Ethics in compulsory treatment of patients with severe mental illness

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Changed
Mon, 04/16/2018 - 14:06

 

“Ethics is knowing the difference between what you have a right to do and what is right to do.”

– Potter Stewart, U.S. Supreme Court Justice
 

An understanding of the difference between what is allowed or even recommended and what is ethical often is contemplated in the treatment of mental illness. Mental illnesses can impair judgment in patients confronted with complex decisions about their treatment. A provider, therefore, has to make a decision between respecting autonomy and/or engaging in what may be considered beneficent. While the line separating beneficent care and the respect for the autonomy of a patient may not be present, the question often arises – especially in inpatient care of patients with severe mental illness.

Dr. Nicolas Badre
Thankfully, my training in residency prepared me well. In the outpatient clinics, I was taught to consciously educate patients on the risk, benefits, and alternatives of treatments. Those interactions were rich in collaboration, patient centered, and rewarding. Having the awareness that my patients understand that their suffering could be addressed by a mutually formulated and agreed-upon plan was not just important for their recovery but also felt right. This rapport building created a partnership that was the essential ingredient in making progress.

In the inpatient units, I was taught to justify and be mindful of any removal of someone’s right. I learned the responsibility of stripping someone’s freedom. Not only would I find myself preventing someone from going where they wanted or from talking to whomever they wanted, but frequently, we involuntary injected patients with neuroactive chemicals. Those measures are used only in extreme circumstances: In most states, one has to be unable to provide themselves with food, clothing, or shelter secondary to mental illness to be subjected to such aggressive treatment.

Currently, the United States is seeing an increase in the focus on providing more treatment: an emphasis on beneficence over autonomy. This change can be witnessed in the passage of compulsory outpatient treatment laws. Those rulings, such as Laura’s Law in California and Kendra’s Law in New York, have been promoted in response to an increased concern over the consequences of untreated mental illness in crime. In this commentary, I present a case where I felt that despite being given the right and expectation to involuntary treat someone, I did not feel that it was ethical to involuntarily medicate him. (I have made appropriate changes to the patient’s case to maintain confidentiality.)
 

Our facility

The Psychiatric Stabilization Unit (PSU) of the San Diego Jails is a 30-bed acute psychiatric unit. We serve the 4,500 male inmates and one of the largest mental health systems in the county. The vast majority (from 70% to 90% at any one time) of patients suffer from a psychotic illness, and more than 50% have a comorbid substance use disorder. Contrary to most inpatient units, we do not have pressure from insurance or utilization review to regularly change dosages or medications, and we do not have significant pressure to discharge patients within a certain time frame. The unit serves very disenfranchised patients with most being homeless prior to their arrest and many having no emergency contact or social support of any sort. The unit is staffed by one attending psychiatrist and two therapists. We are subjected to the same involuntary commitment and involuntary medication laws as are community psychiatric hospitals, but we get a significant number of patients under court orders.

The patient presented in this case came under such court order for restoration of his competency to stand trial. In the United States, one cannot stand trial unless competent. Competency is defined as one’s ability to take a meaningful or active part in a trial, the capacity to understand laws, the capacity to understand personal responsibility, the ability to express a plea, and the capability to instruct legal counsel. When patients are found incompetent, they commonly get court ordered to an unit like the PSU with a court order that they cannot understand the risk, benefits, and alternatives of psychotropic treatment and thus can be involuntarily medicated. Often, including in this case, the court order will mention that the patient will not become competent without treatment, including involuntary antipsychotics.
 

Overview of the case

George is a 50-year-old white male without psychiatric history. He had never been hospitalized psychiatrically voluntarily or involuntarily. He has never engaged in outpatient psychiatric care, has never taken psychotropic medication, and has never been diagnosed with mental illness. He mentions no prior episode of self-harm, suicidality, or suicide attempt. He occasionally drinks alcohol and has smoked marijuana on a few occasions. He despises other drugs, saying that they are “dangerous.” He mentions that his parents had “difficult personalities” but denies any knowledge of them having formal mental illness.

