MDedge Psychiatry

Most psychiatrists live at or below their means, and more than half have a net worth of less than $1 million, according to the Medscape Psychiatrist Debt and Net Worth Report 2020.

An important caveat, however, is that the data for this year’s report were collected as part of the Medscape Physician Compensation Report 2020, prior to Feb. 11, 2020 – and before COVID-19 was declared a pandemic.

Although it will be some time before medical practices become accustomed to a new version of normal, the data provide an overall picture of the debt load and net worth of psychiatrists.
 

Among the lowest earners

According to the Medscape Psychiatrist Compensation Report 2020, psychiatrists are among the lowest earners of all physicians, earning $268,000 on average this year. However, that’s up somewhat from last year’s earnings of $260,000.

Among psychiatrists, 57% report a net worth (total assets minus total liabilities) of less than $1 million; 38% have a net worth between $1 million and $5 million, and 5% top $5 million in net worth.

Among specialists, orthopedists are most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%), according to the overall Medscape Physician Debt and Net Worth Report 2020. The report is based on more than 17,000 physicians and spans 30 specialties.

By gender, more female than male psychiatrists have a net worth of less than $1 million (61% vs. 53%). The percentages are closer between female and male psychiatrists who have a net worth between $1 million and $5 million, at 36% and 41%, respectively. In addition, more male than female psychiatrists have a net worth above $5 million (6% vs. 3%).

As expected, the older the physician, the more money they have as earnings increase and early-career debt decreases. This is the case for psychiatrists, whose net worth over $1 million increased with age.

However, psychiatrists are among the most likely of all physicians to have a net worth of less than $500,000 (at 37%), which is on par with public health and preventive medicine physicians (also at 37%) and just below family medicine physicians (at 46%), pediatricians (44%), neurologists (41%), and internal medicine physicians (40%).

For nearly two-thirds of psychiatrists (63%), mortgage payments on their primary residence are the major expense; 39% of psychiatrists have a mortgage of $300,000 or less, and 12% have a mortgage topping $500,000; 31% have no mortgage at all. Six in 10 psychiatrists live in a house that is 3,000 sq ft or smaller.

Mortgage aside, other top ongoing expenses for psychiatrists are car payments (38%), school loan payments (28%), credit card debt (26%), and medical expenses for self or loved one (20%). At 28%, psychiatrists are toward the top of the list of all physicians when it comes to those still paying off loans for education.
 

Spending vs. saving

The average American has four credit cards, according to the credit reporting agency Experian. More than half of psychiatrists said they have four or fewer credit cards (35% have three or four credit cards, 20% have one or two cards, and 1% have none). A quarter of psychiatrists (25%) have five or six credit cards, and 19% have seven or more at their disposal.

Only a small percentage of psychiatrists (7%) say they live above their means; 53% live at their means, and 39% live below their means.

Most psychiatrists (62%) contribute $1,000 or more to a tax-deferred retirement or college savings account each month; 13% do not do this on a regular basis. Nearly two-thirds (65%) of psychiatrists contribute to a taxable savings account, a tool many use when tax-deferred contributions have reached their limit.

Nearly half of psychiatrists (47%) rely on a mental budget for personal expenses; 16% rely on a written budget or use software or an app for budgeting; and 37% don’t have a budget for personal expenses.

Three-quarters of psychiatrists did not experience a financial loss in 2019. Of those who did have a loss, the main causes were bad investments (6%) and practice-related problems (6%). Other factors were job loss (self or spouse/partner), real estate loss (4%), legal fees (3%), and divorce (3%).

Among psychiatrists who have joint finances with a spouse or partner, 51% pool their income to pay household expenses. For 14%, the person who earns more pays more of the bills and/or expenses. Only a small percentage divide bills and expenses equally, regardless of how much each makes (5%).

About 43% of psychiatrists currently work with a financial planner or have done so in the past, 40% never did, and 17% met with a financial planner but did not pursue working with that person.

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

Most psychiatrists live at or below their means, and more than half have a net worth of less than $1 million, according to the Medscape Psychiatrist Debt and Net Worth Report 2020.

An important caveat, however, is that the data for this year’s report were collected as part of the Medscape Physician Compensation Report 2020, prior to Feb. 11, 2020 – and before COVID-19 was declared a pandemic.

Although it will be some time before medical practices become accustomed to a new version of normal, the data provide an overall picture of the debt load and net worth of psychiatrists.
 

Among the lowest earners

According to the Medscape Psychiatrist Compensation Report 2020, psychiatrists are among the lowest earners of all physicians, earning $268,000 on average this year. However, that’s up somewhat from last year’s earnings of $260,000.

Among psychiatrists, 57% report a net worth (total assets minus total liabilities) of less than $1 million; 38% have a net worth between $1 million and $5 million, and 5% top $5 million in net worth.

Among specialists, orthopedists are most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%), according to the overall Medscape Physician Debt and Net Worth Report 2020. The report is based on more than 17,000 physicians and spans 30 specialties.

By gender, more female than male psychiatrists have a net worth of less than $1 million (61% vs. 53%). The percentages are closer between female and male psychiatrists who have a net worth between $1 million and $5 million, at 36% and 41%, respectively. In addition, more male than female psychiatrists have a net worth above $5 million (6% vs. 3%).

As expected, the older the physician, the more money they have as earnings increase and early-career debt decreases. This is the case for psychiatrists, whose net worth over $1 million increased with age.

However, psychiatrists are among the most likely of all physicians to have a net worth of less than $500,000 (at 37%), which is on par with public health and preventive medicine physicians (also at 37%) and just below family medicine physicians (at 46%), pediatricians (44%), neurologists (41%), and internal medicine physicians (40%).

For nearly two-thirds of psychiatrists (63%), mortgage payments on their primary residence are the major expense; 39% of psychiatrists have a mortgage of $300,000 or less, and 12% have a mortgage topping $500,000; 31% have no mortgage at all. Six in 10 psychiatrists live in a house that is 3,000 sq ft or smaller.

Mortgage aside, other top ongoing expenses for psychiatrists are car payments (38%), school loan payments (28%), credit card debt (26%), and medical expenses for self or loved one (20%). At 28%, psychiatrists are toward the top of the list of all physicians when it comes to those still paying off loans for education.
 

Spending vs. saving

The average American has four credit cards, according to the credit reporting agency Experian. More than half of psychiatrists said they have four or fewer credit cards (35% have three or four credit cards, 20% have one or two cards, and 1% have none). A quarter of psychiatrists (25%) have five or six credit cards, and 19% have seven or more at their disposal.

Only a small percentage of psychiatrists (7%) say they live above their means; 53% live at their means, and 39% live below their means.

Most psychiatrists (62%) contribute $1,000 or more to a tax-deferred retirement or college savings account each month; 13% do not do this on a regular basis. Nearly two-thirds (65%) of psychiatrists contribute to a taxable savings account, a tool many use when tax-deferred contributions have reached their limit.

Nearly half of psychiatrists (47%) rely on a mental budget for personal expenses; 16% rely on a written budget or use software or an app for budgeting; and 37% don’t have a budget for personal expenses.

Three-quarters of psychiatrists did not experience a financial loss in 2019. Of those who did have a loss, the main causes were bad investments (6%) and practice-related problems (6%). Other factors were job loss (self or spouse/partner), real estate loss (4%), legal fees (3%), and divorce (3%).

Among psychiatrists who have joint finances with a spouse or partner, 51% pool their income to pay household expenses. For 14%, the person who earns more pays more of the bills and/or expenses. Only a small percentage divide bills and expenses equally, regardless of how much each makes (5%).

About 43% of psychiatrists currently work with a financial planner or have done so in the past, 40% never did, and 17% met with a financial planner but did not pursue working with that person.

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

Most psychiatrists live at or below their means, and more than half have a net worth of less than $1 million, according to the Medscape Psychiatrist Debt and Net Worth Report 2020.

An important caveat, however, is that the data for this year’s report were collected as part of the Medscape Physician Compensation Report 2020, prior to Feb. 11, 2020 – and before COVID-19 was declared a pandemic.

Although it will be some time before medical practices become accustomed to a new version of normal, the data provide an overall picture of the debt load and net worth of psychiatrists.
 

Among the lowest earners

According to the Medscape Psychiatrist Compensation Report 2020, psychiatrists are among the lowest earners of all physicians, earning $268,000 on average this year. However, that’s up somewhat from last year’s earnings of $260,000.

Among psychiatrists, 57% report a net worth (total assets minus total liabilities) of less than $1 million; 38% have a net worth between $1 million and $5 million, and 5% top $5 million in net worth.

Among specialists, orthopedists are most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%), according to the overall Medscape Physician Debt and Net Worth Report 2020. The report is based on more than 17,000 physicians and spans 30 specialties.

By gender, more female than male psychiatrists have a net worth of less than $1 million (61% vs. 53%). The percentages are closer between female and male psychiatrists who have a net worth between $1 million and $5 million, at 36% and 41%, respectively. In addition, more male than female psychiatrists have a net worth above $5 million (6% vs. 3%).

As expected, the older the physician, the more money they have as earnings increase and early-career debt decreases. This is the case for psychiatrists, whose net worth over $1 million increased with age.

However, psychiatrists are among the most likely of all physicians to have a net worth of less than $500,000 (at 37%), which is on par with public health and preventive medicine physicians (also at 37%) and just below family medicine physicians (at 46%), pediatricians (44%), neurologists (41%), and internal medicine physicians (40%).

For nearly two-thirds of psychiatrists (63%), mortgage payments on their primary residence are the major expense; 39% of psychiatrists have a mortgage of $300,000 or less, and 12% have a mortgage topping $500,000; 31% have no mortgage at all. Six in 10 psychiatrists live in a house that is 3,000 sq ft or smaller.

Mortgage aside, other top ongoing expenses for psychiatrists are car payments (38%), school loan payments (28%), credit card debt (26%), and medical expenses for self or loved one (20%). At 28%, psychiatrists are toward the top of the list of all physicians when it comes to those still paying off loans for education.
 

Spending vs. saving

The average American has four credit cards, according to the credit reporting agency Experian. More than half of psychiatrists said they have four or fewer credit cards (35% have three or four credit cards, 20% have one or two cards, and 1% have none). A quarter of psychiatrists (25%) have five or six credit cards, and 19% have seven or more at their disposal.

Only a small percentage of psychiatrists (7%) say they live above their means; 53% live at their means, and 39% live below their means.

