Clinical tips

Asked whether he had any tips to share with clinicians, Mr. Hottman noted that the best time to have a plan is before something dire happens.

“I would make [the possibility of cyberattacks] part of the emergency preparedness program. What if you don’t have access to computers? What do you do?” It’s important to answer those questions prior to systems going down, he said.

Mr. Hottman reported that after a mechanical failure last year put their computer systems offline for a day, “we started putting all critical information on paper and in a binder,” including phone numbers for the state police.

Dr. Vahia noted that another important step for clinicians “is to just pause and take stock of how digitally dependent” health care is becoming. He also warned that precautions should be taken regarding wearables and apps, as well as for electronic medical records. He noted the importance of strong passwords and two-step verification processes.

Even with the risks, digital technology has had a major impact on health care efficiency. “It’s not perfect, the work is ongoing, and there are big questions that need to be addressed, but in the end, the ability of technology when used right and securely” leads to better patient care, he said.

John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, agreed that digital health care is and will remain very important; but at the same time, security issues need proper attention.

“When you look back at medical hacks that have happened, there’s often a human error behind it. It’s rare for someone to break encryption. I think we have pretty darn good security, but we need to realize that sometimes errors will happen,” he said in an interview.

As an example, Dr. Torous, who is also chair of the American Psychiatric Association’s Health and Technology Committee, cited phishing emails, which depend on a user clicking a link that can cause a virus to be downloaded into their network.

“You can be cautious, but it takes just one person to download an attachment with a virus in it” to cause disruptions, Dr. Torous said.
 

Telehealth implications

After its data breach, Vastaamo posted on its website a notice that video is never recorded during the centers’ telehealth sessions, and so patients need not worry that any videos could be leaked online.

Asked whether video is commonly recorded during telehealth sessions in the United States, Dr. Vahia said that he was not aware of sessions being recorded, especially because the amount of the data would be too great to store indefinitely.

Dr. Appelbaum agreed and said that, to his knowledge, no clinicians at Columbia University are recording telehealth sessions. He said that it would represent a privacy threat, and he noted that most health care providers “don’t have the time to go back and watch videos of their interactions with patients.”

In the case of recordings for research purposes, he emphasized that it would be important to get consent and then store the health information offline.

As for other telehealth security risks, Dr. Vahia noted that it is possible that if a computer or device is compromised, an individual could hack into a camera and observe the session. In addition to microphones, “these pose some especially high vulnerabilities,” he said. “Clinicians need to pay attention as to whether the cameras they’re using for telecare are on or if they’re covered when not in use. And they should pay attention to security settings on smartphones and ensure microphones are not turned on as the default.”

Dr. Appelbaum said the HIPAA requires that telehealth sessions be conducted on secure systems, so clinicians need to ascertain whether the system they’re using complies with that rule.

“Particularly people who are not part of larger systems and would not usually take on that responsibility, maybe they’re in private practice or a small group, they really need to check on the security level and on HIPAA compliance and not just assume that it is adequately secure,” he said.

Dr. Appelbaum, who is also a past president of the APA and director of the Center for Law, Ethics, and Psychiatry at Columbia University, noted that the major risk for hospitals after a cyberattack is probably not liability to individual patients.

“It’s much more likely that they would face fines from HIPAA if it’s found that they failed to live up to HIPAA requirements,” he said.

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

Amid recent reports of hackers targeting and blackmailing health care systems and even patients, the Federal Bureau of Investigation and other agencies have issued warning of “imminent” cyberattacks on more U.S. hospitals.

Thinkstock compilation

A new report released by the Cybersecurity and Infrastructure Security Agency, part of the Department of Homeland Security, noted that the FBI and the Department of Health & Human Services have “credible information of an increased and imminent cybercrime threat to U.S. hospitals and health care providers.”

The agencies are urging “timely and reasonable precautions” to protect health care networks from these threats.

As reported, hackers accessed patient records at Vastaamo, Finland’s largest private psychotherapy system, and emailed some patients last month demanding €200 in bitcoin or else personal health data would be released online.

In June, the University of California, San Francisco, experienced an information technology (IT) “security incident” that led to the payout of $1.14 million to individuals responsible for a malware attack in exchange for the return of data.

In addition, last week, Sky Lakes Medical Center in Klamath Falls, Ore., released a statement in which it said there had been a ransomware attack on its computer systems. Although “there is no evidence that patient information has been compromised,” some of its systems are still down.

“We’re open for business, it’s just not business as usual,” Tom Hottman, public information officer at Sky Lakes, said in an interview.

Paul S. Appelbaum, MD, Dollard Professor of Psychiatry, Medicine, and Law at Columbia University, New York, said in an interview, “People have known for a long time that there are nefarious actors out there.” He said all health care systems should be prepared to deal with these problems.

