MDedge Psychiatry

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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

Taking a daily multivitamin for 3 years is associated with a 60% slowing of cognitive aging, with the effects especially pronounced in patients with cardiovascular (CVD) disease, new research suggests.

©Graça Victoria/iStockphoto.com

In addition to testing the effect of a daily multivitamin on cognition, the COSMOS-Mind study examined the effect of cocoa flavanols, but showed no beneficial effect.

The findings “may have important public health implications, particularly for brain health, given the accessibility of multivitamins and minerals, and their low cost and safety,” said study investigator Laura D. Baker, PhD, professor, gerontology and geriatric medicine, Wake Forest University, Winston-Salem, N.C.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.

 

Placebo-controlled study

The study is a substudy of a large parent trial that compared the effects of cocoa extract (500 mg/day cocoa flavanols) and a standard multivitamin-mineral (MVM) to placebo on cardiovascular and cancer outcomes in more than 21,000 older participants.

COSMOS-Mind included 2,262 adults aged 65 and over without dementia who underwent cognitive testing at baseline and annually for 3 years. The mean age at baseline was 73 years, and 40.4% were men. Most participants (88.7%) were non-Hispanic White and almost half (49.2%) had some post-college education.

All study groups were balanced with respect to demographics, CVD history, diabetes, depression, smoking status, alcohol intake, chocolate intake, and prior multivitamin use. Baseline cognitive scores were similar between study groups. Researchers had complete data on 77% of study participants.

The primary endpoint was the effect of cocoa extract (CE) vs. placebo on Global Cognitive Function composite score. The secondary outcome was the effect of MVM vs. placebo on global cognitive function.

Additional outcomes included the impact of supplements on executive function and memory and the treatment effects for prespecified subgroups, including subjects with a history of CVD.

Using a graph of change over time, Dr. Baker showed there was no effect of cocoa on global cognitive function (effect: 0.03; 95% confidence interval, –0.02 to 0.08; P = .28). “We see the to-be-expected practice effects, but there’s no separation between the active and placebo groups,” she said.

It was a different story for MVM. Here, there was the same practice effect, but the graph showed the lines separated for global cognitive function composite score (effect: 0.07; 95% CI, 0.02-0.12; P = .007).

“We see a positive effect of multivitamins for the active group relative to placebo, peaking at 2 years and then remaining stable over time,” said Dr. Baker.

There were similar findings with MVM for the memory composite score, and the executive function composite score. “We have significance in all three, where the two lines do separate over and above the practice effects,” said Dr. Baker.
 

New evidence

Investigators found a baseline history of CVD, including transient ischemic attack, heart failure, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and stent, but not myocardial infarction or stroke as these were excluded in the parent trial because they affected the response to multivitamins.

As expected, those with CVD had lower cognitive scores at baseline. “But after an initial bump due to practice effect, at year 1, the cardiovascular disease history folks continue to benefit from multivitamins, whereas those who got placebo multivitamins continue to decline over time,” said Dr. Baker.

Based on information from a baseline scatter plot of cognitive function scores by age, the study’s modeling estimated the multivitamin treatment effect had a positive benefit of .028 standard deviations (SD) per year.

“Daily multivitamin-mineral supplementation appears to slow cognitive aging by 60% or by 1.8 years,” Dr. Baker added.

To date, the effect of MVM supplementation on cognition has been tested in only one large randomized clinical trial – the Physicians Health Study II. That study did not show an effect, but included only older male physicians – and cognitive testing began 2.5 years after randomization, said Dr. Baker.

“Our study provides new evidence that daily multivitamin supplementation may benefit cognitive function in older women and men, and the multivitamin effects may be more pronounced in participants with cardiovascular disease,” she noted.

For effects of multivitamins on Alzheimer’s disease prevalence and progression, “stay tuned,” Dr. Baker concluded.

Following the presentation, session cochair Suzanne Schindler, MD, PhD, instructor in the department of neurology at Washington University, St. Louis, said she and her colleagues “always check vitamin B₁₂ levels” in patients with memory and cognitive difficulties and wondered if study subjects with a low level or deficiency of vitamin B₁₂ benefited from the intervention.

“We are asking ourselves that as well,” said Dr. Baker.

“Some of this is a work in progress,” Dr. Baker added. “We still need to look at that more in-depth to understand whether it might be a mechanism for improvement. I think the results are still out on that topic.”

The study received support from the National Institute on Aging. Pfizer Consumer Healthcare (now GSK Consumer Healthcare) provided study pills and packaging. Dr. Baker has disclosed no relevant financial relationships.
 

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

Taking a daily multivitamin for 3 years is associated with a 60% slowing of cognitive aging, with the effects especially pronounced in patients with cardiovascular (CVD) disease, new research suggests.

©Graça Victoria/iStockphoto.com

In addition to testing the effect of a daily multivitamin on cognition, the COSMOS-Mind study examined the effect of cocoa flavanols, but showed no beneficial effect.