 

 

He was born in rural Louisiana to a British mother and an American father. His parents divorced while he was in preschool. His mother remarried, to a salesman, which required them to move frequently to different states for his work. He mentions having performed moderately in school, but poor grades were secondary to his “boredom.” He graduated high school and went to vocational school in technological manufacturing but was unable to graduate. He has since held a series of low-level jobs in retail and janitorial services. He mentions having been in romantic relationships, but when asked to elaborate, he is unable to name any past girlfriends or describe any past relationships. Nonetheless, he describes a wide array of social supports with many friends, though it must be noted that all of his friends have some form of mental illness or intellectual disability.

At this time, he lives with his friend Harry. Harry has a moderate form of autism. George helps him with everything from grocery shopping to financial matters to assistance in personal hygiene. In exchange, Harry provides him with housing that he inherited and financial assistance from his disability benefits. They have lived in the same home for 2 years, since Harry asked George to move in because of concern that he would lose his home over the unsanitary conditions that were present at that time.

George had never been arrested prior to this incarceration. The circumstances of his arrest are unusual. After a neighbor had made complaints that Harry and George were illegally lodging in Harry’s home, the city investigated the matter. George’s report was that Harry was unable to fill out the forms appropriately and was asked to present himself in court. George came along for moral support but became extremely upset when lawyers and judges asked his friend to answer questions he did not have the cognitive ability to answer. Without second thought, George voiced his anger but was asked to remain quiet while not on the stand. He was asked to remain seated and was demanded to follow orders. A few moments later, George was arrested for contempt of court and obstruction to an officer.

Once incarcerated, he declined having any mental illness or needing any treatment during the customary triage visit. He had no problem as an inmate and was never referred to psychiatric services. However, when meeting with his public defender, George derailed into delusions. He talked about how the cops had been conspiring against him all of his life, with his current incarceration as a culmination. He mentioned how the judge was purposely trying to get them evicted so that he could own the house himself. He asked his lawyer to countersue the judge for a violation of his rights. The public defender filed for a competency evaluation of his client.

The forensic psychiatrist evaluated the patient and had a similar interpretation. This was a patient who had delusions and was perseverating on them to the point of being unable to engage in meaningful work with his attorney. The psychiatrist recommended involuntary treatment with an antipsychotic after diagnosing the patient with a psychotic illness.
 

My interactions with George

George is a loud and bucolic man with an usual mix of Southern idioms, a slightly British accent, and East Coast humor. He insisted on telling me why he wanted the staff to refer to him by his Native American nickname prior to the start our interview. He then asked me to listen to his life story to understand why Harry meant so much to him. Despite recounting their truly meaningful relationship, his affect was odd with poor reactivity; he had an incongruent and somewhat ungenuine joyfulness.

Once I heard his account of their friendship, I asked him about his charges and the incident in the courtroom. His answer was a long diatribe about the wrongs that had been done to him, but most of his speech was a series of illogical delusions. I informed him of my thoughts about his fixed and false beliefs, but he was not able to understand my comments. Nonetheless, I felt that he related to me well and that we had established good rapport.

As I was informing him about the antipsychotic I had chosen for his involuntary treatment, he asked me to hold off. He asked me to consider working with him for some time without medications. After all, he did not believe that he had a mental illness and wanted to attempt to engage in the competency training with our therapist without being medicated.
 

 

 

My conceptualization of him

George is a peculiar case. Practically all patients who are committed to my unit for competency restoration are psychotic, and their psychosis prevents their engagement with their attorneys. They have poor insight into their illness, which leads to their commitment. On admission, I confirm the assessment of the forensic psychiatrist and start the ordered involuntary treatment on patients. Many of them are gravely disabled – making the ethical dilemma easier to navigate. For other patients, the idea that they will be kept incarcerated until found competent also makes the forced treatment a simpler decision.

George was different – his impeccable grooming, his dislike of jail food, and his request for appropriately fitting jail clothes were far from disorganized. More importantly, however, he had adequate shelter outside of jail, income for assisting Harry, and a rich network of friends. Despite being riddled with delusions, his thought process was linear, and he was redirectable – even when discussing his delusions. I conceptualized the ethical conflict as such: Not treating him might lead to a longer period of incompetence and a longer incarceration; treating him would go against his desire to remain untreated.

