Commentary

Grandma Exie used to tell a story about her grandmother on her father’s side, who lived in northeastern Arkansas. Towards the end of the Civil War, Northern and Southern troops were expected to “live off the land,” and both sides had torn through her poor dirt farm and carried off all the livestock and crops. The only thing they didn’t take was her bull mastiff, who was a pretty fair hunting and guard dog. Starving, she had no other option than to pack up and head east for Tennessee, where her husband was stationed with Joseph Hooker’s army. Many thousands of destitute women and children, most of whom were related to one of the troops, followed the army, where some of the army’s rations could be shared with them.

She headed out on foot and all went well until day 3 or so, when a panther attacked them, but she, armed with a branch, and her loyal dog were able to drive it off. The panther followed them for 3 days while she hid in a tree at night with her dog at the foot of a tree. Eventually, the panther gave up and she made it to Tennessee to safety.

Grandma Exie said her grandmother had “grit” and used this story whenever any of us would complain about how hard times were or how we were mistreated.

It is time for all of us to buck up and show a little grit in the face of a viral pandemic and social unrest. The answers are not easy or clear, but our health care system and our nation have faced much greater challenges. The 1918 flu pandemic was much more devastating, killing millions worldwide, and recall, 620,000 died in the Civil War, more than all other American wars combined. There is a deep seam of grit and resilience in Americans. We don’t always get it right immediately, but we usually do in the end.

The protests are justifiable outrage over police brutality, fueled by a high unemployment rate, both of which are a cause for frustration. The looting and destruction appears to be opportunistic thievery and some organized vandalization in my opinion. Most of the damage caused by riots and looting is not covered by insurance, and this will be a death blow to many small businesses already facing major financial setbacks as customers have stayed home for months and laying off staff has become necessary.

As for the impact on our practices, most physicians have been lucky and not been looted or burned out. Most of us have resumed practice, at least in a limited fashion, wearing masks; keeping the waiting room mostly empty; using social distancing and hand, air, and surface disinfection. In most of the country, the disease incidence has become lower, and the risk of not seeing the doctor is now greater than catching COVID-19.

So show grit, be careful, be vigilant, and practice your profession. Support your local small businesses, particularly if they have been the victims of senseless violence. We will work our way through these times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He had no disclosures related to this column. Write to him at [email protected].

Grandma Exie used to tell a story about her grandmother on her father’s side, who lived in northeastern Arkansas. Towards the end of the Civil War, Northern and Southern troops were expected to “live off the land,” and both sides had torn through her poor dirt farm and carried off all the livestock and crops. The only thing they didn’t take was her bull mastiff, who was a pretty fair hunting and guard dog. Starving, she had no other option than to pack up and head east for Tennessee, where her husband was stationed with Joseph Hooker’s army. Many thousands of destitute women and children, most of whom were related to one of the troops, followed the army, where some of the army’s rations could be shared with them.

She headed out on foot and all went well until day 3 or so, when a panther attacked them, but she, armed with a branch, and her loyal dog were able to drive it off. The panther followed them for 3 days while she hid in a tree at night with her dog at the foot of a tree. Eventually, the panther gave up and she made it to Tennessee to safety.

Grandma Exie said her grandmother had “grit” and used this story whenever any of us would complain about how hard times were or how we were mistreated.

It is time for all of us to buck up and show a little grit in the face of a viral pandemic and social unrest. The answers are not easy or clear, but our health care system and our nation have faced much greater challenges. The 1918 flu pandemic was much more devastating, killing millions worldwide, and recall, 620,000 died in the Civil War, more than all other American wars combined. There is a deep seam of grit and resilience in Americans. We don’t always get it right immediately, but we usually do in the end.

The protests are justifiable outrage over police brutality, fueled by a high unemployment rate, both of which are a cause for frustration. The looting and destruction appears to be opportunistic thievery and some organized vandalization in my opinion. Most of the damage caused by riots and looting is not covered by insurance, and this will be a death blow to many small businesses already facing major financial setbacks as customers have stayed home for months and laying off staff has become necessary.

As for the impact on our practices, most physicians have been lucky and not been looted or burned out. Most of us have resumed practice, at least in a limited fashion, wearing masks; keeping the waiting room mostly empty; using social distancing and hand, air, and surface disinfection. In most of the country, the disease incidence has become lower, and the risk of not seeing the doctor is now greater than catching COVID-19.

So show grit, be careful, be vigilant, and practice your profession. Support your local small businesses, particularly if they have been the victims of senseless violence. We will work our way through these times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He had no disclosures related to this column. Write to him at [email protected].

Grandma Exie used to tell a story about her grandmother on her father’s side, who lived in northeastern Arkansas. Towards the end of the Civil War, Northern and Southern troops were expected to “live off the land,” and both sides had torn through her poor dirt farm and carried off all the livestock and crops. The only thing they didn’t take was her bull mastiff, who was a pretty fair hunting and guard dog. Starving, she had no other option than to pack up and head east for Tennessee, where her husband was stationed with Joseph Hooker’s army. Many thousands of destitute women and children, most of whom were related to one of the troops, followed the army, where some of the army’s rations could be shared with them.

She headed out on foot and all went well until day 3 or so, when a panther attacked them, but she, armed with a branch, and her loyal dog were able to drive it off. The panther followed them for 3 days while she hid in a tree at night with her dog at the foot of a tree. Eventually, the panther gave up and she made it to Tennessee to safety.

Grandma Exie said her grandmother had “grit” and used this story whenever any of us would complain about how hard times were or how we were mistreated.

It is time for all of us to buck up and show a little grit in the face of a viral pandemic and social unrest. The answers are not easy or clear, but our health care system and our nation have faced much greater challenges. The 1918 flu pandemic was much more devastating, killing millions worldwide, and recall, 620,000 died in the Civil War, more than all other American wars combined. There is a deep seam of grit and resilience in Americans. We don’t always get it right immediately, but we usually do in the end.

The protests are justifiable outrage over police brutality, fueled by a high unemployment rate, both of which are a cause for frustration. The looting and destruction appears to be opportunistic thievery and some organized vandalization in my opinion. Most of the damage caused by riots and looting is not covered by insurance, and this will be a death blow to many small businesses already facing major financial setbacks as customers have stayed home for months and laying off staff has become necessary.

As for the impact on our practices, most physicians have been lucky and not been looted or burned out. Most of us have resumed practice, at least in a limited fashion, wearing masks; keeping the waiting room mostly empty; using social distancing and hand, air, and surface disinfection. In most of the country, the disease incidence has become lower, and the risk of not seeing the doctor is now greater than catching COVID-19.

So show grit, be careful, be vigilant, and practice your profession. Support your local small businesses, particularly if they have been the victims of senseless violence. We will work our way through these times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He had no disclosures related to this column. Write to him at [email protected].

Melissa R. Arbuckle, MD: Hi. I’m Dr. Melissa Arbuckle, vice chair for education and training in the Department of Psychiatry at Columbia University. I’m reporting on behalf of Medscape and our Columbia Psychiatry partnership. Today we’ll be discussing biomarkers with Dr. Jeffrey Lieberman. Welcome.

Jeffrey A. Lieberman, MD: Thanks, Melissa. Great to be here to talk about a subject that is near and dear to my heart.



Dr. Arbuckle: Dr. Lieberman is chair of the Department of Psychiatry at Columbia and is also director of the New York State Psychiatric Institute. Tell us about biomarkers and psychiatry, Dr Lieberman.

Dr. Lieberman: It would be nice if we had some! But first let me tell you what a biomarker is and what it would do for us. A biomarker is a biologic measure, a biologic feature, whether it’s blood pressure, pulse rate, an analyte in blood or cerebrospinal fluid, or a feature of an MRI or PET scan image of the brain that has diagnostic, prognostic, or theragnostic significance. A biomarker identifies an individual with symptoms of a specific disorder, indicates that they have this disorder, and can suggest a particular prognosis – less severe, more severe – or specify which treatment a person would likely respond to. For the entire history of our discipline, as long as physicians have studied mental illness, we have not had a diagnostic test for it. It’s a clinical diagnosis.

All illnesses in medicine began with clinical diagnosis: seizure disorder, epilepsy, was falling sickness; congestive heart failure was dropsy; for diabetes you tasted the urine to see if it was sweet or watery. But when we began to measure glucose and hemoglobin A1c, or when we developed the electrocardiogram to measure heart rhythms, and the electroencephalogram to measure brain activity, those were diagnostic tests based on biomarkers. We just don’t have them yet in psychiatry. The day we do have our first diagnostic tests, courtesy of a validated biomarker, will be a real milestone in the history of our profession.



Dr. Arbuckle: How far off might that be for psychiatry?

Dr. Lieberman: I’ve been in this profession for more than 30 years, and I’ve been saying for a while that it is coming soon. But we’re still waiting. Let me just add a cautionary note. Ever since psychiatry became scientifically minded and used scientific methodology and technology to understand the underpinnings of mental illness, there’s been an effort to identify biomarkers. It began in the 1960s with a series of false leads. There was something called the pink spot, as well as other metabolites, which were indicators on chromatographs linked to schizophrenia. This turned out to be wrong.

There was also the dexamethasone suppression test, to identify people who hypersecreted cortisol, which was believed to be diagnostic of depression. That turned out to be inadequate also.

There was the identification of genes beginning in the late 1980s. But the specific genes that indicated manic depressive illness and schizophrenia were not replicated. And now we know that the genetics of these disorders is polygenic and very complex.

So we cannot overpromise. I don’t want to say exactly when, but I will say that this is an area of intense research. There are a variety of different technologies that could yield this holy grail of diagnostic measures, including imaging measures such as MRI, PET, and nuclear medicine imaging, the use of genetics to create a polygenic risk score, and serologic analyses of blood to develop a panel of measures that may predict a specific condition or specific subtype of a condition.