The findings “may have important public health implications, particularly for brain health, given the accessibility of multivitamins and minerals, and their low cost and safety,” said study investigator Laura D. Baker, PhD, professor, gerontology and geriatric medicine, Wake Forest University, Winston-Salem, N.C.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.

 

Placebo-controlled study

The study is a substudy of a large parent trial that compared the effects of cocoa extract (500 mg/day cocoa flavanols) and a standard multivitamin-mineral (MVM) to placebo on cardiovascular and cancer outcomes in more than 21,000 older participants.

COSMOS-Mind included 2,262 adults aged 65 and over without dementia who underwent cognitive testing at baseline and annually for 3 years. The mean age at baseline was 73 years, and 40.4% were men. Most participants (88.7%) were non-Hispanic White and almost half (49.2%) had some post-college education.

All study groups were balanced with respect to demographics, CVD history, diabetes, depression, smoking status, alcohol intake, chocolate intake, and prior multivitamin use. Baseline cognitive scores were similar between study groups. Researchers had complete data on 77% of study participants.

The primary endpoint was the effect of cocoa extract (CE) vs. placebo on Global Cognitive Function composite score. The secondary outcome was the effect of MVM vs. placebo on global cognitive function.

Additional outcomes included the impact of supplements on executive function and memory and the treatment effects for prespecified subgroups, including subjects with a history of CVD.

Using a graph of change over time, Dr. Baker showed there was no effect of cocoa on global cognitive function (effect: 0.03; 95% confidence interval, –0.02 to 0.08; P = .28). “We see the to-be-expected practice effects, but there’s no separation between the active and placebo groups,” she said.

It was a different story for MVM. Here, there was the same practice effect, but the graph showed the lines separated for global cognitive function composite score (effect: 0.07; 95% CI, 0.02-0.12; P = .007).

“We see a positive effect of multivitamins for the active group relative to placebo, peaking at 2 years and then remaining stable over time,” said Dr. Baker.

There were similar findings with MVM for the memory composite score, and the executive function composite score. “We have significance in all three, where the two lines do separate over and above the practice effects,” said Dr. Baker.
 

New evidence

Investigators found a baseline history of CVD, including transient ischemic attack, heart failure, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and stent, but not myocardial infarction or stroke as these were excluded in the parent trial because they affected the response to multivitamins.

As expected, those with CVD had lower cognitive scores at baseline. “But after an initial bump due to practice effect, at year 1, the cardiovascular disease history folks continue to benefit from multivitamins, whereas those who got placebo multivitamins continue to decline over time,” said Dr. Baker.

Based on information from a baseline scatter plot of cognitive function scores by age, the study’s modeling estimated the multivitamin treatment effect had a positive benefit of .028 standard deviations (SD) per year.

“Daily multivitamin-mineral supplementation appears to slow cognitive aging by 60% or by 1.8 years,” Dr. Baker added.

To date, the effect of MVM supplementation on cognition has been tested in only one large randomized clinical trial – the Physicians Health Study II. That study did not show an effect, but included only older male physicians – and cognitive testing began 2.5 years after randomization, said Dr. Baker.

“Our study provides new evidence that daily multivitamin supplementation may benefit cognitive function in older women and men, and the multivitamin effects may be more pronounced in participants with cardiovascular disease,” she noted.

For effects of multivitamins on Alzheimer’s disease prevalence and progression, “stay tuned,” Dr. Baker concluded.

Following the presentation, session cochair Suzanne Schindler, MD, PhD, instructor in the department of neurology at Washington University, St. Louis, said she and her colleagues “always check vitamin B₁₂ levels” in patients with memory and cognitive difficulties and wondered if study subjects with a low level or deficiency of vitamin B₁₂ benefited from the intervention.

“We are asking ourselves that as well,” said Dr. Baker.

“Some of this is a work in progress,” Dr. Baker added. “We still need to look at that more in-depth to understand whether it might be a mechanism for improvement. I think the results are still out on that topic.”

The study received support from the National Institute on Aging. Pfizer Consumer Healthcare (now GSK Consumer Healthcare) provided study pills and packaging. Dr. Baker has disclosed no relevant financial relationships.
 

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

Taking a daily multivitamin for 3 years is associated with a 60% slowing of cognitive aging, with the effects especially pronounced in patients with cardiovascular (CVD) disease, new research suggests.

©Graça Victoria/iStockphoto.com

In addition to testing the effect of a daily multivitamin on cognition, the COSMOS-Mind study examined the effect of cocoa flavanols, but showed no beneficial effect.

The findings “may have important public health implications, particularly for brain health, given the accessibility of multivitamins and minerals, and their low cost and safety,” said study investigator Laura D. Baker, PhD, professor, gerontology and geriatric medicine, Wake Forest University, Winston-Salem, N.C.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.