“In the face of a warning from the FBI, I’d say that’s even more important now,” Dr. Appelbaum added.
 

‘Malicious cyber actors’

In the new CISA report, the agency noted that it, the FBI, and the HHS have been assessing “malicious cyber actors” targeting health care systems with malware loaders such as TrickBot and BazarLoader, which often lead to data theft, ransomware attacks, and service disruptions.

“The cybercriminal enterprise behind TrickBot, which is likely also the creator of BazarLoader malware, has continued to develop new functionality and tools, increasing the ease, speed, and profitability of victimization,” the report authors wrote.

Phishing campaigns often contain attachments with malware or links to malicious websites. “Loaders start the infection chain by distributing the payload,” the report noted. A backdoor mechanism is then installed on the victim’s device.

In addition to TrickBot and BazarLoader (or BazarBackdoor), the report discussed other malicious tools, including Ryuk and Conti, which are types of ransomware that can infect systems for hackers’ financial gain.

“These issues will be particularly challenging for organizations within the COVID-19 pandemic; therefore, administrators will need to balance this risk when determining their cybersecurity investments,” the agencies wrote.

Dr. Appelbaum said his organization is taking the warning seriously.

“When the report first came out, I received emails from every system that I’m affiliated with warning about it and encouraging me as a member of the medical staff to take the usual prudent precautions,” such as not opening attachments or links from unknown sources, he said.

“The FBI warning has what seems like very reasonable advice, which is that every system should automatically back up their data off site in a separate system that’s differently accessible,” he added.

After a ransomware attack, the most recently entered information may not be backed up and could get lost, but “that’s a lot easier to deal with then losing access to all of your medical records,” said Dr. Appelbaum.

Ipsit Vahia, MD, medical director at the Institute for Technology and Psychiatry at McLean Hospital, Belmont, Mass., noted that, in answer to the FBI warning, he has heard that many centers, including his own, are warning their clinicians not to open any email attachments at this time.
 

Recent attacks

UCSF issued a statement noting that malware detected in early June led to the encryption of “a limited number of servers” in its medical school, making them temporarily inaccessible.

“We do not currently believe patient medical records were exposed,” the university said in the statement.

It added that because the encrypted data were necessary for “some of the academic work” conducted at UCSF, they agreed to pay a portion of the ransom demand – about $1.14 million. The hackers then provided a tool that unlocked the encrypted data.

“We continue to cooperate with law enforcement and we appreciate everyone’s understanding that we are limited in what we can share while we continue our investigation,” the statement reads. UCSF declined a request for further comment.

At Sky Lakes Medical Center, computer systems are still down after its ransomware attack, including use of electronic medical records, but the Oregon-based health care system is still seeing patients.

They are “being interviewed old school,” with the admitting process being conducted on paper, “but patient care goes on,” said Mr. Hottman.

In addition to a teaching hospital, Sky Lakes comprises specialty and primary care clinics, including a cancer treatment center. All remain open to patients at this time.

Diagnostic imaging is also continuing, but “getting the image to a place it can be read” has become more complicated, said Mr. Hottman.

“We have some work-arounds in process, and a plan is being assembled that we think will be in place as early as this weekend so that we can get those images read starting next week,” he said.

In addition, “scheduling is a little clunky,” he reported. However, “we have an awesome staff with a good attitude, so there’s still a whole lot we can do.”

He also noted that his institution has reconfirmed that, as of Nov. 4, no patient data had been compromised.

‘Especially chilling’

Targeting hospitals through cyberattacks isn’t new. In 2017, the WannaCry virus affected more than 200,000 computers in 150 countries, including the operating system of the U.K. National Health Service. The cyberattack locked clinicians out of NHS patient records and other digital tools for 3 days.

Dr. Appelbaum noted that, as hospital systems become more dependent on the Internet and on electronic communications, they become more vulnerable to data breaches.

“I think it’s clear that there have been concerted efforts lately to undertake attacks on health care IT systems to either hold them hostage, as in a ransomware attack, or to download files and use that information for profit,” he said.

Still, Dr. Vahia noted that contacting patients directly, which occurred in the Finland data breach and blackmail scheme, is something new. It is “especially chilling” that individual psychiatric patients were targeted.

“It is difficult to even fathom the kind of damage that can be done by compromised mental health records. It’s difficult to overstate how big a deal this is, and we should be treating it with the appropriate level of urgency,” he said in an interview.

“It shows how badly things can go wrong when security is compromised; and it should make us take a step back and survey the world of digital health to gain recognition of how much risk there might be that we haven’t really understood before,” Dr. Vahia said.
 