Most psychiatrists (62%) contribute $1,000 or more to a tax-deferred retirement or college savings account each month; 13% do not do this on a regular basis. Nearly two-thirds (65%) of psychiatrists contribute to a taxable savings account, a tool many use when tax-deferred contributions have reached their limit.

Nearly half of psychiatrists (47%) rely on a mental budget for personal expenses; 16% rely on a written budget or use software or an app for budgeting; and 37% don’t have a budget for personal expenses.

Three-quarters of psychiatrists did not experience a financial loss in 2019. Of those who did have a loss, the main causes were bad investments (6%) and practice-related problems (6%). Other factors were job loss (self or spouse/partner), real estate loss (4%), legal fees (3%), and divorce (3%).

Among psychiatrists who have joint finances with a spouse or partner, 51% pool their income to pay household expenses. For 14%, the person who earns more pays more of the bills and/or expenses. Only a small percentage divide bills and expenses equally, regardless of how much each makes (5%).

About 43% of psychiatrists currently work with a financial planner or have done so in the past, 40% never did, and 17% met with a financial planner but did not pursue working with that person.

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

An elderly, retired, married African American man sought psychiatric treatment for depression and suicidal thoughts. He had a detailed, lethal suicide plan, but he had not taken any steps to carry it out.

He met DSM-5 criteria for a major depressive episode, and he described a lifelong history of recurrent depressions as well as hypomanic episodes. He was diagnosed with bipolar II disorder, and he began weekly therapy, as well as medication. Despite several static and dynamic suicide risk factors, the psychiatrist also noted that he was help seeking and future oriented. He seemed transparent during his initial appointments. He did not have access to lethal means and welcomed the psychiatrist to communicate openly with his spouse.

The patient had never attempted suicide, there was no family history of suicide, and there was no psychosis or substance use disorder present. He was able to commit to reaching out to the psychiatrist, his spouse, or emergency personnel in the case of worsening suicidal thoughts or imminent suicidal action. He remained in the outpatient setting. His suicidal ideation faded and depression receded as psychotherapy and pharmacotherapy continued.

Discussion

Depression and suicidal ideation are ubiquitous in the practice of psychiatry. Psychiatrists draw from an array of assessment and management tools when this common clinical challenge arises. Among these tools is the no-suicide contract (NSC). The NSC goes by many names, including the no-harm contract and suicide prevention contract.¹ It is a promise, verbal or written, from the patient to not attempt suicide and to tell a loved one or psychiatric provider instead.² The verbal exchange between the patient and therapist described in the case fits the widely accepted clinical definition of an NSC. The contents and implementation of NSCs vary greatly; no standard approach is taught in psychiatric training.³ The American Psychiatric Association has warned against over-reliance on them, emphasizing that they have not been proven effective. It advises that NSCs should not be used independently of other tools or outside well-established patient-provider relationships.⁴ A 2007 review of the literature on NSCs concluded that there were no data to support their effectiveness and some data that they might even cause harm.⁵

The origin of the NSC

The NSC is fairly young and its foundation arguably weak. Its evolution has been traced back to a study published in 1973 by Robert C. Drye, MD, and associates on the effectiveness of a questionnaire for the assessment of suicide risk.⁶ The questionnaire centered on the patient’s reaction to the statement, “No matter what happens, I will not kill myself, accidently or on purpose, at any time.” The authors placed special emphasis on the words “I will,” which they felt to be a stronger indicator of commitment to safety than “I promise.” The authors thought the latter statement sounded like a child’s empty reply to a demanding parent. The authors reported a 100% success rate with “approximately 600 patients” across geographic regions and clinical settings.⁷ The study group is not further described, and that the authors contend that the intervention had “complete effectiveness in evaluating suicide risk” should give pause to anyone aiming to practice evidence-based psychiatry.

The theoretical basis of the NSC has been presumed by others to be based, in part, on the principles of transactional analysis. Specifically, the suicidal patient is seen as occupying the child ego state, and the NSC is seen as a means of moving the patient into the less problematic adult ego state. It has been argued, however, that an NSC can achieve exactly the opposite. The contract can pit the patient against the clinician, entrenching the patient deeper into the child ego and, therefore, suicidal state.⁸

Michael Craig Miller, MD, and associates proposed other psychological reasons why NSCs may be counterproductive. They write, “Psychological pitfalls abound, and any of them may contribute to a contract being thoughtless, unrealistic, irrelevant, cynical, punitive, or coercive.”⁹ They postulated that the NSC grew out of and assumes the same shared decision-making inherent in any therapeutic contract – and they argue that this assumption is flawed given the legal power clinicians have over suicidal patients. While acknowledging this problematic power differential, the authors go on to urge clinicians to aim for shared decision-making and a shared burden of risk when discussing treatment with suicidal patients.

Possible NSC common factors

Psychiatry, like the rest of medicine, is increasingly practiced in an evidence-based manner. The NSC should not be excluded from this movement. To this end, a recently published, randomized study of 97 active duty Army personnel seeking emergency behavioral health evaluation compared the effectiveness of NSCs and with an alternative intervention, the crisis response plan (CRP). The CRP was chosen because it had been suggested by the Joint Commision as an alternative to the NSC, although it also has little evidence supporting its use.¹⁰

The NSC and CRP interventions of the Army study were very similar. Both included suicide risk assessment, supportive listening, provision of crisis resources, and referral to treatment. In addition, the NSC intervention included asking whether the patients could keep themselves safe at home. The CRP intervention included collaboration with the patient to identify warning signs of crisis, self-management skills, and support persons. A seemingly small but interesting difference between the two interventions was which member of the dyad, patient or clinician, created a written record of the discussion. In the NSC group, the assessor did the writing, while in the CRP group, the patient controlled the pen.

The results of the study were intriguing. Suicidal ideation declined faster in the CRP arm. Participants in the CRP arm were 76% less likely to attempt suicide over 6 months, although this effect decreased and lost statistical significance when controlling for baseline severity of suicidal ideation. Despite those promising data, the only completed suicide was in the CRP arm.

The authors compared the makeup of the CRP intervention with key components of dialectical behavior therapy (DBT). They pointed to a 2015 study by Marsha Linehan, PhD, and associates that sought to identify the active ingredients of DBT. The Linehan study indicated that attending to warning signs and using self-management tools and social supports contributed more to the success of DBT than the individual therapy component. Interestingly, these were the same features that set the CRP intervention apart from the NSC in the Army study. Perhaps these are the common factors of effective counseling of suicidal patients.

Indeed, these factors seem to harken back to the NSC as originally envisioned by the late Dr. Drye – a patient-driven collaboration. Dr. Drye and associates wrote: “This approach developed out of our belief that the only therapeutic contracts likely to lead to change are those developed by the patient himself, for which he will assume responsibility.” While the data presented by Dr. Drye and associates were weak, the theory behind their NSC – patient commitment – seems solid. Commitment strategies, which grew out of social psychology, are effective and heavily used in DBT, including to decrease suicidal behaviors.¹¹

Conclusion

Suicidologist Shawn Christopher Shea, MD, argues that the answer to whether or not NSCs can work is conditional on the unique combination of patient, clinician, and therapeutic relationship at play. He considers the limited data available and has warned against resolutely assuming either a pro- or anti-NSC stance. He postulates that NSCs might have the best chance at saving a life in the context of ongoing therapy with a patient with mature defenses, while in other contexts, such as with a patient with borderline personality disorder, it might prove counterproductive. Importantly, he wrote, “there is not a shred of empirical evidence that safety contracting has not been a deterrent with specific clients in the hands of specific clinicians.”

Dr. Shea describes various ways of maximizing the utility of the NSC. First, he describes that NSCs may be more effective as safety assessment tools (paying attention to both verbal and nonverbal cues) than tools to directly deter attempts. Second, NSCs may have increased utility when repeated across time to provide an understanding for how the patient typically engages in contracting. Soliciting a patient’s reasons for living also can enhance a contract’s usefulness because patients with suicidal ideation weigh reasons for living against reasons for dying in their decision-making. Finally, the sound documentation of the process of contracting not only protects against subsequent legal action but also improves the quality of the clinical care, in part by entraining the psychiatrist to incorporate key elements into the contracting process.

Returning to the clinical case, the strengths and weakness of that NSC can now be evaluated. Looking at the NSC through the eyes of Dr. Shea, the young therapeutic relationship diminishes the value of the NSC, while the relationship’s ongoing basis and the patient’s mature defenses bolster it. Dr. Shea would encourage the psychiatrist to use the NSC as an assessment tool, including assessment of ambivalence. In this case, the patient’s ambivalence about suicide comes through, but it could have been explored and expanded through explicit discussion of reasons for living. Applying the lens of Dr. Linehan, the contract is strengthened by the attention paid to social supports, while it would have been improved by specific discussion about warning signs and self-management tools.

In line with Dr. Drye’s original vision of the NSC, the degree to which the patient owns the NSC seems to be particularly crucial. In this case, the patient’s ownership of the no-suicide decision was suggested by his transparency during interview and full engagement in contracting, including identification of crisis resources. Still, the patient could have been encouraged to take additional responsibility for the NSC. One means of transferring responsibility to the patient could have been giving the patient a pen to create a written record of the contract, mobilizing and symbolizing the patient’s greater control of the process and outcome. Finally, and of utmost importance, it should be reiterated that the NSC should be only part of the assessment and planning that a psychiatrist does with a suicidal patient. While there are circumstances and strategies that augment its utility, it should not be overly relied on.
 

References

1. Weiss A. Am J Psychother. 2001;55(3):414-9.

2. Kroll J. Am J Psychiatry. 2000;157(10):1684-6.

3. Shea SC. The Practical Art of Suicide Assessment: A Guide for Mental Health Professionals and Substance Abuse Counselors. Hoboken, N.J.: John Wiley & Sons, 2011.

4. Jacobs DG et al. Practice guideline for the assessment and treatment of patients with suicidal behavior. American Psychiatric Association, 2003 Nov.

5. Lewis LM. Suicide Life Threat Behav. 2007;37(1):50-7.

6. Goin M. Psychiatr News. 2003 Jul 18;38(14):3-38.

7. Drye RC et al. Am J Psychiatry. 1973;130(2):171-4.

8. Farrow TL. J Psychiatr Ment Health Nurs. 2003 Apr;10(2):199-202.

9. Miller MC et al. Harv Rev Psychiatry. 1998;6(2):78-87.

10. Bryan CJ et al. J Affect Disord. 2017 Apr;212:64-72.

11. Pederson LD. Dialectical Behavior Therapy: A Contemporary Guide for Practitioners. Hoboken, N.J.: John Wiley & Sons, 2015.
 