 

Placebo-controlled study

The study is a substudy of a large parent trial that compared the effects of cocoa extract (500 mg/day cocoa flavanols) and a standard multivitamin-mineral (MVM) to placebo on cardiovascular and cancer outcomes in more than 21,000 older participants.

COSMOS-Mind included 2,262 adults aged 65 and over without dementia who underwent cognitive testing at baseline and annually for 3 years. The mean age at baseline was 73 years, and 40.4% were men. Most participants (88.7%) were non-Hispanic White and almost half (49.2%) had some post-college education.

All study groups were balanced with respect to demographics, CVD history, diabetes, depression, smoking status, alcohol intake, chocolate intake, and prior multivitamin use. Baseline cognitive scores were similar between study groups. Researchers had complete data on 77% of study participants.

The primary endpoint was the effect of cocoa extract (CE) vs. placebo on Global Cognitive Function composite score. The secondary outcome was the effect of MVM vs. placebo on global cognitive function.

Additional outcomes included the impact of supplements on executive function and memory and the treatment effects for prespecified subgroups, including subjects with a history of CVD.

Using a graph of change over time, Dr. Baker showed there was no effect of cocoa on global cognitive function (effect: 0.03; 95% confidence interval, –0.02 to 0.08; P = .28). “We see the to-be-expected practice effects, but there’s no separation between the active and placebo groups,” she said.

It was a different story for MVM. Here, there was the same practice effect, but the graph showed the lines separated for global cognitive function composite score (effect: 0.07; 95% CI, 0.02-0.12; P = .007).

“We see a positive effect of multivitamins for the active group relative to placebo, peaking at 2 years and then remaining stable over time,” said Dr. Baker.

There were similar findings with MVM for the memory composite score, and the executive function composite score. “We have significance in all three, where the two lines do separate over and above the practice effects,” said Dr. Baker.
 

New evidence

Investigators found a baseline history of CVD, including transient ischemic attack, heart failure, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and stent, but not myocardial infarction or stroke as these were excluded in the parent trial because they affected the response to multivitamins.

As expected, those with CVD had lower cognitive scores at baseline. “But after an initial bump due to practice effect, at year 1, the cardiovascular disease history folks continue to benefit from multivitamins, whereas those who got placebo multivitamins continue to decline over time,” said Dr. Baker.

Based on information from a baseline scatter plot of cognitive function scores by age, the study’s modeling estimated the multivitamin treatment effect had a positive benefit of .028 standard deviations (SD) per year.

“Daily multivitamin-mineral supplementation appears to slow cognitive aging by 60% or by 1.8 years,” Dr. Baker added.

To date, the effect of MVM supplementation on cognition has been tested in only one large randomized clinical trial – the Physicians Health Study II. That study did not show an effect, but included only older male physicians – and cognitive testing began 2.5 years after randomization, said Dr. Baker.

“Our study provides new evidence that daily multivitamin supplementation may benefit cognitive function in older women and men, and the multivitamin effects may be more pronounced in participants with cardiovascular disease,” she noted.

For effects of multivitamins on Alzheimer’s disease prevalence and progression, “stay tuned,” Dr. Baker concluded.

Following the presentation, session cochair Suzanne Schindler, MD, PhD, instructor in the department of neurology at Washington University, St. Louis, said she and her colleagues “always check vitamin B₁₂ levels” in patients with memory and cognitive difficulties and wondered if study subjects with a low level or deficiency of vitamin B₁₂ benefited from the intervention.

“We are asking ourselves that as well,” said Dr. Baker.

“Some of this is a work in progress,” Dr. Baker added. “We still need to look at that more in-depth to understand whether it might be a mechanism for improvement. I think the results are still out on that topic.”

The study received support from the National Institute on Aging. Pfizer Consumer Healthcare (now GSK Consumer Healthcare) provided study pills and packaging. Dr. Baker has disclosed no relevant financial relationships.
 

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

When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.

xavierarnau/Getty Images

She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.

What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.

“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”

The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.

Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.

Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
 

Signs and symptoms of PTSD

PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.

As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.

“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, trauma has no real timeline and can show up months or even years after the pandemic.”

PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.

She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”

Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
 

The difficulties in isolating COVID-19 as a contributor

Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.

With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.

“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.

In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.

Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.

The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.

Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.

Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.

The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”

Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.

Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
 

A rallying cry for new interventions

Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.

“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”

Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.

Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.

“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”

Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”

The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.

Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.

“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.

“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.

Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
 

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

When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.

xavierarnau/Getty Images

She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.

What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.

“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”

The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.

Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.

Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
 

Signs and symptoms of PTSD

PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.

As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.

“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, trauma has no real timeline and can show up months or even years after the pandemic.”

PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.

She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”

Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
 

The difficulties in isolating COVID-19 as a contributor

Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.

With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.

“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.

In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.

Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.