It’s very likely, though, that we’ll not have a single pathognomonic test. I suspect that we’ll have several measures that, in combination, will be diagnostic or prognostic, in the same way that with cancer you have nomograms that give a prognosis. Or in the case of cardiovascular disease, where you have a lipid panel that takes into account a variety of lipid analytes to give you a risk score. I do believe that certainly within my professional lifetime, and hopefully sooner rather than later, we will see a diagnostic test.



Dr. Arbuckle: Given the different tests that did not pan out, what guidance can we offer clinicians as data come out and new potential biomarkers hit the media? How can we sift through what may or may not hold real promise?

Dr. Lieberman: I can tell practicing clinicians what not to do. Do not do what some of the charlatans in our field do. There are self-promoting psychiatrists out there who use SPECT scans to get a picture of the brain that is little more than pseudo color phrenology, and then they tell patients, “See this? This indicates that you have (this condition or that condition).” You can’t do that. Nothing we have now has that kind of validity or specificity.

However, even though a standard workup for an illness like schizophrenia does not require specific diagnostic tests, other than to rule out other conditions, imaging procedures can be useful additional information. For example, if you have an individual who presents with symptoms that meet criteria for schizophrenia and you obtain an MRI to rule out other possibilities, and the patient turns out to have dilated lateral ventricles or specific reductions in the size or distortions in the shape of certain temporal cortical structures, particularly in the hippocampus, that adds substance to your clinical diagnosis. So those kinds of things are useful. Similarly, with genetic testing, some institutions are now doing exome sequencing or whole genome sequencing that can provide a risk score. It adds something beyond a family history. These are not diagnostic, but they can add to your understanding.

Finally, with respect to schizophrenia and MRI in particular, if it does show structural abnormalities that are among the ones that have been reported for schizophrenia, this can be informative prognostically; such an individual may have a greater likelihood of having a chronic course with progression of the illness. And if that were my patient, I would be thinking that greater effort needs to be taken to ensure that the patient remains on treatment and does not suffer relapse.



Dr. Arbuckle: How do we prepare our trainees for a future of psychiatry with more biomarkers?

Dr. Lieberman: In medical school and postgraduate training, apart from understanding the method of diagnosis and the criteria for diagnoses, it’s important to understand the ancillary measures that are used in clinical medicine: blood testing, electrophysiologic measures, imaging procedures, neurocognitive testing, etc. This is a standard in terms of general medical training.

In terms of then applying it to mental illness and psychiatry, it’s a matter of knowing that these will be relevant at some point, staying apprised of the research literature that is generating data that pertain to the use of these measures for diagnostic, prognostic, or treatment-specific purposes, and then gauging how useful these will be. Right now, these measures are not required for diagnosis. They’re not validated sufficiently so that third-party payers will uniformly reimburse for them, but at some point they will be. Even before that time occurs, there are some measures that can be informative and enhance confidence in the diagnosis or add information about treatment response and outcome.



Dr. Arbuckle: We’re hearing about biotypes and how biotypes may not map to our current diagnostic systems. What are your thoughts about that?

Dr. Lieberman: You know, psychiatry has always been kind of the stepchild of medicine. And related to that, the Diagnostic and Statistical Manual of Mental Disorders (DSM) is the punching bag of the critics of psychiatry and the purported reason it hasn’t progressed faster. Sitting here at Columbia, the home of Robert Spitzer, who was the pioneer of the modern method of nosology that we still use in the DSM, it’s disappointing that we continue to lob tomatoes at this system, which is the best. It took psychiatry out of what was a dark age of clinical methodology and put it on solid scientific footing. That was in the late 1970s with [the development of] DSM-III.

And as much as we would like to have further progress, which would allow for not using a list of criteria in a menu-driven fashion to establish diagnoses, we’d like to have it be like a glucose tolerance test or an angiogram.

We’d like to do that, but we can’t yet. So there’s this aspirational desire to have something better, and this is permeating and motivating a lot of the research, which is good. But to claim that these don’t map to the current DSM and therefore invalidate the DSM-defined diagnoses is wrong and self-defeating. If the biotypes were validated, we would be using them. So if they don’t map to the current DSM diagnosis, is the diagnosis wrong or are the biotypes wrong? I believe it’s wishful thinking; individuals are trying to project their desires onto clinical practice, and it’s not desirable to do that. If there was anything that was an improvement on the DSM, it would have been incorporated into our practice.

The question about the limitations of DSM and the improved methods of neuroscientifically informed diagnostic systems was an issue that brought me into a confrontation with our former director of the National Institute of Mental Health (NIMH) in 2013.

After 5 years of the DSM task force laboring to revise the fifth edition of the DSM, as it was about to be launched, our former director, Tom Insel, disavowed it and proposed as a preferable alternative the research domains criteria (RDoC) system that was in development at the NIMH, which I believe epitomized this kind of sour grapes at what psychiatry didn’t have – an aspiration to have a more neuroscientifically informed diagnostic system. And as soon as he made the statement publicly, he had to walk it back because the RDoC system or any other system was not ready for prime time. It would have been a catastrophe if it would have been the one that informed clinical psychiatry. There was nothing that was superior to the DSM to be used at the time. This shows how frustration sometimes impels people to make rash statements.

We’re on the right track. Our field is progressing enormously, and one has to remember that everything that’s relevant in terms of being scientifically based and validated through empirical research in clinical psychiatry and mental illness has happened since the last half of the 20th century.

It is a very short period of time. We’ve made tremendous progress, and we’re continuing to make progress toward the milestone we’re all hoping for, where we have diagnostic tests. But we shouldn’t shortchange ourselves or underestimate the progress we have made in the meantime.
 

Dr. Arbuckle: This has been a great conversation. Signing off for Medscape and Columbia Psychiatry. Thank you.

Dr. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association. Dr. Arbuckle is vice chair for education and director of resident education in the Department of Psychiatry at Columbia University. She is particularly interested in the role of medical education in translating research into the practice of psychiatry.

This article first appeared on Medscape.com.

Melissa R. Arbuckle, MD: Hi. I’m Dr. Melissa Arbuckle, vice chair for education and training in the Department of Psychiatry at Columbia University. I’m reporting on behalf of Medscape and our Columbia Psychiatry partnership. Today we’ll be discussing biomarkers with Dr. Jeffrey Lieberman. Welcome.

Jeffrey A. Lieberman, MD: Thanks, Melissa. Great to be here to talk about a subject that is near and dear to my heart.



Dr. Arbuckle: Dr. Lieberman is chair of the Department of Psychiatry at Columbia and is also director of the New York State Psychiatric Institute. Tell us about biomarkers and psychiatry, Dr Lieberman.

Dr. Lieberman: It would be nice if we had some! But first let me tell you what a biomarker is and what it would do for us. A biomarker is a biologic measure, a biologic feature, whether it’s blood pressure, pulse rate, an analyte in blood or cerebrospinal fluid, or a feature of an MRI or PET scan image of the brain that has diagnostic, prognostic, or theragnostic significance. A biomarker identifies an individual with symptoms of a specific disorder, indicates that they have this disorder, and can suggest a particular prognosis – less severe, more severe – or specify which treatment a person would likely respond to. For the entire history of our discipline, as long as physicians have studied mental illness, we have not had a diagnostic test for it. It’s a clinical diagnosis.

All illnesses in medicine began with clinical diagnosis: seizure disorder, epilepsy, was falling sickness; congestive heart failure was dropsy; for diabetes you tasted the urine to see if it was sweet or watery. But when we began to measure glucose and hemoglobin A1c, or when we developed the electrocardiogram to measure heart rhythms, and the electroencephalogram to measure brain activity, those were diagnostic tests based on biomarkers. We just don’t have them yet in psychiatry. The day we do have our first diagnostic tests, courtesy of a validated biomarker, will be a real milestone in the history of our profession.



Dr. Arbuckle: How far off might that be for psychiatry?

Dr. Lieberman: I’ve been in this profession for more than 30 years, and I’ve been saying for a while that it is coming soon. But we’re still waiting. Let me just add a cautionary note. Ever since psychiatry became scientifically minded and used scientific methodology and technology to understand the underpinnings of mental illness, there’s been an effort to identify biomarkers. It began in the 1960s with a series of false leads. There was something called the pink spot, as well as other metabolites, which were indicators on chromatographs linked to schizophrenia. This turned out to be wrong.

There was also the dexamethasone suppression test, to identify people who hypersecreted cortisol, which was believed to be diagnostic of depression. That turned out to be inadequate also.

There was the identification of genes beginning in the late 1980s. But the specific genes that indicated manic depressive illness and schizophrenia were not replicated. And now we know that the genetics of these disorders is polygenic and very complex.

So we cannot overpromise. I don’t want to say exactly when, but I will say that this is an area of intense research. There are a variety of different technologies that could yield this holy grail of diagnostic measures, including imaging measures such as MRI, PET, and nuclear medicine imaging, the use of genetics to create a polygenic risk score, and serologic analyses of blood to develop a panel of measures that may predict a specific condition or specific subtype of a condition.

It’s very likely, though, that we’ll not have a single pathognomonic test. I suspect that we’ll have several measures that, in combination, will be diagnostic or prognostic, in the same way that with cancer you have nomograms that give a prognosis. Or in the case of cardiovascular disease, where you have a lipid panel that takes into account a variety of lipid analytes to give you a risk score. I do believe that certainly within my professional lifetime, and hopefully sooner rather than later, we will see a diagnostic test.



Dr. Arbuckle: Given the different tests that did not pan out, what guidance can we offer clinicians as data come out and new potential biomarkers hit the media? How can we sift through what may or may not hold real promise?