After contacting Harry, I was fairly certain that George had suffered from his delusions for at least a significant part of his adult life, if not in its entirety. However, Harry was infinitely thankful for George’s assistance and felt that George had a good life. This added another fundamental question: Would forcing George to engage in formal mental health treatment lead him to have a better life? He was happy, had meaningful relationships, and contributed to his life as well as his friends’ lives in a deep way.

I diagnosed him as having an unspecified psychotic disorder, likely schizophrenia; he had delusions and negative symptoms, like his impaired affect. Despite this diagnosis, I decided to hold off from using involuntary treatment. I met with him daily for more than 2 weeks, and we discussed his story, his feelings, and his beliefs. On occasion, it was hard to separate the delusions from justifiable anger at the system. He had felt that he and Harry had been wronged, when society should have protected their vulnerability. He learned to trust me, and his therapist taught him competency training. Despite a possible 1-year commitment, we declared him competent to stand trial in 2 weeks. He had learned and excelled in all facets of the training.

George still had delusions, but he understood his charges, that he had acted inappropriately in the courtroom, and how to discuss his case with his legal counsel. Harry found George to be at his baseline during visits. George acted appropriately; he followed the complex rules set on inmates and engaged in all groups that are held on the unit.


 

Discussion

I certainly do not question the value of involuntary psychiatric treatment for many patients with grave disabilities, violent tendencies, or incompetence. However, George’s case makes me wonder if many people living with schizophrenia can have rich and meaningful lives without ever being in contact with a mental health provider. I wonder if our almost-obsessive attention to antipsychotics makes us lose sight. Our biological reductionism may lead us to see patients such as George as someone with overactive dopaminergic pathways in need of antidopaminergic antipsychotic. Unfortunately for many, biological reductionism often is based on unsubstantiated evidence.

George reminds me that life, including schizophrenia, is more interesting and complicated than a set of genes, pathways, neurons, or neurotransmitters. Our patients’ lives may be convoluted with delusions, often stemming from truth or impaired affects, which are nonetheless genuine. I don’t know what will happen to George, but his past 50 years suggest that he will continue to have friends, and he will continue to live without being impaired by his delusions. Strangely, I worry less about him than many of my other patients.

Many mental health providers have advocated for a wider and easier access to involuntarily medicate our patients. I think that there is a misguided belief that involuntary antipsychotic treatment will lead to a rise in their use. However, if Carl Rogers, PhD, and others were right in stating that our relationship with our patients was the ultimate factor in their recovery, at what cost are we willing to jeopardize this? My fear is that this cost will be the loss of trust, which is so necessary in treatment. I hope that my short relationship with George did not scare him from ever seeing a psychiatrist again. In some ways, I suspect that by simply listening to George and withholding forced treatment, he will be more inclined to seek treatment in the future.
 

 

 

Take-home points

  • Certain patients with psychosis have fairly high functioning.
  • Milieu therapy is, in certain cases, able to assuage some symptoms of psychosis.
  • Compulsory antipsychotic administration may not be ethical in certain cases of acute psychosis.
  • Biological reductionism may undermine a complete ethical understanding of psychosis.
  • Psychiatric disorders are etiologically complex and multifactorial.
  • Involuntary treatment may provide short-term gains, but prevent long-term trust between patient and provider.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

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“Ethics is knowing the difference between what you have a right to do and what is right to do.”

– Potter Stewart, U.S. Supreme Court Justice
 

An understanding of the difference between what is allowed or even recommended and what is ethical often is contemplated in the treatment of mental illness. Mental illnesses can impair judgment in patients confronted with complex decisions about their treatment. A provider, therefore, has to make a decision between respecting autonomy and/or engaging in what may be considered beneficent. While the line separating beneficent care and the respect for the autonomy of a patient may not be present, the question often arises – especially in inpatient care of patients with severe mental illness.