Dr. Roberts is a board-certified psychiatrist in Northern Virginia, working in both the partial hospital and outpatient settings. She has a special interest in working with patients with serious mental illness and believes in the recovery model of care, in which each patient’s life goals become the focal point of their treatment. Dr. Roberts completed her psychiatry residency at George Washington University, in Washington, where she also served as the 2018-2019 chief outpatient resident. She is a native of Minnesota and earned her medical degree from the University of Minnesota, Minneapolis, in 2015. Dr. Roberts has no disclosures.




 

An elderly, retired, married African American man sought psychiatric treatment for depression and suicidal thoughts. He had a detailed, lethal suicide plan, but he had not taken any steps to carry it out.

He met DSM-5 criteria for a major depressive episode, and he described a lifelong history of recurrent depressions as well as hypomanic episodes. He was diagnosed with bipolar II disorder, and he began weekly therapy, as well as medication. Despite several static and dynamic suicide risk factors, the psychiatrist also noted that he was help seeking and future oriented. He seemed transparent during his initial appointments. He did not have access to lethal means and welcomed the psychiatrist to communicate openly with his spouse.

The patient had never attempted suicide, there was no family history of suicide, and there was no psychosis or substance use disorder present. He was able to commit to reaching out to the psychiatrist, his spouse, or emergency personnel in the case of worsening suicidal thoughts or imminent suicidal action. He remained in the outpatient setting. His suicidal ideation faded and depression receded as psychotherapy and pharmacotherapy continued.

Discussion

Depression and suicidal ideation are ubiquitous in the practice of psychiatry. Psychiatrists draw from an array of assessment and management tools when this common clinical challenge arises. Among these tools is the no-suicide contract (NSC). The NSC goes by many names, including the no-harm contract and suicide prevention contract.¹ It is a promise, verbal or written, from the patient to not attempt suicide and to tell a loved one or psychiatric provider instead.² The verbal exchange between the patient and therapist described in the case fits the widely accepted clinical definition of an NSC. The contents and implementation of NSCs vary greatly; no standard approach is taught in psychiatric training.³ The American Psychiatric Association has warned against over-reliance on them, emphasizing that they have not been proven effective. It advises that NSCs should not be used independently of other tools or outside well-established patient-provider relationships.⁴ A 2007 review of the literature on NSCs concluded that there were no data to support their effectiveness and some data that they might even cause harm.⁵

The origin of the NSC

The NSC is fairly young and its foundation arguably weak. Its evolution has been traced back to a study published in 1973 by Robert C. Drye, MD, and associates on the effectiveness of a questionnaire for the assessment of suicide risk.⁶ The questionnaire centered on the patient’s reaction to the statement, “No matter what happens, I will not kill myself, accidently or on purpose, at any time.” The authors placed special emphasis on the words “I will,” which they felt to be a stronger indicator of commitment to safety than “I promise.” The authors thought the latter statement sounded like a child’s empty reply to a demanding parent. The authors reported a 100% success rate with “approximately 600 patients” across geographic regions and clinical settings.⁷ The study group is not further described, and that the authors contend that the intervention had “complete effectiveness in evaluating suicide risk” should give pause to anyone aiming to practice evidence-based psychiatry.

The theoretical basis of the NSC has been presumed by others to be based, in part, on the principles of transactional analysis. Specifically, the suicidal patient is seen as occupying the child ego state, and the NSC is seen as a means of moving the patient into the less problematic adult ego state. It has been argued, however, that an NSC can achieve exactly the opposite. The contract can pit the patient against the clinician, entrenching the patient deeper into the child ego and, therefore, suicidal state.⁸

Michael Craig Miller, MD, and associates proposed other psychological reasons why NSCs may be counterproductive. They write, “Psychological pitfalls abound, and any of them may contribute to a contract being thoughtless, unrealistic, irrelevant, cynical, punitive, or coercive.”⁹ They postulated that the NSC grew out of and assumes the same shared decision-making inherent in any therapeutic contract – and they argue that this assumption is flawed given the legal power clinicians have over suicidal patients. While acknowledging this problematic power differential, the authors go on to urge clinicians to aim for shared decision-making and a shared burden of risk when discussing treatment with suicidal patients.

Possible NSC common factors

Psychiatry, like the rest of medicine, is increasingly practiced in an evidence-based manner. The NSC should not be excluded from this movement. To this end, a recently published, randomized study of 97 active duty Army personnel seeking emergency behavioral health evaluation compared the effectiveness of NSCs and with an alternative intervention, the crisis response plan (CRP). The CRP was chosen because it had been suggested by the Joint Commision as an alternative to the NSC, although it also has little evidence supporting its use.¹⁰

The NSC and CRP interventions of the Army study were very similar. Both included suicide risk assessment, supportive listening, provision of crisis resources, and referral to treatment. In addition, the NSC intervention included asking whether the patients could keep themselves safe at home. The CRP intervention included collaboration with the patient to identify warning signs of crisis, self-management skills, and support persons. A seemingly small but interesting difference between the two interventions was which member of the dyad, patient or clinician, created a written record of the discussion. In the NSC group, the assessor did the writing, while in the CRP group, the patient controlled the pen.

The results of the study were intriguing. Suicidal ideation declined faster in the CRP arm. Participants in the CRP arm were 76% less likely to attempt suicide over 6 months, although this effect decreased and lost statistical significance when controlling for baseline severity of suicidal ideation. Despite those promising data, the only completed suicide was in the CRP arm.

The authors compared the makeup of the CRP intervention with key components of dialectical behavior therapy (DBT). They pointed to a 2015 study by Marsha Linehan, PhD, and associates that sought to identify the active ingredients of DBT. The Linehan study indicated that attending to warning signs and using self-management tools and social supports contributed more to the success of DBT than the individual therapy component. Interestingly, these were the same features that set the CRP intervention apart from the NSC in the Army study. Perhaps these are the common factors of effective counseling of suicidal patients.

Indeed, these factors seem to harken back to the NSC as originally envisioned by the late Dr. Drye – a patient-driven collaboration. Dr. Drye and associates wrote: “This approach developed out of our belief that the only therapeutic contracts likely to lead to change are those developed by the patient himself, for which he will assume responsibility.” While the data presented by Dr. Drye and associates were weak, the theory behind their NSC – patient commitment – seems solid. Commitment strategies, which grew out of social psychology, are effective and heavily used in DBT, including to decrease suicidal behaviors.¹¹

Conclusion

Suicidologist Shawn Christopher Shea, MD, argues that the answer to whether or not NSCs can work is conditional on the unique combination of patient, clinician, and therapeutic relationship at play. He considers the limited data available and has warned against resolutely assuming either a pro- or anti-NSC stance. He postulates that NSCs might have the best chance at saving a life in the context of ongoing therapy with a patient with mature defenses, while in other contexts, such as with a patient with borderline personality disorder, it might prove counterproductive. Importantly, he wrote, “there is not a shred of empirical evidence that safety contracting has not been a deterrent with specific clients in the hands of specific clinicians.”

Dr. Shea describes various ways of maximizing the utility of the NSC. First, he describes that NSCs may be more effective as safety assessment tools (paying attention to both verbal and nonverbal cues) than tools to directly deter attempts. Second, NSCs may have increased utility when repeated across time to provide an understanding for how the patient typically engages in contracting. Soliciting a patient’s reasons for living also can enhance a contract’s usefulness because patients with suicidal ideation weigh reasons for living against reasons for dying in their decision-making. Finally, the sound documentation of the process of contracting not only protects against subsequent legal action but also improves the quality of the clinical care, in part by entraining the psychiatrist to incorporate key elements into the contracting process.

Returning to the clinical case, the strengths and weakness of that NSC can now be evaluated. Looking at the NSC through the eyes of Dr. Shea, the young therapeutic relationship diminishes the value of the NSC, while the relationship’s ongoing basis and the patient’s mature defenses bolster it. Dr. Shea would encourage the psychiatrist to use the NSC as an assessment tool, including assessment of ambivalence. In this case, the patient’s ambivalence about suicide comes through, but it could have been explored and expanded through explicit discussion of reasons for living. Applying the lens of Dr. Linehan, the contract is strengthened by the attention paid to social supports, while it would have been improved by specific discussion about warning signs and self-management tools.

In line with Dr. Drye’s original vision of the NSC, the degree to which the patient owns the NSC seems to be particularly crucial. In this case, the patient’s ownership of the no-suicide decision was suggested by his transparency during interview and full engagement in contracting, including identification of crisis resources. Still, the patient could have been encouraged to take additional responsibility for the NSC. One means of transferring responsibility to the patient could have been giving the patient a pen to create a written record of the contract, mobilizing and symbolizing the patient’s greater control of the process and outcome. Finally, and of utmost importance, it should be reiterated that the NSC should be only part of the assessment and planning that a psychiatrist does with a suicidal patient. While there are circumstances and strategies that augment its utility, it should not be overly relied on.
 

References

1. Weiss A. Am J Psychother. 2001;55(3):414-9.

2. Kroll J. Am J Psychiatry. 2000;157(10):1684-6.

3. Shea SC. The Practical Art of Suicide Assessment: A Guide for Mental Health Professionals and Substance Abuse Counselors. Hoboken, N.J.: John Wiley & Sons, 2011.

4. Jacobs DG et al. Practice guideline for the assessment and treatment of patients with suicidal behavior. American Psychiatric Association, 2003 Nov.

5. Lewis LM. Suicide Life Threat Behav. 2007;37(1):50-7.

6. Goin M. Psychiatr News. 2003 Jul 18;38(14):3-38.

7. Drye RC et al. Am J Psychiatry. 1973;130(2):171-4.

8. Farrow TL. J Psychiatr Ment Health Nurs. 2003 Apr;10(2):199-202.

9. Miller MC et al. Harv Rev Psychiatry. 1998;6(2):78-87.

10. Bryan CJ et al. J Affect Disord. 2017 Apr;212:64-72.

11. Pederson LD. Dialectical Behavior Therapy: A Contemporary Guide for Practitioners. Hoboken, N.J.: John Wiley & Sons, 2015.
 

Dr. Roberts is a board-certified psychiatrist in Northern Virginia, working in both the partial hospital and outpatient settings. She has a special interest in working with patients with serious mental illness and believes in the recovery model of care, in which each patient’s life goals become the focal point of their treatment. Dr. Roberts completed her psychiatry residency at George Washington University, in Washington, where she also served as the 2018-2019 chief outpatient resident. She is a native of Minnesota and earned her medical degree from the University of Minnesota, Minneapolis, in 2015. Dr. Roberts has no disclosures.