Dr. Lieberman: I can tell practicing clinicians what not to do. Do not do what some of the charlatans in our field do. There are self-promoting psychiatrists out there who use SPECT scans to get a picture of the brain that is little more than pseudo color phrenology, and then they tell patients, “See this? This indicates that you have (this condition or that condition).” You can’t do that. Nothing we have now has that kind of validity or specificity.

However, even though a standard workup for an illness like schizophrenia does not require specific diagnostic tests, other than to rule out other conditions, imaging procedures can be useful additional information. For example, if you have an individual who presents with symptoms that meet criteria for schizophrenia and you obtain an MRI to rule out other possibilities, and the patient turns out to have dilated lateral ventricles or specific reductions in the size or distortions in the shape of certain temporal cortical structures, particularly in the hippocampus, that adds substance to your clinical diagnosis. So those kinds of things are useful. Similarly, with genetic testing, some institutions are now doing exome sequencing or whole genome sequencing that can provide a risk score. It adds something beyond a family history. These are not diagnostic, but they can add to your understanding.

Finally, with respect to schizophrenia and MRI in particular, if it does show structural abnormalities that are among the ones that have been reported for schizophrenia, this can be informative prognostically; such an individual may have a greater likelihood of having a chronic course with progression of the illness. And if that were my patient, I would be thinking that greater effort needs to be taken to ensure that the patient remains on treatment and does not suffer relapse.



Dr. Arbuckle: How do we prepare our trainees for a future of psychiatry with more biomarkers?

Dr. Lieberman: In medical school and postgraduate training, apart from understanding the method of diagnosis and the criteria for diagnoses, it’s important to understand the ancillary measures that are used in clinical medicine: blood testing, electrophysiologic measures, imaging procedures, neurocognitive testing, etc. This is a standard in terms of general medical training.

In terms of then applying it to mental illness and psychiatry, it’s a matter of knowing that these will be relevant at some point, staying apprised of the research literature that is generating data that pertain to the use of these measures for diagnostic, prognostic, or treatment-specific purposes, and then gauging how useful these will be. Right now, these measures are not required for diagnosis. They’re not validated sufficiently so that third-party payers will uniformly reimburse for them, but at some point they will be. Even before that time occurs, there are some measures that can be informative and enhance confidence in the diagnosis or add information about treatment response and outcome.



Dr. Arbuckle: We’re hearing about biotypes and how biotypes may not map to our current diagnostic systems. What are your thoughts about that?

Dr. Lieberman: You know, psychiatry has always been kind of the stepchild of medicine. And related to that, the Diagnostic and Statistical Manual of Mental Disorders (DSM) is the punching bag of the critics of psychiatry and the purported reason it hasn’t progressed faster. Sitting here at Columbia, the home of Robert Spitzer, who was the pioneer of the modern method of nosology that we still use in the DSM, it’s disappointing that we continue to lob tomatoes at this system, which is the best. It took psychiatry out of what was a dark age of clinical methodology and put it on solid scientific footing. That was in the late 1970s with [the development of] DSM-III.

And as much as we would like to have further progress, which would allow for not using a list of criteria in a menu-driven fashion to establish diagnoses, we’d like to have it be like a glucose tolerance test or an angiogram.

We’d like to do that, but we can’t yet. So there’s this aspirational desire to have something better, and this is permeating and motivating a lot of the research, which is good. But to claim that these don’t map to the current DSM and therefore invalidate the DSM-defined diagnoses is wrong and self-defeating. If the biotypes were validated, we would be using them. So if they don’t map to the current DSM diagnosis, is the diagnosis wrong or are the biotypes wrong? I believe it’s wishful thinking; individuals are trying to project their desires onto clinical practice, and it’s not desirable to do that. If there was anything that was an improvement on the DSM, it would have been incorporated into our practice.

The question about the limitations of DSM and the improved methods of neuroscientifically informed diagnostic systems was an issue that brought me into a confrontation with our former director of the National Institute of Mental Health (NIMH) in 2013.

After 5 years of the DSM task force laboring to revise the fifth edition of the DSM, as it was about to be launched, our former director, Tom Insel, disavowed it and proposed as a preferable alternative the research domains criteria (RDoC) system that was in development at the NIMH, which I believe epitomized this kind of sour grapes at what psychiatry didn’t have – an aspiration to have a more neuroscientifically informed diagnostic system. And as soon as he made the statement publicly, he had to walk it back because the RDoC system or any other system was not ready for prime time. It would have been a catastrophe if it would have been the one that informed clinical psychiatry. There was nothing that was superior to the DSM to be used at the time. This shows how frustration sometimes impels people to make rash statements.

We’re on the right track. Our field is progressing enormously, and one has to remember that everything that’s relevant in terms of being scientifically based and validated through empirical research in clinical psychiatry and mental illness has happened since the last half of the 20th century.

It is a very short period of time. We’ve made tremendous progress, and we’re continuing to make progress toward the milestone we’re all hoping for, where we have diagnostic tests. But we shouldn’t shortchange ourselves or underestimate the progress we have made in the meantime.
 

Dr. Arbuckle: This has been a great conversation. Signing off for Medscape and Columbia Psychiatry. Thank you.

Dr. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association. Dr. Arbuckle is vice chair for education and director of resident education in the Department of Psychiatry at Columbia University. She is particularly interested in the role of medical education in translating research into the practice of psychiatry.

This article first appeared on Medscape.com.

Melissa R. Arbuckle, MD: Hi. I’m Dr. Melissa Arbuckle, vice chair for education and training in the Department of Psychiatry at Columbia University. I’m reporting on behalf of Medscape and our Columbia Psychiatry partnership. Today we’ll be discussing biomarkers with Dr. Jeffrey Lieberman. Welcome.

Jeffrey A. Lieberman, MD: Thanks, Melissa. Great to be here to talk about a subject that is near and dear to my heart.



Dr. Arbuckle: Dr. Lieberman is chair of the Department of Psychiatry at Columbia and is also director of the New York State Psychiatric Institute. Tell us about biomarkers and psychiatry, Dr Lieberman.

Dr. Lieberman: It would be nice if we had some! But first let me tell you what a biomarker is and what it would do for us. A biomarker is a biologic measure, a biologic feature, whether it’s blood pressure, pulse rate, an analyte in blood or cerebrospinal fluid, or a feature of an MRI or PET scan image of the brain that has diagnostic, prognostic, or theragnostic significance. A biomarker identifies an individual with symptoms of a specific disorder, indicates that they have this disorder, and can suggest a particular prognosis – less severe, more severe – or specify which treatment a person would likely respond to. For the entire history of our discipline, as long as physicians have studied mental illness, we have not had a diagnostic test for it. It’s a clinical diagnosis.

All illnesses in medicine began with clinical diagnosis: seizure disorder, epilepsy, was falling sickness; congestive heart failure was dropsy; for diabetes you tasted the urine to see if it was sweet or watery. But when we began to measure glucose and hemoglobin A1c, or when we developed the electrocardiogram to measure heart rhythms, and the electroencephalogram to measure brain activity, those were diagnostic tests based on biomarkers. We just don’t have them yet in psychiatry. The day we do have our first diagnostic tests, courtesy of a validated biomarker, will be a real milestone in the history of our profession.



Dr. Arbuckle: How far off might that be for psychiatry?

Dr. Lieberman: I’ve been in this profession for more than 30 years, and I’ve been saying for a while that it is coming soon. But we’re still waiting. Let me just add a cautionary note. Ever since psychiatry became scientifically minded and used scientific methodology and technology to understand the underpinnings of mental illness, there’s been an effort to identify biomarkers. It began in the 1960s with a series of false leads. There was something called the pink spot, as well as other metabolites, which were indicators on chromatographs linked to schizophrenia. This turned out to be wrong.

There was also the dexamethasone suppression test, to identify people who hypersecreted cortisol, which was believed to be diagnostic of depression. That turned out to be inadequate also.

There was the identification of genes beginning in the late 1980s. But the specific genes that indicated manic depressive illness and schizophrenia were not replicated. And now we know that the genetics of these disorders is polygenic and very complex.

So we cannot overpromise. I don’t want to say exactly when, but I will say that this is an area of intense research. There are a variety of different technologies that could yield this holy grail of diagnostic measures, including imaging measures such as MRI, PET, and nuclear medicine imaging, the use of genetics to create a polygenic risk score, and serologic analyses of blood to develop a panel of measures that may predict a specific condition or specific subtype of a condition.

It’s very likely, though, that we’ll not have a single pathognomonic test. I suspect that we’ll have several measures that, in combination, will be diagnostic or prognostic, in the same way that with cancer you have nomograms that give a prognosis. Or in the case of cardiovascular disease, where you have a lipid panel that takes into account a variety of lipid analytes to give you a risk score. I do believe that certainly within my professional lifetime, and hopefully sooner rather than later, we will see a diagnostic test.



Dr. Arbuckle: Given the different tests that did not pan out, what guidance can we offer clinicians as data come out and new potential biomarkers hit the media? How can we sift through what may or may not hold real promise?

Dr. Lieberman: I can tell practicing clinicians what not to do. Do not do what some of the charlatans in our field do. There are self-promoting psychiatrists out there who use SPECT scans to get a picture of the brain that is little more than pseudo color phrenology, and then they tell patients, “See this? This indicates that you have (this condition or that condition).” You can’t do that. Nothing we have now has that kind of validity or specificity.