Dr. Nicolas Badre
Thankfully, my training in residency prepared me well. In the outpatient clinics, I was taught to consciously educate patients on the risk, benefits, and alternatives of treatments. Those interactions were rich in collaboration, patient centered, and rewarding. Having the awareness that my patients understand that their suffering could be addressed by a mutually formulated and agreed-upon plan was not just important for their recovery but also felt right. This rapport building created a partnership that was the essential ingredient in making progress.

In the inpatient units, I was taught to justify and be mindful of any removal of someone’s right. I learned the responsibility of stripping someone’s freedom. Not only would I find myself preventing someone from going where they wanted or from talking to whomever they wanted, but frequently, we involuntary injected patients with neuroactive chemicals. Those measures are used only in extreme circumstances: In most states, one has to be unable to provide themselves with food, clothing, or shelter secondary to mental illness to be subjected to such aggressive treatment.

Currently, the United States is seeing an increase in the focus on providing more treatment: an emphasis on beneficence over autonomy. This change can be witnessed in the passage of compulsory outpatient treatment laws. Those rulings, such as Laura’s Law in California and Kendra’s Law in New York, have been promoted in response to an increased concern over the consequences of untreated mental illness in crime. In this commentary, I present a case where I felt that despite being given the right and expectation to involuntary treat someone, I did not feel that it was ethical to involuntarily medicate him. (I have made appropriate changes to the patient’s case to maintain confidentiality.)
 

Our facility

The Psychiatric Stabilization Unit (PSU) of the San Diego Jails is a 30-bed acute psychiatric unit. We serve the 4,500 male inmates and one of the largest mental health systems in the county. The vast majority (from 70% to 90% at any one time) of patients suffer from a psychotic illness, and more than 50% have a comorbid substance use disorder. Contrary to most inpatient units, we do not have pressure from insurance or utilization review to regularly change dosages or medications, and we do not have significant pressure to discharge patients within a certain time frame. The unit serves very disenfranchised patients with most being homeless prior to their arrest and many having no emergency contact or social support of any sort. The unit is staffed by one attending psychiatrist and two therapists. We are subjected to the same involuntary commitment and involuntary medication laws as are community psychiatric hospitals, but we get a significant number of patients under court orders.

The patient presented in this case came under such court order for restoration of his competency to stand trial. In the United States, one cannot stand trial unless competent. Competency is defined as one’s ability to take a meaningful or active part in a trial, the capacity to understand laws, the capacity to understand personal responsibility, the ability to express a plea, and the capability to instruct legal counsel. When patients are found incompetent, they commonly get court ordered to an unit like the PSU with a court order that they cannot understand the risk, benefits, and alternatives of psychotropic treatment and thus can be involuntarily medicated. Often, including in this case, the court order will mention that the patient will not become competent without treatment, including involuntary antipsychotics.
 

Overview of the case

George is a 50-year-old white male without psychiatric history. He had never been hospitalized psychiatrically voluntarily or involuntarily. He has never engaged in outpatient psychiatric care, has never taken psychotropic medication, and has never been diagnosed with mental illness. He mentions no prior episode of self-harm, suicidality, or suicide attempt. He occasionally drinks alcohol and has smoked marijuana on a few occasions. He despises other drugs, saying that they are “dangerous.” He mentions that his parents had “difficult personalities” but denies any knowledge of them having formal mental illness.

 

 

He was born in rural Louisiana to a British mother and an American father. His parents divorced while he was in preschool. His mother remarried, to a salesman, which required them to move frequently to different states for his work. He mentions having performed moderately in school, but poor grades were secondary to his “boredom.” He graduated high school and went to vocational school in technological manufacturing but was unable to graduate. He has since held a series of low-level jobs in retail and janitorial services. He mentions having been in romantic relationships, but when asked to elaborate, he is unable to name any past girlfriends or describe any past relationships. Nonetheless, he describes a wide array of social supports with many friends, though it must be noted that all of his friends have some form of mental illness or intellectual disability.

At this time, he lives with his friend Harry. Harry has a moderate form of autism. George helps him with everything from grocery shopping to financial matters to assistance in personal hygiene. In exchange, Harry provides him with housing that he inherited and financial assistance from his disability benefits. They have lived in the same home for 2 years, since Harry asked George to move in because of concern that he would lose his home over the unsanitary conditions that were present at that time.