 

An elderly, retired, married African American man sought psychiatric treatment for depression and suicidal thoughts. He had a detailed, lethal suicide plan, but he had not taken any steps to carry it out.

He met DSM-5 criteria for a major depressive episode, and he described a lifelong history of recurrent depressions as well as hypomanic episodes. He was diagnosed with bipolar II disorder, and he began weekly therapy, as well as medication. Despite several static and dynamic suicide risk factors, the psychiatrist also noted that he was help seeking and future oriented. He seemed transparent during his initial appointments. He did not have access to lethal means and welcomed the psychiatrist to communicate openly with his spouse.

The patient had never attempted suicide, there was no family history of suicide, and there was no psychosis or substance use disorder present. He was able to commit to reaching out to the psychiatrist, his spouse, or emergency personnel in the case of worsening suicidal thoughts or imminent suicidal action. He remained in the outpatient setting. His suicidal ideation faded and depression receded as psychotherapy and pharmacotherapy continued.

Discussion

Depression and suicidal ideation are ubiquitous in the practice of psychiatry. Psychiatrists draw from an array of assessment and management tools when this common clinical challenge arises. Among these tools is the no-suicide contract (NSC). The NSC goes by many names, including the no-harm contract and suicide prevention contract.¹ It is a promise, verbal or written, from the patient to not attempt suicide and to tell a loved one or psychiatric provider instead.² The verbal exchange between the patient and therapist described in the case fits the widely accepted clinical definition of an NSC. The contents and implementation of NSCs vary greatly; no standard approach is taught in psychiatric training.³ The American Psychiatric Association has warned against over-reliance on them, emphasizing that they have not been proven effective. It advises that NSCs should not be used independently of other tools or outside well-established patient-provider relationships.⁴ A 2007 review of the literature on NSCs concluded that there were no data to support their effectiveness and some data that they might even cause harm.⁵

The origin of the NSC

The NSC is fairly young and its foundation arguably weak. Its evolution has been traced back to a study published in 1973 by Robert C. Drye, MD, and associates on the effectiveness of a questionnaire for the assessment of suicide risk.⁶ The questionnaire centered on the patient’s reaction to the statement, “No matter what happens, I will not kill myself, accidently or on purpose, at any time.” The authors placed special emphasis on the words “I will,” which they felt to be a stronger indicator of commitment to safety than “I promise.” The authors thought the latter statement sounded like a child’s empty reply to a demanding parent. The authors reported a 100% success rate with “approximately 600 patients” across geographic regions and clinical settings.⁷ The study group is not further described, and that the authors contend that the intervention had “complete effectiveness in evaluating suicide risk” should give pause to anyone aiming to practice evidence-based psychiatry.

The theoretical basis of the NSC has been presumed by others to be based, in part, on the principles of transactional analysis. Specifically, the suicidal patient is seen as occupying the child ego state, and the NSC is seen as a means of moving the patient into the less problematic adult ego state. It has been argued, however, that an NSC can achieve exactly the opposite. The contract can pit the patient against the clinician, entrenching the patient deeper into the child ego and, therefore, suicidal state.⁸

Michael Craig Miller, MD, and associates proposed other psychological reasons why NSCs may be counterproductive. They write, “Psychological pitfalls abound, and any of them may contribute to a contract being thoughtless, unrealistic, irrelevant, cynical, punitive, or coercive.”⁹ They postulated that the NSC grew out of and assumes the same shared decision-making inherent in any therapeutic contract – and they argue that this assumption is flawed given the legal power clinicians have over suicidal patients. While acknowledging this problematic power differential, the authors go on to urge clinicians to aim for shared decision-making and a shared burden of risk when discussing treatment with suicidal patients.

Possible NSC common factors

Psychiatry, like the rest of medicine, is increasingly practiced in an evidence-based manner. The NSC should not be excluded from this movement. To this end, a recently published, randomized study of 97 active duty Army personnel seeking emergency behavioral health evaluation compared the effectiveness of NSCs and with an alternative intervention, the crisis response plan (CRP). The CRP was chosen because it had been suggested by the Joint Commision as an alternative to the NSC, although it also has little evidence supporting its use.¹⁰

The NSC and CRP interventions of the Army study were very similar. Both included suicide risk assessment, supportive listening, provision of crisis resources, and referral to treatment. In addition, the NSC intervention included asking whether the patients could keep themselves safe at home. The CRP intervention included collaboration with the patient to identify warning signs of crisis, self-management skills, and support persons. A seemingly small but interesting difference between the two interventions was which member of the dyad, patient or clinician, created a written record of the discussion. In the NSC group, the assessor did the writing, while in the CRP group, the patient controlled the pen.

The results of the study were intriguing. Suicidal ideation declined faster in the CRP arm. Participants in the CRP arm were 76% less likely to attempt suicide over 6 months, although this effect decreased and lost statistical significance when controlling for baseline severity of suicidal ideation. Despite those promising data, the only completed suicide was in the CRP arm.

The authors compared the makeup of the CRP intervention with key components of dialectical behavior therapy (DBT). They pointed to a 2015 study by Marsha Linehan, PhD, and associates that sought to identify the active ingredients of DBT. The Linehan study indicated that attending to warning signs and using self-management tools and social supports contributed more to the success of DBT than the individual therapy component. Interestingly, these were the same features that set the CRP intervention apart from the NSC in the Army study. Perhaps these are the common factors of effective counseling of suicidal patients.

Indeed, these factors seem to harken back to the NSC as originally envisioned by the late Dr. Drye – a patient-driven collaboration. Dr. Drye and associates wrote: “This approach developed out of our belief that the only therapeutic contracts likely to lead to change are those developed by the patient himself, for which he will assume responsibility.” While the data presented by Dr. Drye and associates were weak, the theory behind their NSC – patient commitment – seems solid. Commitment strategies, which grew out of social psychology, are effective and heavily used in DBT, including to decrease suicidal behaviors.¹¹

Conclusion

Suicidologist Shawn Christopher Shea, MD, argues that the answer to whether or not NSCs can work is conditional on the unique combination of patient, clinician, and therapeutic relationship at play. He considers the limited data available and has warned against resolutely assuming either a pro- or anti-NSC stance. He postulates that NSCs might have the best chance at saving a life in the context of ongoing therapy with a patient with mature defenses, while in other contexts, such as with a patient with borderline personality disorder, it might prove counterproductive. Importantly, he wrote, “there is not a shred of empirical evidence that safety contracting has not been a deterrent with specific clients in the hands of specific clinicians.”

Dr. Shea describes various ways of maximizing the utility of the NSC. First, he describes that NSCs may be more effective as safety assessment tools (paying attention to both verbal and nonverbal cues) than tools to directly deter attempts. Second, NSCs may have increased utility when repeated across time to provide an understanding for how the patient typically engages in contracting. Soliciting a patient’s reasons for living also can enhance a contract’s usefulness because patients with suicidal ideation weigh reasons for living against reasons for dying in their decision-making. Finally, the sound documentation of the process of contracting not only protects against subsequent legal action but also improves the quality of the clinical care, in part by entraining the psychiatrist to incorporate key elements into the contracting process.

Returning to the clinical case, the strengths and weakness of that NSC can now be evaluated. Looking at the NSC through the eyes of Dr. Shea, the young therapeutic relationship diminishes the value of the NSC, while the relationship’s ongoing basis and the patient’s mature defenses bolster it. Dr. Shea would encourage the psychiatrist to use the NSC as an assessment tool, including assessment of ambivalence. In this case, the patient’s ambivalence about suicide comes through, but it could have been explored and expanded through explicit discussion of reasons for living. Applying the lens of Dr. Linehan, the contract is strengthened by the attention paid to social supports, while it would have been improved by specific discussion about warning signs and self-management tools.

In line with Dr. Drye’s original vision of the NSC, the degree to which the patient owns the NSC seems to be particularly crucial. In this case, the patient’s ownership of the no-suicide decision was suggested by his transparency during interview and full engagement in contracting, including identification of crisis resources. Still, the patient could have been encouraged to take additional responsibility for the NSC. One means of transferring responsibility to the patient could have been giving the patient a pen to create a written record of the contract, mobilizing and symbolizing the patient’s greater control of the process and outcome. Finally, and of utmost importance, it should be reiterated that the NSC should be only part of the assessment and planning that a psychiatrist does with a suicidal patient. While there are circumstances and strategies that augment its utility, it should not be overly relied on.
 

References

1. Weiss A. Am J Psychother. 2001;55(3):414-9.

2. Kroll J. Am J Psychiatry. 2000;157(10):1684-6.

3. Shea SC. The Practical Art of Suicide Assessment: A Guide for Mental Health Professionals and Substance Abuse Counselors. Hoboken, N.J.: John Wiley & Sons, 2011.

4. Jacobs DG et al. Practice guideline for the assessment and treatment of patients with suicidal behavior. American Psychiatric Association, 2003 Nov.

5. Lewis LM. Suicide Life Threat Behav. 2007;37(1):50-7.

6. Goin M. Psychiatr News. 2003 Jul 18;38(14):3-38.

7. Drye RC et al. Am J Psychiatry. 1973;130(2):171-4.

8. Farrow TL. J Psychiatr Ment Health Nurs. 2003 Apr;10(2):199-202.

9. Miller MC et al. Harv Rev Psychiatry. 1998;6(2):78-87.

10. Bryan CJ et al. J Affect Disord. 2017 Apr;212:64-72.

11. Pederson LD. Dialectical Behavior Therapy: A Contemporary Guide for Practitioners. Hoboken, N.J.: John Wiley & Sons, 2015.
 

Dr. Roberts is a board-certified psychiatrist in Northern Virginia, working in both the partial hospital and outpatient settings. She has a special interest in working with patients with serious mental illness and believes in the recovery model of care, in which each patient’s life goals become the focal point of their treatment. Dr. Roberts completed her psychiatry residency at George Washington University, in Washington, where she also served as the 2018-2019 chief outpatient resident. She is a native of Minnesota and earned her medical degree from the University of Minnesota, Minneapolis, in 2015. Dr. Roberts has no disclosures.