The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.

Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.

Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.

The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”

Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.

Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
 

A rallying cry for new interventions

Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.

“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”

Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.

Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.

“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”

Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”

The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.

Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.

“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.

“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.

Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
 

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

When the COVID-19 pandemic engulfed the nation well over a year ago, Rebecca Hendrickson, MD, PhD, immersed herself in the shell-shocking revelations that clinicians began posting on social media. The accounts offered just a snapshot of the pandemic’s heavy psychological toll, and Dr. Hendrickson, a psychiatrist at the University of Washington in Seattle and an expert in posttraumatic stress disorder (PTSD), wanted to know more.

xavierarnau/Getty Images

She and her colleagues devised a survey to assess the impact of several pandemic-related factors, including increased work hours, social distancing restrictions, and lack of adequate personal protective equipment.

What began as a survey of health care workers soon expanded in scope. Of the more than 600 survey respondents to date, health care workers account for about 60%, while the rest are first responders – police officers, firefighters, paramedics, and emergency medical technicians – and nonclinical personnel, such as security guards and office staff, in health care settings. The respondents range in age from 19 to 72, and hail from all regions of the country.

“Our findings were really striking,” Dr. Hendrickson said, “including very high rates of thoughts of suicide and thoughts of leaving one’s current field, which were both strongly linked to COVID-19–related occupational stress exposure.”

The distress stemmed from a multitude of factors. Among the most demoralizing: witnessing patients die in isolation and being stretched thin to provide optimal care for all patients amid an unrelenting onslaught of COVID-19 cases, she said. For some health care workers, living in the garage or basement – to avoid infecting family members with the virus – also wore on their psyches.

Of all health care workers in the study, more than three-quarters reported symptoms that fell within the clinical range for depression (76%) and anxiety (78%). More than 25% noted that they had lost a family member or close colleague to the virus.

Dr. Hendrickson, who works with military veterans at the VA Puget Sound Hospital System’s Mental Illness Research, Education, and Clinical Center and its PTSD outpatient clinic, hadn’t expected the experience of loss to be so pervasive. She said the sheer number of people who “crossed the threshold” into despair concerned her deeply.
 

Signs and symptoms of PTSD

PTSD’s prevalence among health care workers has always been variable, said Jessica Gold, MD, assistant professor and director of wellness, engagement, and outreach in the department of psychiatry at Washington University in St. Louis.

As a psychiatrist who sees health care workers in her clinical practice, Dr. Gold has noted poor baseline mental health, including depression and trauma. Significant data have pointed to a relatively higher suicide rate among physicians than among the general population. These problems have been compounded by COVID-19.

“It has been an unrelenting series of new stressors,” she said, citing lack of resources; a feeling of being unable to help; and the high frequency of risk of death to patients, family and friends, and the caregivers themselves as just as few examples. “It is very likely going to increase our baseline trauma, and honestly, I don’t know that we can predict how. To me, trauma has no real timeline and can show up months or even years after the pandemic.”

PTSD can manifest itself in health care workers in several different ways. A few commonalities Dr. Gold has observed are sleep disruption (including insomnia and nightmares), work avoidance by taking disability or quitting, irritability or other changes in mood, trouble concentrating, and hypervigilance.

She said she has seen physical manifestations of trauma – such as body pain, stomachaches, and teeth grinding, which “you might not realize are at all related to trauma but ultimately are.” Sometimes, she added, “people have panic attacks on the way to work or right when they get to work, or are thinking about work.”

Dr. Gold noted that different types of treatment, such as cognitive-behavioral therapy and eye movement desensitization and reprocessing (EMDR), can be effective for PTSD. Medication is often necessary because of comorbid anxiety, depression, or eating disorders, said Dr. Gold, who is conducting a study on the pandemic’s effects on medical students.
 

The difficulties in isolating COVID-19 as a contributor

Not all researchers are convinced that a causal relationship has been established between the pandemic and worsening mental health among those in the health care sector.

With provider burnout being a long-standing concern in medicine, Ankur A. Butala, MD, assistant professor of neurology, psychiatry, and behavioral sciences at the Johns Hopkins University, Baltimore, said he remains a bit skeptical that acute stressors during the pandemic amounted to a uniquely potent driving force that can be extrapolated and quantified in a study.

“It’s hard to interpret a chronic, rolling, ongoing trauma like COVID-19 against tools or scales developed to investigate symptoms from a singular and acute trauma, like a school shooting or a [military] firefight,” Dr. Butala said.

In addition, he noted a reluctance to generalizing results from a study in which participants were recruited via social media as opposed to research methods involving more rigorous selection protocols.

Although Dr. Hendrickson acknowledged the study’s limitations, she said her team nonetheless found strong correlations between COVID-19-related stressors and self-reported struggles in completing work-related tasks, as well as increasing thoughts of leaving one’s current field. They adjusted for previous lifetime trauma exposure, age, gender, and a personal history of contracting COVID-19.