George had never been arrested prior to this incarceration. The circumstances of his arrest are unusual. After a neighbor had made complaints that Harry and George were illegally lodging in Harry’s home, the city investigated the matter. George’s report was that Harry was unable to fill out the forms appropriately and was asked to present himself in court. George came along for moral support but became extremely upset when lawyers and judges asked his friend to answer questions he did not have the cognitive ability to answer. Without second thought, George voiced his anger but was asked to remain quiet while not on the stand. He was asked to remain seated and was demanded to follow orders. A few moments later, George was arrested for contempt of court and obstruction to an officer.

Once incarcerated, he declined having any mental illness or needing any treatment during the customary triage visit. He had no problem as an inmate and was never referred to psychiatric services. However, when meeting with his public defender, George derailed into delusions. He talked about how the cops had been conspiring against him all of his life, with his current incarceration as a culmination. He mentioned how the judge was purposely trying to get them evicted so that he could own the house himself. He asked his lawyer to countersue the judge for a violation of his rights. The public defender filed for a competency evaluation of his client.

The forensic psychiatrist evaluated the patient and had a similar interpretation. This was a patient who had delusions and was perseverating on them to the point of being unable to engage in meaningful work with his attorney. The psychiatrist recommended involuntary treatment with an antipsychotic after diagnosing the patient with a psychotic illness.
 

My interactions with George

George is a loud and bucolic man with an usual mix of Southern idioms, a slightly British accent, and East Coast humor. He insisted on telling me why he wanted the staff to refer to him by his Native American nickname prior to the start our interview. He then asked me to listen to his life story to understand why Harry meant so much to him. Despite recounting their truly meaningful relationship, his affect was odd with poor reactivity; he had an incongruent and somewhat ungenuine joyfulness.

Once I heard his account of their friendship, I asked him about his charges and the incident in the courtroom. His answer was a long diatribe about the wrongs that had been done to him, but most of his speech was a series of illogical delusions. I informed him of my thoughts about his fixed and false beliefs, but he was not able to understand my comments. Nonetheless, I felt that he related to me well and that we had established good rapport.

As I was informing him about the antipsychotic I had chosen for his involuntary treatment, he asked me to hold off. He asked me to consider working with him for some time without medications. After all, he did not believe that he had a mental illness and wanted to attempt to engage in the competency training with our therapist without being medicated.
 

 

 

My conceptualization of him

George is a peculiar case. Practically all patients who are committed to my unit for competency restoration are psychotic, and their psychosis prevents their engagement with their attorneys. They have poor insight into their illness, which leads to their commitment. On admission, I confirm the assessment of the forensic psychiatrist and start the ordered involuntary treatment on patients. Many of them are gravely disabled – making the ethical dilemma easier to navigate. For other patients, the idea that they will be kept incarcerated until found competent also makes the forced treatment a simpler decision.

George was different – his impeccable grooming, his dislike of jail food, and his request for appropriately fitting jail clothes were far from disorganized. More importantly, however, he had adequate shelter outside of jail, income for assisting Harry, and a rich network of friends. Despite being riddled with delusions, his thought process was linear, and he was redirectable – even when discussing his delusions. I conceptualized the ethical conflict as such: Not treating him might lead to a longer period of incompetence and a longer incarceration; treating him would go against his desire to remain untreated.

After contacting Harry, I was fairly certain that George had suffered from his delusions for at least a significant part of his adult life, if not in its entirety. However, Harry was infinitely thankful for George’s assistance and felt that George had a good life. This added another fundamental question: Would forcing George to engage in formal mental health treatment lead him to have a better life? He was happy, had meaningful relationships, and contributed to his life as well as his friends’ lives in a deep way.

I diagnosed him as having an unspecified psychotic disorder, likely schizophrenia; he had delusions and negative symptoms, like his impaired affect. Despite this diagnosis, I decided to hold off from using involuntary treatment. I met with him daily for more than 2 weeks, and we discussed his story, his feelings, and his beliefs. On occasion, it was hard to separate the delusions from justifiable anger at the system. He had felt that he and Harry had been wronged, when society should have protected their vulnerability. He learned to trust me, and his therapist taught him competency training. Despite a possible 1-year commitment, we declared him competent to stand trial in 2 weeks. He had learned and excelled in all facets of the training.