 

The 2012 crime fiction novel, “Defending Jacob,” by William Landay was dramatized into a miniseries created by Mark Bomback that premiered on April 24, 2020, on Apple TV+ (and for those resisting a subscription, “The Morning Show” and “Defending Jacob” are both worth it). Both the “Defending Jacob” novel and the miniseries have themes that are of interest to psychiatry, especially to child and forensic psychiatrists, and both the literary and TV versions are excellent, albeit disturbing, diversions from the current pandemic.

doomu/Thinkstock

(Spoiler alert!) The story is set in the affluent town of Newton, Mass., where crime is generally low and homicides extremely infrequent. Protagonist Andy Barber, a 51-year-old Jewish assistant district attorney, is played by a younger Chris Evans in the miniseries. His wife, Laurie Gold Barber, a 51-year-old Jewish former schoolteacher and stay-at-home mom, is played by a younger Michelle Dockery of Downton Abbey fame. In the miniseries, her character is actively working as a teacher and social activist for children. Other differences between the novel and the miniseries will be pointed out when relevant, but the overall narrative is similar. Both stories are cleverly told through Andy Barber speaking in retrospect as he is being questioned in front of a grand jury for a potential indictment.

When 14-year-old Ben Rifkin is found stabbed to death in Cold Spring Park before school one morning, Andy Barber initially takes the case despite his boss’s reservations that there may be a conflict because Andy’s son Jacob is a student in Ben’s class at school. As the title suggests, it soon becomes clear that Jacob may have had something to do with the murder. At that point, Andy is taken off the case and it is given to a junior colleague, Neal Logiudice, who demonstrates both admiration and contempt for his former mentor, perhaps because of underlying jealousy and insecurity. Neal Logiudice becomes the DA questioning Andy Barber.

Prior to Jacob’s formal accusation of murder, the Barbers appear to be fiercely loyal and unable to fully see and understand their son. The difficulty with objectivity and the reasons why family member physicians should never treat family members – and why family member attorneys should never represent loved ones – is abundantly clear in this story. When Andy receives an anonymous tip that Jacob’s childhood best friend, Derek Yoo, posted on Facebook, “Jake, everyone knows you did it. You have a knife. I’ve seen it,’ ” Andy then looks through Jacob’s drawers and finds a folding knife in one of his T-shirts. In the chapter aptly titled “Denial,” Andy, an experienced prosecutor, does not turn the knife over as evidence, but instead disposes of it – believing Jacob that he did not take the knife to school the day his classmate was stabbed.

After Jacob is indicted, Andy Barber confesses to his wife, Laurie, that his estranged father who left when he was 6 is actually in prison convicted of murdering and raping a woman. In the novel, his grandfather and great-grandfather are also convicted felons. Laurie reveals this family history to Jacob’s attorney, and the attorney subsequently refers the family to a forensic psychologist. In the novel, she is a large Jewish woman; in the miniseries she is played by a very thin Poorna Jagannathan (who incidentally has portrayed a therapist in the television series “Sorry for your Loss,” and a doctor in “The Act,” “Better Call Saul,” “NCIS: Los Angeles,” “House of Cards,” “The Game,” “Law and Order: Criminal Intent,” “Rescue Me,” “Jonny Zero,” “An Actor Prepares,” “The Circle,” “Thanks for Sharing,” and “Montclair.”) Although the goal of the defense was a finding of “not guilty,” a psychiatric defense was going to be used as a last resort if necessary.

Laurie had already googled and learned of “the murder gene,” which was further explained by the forensic psychologist as a mutation called:
 

“MAOA Knockout. It has been argued in court as a trigger for violence before, but the argument was too simplistic, and it was rejected. Our understanding of the gene-environment interplay has improved since then – the science is getting better and very quickly – and we may have better testimony now. The second mutation is located in what’s called the serotonin transporter gene. The official name for the gene is SLC6A4. It’s located on chromosome 17. It encodes a protein that facilitates the activity of the serotonin transporter system, which is what enables the reuptake of serotonin from the synapse back into the neuron.”1

She further explains that there have been many studies on the “nurture” side of the nature/nurture question and that, with new developments in DNA studies, it is now becoming possible to study the “nature” side.

“Defending Jacob” explores the nature/nurture issue, as well as issues with forensic testimony in court and the criminal justice system in general. The issue of repressing feelings and hiding secrets and then having to confront both in a brutal manner is another theme addressed in the story. Andy tried to hide and forget that his father was in prison and the criminal history in his family, but he was forced to face this and his feelings about it when confronted with his own son being accused of murder. Of note, he does not seek help from a therapist despite these life-altering events. (Humongous spoiler alert:) The story that began with a murder of an unrelated child may end with a family murder, one that would be well described and could be understood by psychiatrists using the categories of motives initially described by Phillip Resnick, MD.²

Once again, and unfortunately, as we have pointed out in other media reviews, the portrayal of psychiatric/psychological themes is problematic. Using a psychologist to explain the science of DNA and not a psychiatrist is an interesting choice. Diagnosing a 14-year-old with personality disorders also contributes to misunderstanding and stigma. In addition, no timely attempt is made to refer the accused Jacob for mental health treatment. The stigmatization of psychiatry in the media was addressed by the World Psychiatric Association task force guidance on how to combat stigmatization of psychiatry and psychiatrists,³ including breaking down negative views of psychiatrists and psychiatry in the general public, among medical students, other health professionals, and patients and relatives. The task force made recommendations for national psychiatric societies and for individual practitioners to help reduce stigma of the profession of psychiatry. We would argue that speaking to the media, including fiction authors, to help educate about mental health is an important role for psychiatrists. It would lead to more realistic portrayals in film and books.

Overall, “Defending Jacob” is a compelling story in both the novel and the miniseries. Despite some problems with how it depicts mental health issues, both are engaging and contain thoughtful, extremely well-written themes of interest to many clinical and forensic psychiatrists.


References

1. Landay W. Defending Jacob, a novel. New York: Delacorte Press, 2012.

2. Friedman SH. Family Murder: Pathologies of Love and Hate. Washington: American Psychiatric Association Publishing, 2019.

3. Sartorius N et al. World Psychiatry. 2010 Oct;9(3):131-44.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and on the faculty at Weill Cornell Medical Center. Dr. Hatters Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Association Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law and was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association.

The 2012 crime fiction novel, “Defending Jacob,” by William Landay was dramatized into a miniseries created by Mark Bomback that premiered on April 24, 2020, on Apple TV+ (and for those resisting a subscription, “The Morning Show” and “Defending Jacob” are both worth it). Both the “Defending Jacob” novel and the miniseries have themes that are of interest to psychiatry, especially to child and forensic psychiatrists, and both the literary and TV versions are excellent, albeit disturbing, diversions from the current pandemic.

doomu/Thinkstock

(Spoiler alert!) The story is set in the affluent town of Newton, Mass., where crime is generally low and homicides extremely infrequent. Protagonist Andy Barber, a 51-year-old Jewish assistant district attorney, is played by a younger Chris Evans in the miniseries. His wife, Laurie Gold Barber, a 51-year-old Jewish former schoolteacher and stay-at-home mom, is played by a younger Michelle Dockery of Downton Abbey fame. In the miniseries, her character is actively working as a teacher and social activist for children. Other differences between the novel and the miniseries will be pointed out when relevant, but the overall narrative is similar. Both stories are cleverly told through Andy Barber speaking in retrospect as he is being questioned in front of a grand jury for a potential indictment.

When 14-year-old Ben Rifkin is found stabbed to death in Cold Spring Park before school one morning, Andy Barber initially takes the case despite his boss’s reservations that there may be a conflict because Andy’s son Jacob is a student in Ben’s class at school. As the title suggests, it soon becomes clear that Jacob may have had something to do with the murder. At that point, Andy is taken off the case and it is given to a junior colleague, Neal Logiudice, who demonstrates both admiration and contempt for his former mentor, perhaps because of underlying jealousy and insecurity. Neal Logiudice becomes the DA questioning Andy Barber.

Prior to Jacob’s formal accusation of murder, the Barbers appear to be fiercely loyal and unable to fully see and understand their son. The difficulty with objectivity and the reasons why family member physicians should never treat family members – and why family member attorneys should never represent loved ones – is abundantly clear in this story. When Andy receives an anonymous tip that Jacob’s childhood best friend, Derek Yoo, posted on Facebook, “Jake, everyone knows you did it. You have a knife. I’ve seen it,’ ” Andy then looks through Jacob’s drawers and finds a folding knife in one of his T-shirts. In the chapter aptly titled “Denial,” Andy, an experienced prosecutor, does not turn the knife over as evidence, but instead disposes of it – believing Jacob that he did not take the knife to school the day his classmate was stabbed.

After Jacob is indicted, Andy Barber confesses to his wife, Laurie, that his estranged father who left when he was 6 is actually in prison convicted of murdering and raping a woman. In the novel, his grandfather and great-grandfather are also convicted felons. Laurie reveals this family history to Jacob’s attorney, and the attorney subsequently refers the family to a forensic psychologist. In the novel, she is a large Jewish woman; in the miniseries she is played by a very thin Poorna Jagannathan (who incidentally has portrayed a therapist in the television series “Sorry for your Loss,” and a doctor in “The Act,” “Better Call Saul,” “NCIS: Los Angeles,” “House of Cards,” “The Game,” “Law and Order: Criminal Intent,” “Rescue Me,” “Jonny Zero,” “An Actor Prepares,” “The Circle,” “Thanks for Sharing,” and “Montclair.”) Although the goal of the defense was a finding of “not guilty,” a psychiatric defense was going to be used as a last resort if necessary.

Laurie had already googled and learned of “the murder gene,” which was further explained by the forensic psychologist as a mutation called:
 

“MAOA Knockout. It has been argued in court as a trigger for violence before, but the argument was too simplistic, and it was rejected. Our understanding of the gene-environment interplay has improved since then – the science is getting better and very quickly – and we may have better testimony now. The second mutation is located in what’s called the serotonin transporter gene. The official name for the gene is SLC6A4. It’s located on chromosome 17. It encodes a protein that facilitates the activity of the serotonin transporter system, which is what enables the reuptake of serotonin from the synapse back into the neuron.”1

She further explains that there have been many studies on the “nurture” side of the nature/nurture question and that, with new developments in DNA studies, it is now becoming possible to study the “nature” side.