Clinical tips

Asked whether he had any tips to share with clinicians, Mr. Hottman noted that the best time to have a plan is before something dire happens.

“I would make [the possibility of cyberattacks] part of the emergency preparedness program. What if you don’t have access to computers? What do you do?” It’s important to answer those questions prior to systems going down, he said.

Mr. Hottman reported that after a mechanical failure last year put their computer systems offline for a day, “we started putting all critical information on paper and in a binder,” including phone numbers for the state police.

Dr. Vahia noted that another important step for clinicians “is to just pause and take stock of how digitally dependent” health care is becoming. He also warned that precautions should be taken regarding wearables and apps, as well as for electronic medical records. He noted the importance of strong passwords and two-step verification processes.

Even with the risks, digital technology has had a major impact on health care efficiency. “It’s not perfect, the work is ongoing, and there are big questions that need to be addressed, but in the end, the ability of technology when used right and securely” leads to better patient care, he said.

John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, agreed that digital health care is and will remain very important; but at the same time, security issues need proper attention.

“When you look back at medical hacks that have happened, there’s often a human error behind it. It’s rare for someone to break encryption. I think we have pretty darn good security, but we need to realize that sometimes errors will happen,” he said in an interview.

As an example, Dr. Torous, who is also chair of the American Psychiatric Association’s Health and Technology Committee, cited phishing emails, which depend on a user clicking a link that can cause a virus to be downloaded into their network.

“You can be cautious, but it takes just one person to download an attachment with a virus in it” to cause disruptions, Dr. Torous said.
 

Telehealth implications

After its data breach, Vastaamo posted on its website a notice that video is never recorded during the centers’ telehealth sessions, and so patients need not worry that any videos could be leaked online.

Asked whether video is commonly recorded during telehealth sessions in the United States, Dr. Vahia said that he was not aware of sessions being recorded, especially because the amount of the data would be too great to store indefinitely.

Dr. Appelbaum agreed and said that, to his knowledge, no clinicians at Columbia University are recording telehealth sessions. He said that it would represent a privacy threat, and he noted that most health care providers “don’t have the time to go back and watch videos of their interactions with patients.”

In the case of recordings for research purposes, he emphasized that it would be important to get consent and then store the health information offline.

As for other telehealth security risks, Dr. Vahia noted that it is possible that if a computer or device is compromised, an individual could hack into a camera and observe the session. In addition to microphones, “these pose some especially high vulnerabilities,” he said. “Clinicians need to pay attention as to whether the cameras they’re using for telecare are on or if they’re covered when not in use. And they should pay attention to security settings on smartphones and ensure microphones are not turned on as the default.”

Dr. Appelbaum said the HIPAA requires that telehealth sessions be conducted on secure systems, so clinicians need to ascertain whether the system they’re using complies with that rule.

“Particularly people who are not part of larger systems and would not usually take on that responsibility, maybe they’re in private practice or a small group, they really need to check on the security level and on HIPAA compliance and not just assume that it is adequately secure,” he said.

Dr. Appelbaum, who is also a past president of the APA and director of the Center for Law, Ethics, and Psychiatry at Columbia University, noted that the major risk for hospitals after a cyberattack is probably not liability to individual patients.

“It’s much more likely that they would face fines from HIPAA if it’s found that they failed to live up to HIPAA requirements,” he said.

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

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

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

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

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

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

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

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

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

There’s a reason they’re called smartphones.

Indeed, how patients use their smartphones and where they take them provides insight into what has been termed their “digital phenotype.” It’s information that, analyzed correctly, becomes useful in differentiating bipolar disorder from borderline personality disorder, a distinction that’s often challenging in clinical practice, Kate E.A. Saunders, MD, DPhil, said at the virtual congress of the European College of Neuropsychopharmacology.

Dr. Saunders, a psychiatrist at the University of Oxford (England), and colleagues have developed a smartphone app enabling patients to briefly characterize their current mood on a daily basis, as well as a machine learning model to analyze this data stream as patients’ moods evolve over time. In their prospective longitudinal Automated Monitoring of Symptom Severity (AMoSS) study of 48 patients with a confirmed diagnosis of bipolar disorder, 31 with borderline personality disorder, and 51 healthy volunteers, the tool correctly classified 75% of participants into the correct diagnostic category on the basis of 20 daily mood ratings (Transl Psychiatry. 2018 Dec 13;81:274. doi: 10.1038/s41398-018-0334-0).

The app also monitors activity via accelerometry and geolocation to assess an individual’s circadian rest-activity patterns, as well as telephone use and texting behavior. In another report from AMoSS, Dr. Saunders and coinvestigators showed that these patterns also distinguish persons with bipolar disorder from those with borderline personality disorder, who in turn differ from healthy controls (Transl Psychiatry. 2019 Aug 20;91:195. doi: 10.1038/s41398-019-0526-2).