George still had delusions, but he understood his charges, that he had acted inappropriately in the courtroom, and how to discuss his case with his legal counsel. Harry found George to be at his baseline during visits. George acted appropriately; he followed the complex rules set on inmates and engaged in all groups that are held on the unit.


 

Discussion

I certainly do not question the value of involuntary psychiatric treatment for many patients with grave disabilities, violent tendencies, or incompetence. However, George’s case makes me wonder if many people living with schizophrenia can have rich and meaningful lives without ever being in contact with a mental health provider. I wonder if our almost-obsessive attention to antipsychotics makes us lose sight. Our biological reductionism may lead us to see patients such as George as someone with overactive dopaminergic pathways in need of antidopaminergic antipsychotic. Unfortunately for many, biological reductionism often is based on unsubstantiated evidence.

George reminds me that life, including schizophrenia, is more interesting and complicated than a set of genes, pathways, neurons, or neurotransmitters. Our patients’ lives may be convoluted with delusions, often stemming from truth or impaired affects, which are nonetheless genuine. I don’t know what will happen to George, but his past 50 years suggest that he will continue to have friends, and he will continue to live without being impaired by his delusions. Strangely, I worry less about him than many of my other patients.

Many mental health providers have advocated for a wider and easier access to involuntarily medicate our patients. I think that there is a misguided belief that involuntary antipsychotic treatment will lead to a rise in their use. However, if Carl Rogers, PhD, and others were right in stating that our relationship with our patients was the ultimate factor in their recovery, at what cost are we willing to jeopardize this? My fear is that this cost will be the loss of trust, which is so necessary in treatment. I hope that my short relationship with George did not scare him from ever seeing a psychiatrist again. In some ways, I suspect that by simply listening to George and withholding forced treatment, he will be more inclined to seek treatment in the future.
 

 

 

Take-home points

  • Certain patients with psychosis have fairly high functioning.
  • Milieu therapy is, in certain cases, able to assuage some symptoms of psychosis.
  • Compulsory antipsychotic administration may not be ethical in certain cases of acute psychosis.
  • Biological reductionism may undermine a complete ethical understanding of psychosis.
  • Psychiatric disorders are etiologically complex and multifactorial.
  • Involuntary treatment may provide short-term gains, but prevent long-term trust between patient and provider.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

 

“Ethics is knowing the difference between what you have a right to do and what is right to do.”

– Potter Stewart, U.S. Supreme Court Justice
 

An understanding of the difference between what is allowed or even recommended and what is ethical often is contemplated in the treatment of mental illness. Mental illnesses can impair judgment in patients confronted with complex decisions about their treatment. A provider, therefore, has to make a decision between respecting autonomy and/or engaging in what may be considered beneficent. While the line separating beneficent care and the respect for the autonomy of a patient may not be present, the question often arises – especially in inpatient care of patients with severe mental illness.

Dr. Nicolas Badre
Thankfully, my training in residency prepared me well. In the outpatient clinics, I was taught to consciously educate patients on the risk, benefits, and alternatives of treatments. Those interactions were rich in collaboration, patient centered, and rewarding. Having the awareness that my patients understand that their suffering could be addressed by a mutually formulated and agreed-upon plan was not just important for their recovery but also felt right. This rapport building created a partnership that was the essential ingredient in making progress.

In the inpatient units, I was taught to justify and be mindful of any removal of someone’s right. I learned the responsibility of stripping someone’s freedom. Not only would I find myself preventing someone from going where they wanted or from talking to whomever they wanted, but frequently, we involuntary injected patients with neuroactive chemicals. Those measures are used only in extreme circumstances: In most states, one has to be unable to provide themselves with food, clothing, or shelter secondary to mental illness to be subjected to such aggressive treatment.