“Defending Jacob” explores the nature/nurture issue, as well as issues with forensic testimony in court and the criminal justice system in general. The issue of repressing feelings and hiding secrets and then having to confront both in a brutal manner is another theme addressed in the story. Andy tried to hide and forget that his father was in prison and the criminal history in his family, but he was forced to face this and his feelings about it when confronted with his own son being accused of murder. Of note, he does not seek help from a therapist despite these life-altering events. (Humongous spoiler alert:) The story that began with a murder of an unrelated child may end with a family murder, one that would be well described and could be understood by psychiatrists using the categories of motives initially described by Phillip Resnick, MD.²

Once again, and unfortunately, as we have pointed out in other media reviews, the portrayal of psychiatric/psychological themes is problematic. Using a psychologist to explain the science of DNA and not a psychiatrist is an interesting choice. Diagnosing a 14-year-old with personality disorders also contributes to misunderstanding and stigma. In addition, no timely attempt is made to refer the accused Jacob for mental health treatment. The stigmatization of psychiatry in the media was addressed by the World Psychiatric Association task force guidance on how to combat stigmatization of psychiatry and psychiatrists,³ including breaking down negative views of psychiatrists and psychiatry in the general public, among medical students, other health professionals, and patients and relatives. The task force made recommendations for national psychiatric societies and for individual practitioners to help reduce stigma of the profession of psychiatry. We would argue that speaking to the media, including fiction authors, to help educate about mental health is an important role for psychiatrists. It would lead to more realistic portrayals in film and books.

Overall, “Defending Jacob” is a compelling story in both the novel and the miniseries. Despite some problems with how it depicts mental health issues, both are engaging and contain thoughtful, extremely well-written themes of interest to many clinical and forensic psychiatrists.


References

1. Landay W. Defending Jacob, a novel. New York: Delacorte Press, 2012.

2. Friedman SH. Family Murder: Pathologies of Love and Hate. Washington: American Psychiatric Association Publishing, 2019.

3. Sartorius N et al. World Psychiatry. 2010 Oct;9(3):131-44.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and on the faculty at Weill Cornell Medical Center. Dr. Hatters Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Association Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law and was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association.

The 2012 crime fiction novel, “Defending Jacob,” by William Landay was dramatized into a miniseries created by Mark Bomback that premiered on April 24, 2020, on Apple TV+ (and for those resisting a subscription, “The Morning Show” and “Defending Jacob” are both worth it). Both the “Defending Jacob” novel and the miniseries have themes that are of interest to psychiatry, especially to child and forensic psychiatrists, and both the literary and TV versions are excellent, albeit disturbing, diversions from the current pandemic.

doomu/Thinkstock

(Spoiler alert!) The story is set in the affluent town of Newton, Mass., where crime is generally low and homicides extremely infrequent. Protagonist Andy Barber, a 51-year-old Jewish assistant district attorney, is played by a younger Chris Evans in the miniseries. His wife, Laurie Gold Barber, a 51-year-old Jewish former schoolteacher and stay-at-home mom, is played by a younger Michelle Dockery of Downton Abbey fame. In the miniseries, her character is actively working as a teacher and social activist for children. Other differences between the novel and the miniseries will be pointed out when relevant, but the overall narrative is similar. Both stories are cleverly told through Andy Barber speaking in retrospect as he is being questioned in front of a grand jury for a potential indictment.

When 14-year-old Ben Rifkin is found stabbed to death in Cold Spring Park before school one morning, Andy Barber initially takes the case despite his boss’s reservations that there may be a conflict because Andy’s son Jacob is a student in Ben’s class at school. As the title suggests, it soon becomes clear that Jacob may have had something to do with the murder. At that point, Andy is taken off the case and it is given to a junior colleague, Neal Logiudice, who demonstrates both admiration and contempt for his former mentor, perhaps because of underlying jealousy and insecurity. Neal Logiudice becomes the DA questioning Andy Barber.

Prior to Jacob’s formal accusation of murder, the Barbers appear to be fiercely loyal and unable to fully see and understand their son. The difficulty with objectivity and the reasons why family member physicians should never treat family members – and why family member attorneys should never represent loved ones – is abundantly clear in this story. When Andy receives an anonymous tip that Jacob’s childhood best friend, Derek Yoo, posted on Facebook, “Jake, everyone knows you did it. You have a knife. I’ve seen it,’ ” Andy then looks through Jacob’s drawers and finds a folding knife in one of his T-shirts. In the chapter aptly titled “Denial,” Andy, an experienced prosecutor, does not turn the knife over as evidence, but instead disposes of it – believing Jacob that he did not take the knife to school the day his classmate was stabbed.

After Jacob is indicted, Andy Barber confesses to his wife, Laurie, that his estranged father who left when he was 6 is actually in prison convicted of murdering and raping a woman. In the novel, his grandfather and great-grandfather are also convicted felons. Laurie reveals this family history to Jacob’s attorney, and the attorney subsequently refers the family to a forensic psychologist. In the novel, she is a large Jewish woman; in the miniseries she is played by a very thin Poorna Jagannathan (who incidentally has portrayed a therapist in the television series “Sorry for your Loss,” and a doctor in “The Act,” “Better Call Saul,” “NCIS: Los Angeles,” “House of Cards,” “The Game,” “Law and Order: Criminal Intent,” “Rescue Me,” “Jonny Zero,” “An Actor Prepares,” “The Circle,” “Thanks for Sharing,” and “Montclair.”) Although the goal of the defense was a finding of “not guilty,” a psychiatric defense was going to be used as a last resort if necessary.

Laurie had already googled and learned of “the murder gene,” which was further explained by the forensic psychologist as a mutation called:
 

“MAOA Knockout. It has been argued in court as a trigger for violence before, but the argument was too simplistic, and it was rejected. Our understanding of the gene-environment interplay has improved since then – the science is getting better and very quickly – and we may have better testimony now. The second mutation is located in what’s called the serotonin transporter gene. The official name for the gene is SLC6A4. It’s located on chromosome 17. It encodes a protein that facilitates the activity of the serotonin transporter system, which is what enables the reuptake of serotonin from the synapse back into the neuron.”1

She further explains that there have been many studies on the “nurture” side of the nature/nurture question and that, with new developments in DNA studies, it is now becoming possible to study the “nature” side.

“Defending Jacob” explores the nature/nurture issue, as well as issues with forensic testimony in court and the criminal justice system in general. The issue of repressing feelings and hiding secrets and then having to confront both in a brutal manner is another theme addressed in the story. Andy tried to hide and forget that his father was in prison and the criminal history in his family, but he was forced to face this and his feelings about it when confronted with his own son being accused of murder. Of note, he does not seek help from a therapist despite these life-altering events. (Humongous spoiler alert:) The story that began with a murder of an unrelated child may end with a family murder, one that would be well described and could be understood by psychiatrists using the categories of motives initially described by Phillip Resnick, MD.²

Once again, and unfortunately, as we have pointed out in other media reviews, the portrayal of psychiatric/psychological themes is problematic. Using a psychologist to explain the science of DNA and not a psychiatrist is an interesting choice. Diagnosing a 14-year-old with personality disorders also contributes to misunderstanding and stigma. In addition, no timely attempt is made to refer the accused Jacob for mental health treatment. The stigmatization of psychiatry in the media was addressed by the World Psychiatric Association task force guidance on how to combat stigmatization of psychiatry and psychiatrists,³ including breaking down negative views of psychiatrists and psychiatry in the general public, among medical students, other health professionals, and patients and relatives. The task force made recommendations for national psychiatric societies and for individual practitioners to help reduce stigma of the profession of psychiatry. We would argue that speaking to the media, including fiction authors, to help educate about mental health is an important role for psychiatrists. It would lead to more realistic portrayals in film and books.

Overall, “Defending Jacob” is a compelling story in both the novel and the miniseries. Despite some problems with how it depicts mental health issues, both are engaging and contain thoughtful, extremely well-written themes of interest to many clinical and forensic psychiatrists.


References

1. Landay W. Defending Jacob, a novel. New York: Delacorte Press, 2012.

2. Friedman SH. Family Murder: Pathologies of Love and Hate. Washington: American Psychiatric Association Publishing, 2019.

3. Sartorius N et al. World Psychiatry. 2010 Oct;9(3):131-44.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and on the faculty at Weill Cornell Medical Center. Dr. Hatters Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Association Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law and was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association.

The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.

The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.

The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.

“This is the first clinical demonstration of an epigenetic mode of action in psychiatry to date,” Bullock added.

However, another expert urged prudence when interpreting the findings.

“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.

The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Little evidence available

“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.

In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.

“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.

REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.

Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.

In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.

Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.

The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
 

Significantly improved scores

Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).

Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.

Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).

Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.

In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).

“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.

Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”

First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
 

Several limitations

Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).

“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.

In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.

There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.

Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.

Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”

That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.

For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”

The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.

This article first appeared on Medscape.com.

The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.

The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.

The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.

“This is the first clinical demonstration of an epigenetic mode of action in psychiatry to date,” Bullock added.

However, another expert urged prudence when interpreting the findings.

“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.

The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Little evidence available

“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.

In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.

“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.

REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.

Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.

In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.

Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.

The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
 

Significantly improved scores

Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).

Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.

Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).

Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.

In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).

“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.

Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”

First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
 

Several limitations

Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).

“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.

In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.

There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.

Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.

Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”

That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.

For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”

The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.

This article first appeared on Medscape.com.

The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.

The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.

The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.

“This is the first clinical demonstration of an epigenetic mode of action in psychiatry to date,” Bullock added.

However, another expert urged prudence when interpreting the findings.

“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.

The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
 

Little evidence available

“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.

In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.

“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.

REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.

Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.

In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.

Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.

The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
 

Significantly improved scores

Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).

Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.

Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).

Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.

In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).

“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.

Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”

First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
 

Several limitations

Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).

“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.

In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.

There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.

Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.

Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”

That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.

For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”

The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.

This article first appeared on Medscape.com.

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Antibody levels in patients with mild COVID-19, the level of disease most people have, appear to drop by half within 36 days, new research suggests. The research was conducted by F. Javier Ibarrondo, PhD, and colleagues and was published online on July 21 in a letter to the editor of the New England Journal of Medicine. Ibarrondo is associate researcher at the University of California, Los Angeles. (The original letter incorrectly calculated the half-life at 73 days.)

Coauthor Otto Yang, MD, professor of medicine in the division of infectious diseases at UCLA, told Medscape Medical News that the rapidity in the antibody drop at 5 weeks “is striking compared to other infections.”

The phenomenon has been suspected and has been observed before but had not been quantified.

“Our paper is the first to put firm numbers on the dropping of antibodies after early infection,” he said.

The researchers evaluated 34 people (average age, 43 years) who had recovered from mild COVID-19 and had referred themselves to UCLA for observational research.
 

Previous report also found a quick fade

As Medscape Medical News reported, a previous study from China that was published in Nature Medicine also found that the antibodies fade quickly.

Interpreting the meaning of the current research comes with a few caveats, Dr. Yang said.