However, even though a standard workup for an illness like schizophrenia does not require specific diagnostic tests, other than to rule out other conditions, imaging procedures can be useful additional information. For example, if you have an individual who presents with symptoms that meet criteria for schizophrenia and you obtain an MRI to rule out other possibilities, and the patient turns out to have dilated lateral ventricles or specific reductions in the size or distortions in the shape of certain temporal cortical structures, particularly in the hippocampus, that adds substance to your clinical diagnosis. So those kinds of things are useful. Similarly, with genetic testing, some institutions are now doing exome sequencing or whole genome sequencing that can provide a risk score. It adds something beyond a family history. These are not diagnostic, but they can add to your understanding.

Finally, with respect to schizophrenia and MRI in particular, if it does show structural abnormalities that are among the ones that have been reported for schizophrenia, this can be informative prognostically; such an individual may have a greater likelihood of having a chronic course with progression of the illness. And if that were my patient, I would be thinking that greater effort needs to be taken to ensure that the patient remains on treatment and does not suffer relapse.



Dr. Arbuckle: How do we prepare our trainees for a future of psychiatry with more biomarkers?

Dr. Lieberman: In medical school and postgraduate training, apart from understanding the method of diagnosis and the criteria for diagnoses, it’s important to understand the ancillary measures that are used in clinical medicine: blood testing, electrophysiologic measures, imaging procedures, neurocognitive testing, etc. This is a standard in terms of general medical training.

In terms of then applying it to mental illness and psychiatry, it’s a matter of knowing that these will be relevant at some point, staying apprised of the research literature that is generating data that pertain to the use of these measures for diagnostic, prognostic, or treatment-specific purposes, and then gauging how useful these will be. Right now, these measures are not required for diagnosis. They’re not validated sufficiently so that third-party payers will uniformly reimburse for them, but at some point they will be. Even before that time occurs, there are some measures that can be informative and enhance confidence in the diagnosis or add information about treatment response and outcome.



Dr. Arbuckle: We’re hearing about biotypes and how biotypes may not map to our current diagnostic systems. What are your thoughts about that?

Dr. Lieberman: You know, psychiatry has always been kind of the stepchild of medicine. And related to that, the Diagnostic and Statistical Manual of Mental Disorders (DSM) is the punching bag of the critics of psychiatry and the purported reason it hasn’t progressed faster. Sitting here at Columbia, the home of Robert Spitzer, who was the pioneer of the modern method of nosology that we still use in the DSM, it’s disappointing that we continue to lob tomatoes at this system, which is the best. It took psychiatry out of what was a dark age of clinical methodology and put it on solid scientific footing. That was in the late 1970s with [the development of] DSM-III.

And as much as we would like to have further progress, which would allow for not using a list of criteria in a menu-driven fashion to establish diagnoses, we’d like to have it be like a glucose tolerance test or an angiogram.

We’d like to do that, but we can’t yet. So there’s this aspirational desire to have something better, and this is permeating and motivating a lot of the research, which is good. But to claim that these don’t map to the current DSM and therefore invalidate the DSM-defined diagnoses is wrong and self-defeating. If the biotypes were validated, we would be using them. So if they don’t map to the current DSM diagnosis, is the diagnosis wrong or are the biotypes wrong? I believe it’s wishful thinking; individuals are trying to project their desires onto clinical practice, and it’s not desirable to do that. If there was anything that was an improvement on the DSM, it would have been incorporated into our practice.

The question about the limitations of DSM and the improved methods of neuroscientifically informed diagnostic systems was an issue that brought me into a confrontation with our former director of the National Institute of Mental Health (NIMH) in 2013.

After 5 years of the DSM task force laboring to revise the fifth edition of the DSM, as it was about to be launched, our former director, Tom Insel, disavowed it and proposed as a preferable alternative the research domains criteria (RDoC) system that was in development at the NIMH, which I believe epitomized this kind of sour grapes at what psychiatry didn’t have – an aspiration to have a more neuroscientifically informed diagnostic system. And as soon as he made the statement publicly, he had to walk it back because the RDoC system or any other system was not ready for prime time. It would have been a catastrophe if it would have been the one that informed clinical psychiatry. There was nothing that was superior to the DSM to be used at the time. This shows how frustration sometimes impels people to make rash statements.

We’re on the right track. Our field is progressing enormously, and one has to remember that everything that’s relevant in terms of being scientifically based and validated through empirical research in clinical psychiatry and mental illness has happened since the last half of the 20th century.

It is a very short period of time. We’ve made tremendous progress, and we’re continuing to make progress toward the milestone we’re all hoping for, where we have diagnostic tests. But we shouldn’t shortchange ourselves or underestimate the progress we have made in the meantime.
 

Dr. Arbuckle: This has been a great conversation. Signing off for Medscape and Columbia Psychiatry. Thank you.

Dr. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association. Dr. Arbuckle is vice chair for education and director of resident education in the Department of Psychiatry at Columbia University. She is particularly interested in the role of medical education in translating research into the practice of psychiatry.

This article first appeared on Medscape.com.

It is clear that the coronavirus 2019 disease (COVID-19) pandemic is one of the most extraordinary epochs of our professional and personal lives. Besides the challenges to the techniques and technologies of care for this illness, we are seeing challenges to the fundamentals of health care, both to the systems whereby it is delivered, and to the ethical principles that guide that delivery. There is unprecedented relevance of certain ethical issues in the practice of medicine, many of which have previously been discussed in classrooms and textbooks, but now are at play in daily practice, particularly at the frontlines of the war against COVID-19.¹ In this article, I highlight several ethical dilemmas that are salient to these unique times. Some of the most compelling issues can be sorted into 2 clearly overlapping domains: triage ethics and equity ethics.

Triage ethics

In the areas most greatly affected by the COVID-19 pandemic, scarcity of treatment resources, such as ventilators, is a legitimate concern. French surgeon Dominique Jean Larry was the first to establish medical sorting protocols in the context of the battles of the Napoleonic wars, for which he used the French word triage, meaning “sorting.”² He articulated 3 prognostic categories: 1) those who would die even with treatment, 2) those who would live without treatment, and 3) those who would die unless treated. Triage decisions arise in the context of insufficient resources, particularly space, staff, and supplies. Although usually identified with disasters, these decisions can arise in other contexts where personnel or technological resources are inadequate. Indeed, one of the first modern incarnations of triage ethics in American civilian life was in the early days of hemodialysis, when so-called “God committees” made complex decisions about which patients would be able to use this new, rare technology.³

Two fundamental moral constructs undergird medical ethics: deontological and utilitarian. The former, in which most clinicians traffic in ordinary practice, is driven by principles or moral rules such as the sanctity of life, the rule of fairness, and the principle of autonomy.⁴ They apply primarily in the context of treating an individual patient. The utilitarian way of reasoning is not as familiar to clinicians. It is focused on the broader context, the common good, the health of the group. It asks to calculate “the greatest good for the greatest number” as a means of navigating ethical dilemmas.⁵ The utilitarian perspective is far more familiar to policymakers, health care administrators, and public health professionals. It tends to be anathema to clinicians. However, disasters such as the COVID-19 pandemic ask some clinicians, particularly inpatient physicians, to shift from their usual deontological perspective to a utilitarian one, because triage ethics fundamentally draw on utilitarian reasoning. This can be quite anguishing to clinicians who typically work with individual patients in settings of more adequate, if not abundant, resources. What may feel wrong in a deontological mode can be seen as ethically right in a utilitarian framework.

The Table compares and contrasts these 2 paradigms and how they manifest in the clinical trenches, in a protracted health care crisis with limited resources.

The COVID-19 crisis has produced an unprecedented and extended exposure of clinicians to triage situations in the face of limited resources such as ventilators, personnel, personal protective equipment, etc.⁶ Numerous possible approaches to deploying limited supplies are being considered. On what basis should such decisions be made? How can fairness be optimally manifest? Some possibilities include:

• first come, first served
• youngest first
• lottery
• short-term survivability
• long-term prognosis for quality of life
• value of a patient to the lives of others (eg, parents, health care workers, vaccine researchers).

One particularly interesting exploration of these questions was done in Maryland and reported in the “Maryland Framework for the Allocation of Scarce Life-sustaining Medical Resources in a Catastrophic Public Health Emergency.”⁷ This was the product of a multi-year consultation, ending in 2017, with several constituencies, including clinicians, politicians, hospital administrators, and members of the public brainstorming about approaches to allocating a hypothetical scarcity of ventilators. Interestingly, there was one broad consensus among these groups: a ventilator should not be withdrawn from a patient already using it to give to a “better” candidate who comes along later.

Some institutions have developed a method of making triage decisions that takes such decisions out of the hands of individual clinicians and instead assigns them to specialized “triage teams” made up of ethicists and clinicians experienced in critical care, to develop more distance from the emotions at the bedside. To minimize bias, such teams are often insulated from getting personal information about the patient, and receive only acute clinical information.⁸

Continue to: The pros and cons of these approaches...

The pros and cons of these approaches and the underlying ethical reasoning is beyond the scope of this overview. Policy documents from different states, regions, nations, and institutions have various approaches to making these choices. Presently, there is no coherent national or international agreement on triage ethics.⁹ It is important, however, that there be transparency in whatever approach an institution adopts for triage decisions.

Equity ethics

Though the equitable distribution of health care delivery has long been a concern, this problem has become magnified by the COVID-19 crisis. Race, sex, age, socioeconomic class, and type of illness have all been perennial sources of division between those who have better or worse access to health care and its outcomes. All of these distinctions have created differentials in rates of cases, hospitalizations, and deaths in the COVID-19 pandemic.¹⁰

The shifting of acute health care facilities to mostly COVID-19–related treatment, and postponing less critical and more “elective” care, creates a divide based on illness type. Many facilities have stopped taking admissions for other kinds of cases. This is particularly relevant to psychiatric units, many of which have had to decrease their bed capacities to make all rooms private, and limit their usual treatments offered to inpatients.¹¹ Many long-term units, such as at state hospitals, are closing to new admissions. Many day hospitals and intensive outpatient programs remain closed, not even shifting to telehealth. In areas most affected by COVID-19, some institutions have closed psychiatric wards and reallocated psychiatrists to cover some of the medical units. So the availability of the more intensive, institutionally-based levels of care is significantly reduced, particularly for psychiatric patients.¹² These patients already are a disadvantaged population in the distribution of health care resources, and the care of individuals with serious mental illness is more likely to be seen as “nonessential” in this time of suddenly scarcer institutional resources.