“I think we can use these approaches to inform our diagnostic practice. It doesn’t replace doctors, but clearly it can add to diagnostic accuracy,” she said.

Borderline personality disorder and bipolar disorder are common diagnoses with quite different treatment approaches and prognoses. Studies have shown that rates of misdiagnosis of the two disorders are significant. The challenge is that they share overlapping diagnostic criteria, including prominent mood instability, which is difficult to assess reliably in clinical practice. That’s because the assessment relies on retrospective self-report of how patients felt in the past, which is often colored by their present mood state. The smartphone app sidesteps that limitation by having patients rate their mood daily digitally across six categories – anxiety, elation, sadness, anger, irritability, and energy – on a 1-7 scale.

The machine learning model that analyzes this information organizes the voluminous data into what Dr. Saunders called “signatures of mood” and breaks them down using rough path theory, a mathematical concept based upon differential equations. Dr. Saunders and colleagues have demonstrated that the shifting daily mood self-rating patterns can be used not only to sharpen the differential diagnosis between bipolar disorder and borderline personality disorder, but also to predict future mood. Automated analysis of the past 20 previous mood self-ratings predicted the next day’s mood in healthy controls with 89%-98% accuracy, depending upon which of the six mood categories was under scrutiny.

The predictive power in patients with bipolar disorder was also good, ranging from 82% accuracy for the energetic and anxious domains to 90% for the angry mood category. This ability to predict future mood states could have clinical value by assisting bipolar patients in enhancing proactive self-management and managing their mood stability to avoid depressive or manic relapse, although this has yet to be studied.

“For borderline personality disorder the predictive accuracy was not so good – 70%-78% – but perhaps that doesn’t matter,” Dr. Saunders said. “Perhaps that difficulty in predicting mood may actually be quite a useful diagnostic marker.”

‘Mr. Jones, the doctor is ready to see your phone now.’

The app’s accelerometry and geolocation capabilities can also enhance diagnostic accuracy, as has been shown in the AMoSS study.

The geolocation analysis generates data on the places a patient has gone and how much time was spent there. Feeding that information into the machine learning model predicted the presence or absence of depression with 85% accuracy for bipolar disorder, but couldn’t predict depression at all in borderline personality disorder.

“So we get a sense that people with bipolar disorder have behavioral manifestations of their mood symptoms which are much more consistent with one another and appear to change very consistently with their mood state, whereas borderline personality disorder seems to be characterized by something that’s much more unstable and unpredictable – and we can pick up these predictive variables using our smartphones,” Dr. Saunders said.

As depressive symptoms arise in patients with bipolar disorder, affected individuals display much less day-to-day variability in movement as measured by accelerometry. These changes predicted bipolar disorder with 76% specificity and 48% sensitivity.

“That’s OK. But we can’t do that at all in people with borderline personality disorder, again highlighting the fact that behavioral manifestations and symptoms in these groups are very, very different,” Dr. Saunders observed.

In AMoSS, analysis of activity, geolocation, and distal temperature rhythms showed that the individuals with borderline personality disorder displayed evidence of delayed circadian function, with a distinctive rest-activity pattern that differed from persons with bipolar disorder. This delayed circadian function might provide a novel therapeutic target in borderline personality disorder, a condition for which there is a notable lack of effective pharmacologic and psychotherapeutic interventions.

Phone use patterns were revealing. Patients with bipolar disorder had an increased total telephone call frequency relative to the healthy controls, whereas those with borderline personality disorder used text messaging much more frequently, consistent with the notion that borderline patients have difficulty in interpersonal communication.

Smartphone-based diagnostic differentiation between bipolar disorder and borderline personality disorder isn’t ready for prime time use in clinical practice, Dr. Saunders said. This is groundbreaking work that needs to be refined and replicated in larger studies. There are important ethical and data protection issues that require attention. But patients are gung-ho. Dr. Saunders noted that participant compliance in AMoSS was “extraordinarily good,” at 82%. Moreover, even though the study lasted for 3 months, more than 60% of subjects continued filing mood reports for 12 months.

“Smartphones may also give us an improved understanding of the lived experience of people with mental health problems. That’s certainly the feedback we got a lot from patients. They enjoy using this technology. They feel it’s helpful to be able to show their clinician this is what it’s like for them,” Dr. Saunders said.
 

Clinical usefulness is limited

The study was interesting as a pilot, and it is technologically very innovative. However, at this stage, it is unclear how the results can be used clinically, said Igor Galynker, MD, PhD, when asked about the findings.