“One is that we don’t know for sure that antibodies are what protect people from getting infected,” he said. Although it’s a reasonable assumption, he said, that’s not always the case.

Another caveat is that even if antibodies do protect, the tests being used to measure them – including the test that was used in this study – may not measure them the right way, and it is not yet known how many antibodies are needed for protection, he explained.

The UCLA researchers used an enzyme-linked immunosorbent assay to detect anti–SARS-CoV-2 spike receptor–binding domain immunoglobulin G concentrations.
 

“No reason for anybody to be getting an antibody test medically”

The study provides further proof that “[t]here’s no reason for anybody to be getting an antibody test medically right now,” Dr. Yang said.

Additionally, “FDA-approved tests are not approved for quantitative measures, only qualitative,” he continued. He noted that the findings may have implications with respect to herd immunity.

“Herd immunity depends on a lot of people having immunity to the infection all at the same time. If infection is followed by only brief protection from infection, the natural infection is not going to reach herd immunity,” he explained.

Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program in Nashville, Tenn., pointed out that antibodies “are just part of the story.”

“When we make an immune response to any germ,” he said, “we not only make an immune response for the time being but for the future. The next time we’re exposed, we can call into action B cells and T cells who have been there and done that.”

So even though the antibodies fade over time, other arms of the immune system are being trained for future action, he said.

Herd immunity does not require that populations have a huge level of antibodies that remains forever, he explained.

“It requires that in general, we’re not going to get infected as easily, and we’re not going to have disease as easily, and we’re not going to transmit the virus for as long,” he said.

Dr. Creech said he and others researching COVID-19 find that studies that show that antibodies fade quickly provide more proof “that this coronavirus is going to be here to stay unless we can take care of it through very effective treatments to take it from potentially fatal disease to one that is nothing more than a cold” or until a vaccine is developed.

He noted there are four other coronaviruses in widespread circulation every year that “amount to about 25% of the common cold.”

This study may help narrow the window as to when convalescent plasma – plasma that is taken from people who have recovered from COVID-19 and that is used to help people who are acutely ill with the disease – will be most effective, Dr. Creech explained. He said the results suggest that it is important that plasma be collected within the first couple of months after recovery so as to capture the most antibodies.

This study is important as another snapshot “so we understand the differences between severe and mild disease, so we can study it over time, so we have all the tools we need as we start these pivotal vaccine studies to make sure we’re making the right immune response for the right duration of time so we can put an end to this pandemic,” Dr. Creech concluded.

The study was supported by grants from the AIDS Healthcare Foundation, the Doris Duke Charitable Foundation, the National Institutes of Health, the James B. Pendleton Charitable Trust, and the McCarthy Family Foundation. A coauthor reports receiving grants from Gilead outside the submitted work. Dr. Creech has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

A study that observed oral petechial lesions in a small number of COVID-19 patients with skin rash fortifies growing evidence that the virus has dermatologic manifestations. Larger studies should explore and confirm this association, the study’s authors and other experts suggested.

Dermatologists are already aware of the connection between enanthem and viral etiology. “As seen with other viral infections, we wondered if COVID-19 could produce enanthem in addition to skin rash exanthem,” one of the study author’s, Juan Jiménez-Cauhe, MD, a dermatologist with Hospital Universitario Ramon y Cajal, Madrid, said in an interview. He and his colleagues summarized their findings in a research letter in JAMA Dermatology.

They examined the oral cavity of 21 COVID-19 patients at a tertiary care hospital who also had a skin rash from March 30 to April 8. They classified enanthems into four categories: petechial, macular, macular with petechiae, or erythematovesicular. Six of the patients presented with oral lesions, all of them located in the palate; in one patient, the enanthem was macular, it was petechial in two patients and was macular with petechiae in three patients. The six patients ranged between the ages of 40 and 69 years; four were women.

Petechial or vesicular patterns are often associated with viral infections. In this particular study, the investigators did not observe vesicular lesions.

On average, mucocutaneous lesions appeared about 12 days after the onset of COVID-19 symptoms. “Interestingly, this latency was shorter in patients with petechial enanthem, compared with those with a macular lesion with petechiae appearance,” the authors wrote.

This shorter time might suggest an association for SARS-CoV-2, said Dr. Jiménez-Cauhe. Strong cough may have also caused petechial lesions on the palate, but it’s unlikely, as they appeared close in time to COVID-19 symptoms. It’s also unlikely that any drugs caused the lesions, as drug rashes can take 2-3 weeks to appear.

This fits in line with other evidence of broader skin manifestations appearing at the same time or after COVID-19, Esther Freeman, MD, said in an interview. Dr. Freeman, director of global health dermatology at Massachusetts General Hospital, Boston, is the principal investigator of the COVID-19 Dermatology Registry, a collaboration of the American Academy of Dermatology and International League of Dermatological Societies.

The study’s small cohort made it difficult to establish a solid association between the oral lesions and SARS-CoV-2. “However, the presence of enanthem in a patient with a skin rash is a useful finding that suggests a viral etiology rather than a drug reaction. This is particularly useful in COVID-19 patients, who were receiving many drugs as part of the treatment,” Dr. Jimenez-Cauhe said. Future studies should assess whether the presence of enanthem and exanthem lead physicians to consider SARS-CoV-2 as possible agents, ruling out infection with a blood or nasopharyngeal test.

This study adds to the growing body of knowledge on cutaneous and mucocutaneous findings associated with SARS-CoV-2 infection, Jules Lipoff, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, said in an interview. “One challenge in evaluating these findings is that these findings are nonspecific, and medication reactions can often cause similar rashes, such as morbilliform eruptions that can be associated with both viruses and medications.”

Enanthems, as the study authors noted, are more specific to viral infections and are less commonly associated with medication reactions. “So, even though this is a small case series with significant limitations, it does add more evidence that COVID-19 is directly responsible for findings in the skin and mucous membranes,” said Dr. Lipoff.

Dr. Freeman noted that the study may also encourage clinicians to look in a patient’s mouth when assessing for SARS-CoV-2. Additional research should examine these data in a larger population.

Several studies by Dr. Freeman, Dr. Lipoff, and others strongly suggest that SARS-CoV-2 has a spectrum of associated dermatologic manifestations. One evaluated perniolike skin lesions (J Am Acad Dermatol. 2020 Aug; 83[2]:486-92). The other was a case series from the COVID-19 registry that examined 716 cases of new-onset dermatologic symptoms in patients from 31 countries with confirmed/suspected SARS-CoV-2 (J Am Acad Dermatol. 2020 Jul 2;S0190-9622[20]32126-5.).

The authors of the report had no disclosures.

SOURCE: Jimenez-Cauhe J et al. JAMA Dermatol. 2020 Jul 15. doi: 10.1001/jamadermatol.2020.2550.

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

In early April, Maura Quinlan, MD, was working nights on the labor and delivery unit at Northwestern Medicine Prentice Women’s Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for SARS-CoV-2. Women in labor wore N95 masks, but only while pushing – and practitioners didn’t always don proper protection in time.

Babies came and families rejoiced. But Dr. Quinlan looks back on those weeks with a degree of horror. “We were laboring a bunch of patients that probably had COVID,” she said, and they were doing so without proper protection.

She’s probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk.

Dr. Quinlan already knew she and her fellow ob.gyns. had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus.

Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their health care workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.
 

Shifting recommendations

One case study of women in a New York City hospital during the height of the city’s surge found that, of seven confirmed COVID-19–positive patients, two were asymptomatic upon admission to the obstetrical service, and these same two patients ultimately required unplanned ICU admission. The women’s care prior to their positive diagnosis had exposed multiple health care workers, all of whom lacked appropriate personal protective equipment (PPE), the study authors wrote. “Further, five of seven confirmed COVID-19–positive women were afebrile on initial screen, and four did not first report a cough. In some locations where testing availability remains limited, the minimal symptoms reported for some of these cases might have been insufficient to prompt COVID-19 testing.”

As studies like this pour in, societies continue to update their recommendations accordingly. The latest guidance from the American College of Obstetricians and Gynecologists came on July 1. The group suggests testing all labor and delivery patients, particularly in high-prevalence areas. If tests are in short supply, it recommends prioritizing testing pregnant women with suspected COVID-19 and those who develop symptoms during admission.

At Northwestern, the hospital requests patients stay home and quarantine for the weeks leading up to their delivery date. Then, they rapidly test every patient who comes in for delivery and aim to have results available within a few hours.

The hospital’s 30-room labor and delivery wing remains reserved for patients who test negative. Those with positive COVID-19 results are sent to a 6-bed COVID labor and delivery unit elsewhere in the hospital. “We were lucky we had the space to do that, because smaller community hospitals wouldn’t have a separate unused unit where they could put these women,” Dr. Quinlan said.

In the COVID unit, women deliver without a support person – no partner, doula, or family member can join. Doctors and nurses wear full PPE and work only in that ward. And because some research shows that pregnant women who are asymptomatic or presymptomatic may develop symptoms quickly after starting labor with no measurable illness, Dr. Quinlan must decide on a case-by-case basis what to do, if anything at all.

Delaying an induction could allow the infection to resolve or it could result in her patient moving from presymptomatic disease to full-blown pneumonia. Accelerating labor could bring on symptoms or it could allow a mother to deliver safely and get out of the hospital as quickly as possible. “There is an advantage to having the baby now if you feel okay – even if it’s alone – and getting home,” Dr. Quinlan said.

The hospital also tests the partners of women who are COVID-19 positive. Those with negative results can take the newborn home and try to maintain distance until the mother is no longer symptomatic.

In different parts of the country, hospitals have developed different approaches. Southern California is experiencing its own surge, but at the Ronald Reagan University of California, Los Angeles, Medical Center there still haven’t been enough COVID-19 patients to warrant a separate labor and delivery unit.

At UCLA, staff swab patients when they enter the labor and delivery ward — those who test positive have specific room designations. For both COVID-19–positive patients and women who progress faster than test results can be returned, the goals are the same, said Rashmi Rao, MD, an ob.gyn. at UCLA: Deliver in the safest way possible for both mother and baby.

All women, positive or negative, must wear masks during labor – as much as they can tolerate, at least. For patients who are only mildly ill or asymptomatic, the only difference is that everyone wears protective gear. But if a patient’s oxygen levels dip, or her baby is in distress, the team moves more quickly to a cesarean delivery than they’d do with a healthy patient.