One of the cherished ethical values in health care is autonomy, and in a deontological triage environment, honoring patient autonomy is carefully and tenderly administered. However, in a utilitarian-driven triage environment, considerations of the common good can trump autonomy, even in subtle ways that create inequities. Clinicians have been advised to have more frank conversations with patients, particularly those with chronic illnesses, stepping up initiatives to make advanced directives during this crisis, explicitly reminding patients that there may not be enough ventilators for all who need one.¹³ Some have argued that such physician-initiated conversations can be inherently coercive, making these decisions not as autonomous as it may appear, similar to physicians suggesting medical euthanasia as an option.¹⁴ Interestingly, some jurisdictions that offer euthanasia have been suspending such services during the COVID-19 crisis.¹⁵ Some hospitals have even wrestled with the possibility that all COVID-19 admissions should be considered “do not resuscitate,” especially because cardiopulmonary resuscitation significantly elevates the risks of viral exposure for the treatment team.^16,17 A more explicit example of how current standards protecting patient autonomy may be challenged is patients who are admitted involuntarily to a psychiatric unit. These are patients whose presumptively impaired autonomy is already being overridden by the involuntary nature of the admission. If a psychiatric unit requires admissions to be COVID-19–negative, and if patients refuse COVID-19 testing, should the testing be forced upon them to protect the entire milieu?

Many ethicists are highlighting the embedded equity bias known as “ableism” inherent in triage decisions—implicitly disfavoring resources for patients with COVID-19 who are already physically or intellectually disabled, chronically ill, aged, homeless, psychosocially low functioning, etc.¹⁸ Without explicit protections for individuals who are chronically disabled, triage decisions unguided by policy safeguards may reflexively favor the more “abled.” This bias towards the more abled is often inherent in how difficult it is to access health care. It can also be manifested in bedside triage decisions made in the moment by individual clinicians. Many disability rights advocates have been sounding this alarm during the COVID-19 crisis.¹⁹

Continue to: A special circumstance of equity...

A special circumstance of equity is arising during this ongoing pandemic—the possibility of treating health care workers as a privileged class. Unlike typical disasters, where health care workers come in afterwards, and therefore are in relatively less danger, pandemics create particularly high risks of danger for such individuals, with repeated exposure to the virus. They are both responders and potential victims. Should they have higher priority for ventilators, vaccines, funding, etc?⁶ This is a more robust degree of compensatory justice than merely giving appreciation. Giving health care workers such advantages may seem intuitively appealing, but perhaps professionalism and the self-obligation of duty mitigates such claims.²⁰

A unique opportunity

The magnitude and pervasiveness of this pandemic crisis is unique in our lifetimes, as both professionals and as citizens. In the crucible of this extraordinary time, these and other medical ethics dilemmas burn hotter than ever before. Different societies and institutions may come up with different answers, based on their cultures and values. It is important, however, that the venerable ethos of medical ethics, which has evolved through the millennia, codified in oaths, codes, and scholarship, can be a compass at the bedside and in the meetings of legislatures, leaders, and policymakers. Perhaps we can emerge from this time with more clarity about how to balance the preciousness of individual rights with the needs of the common good.

Bottom Line

The coronavirus disease 2019 (COVID-19) pandemic has brought increased attention to triage ethics and equity ethics. There is no coherent national or international agreement on how to best deploy limited supplies such as ventilators and personal protective equipment. Although the equitable distribution of health care delivery has long been a concern, this problem has become magnified by COVID-19. Clinicians may be asked to view health care through the less familiar lens of the common good, as opposed to focusing strictly on an individual patient.

Related Resources

• Johns Hopkins Berman Institute of Bioethics. Coronavirus ethics and policy insights and resources. https://bioethics.jhu.edu/research-and-outreach/covid-19-bioethics-expert-insights/.
• Daugherty-Biddison L, Gwon H, Regenberg A, et al. Maryland framework for the allocation of scarce lifesustaining medical resources in a catastrophic public health emergency. www.law.umaryland.edu/media/SOL/pdfs/Programs/Health-Law/MHECN/ASR%20Framework_Final.pdf.

It is clear that the coronavirus 2019 disease (COVID-19) pandemic is one of the most extraordinary epochs of our professional and personal lives. Besides the challenges to the techniques and technologies of care for this illness, we are seeing challenges to the fundamentals of health care, both to the systems whereby it is delivered, and to the ethical principles that guide that delivery. There is unprecedented relevance of certain ethical issues in the practice of medicine, many of which have previously been discussed in classrooms and textbooks, but now are at play in daily practice, particularly at the frontlines of the war against COVID-19.¹ In this article, I highlight several ethical dilemmas that are salient to these unique times. Some of the most compelling issues can be sorted into 2 clearly overlapping domains: triage ethics and equity ethics.

Triage ethics

In the areas most greatly affected by the COVID-19 pandemic, scarcity of treatment resources, such as ventilators, is a legitimate concern. French surgeon Dominique Jean Larry was the first to establish medical sorting protocols in the context of the battles of the Napoleonic wars, for which he used the French word triage, meaning “sorting.”² He articulated 3 prognostic categories: 1) those who would die even with treatment, 2) those who would live without treatment, and 3) those who would die unless treated. Triage decisions arise in the context of insufficient resources, particularly space, staff, and supplies. Although usually identified with disasters, these decisions can arise in other contexts where personnel or technological resources are inadequate. Indeed, one of the first modern incarnations of triage ethics in American civilian life was in the early days of hemodialysis, when so-called “God committees” made complex decisions about which patients would be able to use this new, rare technology.³

Two fundamental moral constructs undergird medical ethics: deontological and utilitarian. The former, in which most clinicians traffic in ordinary practice, is driven by principles or moral rules such as the sanctity of life, the rule of fairness, and the principle of autonomy.⁴ They apply primarily in the context of treating an individual patient. The utilitarian way of reasoning is not as familiar to clinicians. It is focused on the broader context, the common good, the health of the group. It asks to calculate “the greatest good for the greatest number” as a means of navigating ethical dilemmas.⁵ The utilitarian perspective is far more familiar to policymakers, health care administrators, and public health professionals. It tends to be anathema to clinicians. However, disasters such as the COVID-19 pandemic ask some clinicians, particularly inpatient physicians, to shift from their usual deontological perspective to a utilitarian one, because triage ethics fundamentally draw on utilitarian reasoning. This can be quite anguishing to clinicians who typically work with individual patients in settings of more adequate, if not abundant, resources. What may feel wrong in a deontological mode can be seen as ethically right in a utilitarian framework.

The Table compares and contrasts these 2 paradigms and how they manifest in the clinical trenches, in a protracted health care crisis with limited resources.

The COVID-19 crisis has produced an unprecedented and extended exposure of clinicians to triage situations in the face of limited resources such as ventilators, personnel, personal protective equipment, etc.⁶ Numerous possible approaches to deploying limited supplies are being considered. On what basis should such decisions be made? How can fairness be optimally manifest? Some possibilities include:

• first come, first served
• youngest first
• lottery
• short-term survivability
• long-term prognosis for quality of life
• value of a patient to the lives of others (eg, parents, health care workers, vaccine researchers).

One particularly interesting exploration of these questions was done in Maryland and reported in the “Maryland Framework for the Allocation of Scarce Life-sustaining Medical Resources in a Catastrophic Public Health Emergency.”⁷ This was the product of a multi-year consultation, ending in 2017, with several constituencies, including clinicians, politicians, hospital administrators, and members of the public brainstorming about approaches to allocating a hypothetical scarcity of ventilators. Interestingly, there was one broad consensus among these groups: a ventilator should not be withdrawn from a patient already using it to give to a “better” candidate who comes along later.

Some institutions have developed a method of making triage decisions that takes such decisions out of the hands of individual clinicians and instead assigns them to specialized “triage teams” made up of ethicists and clinicians experienced in critical care, to develop more distance from the emotions at the bedside. To minimize bias, such teams are often insulated from getting personal information about the patient, and receive only acute clinical information.⁸

Continue to: The pros and cons of these approaches...

The pros and cons of these approaches and the underlying ethical reasoning is beyond the scope of this overview. Policy documents from different states, regions, nations, and institutions have various approaches to making these choices. Presently, there is no coherent national or international agreement on triage ethics.⁹ It is important, however, that there be transparency in whatever approach an institution adopts for triage decisions.

Equity ethics

Though the equitable distribution of health care delivery has long been a concern, this problem has become magnified by the COVID-19 crisis. Race, sex, age, socioeconomic class, and type of illness have all been perennial sources of division between those who have better or worse access to health care and its outcomes. All of these distinctions have created differentials in rates of cases, hospitalizations, and deaths in the COVID-19 pandemic.¹⁰

The shifting of acute health care facilities to mostly COVID-19–related treatment, and postponing less critical and more “elective” care, creates a divide based on illness type. Many facilities have stopped taking admissions for other kinds of cases. This is particularly relevant to psychiatric units, many of which have had to decrease their bed capacities to make all rooms private, and limit their usual treatments offered to inpatients.¹¹ Many long-term units, such as at state hospitals, are closing to new admissions. Many day hospitals and intensive outpatient programs remain closed, not even shifting to telehealth. In areas most affected by COVID-19, some institutions have closed psychiatric wards and reallocated psychiatrists to cover some of the medical units. So the availability of the more intensive, institutionally-based levels of care is significantly reduced, particularly for psychiatric patients.¹² These patients already are a disadvantaged population in the distribution of health care resources, and the care of individuals with serious mental illness is more likely to be seen as “nonessential” in this time of suddenly scarcer institutional resources.