There is a place for using this type of technology for patients living in remote areas, for example. However, Dr. Galynker, director of the Richard and Cynthia Zirinsky Center for Bipolar Disorder in New York, said such technology should be viewed as augmentation rather than as a substitute for face-to-face treatment.

“Typically, if clinicians have enough time to speak to the patient and to take history, they can differentiate between bipolar disorder and borderline personality disorder: The former is cyclical, the latter is less so. However, this is hard to do without face-to-face contact, or when you only have 10 minutes,” said Dr. Galynker, professor of psychiatry at the Icahn School of Medicine and director of the Galynker Research and Prevention Laboratory, both at Mount Sinai in New York.

Dr. Saunders’ work is funded by the Wellcome Trust and the National Institute for Health Research. Dr. Galynker reported receiving funding from the National Institute of Mental Health and the American Foundation for Suicide Prevention. He has no other disclosures.

[email protected]

SOURCE: ECNP 2020. Session S21.

There’s a reason they’re called smartphones.

Indeed, how patients use their smartphones and where they take them provides insight into what has been termed their “digital phenotype.” It’s information that, analyzed correctly, becomes useful in differentiating bipolar disorder from borderline personality disorder, a distinction that’s often challenging in clinical practice, Kate E.A. Saunders, MD, DPhil, said at the virtual congress of the European College of Neuropsychopharmacology.

Dr. Saunders, a psychiatrist at the University of Oxford (England), and colleagues have developed a smartphone app enabling patients to briefly characterize their current mood on a daily basis, as well as a machine learning model to analyze this data stream as patients’ moods evolve over time. In their prospective longitudinal Automated Monitoring of Symptom Severity (AMoSS) study of 48 patients with a confirmed diagnosis of bipolar disorder, 31 with borderline personality disorder, and 51 healthy volunteers, the tool correctly classified 75% of participants into the correct diagnostic category on the basis of 20 daily mood ratings (Transl Psychiatry. 2018 Dec 13;81:274. doi: 10.1038/s41398-018-0334-0).

The app also monitors activity via accelerometry and geolocation to assess an individual’s circadian rest-activity patterns, as well as telephone use and texting behavior. In another report from AMoSS, Dr. Saunders and coinvestigators showed that these patterns also distinguish persons with bipolar disorder from those with borderline personality disorder, who in turn differ from healthy controls (Transl Psychiatry. 2019 Aug 20;91:195. doi: 10.1038/s41398-019-0526-2).

“I think we can use these approaches to inform our diagnostic practice. It doesn’t replace doctors, but clearly it can add to diagnostic accuracy,” she said.

Borderline personality disorder and bipolar disorder are common diagnoses with quite different treatment approaches and prognoses. Studies have shown that rates of misdiagnosis of the two disorders are significant. The challenge is that they share overlapping diagnostic criteria, including prominent mood instability, which is difficult to assess reliably in clinical practice. That’s because the assessment relies on retrospective self-report of how patients felt in the past, which is often colored by their present mood state. The smartphone app sidesteps that limitation by having patients rate their mood daily digitally across six categories – anxiety, elation, sadness, anger, irritability, and energy – on a 1-7 scale.

The machine learning model that analyzes this information organizes the voluminous data into what Dr. Saunders called “signatures of mood” and breaks them down using rough path theory, a mathematical concept based upon differential equations. Dr. Saunders and colleagues have demonstrated that the shifting daily mood self-rating patterns can be used not only to sharpen the differential diagnosis between bipolar disorder and borderline personality disorder, but also to predict future mood. Automated analysis of the past 20 previous mood self-ratings predicted the next day’s mood in healthy controls with 89%-98% accuracy, depending upon which of the six mood categories was under scrutiny.

The predictive power in patients with bipolar disorder was also good, ranging from 82% accuracy for the energetic and anxious domains to 90% for the angry mood category. This ability to predict future mood states could have clinical value by assisting bipolar patients in enhancing proactive self-management and managing their mood stability to avoid depressive or manic relapse, although this has yet to be studied.

“For borderline personality disorder the predictive accuracy was not so good – 70%-78% – but perhaps that doesn’t matter,” Dr. Saunders said. “Perhaps that difficulty in predicting mood may actually be quite a useful diagnostic marker.”

‘Mr. Jones, the doctor is ready to see your phone now.’

The app’s accelerometry and geolocation capabilities can also enhance diagnostic accuracy, as has been shown in the AMoSS study.

The geolocation analysis generates data on the places a patient has gone and how much time was spent there. Feeding that information into the machine learning model predicted the presence or absence of depression with 85% accuracy for bipolar disorder, but couldn’t predict depression at all in borderline personality disorder.