Currently, the United States is seeing an increase in the focus on providing more treatment: an emphasis on beneficence over autonomy. This change can be witnessed in the passage of compulsory outpatient treatment laws. Those rulings, such as Laura’s Law in California and Kendra’s Law in New York, have been promoted in response to an increased concern over the consequences of untreated mental illness in crime. In this commentary, I present a case where I felt that despite being given the right and expectation to involuntary treat someone, I did not feel that it was ethical to involuntarily medicate him. (I have made appropriate changes to the patient’s case to maintain confidentiality.)
 

Our facility

The Psychiatric Stabilization Unit (PSU) of the San Diego Jails is a 30-bed acute psychiatric unit. We serve the 4,500 male inmates and one of the largest mental health systems in the county. The vast majority (from 70% to 90% at any one time) of patients suffer from a psychotic illness, and more than 50% have a comorbid substance use disorder. Contrary to most inpatient units, we do not have pressure from insurance or utilization review to regularly change dosages or medications, and we do not have significant pressure to discharge patients within a certain time frame. The unit serves very disenfranchised patients with most being homeless prior to their arrest and many having no emergency contact or social support of any sort. The unit is staffed by one attending psychiatrist and two therapists. We are subjected to the same involuntary commitment and involuntary medication laws as are community psychiatric hospitals, but we get a significant number of patients under court orders.

The patient presented in this case came under such court order for restoration of his competency to stand trial. In the United States, one cannot stand trial unless competent. Competency is defined as one’s ability to take a meaningful or active part in a trial, the capacity to understand laws, the capacity to understand personal responsibility, the ability to express a plea, and the capability to instruct legal counsel. When patients are found incompetent, they commonly get court ordered to an unit like the PSU with a court order that they cannot understand the risk, benefits, and alternatives of psychotropic treatment and thus can be involuntarily medicated. Often, including in this case, the court order will mention that the patient will not become competent without treatment, including involuntary antipsychotics.
 

Overview of the case

George is a 50-year-old white male without psychiatric history. He had never been hospitalized psychiatrically voluntarily or involuntarily. He has never engaged in outpatient psychiatric care, has never taken psychotropic medication, and has never been diagnosed with mental illness. He mentions no prior episode of self-harm, suicidality, or suicide attempt. He occasionally drinks alcohol and has smoked marijuana on a few occasions. He despises other drugs, saying that they are “dangerous.” He mentions that his parents had “difficult personalities” but denies any knowledge of them having formal mental illness.

 

 

He was born in rural Louisiana to a British mother and an American father. His parents divorced while he was in preschool. His mother remarried, to a salesman, which required them to move frequently to different states for his work. He mentions having performed moderately in school, but poor grades were secondary to his “boredom.” He graduated high school and went to vocational school in technological manufacturing but was unable to graduate. He has since held a series of low-level jobs in retail and janitorial services. He mentions having been in romantic relationships, but when asked to elaborate, he is unable to name any past girlfriends or describe any past relationships. Nonetheless, he describes a wide array of social supports with many friends, though it must be noted that all of his friends have some form of mental illness or intellectual disability.

At this time, he lives with his friend Harry. Harry has a moderate form of autism. George helps him with everything from grocery shopping to financial matters to assistance in personal hygiene. In exchange, Harry provides him with housing that he inherited and financial assistance from his disability benefits. They have lived in the same home for 2 years, since Harry asked George to move in because of concern that he would lose his home over the unsanitary conditions that were present at that time.

George had never been arrested prior to this incarceration. The circumstances of his arrest are unusual. After a neighbor had made complaints that Harry and George were illegally lodging in Harry’s home, the city investigated the matter. George’s report was that Harry was unable to fill out the forms appropriately and was asked to present himself in court. George came along for moral support but became extremely upset when lawyers and judges asked his friend to answer questions he did not have the cognitive ability to answer. Without second thought, George voiced his anger but was asked to remain quiet while not on the stand. He was asked to remain seated and was demanded to follow orders. A few moments later, George was arrested for contempt of court and obstruction to an officer.