The underlying premise of the study could be confirmed with repeated surveys over time, Dr. Butala said, as the COVID-19 pandemic evolves and the vaccination effort unfolds.

Follow-up surveys are being sent to participants every 2 weeks and every 3 months to gauge their mood, for a total follow-up period of 9 months per individual. New participants are still welcome. “We will continue to enroll as long as it seems relevant,” Dr. Hendrickson said.

Carol S. North, MD, MPE, who has added to the growing research on the pandemic’s toll on mental health, noted that because symptom scales do not provide psychiatric diagnoses, it is difficult to attribute the prevalence of psychiatric disorders to the pandemic. Dr. North is chair and professor of crisis psychiatry at UT Southwestern Medical Center in Dallas, and director of the program in trauma and disaster at VA North Texas Health Care System.

The DSM-5 criteria exclude naturally occurring illness, such as a virus (even during a pandemic) as a qualifying trauma for the diagnosis of PTSD. According to current criteria by the American Psychiatric Association, COVID-19 and the pandemic are not defined as trauma, Dr. North said, while noting that “just because it’s not trauma or PTSD does not mean that the pandemic should be discounted as not stressful; people are finding it very stressful.”

Identifying the exact source of distress would still be difficult, Dr. North said, as the pandemic has produced severe economic consequences and prolonged social isolation, as well as occurring alongside nationwide protests over racial and ethnic divisions. Studies to date haven’t effectively separated out for these stressors, making it impossible to weigh their relative impact.

Furthermore, “most of us face many other stressors in our daily lives, such as grief, losses, broken relationships, and personal failures,” she said. “All of these may contribute to psychological distress, and research is needed to determine how much was a product of the virus, other aspects of the pandemic, or unrelated life stressors.”
 

A rallying cry for new interventions

Despite such doubts, a growing number of studies are reporting that health care workers and first responders are experiencing intensified PTSD, depression, anxiety, and insomnia as a result of the pandemic, said Hrayr Pierre Attarian, MD, professor of neurology at Northwestern University, Chicago. These results should act as a rallying cry for implementing more policies tailored to prevent burnout, he said.

“What we are seeing during this terrible pandemic is burnout on steroids,” said Dr. Attarian, medical director of Northwestern’s Center for Sleep Disorders. There are already high burnout rates, “so this should be doubly important.”

Rooting out this problem starts at the institutional level, but merely advising providers to “be well” wouldn’t make inroads. “There needs to be fluid dialogue between health care workers and the leadership,” he said.

Among his proposed remedies: Access to confidential and free mental health resources, increased administrative support, flexible hours, respect for work-life balance, and forgiveness for occasional errors that don’t result in harm.

“Sometimes even the perception that a mistake has been made is taken as proof of guilt,” Dr. Attarian said. “It is not conducive to wellness. Extra income does not replace a nurturing work environment.”

Furthermore, “as a profession, we must stop glorifying ‘overwork.’ We must stop wearing ‘lack of sleep’ as badge of honor,” he said. “Sleep is a biological imperative like self-preservation, hunger, and thirst. When we don’t sleep anxiety, pain, and depression get amplified. Our perception of distress is off, as is our judgment.”

The Federation of State Physician Health Programs provides a directory that physicians can use for referrals to confidential consultation or treatment.

Christopher Bundy, MD, MPH, executive medical director of Washington Physicians Health Program in Seattle, has been following Dr. Hendrickson’s longitudinal study with keen interest. As president of the Federation of State Physician Health Programs, he hopes to translate the findings into practice.

“Obviously, the COVID-19 pandemic has been a ‘black swan’ in terms of workforce sustainability issues,” Dr. Bundy said, citing “high rates of burnout, disillusionment, and dissatisfaction.” He sees some similarities with his former role in treating war veterans.

“The invisible wounds of combat, the psychological scars don’t really become apparent until after you’re out of the war zone,” said Dr. Bundy, clinical associate professor of psychiatry at the University of Washington.

Likewise, he expects the “emotional chickens will come home to roost as the pandemic subsides.” Until then, “people are just focused on survival, and in doing their jobs and protecting their patients.” Eventually, “their own wounds inside the pandemic will take hold.”
 

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

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

A single infusion of ketamine rapidly improves distorted thinking and reasoning to reduce suicidal thoughts, independent of the drug’s effect on severe depression, new research shows.

“Previously it was shown that ketamine rapidly improved depression and that explained part of the rapid improvement in suicidal ideation,” senior author J. John Mann, MD, with Columbia University, New York, said in an interview.

“What was unclear was what else changed that could decrease suicidal ideation and the risk for suicidal behavior. This study identifies a second new domain of improvement – namely rapid improvement in several cognitive functions that can potentially reduce suicide risk,” said Dr. Mann.