One of the cherished ethical values in health care is autonomy, and in a deontological triage environment, honoring patient autonomy is carefully and tenderly administered. However, in a utilitarian-driven triage environment, considerations of the common good can trump autonomy, even in subtle ways that create inequities. Clinicians have been advised to have more frank conversations with patients, particularly those with chronic illnesses, stepping up initiatives to make advanced directives during this crisis, explicitly reminding patients that there may not be enough ventilators for all who need one.¹³ Some have argued that such physician-initiated conversations can be inherently coercive, making these decisions not as autonomous as it may appear, similar to physicians suggesting medical euthanasia as an option.¹⁴ Interestingly, some jurisdictions that offer euthanasia have been suspending such services during the COVID-19 crisis.¹⁵ Some hospitals have even wrestled with the possibility that all COVID-19 admissions should be considered “do not resuscitate,” especially because cardiopulmonary resuscitation significantly elevates the risks of viral exposure for the treatment team.^16,17 A more explicit example of how current standards protecting patient autonomy may be challenged is patients who are admitted involuntarily to a psychiatric unit. These are patients whose presumptively impaired autonomy is already being overridden by the involuntary nature of the admission. If a psychiatric unit requires admissions to be COVID-19–negative, and if patients refuse COVID-19 testing, should the testing be forced upon them to protect the entire milieu?

Many ethicists are highlighting the embedded equity bias known as “ableism” inherent in triage decisions—implicitly disfavoring resources for patients with COVID-19 who are already physically or intellectually disabled, chronically ill, aged, homeless, psychosocially low functioning, etc.¹⁸ Without explicit protections for individuals who are chronically disabled, triage decisions unguided by policy safeguards may reflexively favor the more “abled.” This bias towards the more abled is often inherent in how difficult it is to access health care. It can also be manifested in bedside triage decisions made in the moment by individual clinicians. Many disability rights advocates have been sounding this alarm during the COVID-19 crisis.¹⁹

Continue to: A special circumstance of equity...

A special circumstance of equity is arising during this ongoing pandemic—the possibility of treating health care workers as a privileged class. Unlike typical disasters, where health care workers come in afterwards, and therefore are in relatively less danger, pandemics create particularly high risks of danger for such individuals, with repeated exposure to the virus. They are both responders and potential victims. Should they have higher priority for ventilators, vaccines, funding, etc?⁶ This is a more robust degree of compensatory justice than merely giving appreciation. Giving health care workers such advantages may seem intuitively appealing, but perhaps professionalism and the self-obligation of duty mitigates such claims.²⁰

A unique opportunity

The magnitude and pervasiveness of this pandemic crisis is unique in our lifetimes, as both professionals and as citizens. In the crucible of this extraordinary time, these and other medical ethics dilemmas burn hotter than ever before. Different societies and institutions may come up with different answers, based on their cultures and values. It is important, however, that the venerable ethos of medical ethics, which has evolved through the millennia, codified in oaths, codes, and scholarship, can be a compass at the bedside and in the meetings of legislatures, leaders, and policymakers. Perhaps we can emerge from this time with more clarity about how to balance the preciousness of individual rights with the needs of the common good.

Bottom Line

The coronavirus disease 2019 (COVID-19) pandemic has brought increased attention to triage ethics and equity ethics. There is no coherent national or international agreement on how to best deploy limited supplies such as ventilators and personal protective equipment. Although the equitable distribution of health care delivery has long been a concern, this problem has become magnified by COVID-19. Clinicians may be asked to view health care through the less familiar lens of the common good, as opposed to focusing strictly on an individual patient.

Related Resources

• Johns Hopkins Berman Institute of Bioethics. Coronavirus ethics and policy insights and resources. https://bioethics.jhu.edu/research-and-outreach/covid-19-bioethics-expert-insights/.
• Daugherty-Biddison L, Gwon H, Regenberg A, et al. Maryland framework for the allocation of scarce lifesustaining medical resources in a catastrophic public health emergency. www.law.umaryland.edu/media/SOL/pdfs/Programs/Health-Law/MHECN/ASR%20Framework_Final.pdf.

It is clear that the coronavirus 2019 disease (COVID-19) pandemic is one of the most extraordinary epochs of our professional and personal lives. Besides the challenges to the techniques and technologies of care for this illness, we are seeing challenges to the fundamentals of health care, both to the systems whereby it is delivered, and to the ethical principles that guide that delivery. There is unprecedented relevance of certain ethical issues in the practice of medicine, many of which have previously been discussed in classrooms and textbooks, but now are at play in daily practice, particularly at the frontlines of the war against COVID-19.¹ In this article, I highlight several ethical dilemmas that are salient to these unique times. Some of the most compelling issues can be sorted into 2 clearly overlapping domains: triage ethics and equity ethics.

Triage ethics

In the areas most greatly affected by the COVID-19 pandemic, scarcity of treatment resources, such as ventilators, is a legitimate concern. French surgeon Dominique Jean Larry was the first to establish medical sorting protocols in the context of the battles of the Napoleonic wars, for which he used the French word triage, meaning “sorting.”² He articulated 3 prognostic categories: 1) those who would die even with treatment, 2) those who would live without treatment, and 3) those who would die unless treated. Triage decisions arise in the context of insufficient resources, particularly space, staff, and supplies. Although usually identified with disasters, these decisions can arise in other contexts where personnel or technological resources are inadequate. Indeed, one of the first modern incarnations of triage ethics in American civilian life was in the early days of hemodialysis, when so-called “God committees” made complex decisions about which patients would be able to use this new, rare technology.³

Two fundamental moral constructs undergird medical ethics: deontological and utilitarian. The former, in which most clinicians traffic in ordinary practice, is driven by principles or moral rules such as the sanctity of life, the rule of fairness, and the principle of autonomy.⁴ They apply primarily in the context of treating an individual patient. The utilitarian way of reasoning is not as familiar to clinicians. It is focused on the broader context, the common good, the health of the group. It asks to calculate “the greatest good for the greatest number” as a means of navigating ethical dilemmas.⁵ The utilitarian perspective is far more familiar to policymakers, health care administrators, and public health professionals. It tends to be anathema to clinicians. However, disasters such as the COVID-19 pandemic ask some clinicians, particularly inpatient physicians, to shift from their usual deontological perspective to a utilitarian one, because triage ethics fundamentally draw on utilitarian reasoning. This can be quite anguishing to clinicians who typically work with individual patients in settings of more adequate, if not abundant, resources. What may feel wrong in a deontological mode can be seen as ethically right in a utilitarian framework.

The Table compares and contrasts these 2 paradigms and how they manifest in the clinical trenches, in a protracted health care crisis with limited resources.

The COVID-19 crisis has produced an unprecedented and extended exposure of clinicians to triage situations in the face of limited resources such as ventilators, personnel, personal protective equipment, etc.⁶ Numerous possible approaches to deploying limited supplies are being considered. On what basis should such decisions be made? How can fairness be optimally manifest? Some possibilities include:

• first come, first served
• youngest first
• lottery
• short-term survivability
• long-term prognosis for quality of life
• value of a patient to the lives of others (eg, parents, health care workers, vaccine researchers).

One particularly interesting exploration of these questions was done in Maryland and reported in the “Maryland Framework for the Allocation of Scarce Life-sustaining Medical Resources in a Catastrophic Public Health Emergency.”⁷ This was the product of a multi-year consultation, ending in 2017, with several constituencies, including clinicians, politicians, hospital administrators, and members of the public brainstorming about approaches to allocating a hypothetical scarcity of ventilators. Interestingly, there was one broad consensus among these groups: a ventilator should not be withdrawn from a patient already using it to give to a “better” candidate who comes along later.

Some institutions have developed a method of making triage decisions that takes such decisions out of the hands of individual clinicians and instead assigns them to specialized “triage teams” made up of ethicists and clinicians experienced in critical care, to develop more distance from the emotions at the bedside. To minimize bias, such teams are often insulated from getting personal information about the patient, and receive only acute clinical information.⁸

Continue to: The pros and cons of these approaches...

The pros and cons of these approaches and the underlying ethical reasoning is beyond the scope of this overview. Policy documents from different states, regions, nations, and institutions have various approaches to making these choices. Presently, there is no coherent national or international agreement on triage ethics.⁹ It is important, however, that there be transparency in whatever approach an institution adopts for triage decisions.

Equity ethics

Though the equitable distribution of health care delivery has long been a concern, this problem has become magnified by the COVID-19 crisis. Race, sex, age, socioeconomic class, and type of illness have all been perennial sources of division between those who have better or worse access to health care and its outcomes. All of these distinctions have created differentials in rates of cases, hospitalizations, and deaths in the COVID-19 pandemic.¹⁰

The shifting of acute health care facilities to mostly COVID-19–related treatment, and postponing less critical and more “elective” care, creates a divide based on illness type. Many facilities have stopped taking admissions for other kinds of cases. This is particularly relevant to psychiatric units, many of which have had to decrease their bed capacities to make all rooms private, and limit their usual treatments offered to inpatients.¹¹ Many long-term units, such as at state hospitals, are closing to new admissions. Many day hospitals and intensive outpatient programs remain closed, not even shifting to telehealth. In areas most affected by COVID-19, some institutions have closed psychiatric wards and reallocated psychiatrists to cover some of the medical units. So the availability of the more intensive, institutionally-based levels of care is significantly reduced, particularly for psychiatric patients.¹² These patients already are a disadvantaged population in the distribution of health care resources, and the care of individuals with serious mental illness is more likely to be seen as “nonessential” in this time of suddenly scarcer institutional resources.