“So we get a sense that people with bipolar disorder have behavioral manifestations of their mood symptoms which are much more consistent with one another and appear to change very consistently with their mood state, whereas borderline personality disorder seems to be characterized by something that’s much more unstable and unpredictable – and we can pick up these predictive variables using our smartphones,” Dr. Saunders said.

As depressive symptoms arise in patients with bipolar disorder, affected individuals display much less day-to-day variability in movement as measured by accelerometry. These changes predicted bipolar disorder with 76% specificity and 48% sensitivity.

“That’s OK. But we can’t do that at all in people with borderline personality disorder, again highlighting the fact that behavioral manifestations and symptoms in these groups are very, very different,” Dr. Saunders observed.

In AMoSS, analysis of activity, geolocation, and distal temperature rhythms showed that the individuals with borderline personality disorder displayed evidence of delayed circadian function, with a distinctive rest-activity pattern that differed from persons with bipolar disorder. This delayed circadian function might provide a novel therapeutic target in borderline personality disorder, a condition for which there is a notable lack of effective pharmacologic and psychotherapeutic interventions.

Phone use patterns were revealing. Patients with bipolar disorder had an increased total telephone call frequency relative to the healthy controls, whereas those with borderline personality disorder used text messaging much more frequently, consistent with the notion that borderline patients have difficulty in interpersonal communication.

Smartphone-based diagnostic differentiation between bipolar disorder and borderline personality disorder isn’t ready for prime time use in clinical practice, Dr. Saunders said. This is groundbreaking work that needs to be refined and replicated in larger studies. There are important ethical and data protection issues that require attention. But patients are gung-ho. Dr. Saunders noted that participant compliance in AMoSS was “extraordinarily good,” at 82%. Moreover, even though the study lasted for 3 months, more than 60% of subjects continued filing mood reports for 12 months.

“Smartphones may also give us an improved understanding of the lived experience of people with mental health problems. That’s certainly the feedback we got a lot from patients. They enjoy using this technology. They feel it’s helpful to be able to show their clinician this is what it’s like for them,” Dr. Saunders said.
 

Clinical usefulness is limited

The study was interesting as a pilot, and it is technologically very innovative. However, at this stage, it is unclear how the results can be used clinically, said Igor Galynker, MD, PhD, when asked about the findings.

There is a place for using this type of technology for patients living in remote areas, for example. However, Dr. Galynker, director of the Richard and Cynthia Zirinsky Center for Bipolar Disorder in New York, said such technology should be viewed as augmentation rather than as a substitute for face-to-face treatment.

“Typically, if clinicians have enough time to speak to the patient and to take history, they can differentiate between bipolar disorder and borderline personality disorder: The former is cyclical, the latter is less so. However, this is hard to do without face-to-face contact, or when you only have 10 minutes,” said Dr. Galynker, professor of psychiatry at the Icahn School of Medicine and director of the Galynker Research and Prevention Laboratory, both at Mount Sinai in New York.

Dr. Saunders’ work is funded by the Wellcome Trust and the National Institute for Health Research. Dr. Galynker reported receiving funding from the National Institute of Mental Health and the American Foundation for Suicide Prevention. He has no other disclosures.

[email protected]

SOURCE: ECNP 2020. Session S21.

There’s a reason they’re called smartphones.

Indeed, how patients use their smartphones and where they take them provides insight into what has been termed their “digital phenotype.” It’s information that, analyzed correctly, becomes useful in differentiating bipolar disorder from borderline personality disorder, a distinction that’s often challenging in clinical practice, Kate E.A. Saunders, MD, DPhil, said at the virtual congress of the European College of Neuropsychopharmacology.

Dr. Saunders, a psychiatrist at the University of Oxford (England), and colleagues have developed a smartphone app enabling patients to briefly characterize their current mood on a daily basis, as well as a machine learning model to analyze this data stream as patients’ moods evolve over time. In their prospective longitudinal Automated Monitoring of Symptom Severity (AMoSS) study of 48 patients with a confirmed diagnosis of bipolar disorder, 31 with borderline personality disorder, and 51 healthy volunteers, the tool correctly classified 75% of participants into the correct diagnostic category on the basis of 20 daily mood ratings (Transl Psychiatry. 2018 Dec 13;81:274. doi: 10.1038/s41398-018-0334-0).

The app also monitors activity via accelerometry and geolocation to assess an individual’s circadian rest-activity patterns, as well as telephone use and texting behavior. In another report from AMoSS, Dr. Saunders and coinvestigators showed that these patterns also distinguish persons with bipolar disorder from those with borderline personality disorder, who in turn differ from healthy controls (Transl Psychiatry. 2019 Aug 20;91:195. doi: 10.1038/s41398-019-0526-2).