The study was published online Nov. 2, 2021, in the Journal of Clinical Psychiatry.
 

Boosts cognitive function

A total of 78 adults with major depressive disorder and clinically significant suicidal ideation underwent neuropsychological testing before, and 1 day after, double-blind treatment with a single intravenous infusion of ketamine or midazolam.

“Ketamine produced rapid improvement in suicidal ideation and mood” compared with midazolam, the authors reported.

Ketamine was linked to specific improvement in reaction time and cognitive control/interference processing – a measure that has been associated with previous suicide attempt in depression.

A subgroup of patients whose suicidal ideation did not remit on midazolam were later treated with unblinded ketamine and retested. In these individuals, reaction time and cognitive control/interference processing also improved relative to preketamine assessments.

Neurocognitive improvement, however, was not correlated with changes in depression, suicidal thinking, or general mood, the researchers noted.

Nonetheless, they say ketamine had a “positive therapeutic effect” on neurocognition 1 day after treatment on at least one measure associated with suicidal behavior in the context of depression.

The results suggest “additional independent therapeutic effects for ketamine in the treatment of depressed patients at risk for suicidal behavior,” they wrote.

“Ketamine modulates many neurotransmitter systems including glutamate transmission which is crucial for learning and memory. It increases the number of synapses or connections between neurons. These effects are fundamental to cognition and are logical explanations of the beneficial effects observed in this study,” Dr. Mann said in an interview.

“Our study helped us gain a better understanding of how ketamine works in the brain and how quickly it can improve distorted thinking. Being able to think more clearly can make someone feel less suicidal,” study investigator Ravi. N. Shah, MD, chief innovation officer, Columbia Psychiatry, said in a news release.
 

Important research with caveats

In a comment, James Murrough, MD, PhD, director of the Depression and Anxiety Center for Discovery and Treatment at Mount Sinai in New York, said the study is important and “adds to a growing understanding of how ketamine affects brain systems and thinking in the context of depression and suicide risk.”

“One reason this study is significant is that prior studies have shown that ketamine can have harmful effects on cognitive functioning in the context of ketamine misuse and exposures to high doses for long periods of time,” Dr. Murrough, who wasn’t involved in the study, said in an interview.

“In contrast in this study, a single low-dose treatment of ketamine can have the opposite effects, actually boosting some markers of cognitive functioning, at least in the short-term,” he noted.

Dr. Murrough said one caveat to the study is that it only examined the effect of ketamine on cognition once, 1 day after a single treatment.

“While this is an important initial observation, we don’t yet have any understanding of how persistent this effect on cognition is, or how this observed change may be related to any benefit ketamine may have on depression or suicide risk,” Dr. Murrough said.

“In fact, the researchers found that there was no association between change in cognitive functioning following ketamine and change in depression or suicidal thinking. The patients who showed improved cognitive function following ketamine did not differ in terms of mood or suicide risk compared to patients who did not show an improvement in cognition,” Dr. Murrough noted.

“This raises the important question of what is the relevance of change in cognition to the potential benefits of ketamine. This is an important area and should be the focus of future research in order to improve outcomes for patients with depression and who are at risk for suicide,” he added.

Also weighing in, Roger S. McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit, University of Toronto, said the study is “very interesting and in keeping” with some previous work that he and his colleagues have done showing that ketamine “seems to benefit aspects of cognition which is a core element in depression.”

“It’s a testable hypothesis that the improvement in cognition now being reported and replicated could play some role in the improved quality of life and functioning with this treatment and as well reduce reducing suicide,” said Dr. McIntyre.

This study was supported by the National Institute of Mental Health. Dr. Mann receives royalties for commercial use of the Columbia-Suicide Severity Rating Scale, which was not used in this study. Dr. Murrough’s institution was involved in research involving esketamine (Spravato) for treatment-resistant depression and receives financial remuneration from the manufacturer of esketamine. Dr. McIntyre has received research grant support from the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Expanding suicide risk screening in primary care to identify patients at highest risk may help boost prevention efforts and make better use of health care resources, according to a new study.

Craig J. Bryan, PsyD, ABPP, with the department of psychiatry and behavioral health at Ohio State University Wexner Medical Center, Columbus, led the study, published online on Nov. 8, 2021, in Annals of Family Medicine.

The authors cited the urgency highlighted by statistics showing that, from 1999 to 2017, the U.S. suicide rate increased by more than 33% and was particularly high among military personnel and veterans.

Primary care offices are seen as a prime target for prevention efforts as nearly one-half of people who die by suicide in the United States visit a primary care office in the months before their deaths.

A common approach to screening for suicide risk has been to use the Patient Health Questionnaire–9 (PHQ-9). The first two questions assess the frequency of depressed mood and anhedonia in the past 2 weeks. If patients screen positive on those two questions, they are given the remaining seven questions.