One of the cherished ethical values in health care is autonomy, and in a deontological triage environment, honoring patient autonomy is carefully and tenderly administered. However, in a utilitarian-driven triage environment, considerations of the common good can trump autonomy, even in subtle ways that create inequities. Clinicians have been advised to have more frank conversations with patients, particularly those with chronic illnesses, stepping up initiatives to make advanced directives during this crisis, explicitly reminding patients that there may not be enough ventilators for all who need one.¹³ Some have argued that such physician-initiated conversations can be inherently coercive, making these decisions not as autonomous as it may appear, similar to physicians suggesting medical euthanasia as an option.¹⁴ Interestingly, some jurisdictions that offer euthanasia have been suspending such services during the COVID-19 crisis.¹⁵ Some hospitals have even wrestled with the possibility that all COVID-19 admissions should be considered “do not resuscitate,” especially because cardiopulmonary resuscitation significantly elevates the risks of viral exposure for the treatment team.^16,17 A more explicit example of how current standards protecting patient autonomy may be challenged is patients who are admitted involuntarily to a psychiatric unit. These are patients whose presumptively impaired autonomy is already being overridden by the involuntary nature of the admission. If a psychiatric unit requires admissions to be COVID-19–negative, and if patients refuse COVID-19 testing, should the testing be forced upon them to protect the entire milieu?

Many ethicists are highlighting the embedded equity bias known as “ableism” inherent in triage decisions—implicitly disfavoring resources for patients with COVID-19 who are already physically or intellectually disabled, chronically ill, aged, homeless, psychosocially low functioning, etc.¹⁸ Without explicit protections for individuals who are chronically disabled, triage decisions unguided by policy safeguards may reflexively favor the more “abled.” This bias towards the more abled is often inherent in how difficult it is to access health care. It can also be manifested in bedside triage decisions made in the moment by individual clinicians. Many disability rights advocates have been sounding this alarm during the COVID-19 crisis.¹⁹

Continue to: A special circumstance of equity...

A special circumstance of equity is arising during this ongoing pandemic—the possibility of treating health care workers as a privileged class. Unlike typical disasters, where health care workers come in afterwards, and therefore are in relatively less danger, pandemics create particularly high risks of danger for such individuals, with repeated exposure to the virus. They are both responders and potential victims. Should they have higher priority for ventilators, vaccines, funding, etc?⁶ This is a more robust degree of compensatory justice than merely giving appreciation. Giving health care workers such advantages may seem intuitively appealing, but perhaps professionalism and the self-obligation of duty mitigates such claims.²⁰

A unique opportunity

The magnitude and pervasiveness of this pandemic crisis is unique in our lifetimes, as both professionals and as citizens. In the crucible of this extraordinary time, these and other medical ethics dilemmas burn hotter than ever before. Different societies and institutions may come up with different answers, based on their cultures and values. It is important, however, that the venerable ethos of medical ethics, which has evolved through the millennia, codified in oaths, codes, and scholarship, can be a compass at the bedside and in the meetings of legislatures, leaders, and policymakers. Perhaps we can emerge from this time with more clarity about how to balance the preciousness of individual rights with the needs of the common good.

Bottom Line

The coronavirus disease 2019 (COVID-19) pandemic has brought increased attention to triage ethics and equity ethics. There is no coherent national or international agreement on how to best deploy limited supplies such as ventilators and personal protective equipment. Although the equitable distribution of health care delivery has long been a concern, this problem has become magnified by COVID-19. Clinicians may be asked to view health care through the less familiar lens of the common good, as opposed to focusing strictly on an individual patient.

Related Resources

• Johns Hopkins Berman Institute of Bioethics. Coronavirus ethics and policy insights and resources. https://bioethics.jhu.edu/research-and-outreach/covid-19-bioethics-expert-insights/.
• Daugherty-Biddison L, Gwon H, Regenberg A, et al. Maryland framework for the allocation of scarce lifesustaining medical resources in a catastrophic public health emergency. www.law.umaryland.edu/media/SOL/pdfs/Programs/Health-Law/MHECN/ASR%20Framework_Final.pdf.

Food insecurity is not knowing how you will get your next meal. This pandemic has led to a lot of it, especially as a result of massive unemployment. Now imagine being in that situation with a food-allergic child. It would be frightening.

There is always a level of anxiety for parents of food-allergic children, but the Food and Drug Administration–mandated labeling of food allergens has helped to allay some of those concerns. Shopping can feel safer, even if it’s not foolproof.

Now, that fear for the safety of food-allergic children is going to be compounded by the FDA’s latest announcement, made at the behest of the food industry.

Disruptions in the food supply chain caused by the COVID-19 pandemic have created some problems for the food industry. The industry sought – and received – relief from the FDA; they are now allowing some ingredient substitutions without mandating a change in labeling. These changes were made without opportunity for public comment, according to the FDA, because of the exigency of the situation. Furthermore, the changes may stay in effect for an indeterminate period of time after the pandemic is deemed under control.

Labeling of gluten and the major eight allergens (peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish) cannot change under the new guidelines. The FDA also advised “consideration” of major food allergens recognized in other countries (sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard). Of these, lupin is known to cross-react with peanut, and sesame seed allergy is increasingly prevalent. In fact, the FDA has considered adding it to the list of major allergens.

Meanwhile, according to this temporary FDA policy, substitutions should be limited to no more than 2% of the weight of the final product unless it is a variety of the same ingredient. The example provided is substitution of one type of mushroom for another, but even that could be an issue for the rare patient. And what if this is misinterpreted – as will surely happen somewhere – and one seed is substituted for another?

A friend of mine is a pediatrician and mother of a child who is allergic to sesame, peanuts, tree nuts, and garbanzo beans. Naturally, she had grave concerns about these changes. She also wondered what the liability would be for the food manufacturing company in the current situation despite the FDA notice, which seems like a valid point. It is worth noting that, at the very top of this FDA notice, are the words “contains nonbinding recommendations,” so manufacturers may want to think twice about how they approach this. A minority of companies have pledged to relabel foods if necessary. Meanwhile, without any alert in advance, it is now up to patients and their physicians to sort out the attendant risks.

The FDA should have advised or mandated that food manufacturers give notice to online and physical retailers of ingredient changes. A simple sign in front of a display or alert online would be a very reasonable solution and pose no burden to those involved. It should be self-evident that mistakes always happen, especially under duress, and that the loosening of these regulations will have unintended consequences. To the severe problem of food insecurity, we can add one more concern for the parents of allergic children: food-allergen insecurity.

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

Food insecurity is not knowing how you will get your next meal. This pandemic has led to a lot of it, especially as a result of massive unemployment. Now imagine being in that situation with a food-allergic child. It would be frightening.

There is always a level of anxiety for parents of food-allergic children, but the Food and Drug Administration–mandated labeling of food allergens has helped to allay some of those concerns. Shopping can feel safer, even if it’s not foolproof.

Now, that fear for the safety of food-allergic children is going to be compounded by the FDA’s latest announcement, made at the behest of the food industry.

Disruptions in the food supply chain caused by the COVID-19 pandemic have created some problems for the food industry. The industry sought – and received – relief from the FDA; they are now allowing some ingredient substitutions without mandating a change in labeling. These changes were made without opportunity for public comment, according to the FDA, because of the exigency of the situation. Furthermore, the changes may stay in effect for an indeterminate period of time after the pandemic is deemed under control.

Labeling of gluten and the major eight allergens (peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish) cannot change under the new guidelines. The FDA also advised “consideration” of major food allergens recognized in other countries (sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard). Of these, lupin is known to cross-react with peanut, and sesame seed allergy is increasingly prevalent. In fact, the FDA has considered adding it to the list of major allergens.

Meanwhile, according to this temporary FDA policy, substitutions should be limited to no more than 2% of the weight of the final product unless it is a variety of the same ingredient. The example provided is substitution of one type of mushroom for another, but even that could be an issue for the rare patient. And what if this is misinterpreted – as will surely happen somewhere – and one seed is substituted for another?

A friend of mine is a pediatrician and mother of a child who is allergic to sesame, peanuts, tree nuts, and garbanzo beans. Naturally, she had grave concerns about these changes. She also wondered what the liability would be for the food manufacturing company in the current situation despite the FDA notice, which seems like a valid point. It is worth noting that, at the very top of this FDA notice, are the words “contains nonbinding recommendations,” so manufacturers may want to think twice about how they approach this. A minority of companies have pledged to relabel foods if necessary. Meanwhile, without any alert in advance, it is now up to patients and their physicians to sort out the attendant risks.

The FDA should have advised or mandated that food manufacturers give notice to online and physical retailers of ingredient changes. A simple sign in front of a display or alert online would be a very reasonable solution and pose no burden to those involved. It should be self-evident that mistakes always happen, especially under duress, and that the loosening of these regulations will have unintended consequences. To the severe problem of food insecurity, we can add one more concern for the parents of allergic children: food-allergen insecurity.

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

Food insecurity is not knowing how you will get your next meal. This pandemic has led to a lot of it, especially as a result of massive unemployment. Now imagine being in that situation with a food-allergic child. It would be frightening.

There is always a level of anxiety for parents of food-allergic children, but the Food and Drug Administration–mandated labeling of food allergens has helped to allay some of those concerns. Shopping can feel safer, even if it’s not foolproof.

Now, that fear for the safety of food-allergic children is going to be compounded by the FDA’s latest announcement, made at the behest of the food industry.