Just as hospital policies have been evolving, rules for visitors have been constantly changing too. Initially, UCLA allowed a support person to be present during delivery but had to leave immediately following. Now, each new mother is allowed one visitor for the duration of their stay. And the hospital suggests that patients who are COVID-19 positive recover in separate rooms from their babies and encourages them to maintain distance from their infants, except when breastfeeding.

“We respect and understand that this is a joyous occasion and we’re trying to keep families together as much as possible,” Dr. Rao said.
 

Care conundrums

How hospitals protect their smallest charges keeps changing too. Reports have been circulating about newborns being taken away from COVID-19-positive mothers, especially in marginalized communities. The stories have led many to worry they’d be forcibly separated from their babies. Most hospitals, however, leave it up to the woman and her doctors to decide how much separation is needed. “After delivery, it depends on how someone is feeling,” Dr. Rao said.

The American Academy of Pediatrics recommends that mothers who are COVID-19–positive pump breast milk and have a healthy caregiver use that milk, or formula, to bottle-feed the baby, with the new mother remaining 6 feet away from the child as much as she can. If that’s not possible, she should wear gloves and a mask while breastfeeding until she has been naturally afebrile for 72 hours and at least 1 week removed from the first appearance of her symptoms.

“It’s tragically hard,” said Dr. Quinlan, to keep a COVID-19–positive mother even 6 feet away from her newborn baby. “If a mother declines separation, we ask the acting pediatric team to discuss the theoretical risks and paucity of data.”

Until recently, research indicated that SARS-CoV-2 wasn’t being transmitted through the uterus from mothers to their babies. And despite a recent case study reporting transplacental transmission between a mother and her fetus in France, researchers still say that the risk of transference is low. To ensure newborn risk remains as low as possible, UCLA’s policy is to swab the baby when he/she is 24 hours old and keep watch for signs of infection: increased lethargy, difficulty waking, or gastrointestinal symptoms like vomiting.

Transmission via breast milk has also, to date, proven relatively unlikely. One study in The Lancet detected the novel coronavirus in breast milk, although it’s not clear that the virus can be passed on in the fluid, says Christina Chambers, PhD, a professor of pediatrics at the University of California, San Diego. Dr. Chambers is studying breast milk to see if the virus or antibodies to it are present. She is also investigating how infection with SARS-CoV-2 impacts women at different times in pregnancy, something that’s still an open question.

“[In] pregnant women with a deteriorating infection, the decisions are the same you would make with any delivery: Save the mom and save the baby,” Dr. Chambers said. “Beyond that, I am encouraged to see that pregnant women are prioritized to being tested,” something that will help researchers understand prevalence of disease in order to better understand whether some symptoms are more dangerous than others.

The situation is evolving so quickly that hospitals and providers are simply trying to stay abreast of the flood of new research. In the absence of definitive answers, they are using the information available and adjusting on the fly. “We are cautiously waiting for more data,” said Dr. Rao. “With the information we have we are doing the best we can to keep our patients safe. And we’re just going to keep at it.”

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

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As more and more reopened medical practices ramp up toward normal activity, the safety of patients and health care workers alike remains paramount. As always, the responsibility for enforcing all the new safety guidelines ultimately rests with the Occupational Health and Safety Administration (OSHA).

Most of the modified guidelines are already familiar: wear masks (and other personal protective equipment as necessary); maintain social distancing; have hand cleaner, soap, and water readily available; and sanitize between patient examinations.

It is also important to remember that COVID-19 is now a reportable disease; check with your local health authorities as to where and how. Also remember that, if you decide to screen employees and/or patients for fevers and other symptoms of COVID-19, those data are subject to HIPAA rules and must be kept confidential.

Now might be a good time to confirm that you remain in compliance with both the new and old regulations. Even if you hold regular safety meetings – which often is not the case – it is always a good idea to occasionally conduct a comprehensive review, which could save you a lot in fines.

So get your OSHA logs out, and walk through your office. Start by making sure you have an official OSHA poster, which enumerates employee rights and explains how to file complaints. Every office must have one posted in plain site, and is what an OSHA inspector will look for first. They are available for free at OSHA’s website or you can order one by calling 800-321-OSHA.

How long have you had your written exposure control plan for blood-borne pathogens? This plan should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, as well as your implementation of universal precautions. It should be updated annually to reflect changes in technology – and new threats, such as COVID-19.

Review your list of hazardous substances, which all employees have a right to know about. OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are classified as “hazardous.” Also remember that you’re probably using new disinfectants, which may need to be added to your list. For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

It is not necessary to adopt every new safety device as it comes on the market, but you should document which ones you are using and which ones you decide not to use – and why. For example, if you and your employees decide against buying a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it is worth, you still should document how you made that decision and why you believe that your current protocol is as good or better.

All at-risk employees should be provided with hepatitis B vaccine at no cost to them. And after any exposure to dangerous pathogens – which now include COVID-19 – you also must provide and pay for appropriate medical treatment and follow-up.

Another important consideration in your review: Electrical devices and their power sources in the office. All electrically powered equipment – medical or clerical – must operate safely and should all be examined. It is particularly important to check how wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it and that circuit breakers are present and functioning.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Medical and dental offices are not required to keep an injury and illness log under federal OSHA regulations, which other businesses must. However, your state may have a requirement that supersedes the federal law so you should check with your state, or with your local OSHA office, regarding any such requirements.

It is important to take OSHA regulations seriously because failure to comply with them can result in stiff penalties running into many thousands of dollars.

To be certain you are complying with all the rules, you can call your local OSHA office and request an inspection. This is the easiest and cheapest way because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they discover.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Use of weight-promoting medications may contribute to postmenopausal abdominal weight gain in women, based on data from more than 76,000 individuals in the Women’s Health Initiative.

“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.

“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.

In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.

During a 3-year follow-up period, the average BMI increase was 0.37 kg/m² in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m² in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.

In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.

“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”

The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.

However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.

“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.

“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”

The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.

“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.

The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.

SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.

Use of weight-promoting medications may contribute to postmenopausal abdominal weight gain in women, based on data from more than 76,000 individuals in the Women’s Health Initiative.

“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.

“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.

In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.

During a 3-year follow-up period, the average BMI increase was 0.37 kg/m² in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m² in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.

In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.

“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”

The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.

However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.

“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.

“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”

The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.

“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.

The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.

SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.

Use of weight-promoting medications may contribute to postmenopausal abdominal weight gain in women, based on data from more than 76,000 individuals in the Women’s Health Initiative.

“Many of the medications prescribed to treat obesity-related comorbidities such as hypertension, type 2 diabetes, and depression have been linked to weight gain,” but the impact of such medications in relation to changes in body mass index (BMI) and waist circumference in postmenopausal women in particular has not been studied, wrote Fatima Cody Stanford, MD, of Harvard Medical School, Boston, and colleagues.

“Postmenopausal women are of significant interest as those who have obesity and normal weight central obesity are at increased risk for conditions such as invasive breast cancer, sleep disturbances, and type 2 diabetes, as well as mortality,” they wrote.

In a study published in the journal Menopause, the researchers identified 76,252 postmenopausal women aged 50-79 years and measured body mass index at baseline and after 3 years. Medication use was determined by a medication inventory of pill bottles brought to baseline and year-3 visits.

During a 3-year follow-up period, the average BMI increase was 0.37 kg/m² in women taking at least one weight-promoting medication, compared with an average increase of 0.27 kg/m² in women not taking such medications (P = .0045). Weight-promoting medications in the study included antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. The researchers used generalized linear models to assess the impact of these medications on increased BMI and waist circumference.

In addition, the average increase in waist circumference was 1.10 cm in women taking at least one weight-promoting medication, compared with 0.89 cm (P = .0077) for women not on such medications.

“Type of medication, dosage, and race/ethnicity may have important interrelationships,” in postmenopausal weight gain, as do individual susceptibility and genetics, the researchers noted. “Options to mitigate the weight gain may include proactive lifestyle modifications, reduction in dose, change to another agent, or discontinuation of the medication altogether. If alternative medications are not an option, lifestyle factors such as diet quality, physical activity level, and sleep quality and duration warrant emphasis.”

The study findings were limited by several factors, including a lack of data on indications and underlying health conditions surrounding the prescription of various medications, notably psychotropics and antipsychotics, the researchers wrote.

However, the data “may help to inform clinical decision-making and support increased attention to lifestyle modifications and other strategies” to mitigate the potential for weight gain in a population already at risk for overweight and obesity over time, they concluded.

“Given the obesity epidemic, addressing factors contributing to weight gain in midlife [a time associated with weight gain] women is critical,” Stephanie S. Faubion, MD, of the Mayo Clinic in Jacksonville, Fla., said in an interview. Dr. Faubion said that the study findings were not surprising given the widespread use of known weight-promoting medications by midlife women for such as hypertension, diabetes, and depression.

“Clinicians need to ensure that they prescribe medications that are truly needed and utilize the lowest dose required to achieve treatment goals,” Dr. Faubion said. “When possible, alternative therapies that do not cause weight gain should be considered. In addition, patients should be warned of the potential for weight gain, and clinicians should advocate for lifestyle measures aimed at mitigating these effects.”

The findings do not encourage the use of alternative therapies for menopausal symptoms per se, added Dr. Faubion, who is also medical director of the North American Menopause Society. “Hormone therapy is not associated with weight gain, and if anything, it is weight favorable and associated with less weight around the midsection. It is the alternative strategies for management of hot flashes that are associated with weight gain, such as antidepressants and gabapentin.

“We need to focus efforts on strategies to prevent weight gain in midlife to avoid the development of conditions that necessitate initiation of many of these weight-promoting medications,” Dr. Faubion said.

The study was supported by the National Institutes of Health and Massachusetts General Hospital Executive Committee on Research, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases. The researchers had no financial conflicts to disclose. Dr. Faubion had no financial conflicts to disclose.

SOURCE: Stanford FC et al. Menopause. 2020 Jul 13. doi: 10.1097/GME.0000000000001589.

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.

Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.

The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.

As reported by Medscape Medical News from the World Sleep 2019 meeting, Xywav demonstrated highly statistically significant differences (P < .0001) in weekly number of cataplexy attacks (primary efficacy endpoint) and Epworth Sleepiness Scale scores (key secondary outcome) vs placebo.

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy,” lead investigator Richard K. Bogan, MD, said in the company’s news release.

He noted that the average American consumes too much sodium. “Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease,” said Dr. Bogan, associate clinical professor at the University of South Carolina School of Medicine, Columbia.

“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” he added.

The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.

Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.

The company plans to launch Xywav by the end of the year. Full prescribing information and a medication guide are available online.

This article first appeared on Medscape.com.