“I think we can use these approaches to inform our diagnostic practice. It doesn’t replace doctors, but clearly it can add to diagnostic accuracy,” she said.

Borderline personality disorder and bipolar disorder are common diagnoses with quite different treatment approaches and prognoses. Studies have shown that rates of misdiagnosis of the two disorders are significant. The challenge is that they share overlapping diagnostic criteria, including prominent mood instability, which is difficult to assess reliably in clinical practice. That’s because the assessment relies on retrospective self-report of how patients felt in the past, which is often colored by their present mood state. The smartphone app sidesteps that limitation by having patients rate their mood daily digitally across six categories – anxiety, elation, sadness, anger, irritability, and energy – on a 1-7 scale.

The machine learning model that analyzes this information organizes the voluminous data into what Dr. Saunders called “signatures of mood” and breaks them down using rough path theory, a mathematical concept based upon differential equations. Dr. Saunders and colleagues have demonstrated that the shifting daily mood self-rating patterns can be used not only to sharpen the differential diagnosis between bipolar disorder and borderline personality disorder, but also to predict future mood. Automated analysis of the past 20 previous mood self-ratings predicted the next day’s mood in healthy controls with 89%-98% accuracy, depending upon which of the six mood categories was under scrutiny.

The predictive power in patients with bipolar disorder was also good, ranging from 82% accuracy for the energetic and anxious domains to 90% for the angry mood category. This ability to predict future mood states could have clinical value by assisting bipolar patients in enhancing proactive self-management and managing their mood stability to avoid depressive or manic relapse, although this has yet to be studied.

“For borderline personality disorder the predictive accuracy was not so good – 70%-78% – but perhaps that doesn’t matter,” Dr. Saunders said. “Perhaps that difficulty in predicting mood may actually be quite a useful diagnostic marker.”

‘Mr. Jones, the doctor is ready to see your phone now.’

The app’s accelerometry and geolocation capabilities can also enhance diagnostic accuracy, as has been shown in the AMoSS study.

The geolocation analysis generates data on the places a patient has gone and how much time was spent there. Feeding that information into the machine learning model predicted the presence or absence of depression with 85% accuracy for bipolar disorder, but couldn’t predict depression at all in borderline personality disorder.

“So we get a sense that people with bipolar disorder have behavioral manifestations of their mood symptoms which are much more consistent with one another and appear to change very consistently with their mood state, whereas borderline personality disorder seems to be characterized by something that’s much more unstable and unpredictable – and we can pick up these predictive variables using our smartphones,” Dr. Saunders said.

As depressive symptoms arise in patients with bipolar disorder, affected individuals display much less day-to-day variability in movement as measured by accelerometry. These changes predicted bipolar disorder with 76% specificity and 48% sensitivity.

“That’s OK. But we can’t do that at all in people with borderline personality disorder, again highlighting the fact that behavioral manifestations and symptoms in these groups are very, very different,” Dr. Saunders observed.

In AMoSS, analysis of activity, geolocation, and distal temperature rhythms showed that the individuals with borderline personality disorder displayed evidence of delayed circadian function, with a distinctive rest-activity pattern that differed from persons with bipolar disorder. This delayed circadian function might provide a novel therapeutic target in borderline personality disorder, a condition for which there is a notable lack of effective pharmacologic and psychotherapeutic interventions.

Phone use patterns were revealing. Patients with bipolar disorder had an increased total telephone call frequency relative to the healthy controls, whereas those with borderline personality disorder used text messaging much more frequently, consistent with the notion that borderline patients have difficulty in interpersonal communication.

Smartphone-based diagnostic differentiation between bipolar disorder and borderline personality disorder isn’t ready for prime time use in clinical practice, Dr. Saunders said. This is groundbreaking work that needs to be refined and replicated in larger studies. There are important ethical and data protection issues that require attention. But patients are gung-ho. Dr. Saunders noted that participant compliance in AMoSS was “extraordinarily good,” at 82%. Moreover, even though the study lasted for 3 months, more than 60% of subjects continued filing mood reports for 12 months.

“Smartphones may also give us an improved understanding of the lived experience of people with mental health problems. That’s certainly the feedback we got a lot from patients. They enjoy using this technology. They feel it’s helpful to be able to show their clinician this is what it’s like for them,” Dr. Saunders said.
 

Clinical usefulness is limited

The study was interesting as a pilot, and it is technologically very innovative. However, at this stage, it is unclear how the results can be used clinically, said Igor Galynker, MD, PhD, when asked about the findings.

There is a place for using this type of technology for patients living in remote areas, for example. However, Dr. Galynker, director of the Richard and Cynthia Zirinsky Center for Bipolar Disorder in New York, said such technology should be viewed as augmentation rather than as a substitute for face-to-face treatment.