Disruptions in the food supply chain caused by the COVID-19 pandemic have created some problems for the food industry. The industry sought – and received – relief from the FDA; they are now allowing some ingredient substitutions without mandating a change in labeling. These changes were made without opportunity for public comment, according to the FDA, because of the exigency of the situation. Furthermore, the changes may stay in effect for an indeterminate period of time after the pandemic is deemed under control.

Labeling of gluten and the major eight allergens (peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish) cannot change under the new guidelines. The FDA also advised “consideration” of major food allergens recognized in other countries (sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard). Of these, lupin is known to cross-react with peanut, and sesame seed allergy is increasingly prevalent. In fact, the FDA has considered adding it to the list of major allergens.

Meanwhile, according to this temporary FDA policy, substitutions should be limited to no more than 2% of the weight of the final product unless it is a variety of the same ingredient. The example provided is substitution of one type of mushroom for another, but even that could be an issue for the rare patient. And what if this is misinterpreted – as will surely happen somewhere – and one seed is substituted for another?

A friend of mine is a pediatrician and mother of a child who is allergic to sesame, peanuts, tree nuts, and garbanzo beans. Naturally, she had grave concerns about these changes. She also wondered what the liability would be for the food manufacturing company in the current situation despite the FDA notice, which seems like a valid point. It is worth noting that, at the very top of this FDA notice, are the words “contains nonbinding recommendations,” so manufacturers may want to think twice about how they approach this. A minority of companies have pledged to relabel foods if necessary. Meanwhile, without any alert in advance, it is now up to patients and their physicians to sort out the attendant risks.

The FDA should have advised or mandated that food manufacturers give notice to online and physical retailers of ingredient changes. A simple sign in front of a display or alert online would be a very reasonable solution and pose no burden to those involved. It should be self-evident that mistakes always happen, especially under duress, and that the loosening of these regulations will have unintended consequences. To the severe problem of food insecurity, we can add one more concern for the parents of allergic children: food-allergen insecurity.

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

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

I am writing this commentary to bring to readers’ attention a medical and ethical complexity related to human sitters for presumably suicidal, COVID-19–positive hospitalized patients.

To shape and bundle the ethics issues addressed here into a single question, I offer the following: Should policies and practices requiring that patients in presumed need of a sitter because of assessed suicidality change when the patient is COVID-19–positive? Although the analysis might be similar when a sitter is monitoring a Patient Under Investigation (PUI), here I focus only on COVID-19–positive patients. Similarly, there are other reasons for sitters, of course, such as to prevent elopement, or, if a patient is in restraints, to prevent the patient from pulling out lines or tubes. Again, discussion of some of these ethical complications is beyond the scope of this piece. Just considering the matter of potential suicidality and sitters is complex enough. And so, to start, I sought out existing sources for guidance.

In looking for such sources, I first turned to the Centers for Medicare and Medicaid Services before COVID-19. CMS has required that there be a sitter for a patient who is suicidal and that the sitter remain in the room so that the sitter can intervene expeditiously if the patient tries to hurt himself or herself. There has been no change in this guidance since the COVID-19 pandemic in the United States. To the best of my knowledge, there is no substantive guidance for protecting sitters from contagion other than PPE. Given this, it begs the question: Shouldn’t the CMS guidance be changed to allow for hospitals to study different approaches to contagion reduction for sitters?

In my hospital, I already have begun discussing the potential risks of harm and potential benefits to our suicidal patients of having a sitter directly outside the patient’s room. I also have considered whether to have one sitter watching several room cameras at once, commonly referred to as “telehealth strategies.”

To be sure, sitting for hours in the room of a COVID-19–positive patient is onerous. The sitter is required to be in full PPE (N-95 mask, gown, and gloves), which is hot and uncomfortable. Current practice is resource intensive in other ways. It requires changing out the sitter every 2 hours, which uses substantial amounts of PPE and multiple sitters.

Regardless, however, there are really no data upon which to base any sound ethics judgment about what should or should not be tried. We just have no information on how to attempt to balance potential risks and prospects for the benefit of whom and when. And, given that good clinical ethics always begin with the facts, I write this piece to see whether readers have thought about these issues before – and whether any of clinicians have started collecting the valuable data needed to begin making sound ethical judgments about how to care for our presumably suicidal COVID-19–positive patients and the sitters who watch over them.
 

Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].

This column is an outcome of a discussion that occurred during Psych/Ethics rounds on June 5, and does not represent any official statements of Medstar Washington Hospital Center or any entity of the MedStar Corp. Dr. Ritchie would like to thank Evan G. DeRenzo, PhD, of the John J. Lynch Center for Ethics, for her thoughtful review of a previous draft of this commentary.

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

In “Asthma: Newer Tx options mean more targeted therapy” (J Fam Pract. 2020;65:135-144), Rali et al recommend azithromycin as an add-on therapy to ICS-LABA for a select group of patients with uncontrolled persistent asthma (neutrophilic phenotype)—a Grade C recommendation. However, the best available evidence demonstrates that azithromycin is equally efficacious for uncontrolled persistent eosinophilic asthma.^1,2 Thus, family physicians need not refer patients for bronchoscopy to identify the inflammatory “phenotype.”

An important unanswered question is whether azithromycin needs to be administered continuously. Emerging evidence indicates that some patients may experience prolonged benefit after time-limited azithromycin treatment. This suggests that the mechanism of action, which has been described as anti-inflammatory, is (at least in part) antimicrobial.³

For azithromycin-treated asthma patients who experience a significant clinical response after 3 to 6 months of treatment, I recommend that the prescribing clinician try taking the patient off azithromycin to assess whether clinical improvement persists or wanes. Nothing is lost, and much is gained, by this approach; patients who relapse can resume azithromycin, and patients who remain improved are spared exposure to an unnecessary and prolonged treatment.

David L. Hahn, MD, MS
Madison, WI

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The basic primary care ­evaluation recommended by Dr. Brieler et al in “Working adeptly to diagnose and treat adult ADHD” (J Fam Pract. 2020;69:145-149) is a step up from what occurs in some practices. Nonetheless, I was concerned about the idea that an attention-deficit/hyperactivity disorder (ADHD) evaluation in a primary care office might not include a behavioral health specialist. The gold standard remains a comprehensive, multidisciplinary evaluation.

Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

As a family physician who has performed comprehensive ADHD evaluations for more than 25 years, I have frequently seen adults with ADHD who were diagnosed elsewhere, without a comprehensive evaluation, and had various undiagnosed comorbidities. Unless these other problems are addressed, treatment focused only on ADHD often yields suboptimal results.

We, as primary care physicians, can provide better care for our patients if we include a behavioral health specialist in the evaluation process.

H. C. Bean, MD, FAAFP, CPE
MGC Carolina Family Physicians
Spartanburg, SC

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.

The inevitable consequences of aging finally hit me last year, at age 64. Before then, I was a (reasonably) healthy, active person. I exercised a little, ate reasonably healthy meals, and took no medications. My only visits to my doctor were for annual (sort of) exams. That all changed when I began to have neurogenic claudication in both legs. I had no history of back injury but, with worsening pain, I sought the opinion of my physician.

I was told that my insurance premium would jump to more than 4 times the previous premium because of a CAC score of 22.

It turned out that I had a dynamic spondylolisthesis and disc herniation that could only be fixed with a single-level fusion. From a neurologic perspective, the procedure was an unequivocal success. However, my recovery (with lack of exercise) had the unintended “side effect” of a 25-pound weight gain. As a family doctor, I know that the best way to reverse this gain is by increasing my exercise. However, I also know that, at my age, many specialty organizations recommend a cardiac evaluation before beginning strenuous exercise.¹

So, I set up a routine treadmill test. Although I exercised to a moderate level of intensity, the interpreting cardiologist was unwilling to call my test “totally normal” and recommended further evaluation. (One of the “unwritten rules” I’ve discovered during my career is that adverse outcomes are far more likely in medical personnel than in nonmedical personnel!)

He recommended undergoing coronary artery computed tomography angiography with coronary artery calcium (CAC) scoring. The result? A left anterior descending artery CAC score of 22, which placed me at a slightly increased risk of an adverse event over the next 10 years. (The benefit of exercise, however, far outweighed the risk.) I’m happy to report that I have lost five pounds with only mildly intensive exercise.

Along with facing the health aspects of aging, I am also faced with the economic realities. I have carried group term life insurance throughout my career. My 10-year term just happened to expire when I turned 65. I have always been insured as a “Tier 1” customer, meaning that I qualified for the best premiums due to my “healthy” ­status. That said, the transition to age 65 carries with it a significant premium increase.

Imagine my shock, though, when I was told that my premium would jump to MORE THAN 4 TIMES the previous premium for ONE-THIRD of my previous coverage! The culprit? The CAC score of 22!

It turns out that the insurance industry has adopted an underwriting standard that uses CAC—measured over a broad population, rather than a more age-confined one—to determine actuarial risk when rating life insurance policies.² As a result, my underwriting profile went all the way to “Tier 3.”

Continue to: We're used to medical consequences...

We’re used to medical consequences for tests that we order—whether a prostate biopsy for an elevated prostate-specific antigen test result, breast biopsy after abnormal mammogram, or a hemoglobin A1C test after an elevated fasting blood sugar. We can handle discussions with patients about potential diagnostic paths and readily include that information as part of shared decision-making with patients. Unfortunately, many entities are increasingly using medical information to make nonmedical decisions.

Using the CAC score to discuss the risk of adverse coronary events with my patients may be appropriate. In nonmedical settings, however, this data may be incorrectly, unfairly, or dangerously applied to our patients. I’ve begun thinking about these nonmedical applications as part of the shared decision-making process with my patients. It’s making these conversations more complicated, but life and life events for our patients take place far beyond the walls of our exam rooms.