A single item – question 9 – asks about how often a patient has “thoughts that you would be better off dead, or of hurting yourself in some way” during the past 2 weeks.

Yet, more that 95% of patients who screen positive on the PHQ-9 suicide risk question do not attempt or die by suicide, the authors noted.
 

Two methods tested for improving screening

Dr. Bryan and colleagues wanted to assess whether suicide risk screening could be improved in primary care and evaluated two methods.

One was to see whether using any of the other PHQ-9 items could be better than just using item 9 alone to identify the patients who were most likely to attempt suicide in the near future. Researchers found that method was not significantly beneficial. The second was to evaluate the performance of the 16 items on the Suicide Cognitions Scale (SCS), a questionnaire that asks patients to rate the extent to which they agree or disagree with statements that are commonly endorsed by suicidal people.

Patients who were eligible for medical treatment from the Department of Defense medical system were recruited from six large and small military primary care clinics across the United States from July 2015 to August 2018.

Patients answered questions on the PHQ-9 and 16 items from the SCS during routine primary care visits. Evaluators, who were blind to screening results, assessed postbaseline suicide attempts, interrupted attempts and aborted attempts by interviewing patients.

The study included 2,744 primary care patients, ranging from 18 to 89 years of age, with an average age of 40.
 

Adding at least one question may help

Researchers found that the accuracy of suicide risk screening using the PHQ-9 can be significantly improved by adding one or more questions from the SCS. Three items from SCS contributed most to meaningful improvements in identifying patients who went on to exhibit suicidal behaviors within 30-90 days of screening.

One question was item 16: “I don’t deserve to live another moment.”

Two SCS items improved specificity and positive predictive value without reducing sensitivity, the authors wrote. They are: “It is unbearable when I get this upset” (item 8) and “I can’t imagine anyone being able to withstand this kind of pain” (item 13).

“For example,” the authors wrote, “only 4.1% of patients who screened positive on the PHQ-9 suicide risk item 9 engaged in suicidal behavior within the next 30 days, but when the PHQ-9 suicide risk item 9 was combined with SCS item 13 (the best-performing SCS item), this percentage nearly doubled, to 7.6% of patients.”

Adding one of these SCS items to the PHQ-9 “could provide a simple, accessible, and low-cost method for more accurately identifying primary care patients who require more immediate clinical intervention,” the authors wrote.
 

Outside expert perspective

Meredith Williamson, PhD, a mental health diagnosis and psychotherapy expert and clinical assistant professor at Texas A&M University, Bryan, said that, though the SCS questions are valuable, neither they nor the PHQ-9 question get to the direct question of whether the person is likely to act on their thoughts and attempt or complete suicide.

“Someone with depression may have thought of wishing they were dead or wishing they weren’t here but that doesn’t always mean they necessarily want to kill themselves,” she said in an interview. “It’s our responsibility as providers to really clarify the meaning of that item.”

Dr. Williamson noted the PHQ-9 is a very accessible method to screen for depression in primary care settings and is a way to catch large numbers of people screening positive, but its shortcomings are well known and additional information is needed.

She said that, in her practice, if a patient screens positive on PHQ-9, clinicians ask more about their intentions, how frequently they occur and whether patients have developed a plan for killing themselves.

The challenge is that “we have yet to predict who is and who is not going to kill themselves.”

Dr. Williamson said she finds the Columbia-Suicide Severity Rating Scale a valuable tool used in research settings that looks at prior attempts and current desire to engage in an attempt in more detail.

“It doesn’t stop people from killing themselves, but helps to better understand their suicidal behavior,” she explained.

This project was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Defense Medical Research and Development Program. Dr. Williamson has no relevant financial disclosures. Dr. Bryan is a paid consultant to Oui Therapeutics and Neurostat Analytical Solutions. He is a principal of Anduril, which conducts training workshops and provides mental health consultation focused on suicide prevention and PTSD.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.

Recent research suggests that some pediatric patients who develop neuropsychiatric symptoms from COVID-19 may have intrathecal antineural SARS-CoV-2 autoantibodies, which may hint at central nervous system (CNS) autoimmunity in these patients.

“Overall, these findings indicate that severe neuropsychiatric symptoms can occur in the setting of pediatric COVID-19, including patients who lack many of the cardinal systemic features,” Christopher M. Bartley, MD, PhD, of the Weill Institute for Neurosciences at the University of California, San Francisco, and colleagues wrote in their study. “These data highlight the possibility of SARS-CoV-2 neuroinvasion and/or CNS autoimmunity in pediatric patients with COVID-19 and neuropsychiatric symptoms.”

In a case series published Oct. 25 in JAMA Neurology (doi: 10.1001/jamaneurol.2021.3821), Dr. Bartley and colleagues examined three pediatric patients who were infected with SARS-CoV-2 and, over a period of 5 months in 2020, were admitted to the hospital – where they received a neurology consultation for “subacute, functionally impairing behavioral changes.”