“Typically, if clinicians have enough time to speak to the patient and to take history, they can differentiate between bipolar disorder and borderline personality disorder: The former is cyclical, the latter is less so. However, this is hard to do without face-to-face contact, or when you only have 10 minutes,” said Dr. Galynker, professor of psychiatry at the Icahn School of Medicine and director of the Galynker Research and Prevention Laboratory, both at Mount Sinai in New York.

Dr. Saunders’ work is funded by the Wellcome Trust and the National Institute for Health Research. Dr. Galynker reported receiving funding from the National Institute of Mental Health and the American Foundation for Suicide Prevention. He has no other disclosures.

[email protected]

SOURCE: ECNP 2020. Session S21.

Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.

In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.

“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.

Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.

“Denial is a Freudian concept and we can see how it is rearing its ugly head in a number of prominent ways all around us, including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.

“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
 

“A new partnership”

“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”

He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”

To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.

Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.

Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.

“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.

Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.

“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.

Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”

Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.

However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
 

Is “denial” evidence-based?

Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.

“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”

For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.

Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”

Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.

Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”

McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.

Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.

“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”

Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”

Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”

Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”

Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”

Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.

This article first appeared on Medscape.com.

Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.

In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.

“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.

Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.

“Denial is a Freudian concept and we can see how it is rearing its ugly head in a number of prominent ways all around us, including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.

“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
 

“A new partnership”

“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”

He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”

To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.

Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.

Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.

“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.

Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.

“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.

Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”

Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.

However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
 

Is “denial” evidence-based?

Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.

“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”

For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.

Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”

Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.

Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”

McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.

Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.

“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”

Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”

Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”

Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”

Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”

Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.

This article first appeared on Medscape.com.

Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.

In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.

“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.

Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.

“Denial is a Freudian concept and we can see how it is rearing its ugly head in a number of prominent ways all around us, including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.

“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
 

“A new partnership”

“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”

He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”

To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.

Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.

Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.

“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.

Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.

“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.

Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”

Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.

However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
 

Is “denial” evidence-based?

Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.

“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”

For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.

Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”

Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.

Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”

McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.

Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.

“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”

Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”

Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”

Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”

Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”

Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.

This article first appeared on Medscape.com.

A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

A history of prior depressive illness conferred a sevenfold increased risk of developing treatment-limiting mood symptoms in patients on isotretinoin for acne in a large Scottish observational study, Sanaa Butt, MD, reported at the virtual annual congress of the European Academy of Dermatology and Venereology.

© Ocskay Bence/Fotolia.com

This was, however, the sole identifiable risk factor for treatment-limiting depressive symptoms in acne patients on isotretinoin in the study of 3,151 consecutive acne patients taking isotretinoin. There was no significant difference between those who did or did not develop depression on the oral retinoid in terms of age, gender, or daily dose of the drug at the time it was discontinued.

“Depressive symptoms occurred at any time from the date of initiation of isotretinoin up to 6 months into therapy, with no identifiable peak time period,” said Dr. Butt, a dermatologist with the U.K. National Health Service Tayside district at Ninewells Hospital, Dundee, Scotland. “Lower doses appear not to be protective,” she added.

The Tayside district has a catchment of roughly 450,000 people. The local population tends to stay put because Tayside is an economically disadvantaged and remote part of Scotland. There are very few private practice dermatologists in the area, so Dr. Butt and coinvestigators are confident their observational study of NHS patients captured the great majority of isotretinoin users in northern Scotland.

The investigators utilized software to analyze the contents of more than 8,000 digitized letters exchanged between NHS Tayside dermatologists and general practitioners during 2005-2018, zeroing in on 3,151 consecutive patients on isotretinoin for acne and 158 on the drug for other conditions, most often rosacea or folliculitis. They then drilled down further through the letters, electronically searching for key words such as suicide, depression, and anxiety. In this way, they ultimately identified 30 patients who discontinued the drug because they developed depressive symptoms. All 30 were on the drug for acne.

The annual incidence of treatment-limiting depressive mood changes was 0.96%, a figure that remained steady over the 13-year study period, even though prescribing of isotretinoin increased over time. This flat incidence rate effectively rules out the potential for confounding because of assessor bias, especially since many different NHS dermatologists were prescribing the drug, Dr. Butt said.

Half of acne patients prescribed isotretinoin were female and 50% were male. And 15 cases of treatment discontinuation caused by development of depressive symptoms occurred in females, 15 in males. A history of past depressive illness was present in 9.3% of females who started on isotretinoin and in 4.5% of the males. The relative risk of treatment-limiting depressive mood changes was increased 790% among females with a prior history of depressive illness and 440% in males with such a history.

Dr. Butt reported having no financial conflicts regarding her NHS-funded study.

[email protected]

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.