Patient 1 had a history of unspecified anxiety and depression, and was admitted for erratic behavior, paranoia-like fears, social withdrawal, and insomnia. The patient did not respond to treatment with risperidone and gabapentin, and was readmitted soon after discharge, then treated with olanzapine followed by a transition to valproate and lorazepam. It was found the patient had cerebrospinal fluid (CSF) abnormalities in the form of elevated protein levels, and an elevated IgG index, and was given intravenous immunoglobulin followed by IV methylprednisolone. While symptoms such as paranoia improved and the patient was able to better organize thoughts after 5 days, other symptoms such as delusions and hyperreflexia persisted for at least 1 month before resolving, and some symptoms, such as lability, did not resolve before discharge.

Patient 2 had a history of motor tics and anxiety, but showed signs of insomnia, mood lability, impaired concentration, difficulty finding words, and problems completing homework following a SARS-CoV-2 infection. The patient’s father previously had been diagnosed with COVID-19 and the patient developed respiratory symptoms and fever; an IgG serology test later confirmed a SARS-CoV-2 infection. The patient went on to experience internal preoccupation, aggression, and suicidal ideation. The patients was treated with aripiprazole and risperidone, but did not respond, and was admitted to the hospital. As with patient 1, patient 2 had CSF abnormalities in the form of elevated protein levels, and responded to IV methylprednisolone, with working memory and bradyphrenia improving. However, the patient developed insomnia, extreme anxiety, suicidal ideation, aggression, and sadness after discharge, and was readmitted. The patient was treated with IV immunoglobulin, and discharged with quetiapine and lithium.

“Six months later, although improved from initial presentation, the patient required academic accommodations and continued to endorse forgetfulness and attention difficulties. The patient’s chronic tics and anxiety were unchanged,” Dr. Bartley and colleagues wrote.

Patient 3 had no psychiatric history but started to demonstrate “odd behavior, including repetitive behaviors, anorexia, and insomnia” following a SARS-CoV-2 infection. After being hospitalized, the patient showed signs of “ideomotor apraxia, abulia, disorganized behavior, agitation, and diffusely brisk reflexes” and had a high white blood cell count, creatine kinase level, and C-reactive protein level. CSF was also abnormal for this patient, with three unique oligoclonal bands identified. The patient was treated with lorazepam and olanzapine, did not receive immunotherapy, and was discharged without psychiatric medications after 4 days.

When the researchers performed testing on each of the three patients, they found intrathecal anti–SARS-CoV-2 IgG and immunostained mouse brain tissue, and “a diverse set of candidate autoantigens by human phage immunoprecipitation sequencing” in patient 1 and patient 2. In comparison, patient 3 “neither appreciably immunostained nor enriched candidates by human phage immunoprecipitation sequencing,” the researchers said.

“These data motivate a systematic study of humoral immunity in the CSF of pediatric patients with COVID-19 and neuropsychiatric involvement and the potential for immunotherapy in some,” Dr. Bartley and colleagues concluded.
 

Potential of CNS autoimmunity

Evan J. Kyzar, MD, PhD, a resident physician in psychiatry at New York State Psychiatric Institute in New York Presbyterian–Columbia Campus, said in an interview that the results of the case series show some pediatric patients with neuropsychiatric symptoms can have anti-SARS-CoV-2 antibodies after viral clearance.

“Interestingly, some of the patients in this study also had antibodies in the CSF that targeted native proteins, demonstrating that COVID-19 may lead to autoimmunity directed at the brain,” he said. “This study increases our knowledge of how COVID-19 interacts with the nervous system and how autoimmune mechanisms might be contributing to at least a portion of patients with neuropsychiatric symptoms during acute infection, and possibly even after viral clearance.”

Dr. Kyzar noted that the immunological methods in the study were “cutting-edge” and the validation exploring the immune responses was detailed, but was limited because of the small sample size.

“[T]he researchers are using similar techniques to explore psychiatric disorders such as depression and schizophrenia to determine if some patients diagnosed with these conditions may have CNS-targeting autoantibodies that contribute to their symptoms and clinical presentation,” Dr. Kyzar said. “This work has the potential to discover novel neuroimmune mechanisms contributing to neuropsychiatric disease and offer possible pathways for the discovery of new treatments.”

The authors reported financial relationships with Allen & Company, the Chan Zuckerberg Initiative, National Institutes of Health, Novartis, Public Health Company, Roche/Genentech, Sandler Foundation, and Takeda in the form of grants and personal fees. They reported funding and/or support from the Brain Research Foundation, Hanna H. Gray Fellowship, Howard Hughes Medical Institute, John A. Watson Scholar Program, Latinx Center of Excellence, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, President’s Postdoctoral Fellowship Program, and Shared Instrumentation grant. Dr. Kyzar reported no relevant financial disclosures.