Once incarcerated, he declined having any mental illness or needing any treatment during the customary triage visit. He had no problem as an inmate and was never referred to psychiatric services. However, when meeting with his public defender, George derailed into delusions. He talked about how the cops had been conspiring against him all of his life, with his current incarceration as a culmination. He mentioned how the judge was purposely trying to get them evicted so that he could own the house himself. He asked his lawyer to countersue the judge for a violation of his rights. The public defender filed for a competency evaluation of his client.

The forensic psychiatrist evaluated the patient and had a similar interpretation. This was a patient who had delusions and was perseverating on them to the point of being unable to engage in meaningful work with his attorney. The psychiatrist recommended involuntary treatment with an antipsychotic after diagnosing the patient with a psychotic illness.
 

My interactions with George

George is a loud and bucolic man with an usual mix of Southern idioms, a slightly British accent, and East Coast humor. He insisted on telling me why he wanted the staff to refer to him by his Native American nickname prior to the start our interview. He then asked me to listen to his life story to understand why Harry meant so much to him. Despite recounting their truly meaningful relationship, his affect was odd with poor reactivity; he had an incongruent and somewhat ungenuine joyfulness.

Once I heard his account of their friendship, I asked him about his charges and the incident in the courtroom. His answer was a long diatribe about the wrongs that had been done to him, but most of his speech was a series of illogical delusions. I informed him of my thoughts about his fixed and false beliefs, but he was not able to understand my comments. Nonetheless, I felt that he related to me well and that we had established good rapport.

As I was informing him about the antipsychotic I had chosen for his involuntary treatment, he asked me to hold off. He asked me to consider working with him for some time without medications. After all, he did not believe that he had a mental illness and wanted to attempt to engage in the competency training with our therapist without being medicated.
 

 

 

My conceptualization of him

George is a peculiar case. Practically all patients who are committed to my unit for competency restoration are psychotic, and their psychosis prevents their engagement with their attorneys. They have poor insight into their illness, which leads to their commitment. On admission, I confirm the assessment of the forensic psychiatrist and start the ordered involuntary treatment on patients. Many of them are gravely disabled – making the ethical dilemma easier to navigate. For other patients, the idea that they will be kept incarcerated until found competent also makes the forced treatment a simpler decision.

George was different – his impeccable grooming, his dislike of jail food, and his request for appropriately fitting jail clothes were far from disorganized. More importantly, however, he had adequate shelter outside of jail, income for assisting Harry, and a rich network of friends. Despite being riddled with delusions, his thought process was linear, and he was redirectable – even when discussing his delusions. I conceptualized the ethical conflict as such: Not treating him might lead to a longer period of incompetence and a longer incarceration; treating him would go against his desire to remain untreated.

After contacting Harry, I was fairly certain that George had suffered from his delusions for at least a significant part of his adult life, if not in its entirety. However, Harry was infinitely thankful for George’s assistance and felt that George had a good life. This added another fundamental question: Would forcing George to engage in formal mental health treatment lead him to have a better life? He was happy, had meaningful relationships, and contributed to his life as well as his friends’ lives in a deep way.

I diagnosed him as having an unspecified psychotic disorder, likely schizophrenia; he had delusions and negative symptoms, like his impaired affect. Despite this diagnosis, I decided to hold off from using involuntary treatment. I met with him daily for more than 2 weeks, and we discussed his story, his feelings, and his beliefs. On occasion, it was hard to separate the delusions from justifiable anger at the system. He had felt that he and Harry had been wronged, when society should have protected their vulnerability. He learned to trust me, and his therapist taught him competency training. Despite a possible 1-year commitment, we declared him competent to stand trial in 2 weeks. He had learned and excelled in all facets of the training.

George still had delusions, but he understood his charges, that he had acted inappropriately in the courtroom, and how to discuss his case with his legal counsel. Harry found George to be at his baseline during visits. George acted appropriately; he followed the complex rules set on inmates and engaged in all groups that are held on the unit.


 

Discussion

I certainly do not question the value of involuntary psychiatric treatment for many patients with grave disabilities, violent tendencies, or incompetence. However, George’s case makes me wonder if many people living with schizophrenia can have rich and meaningful lives without ever being in contact with a mental health provider. I wonder if our almost-obsessive attention to antipsychotics makes us lose sight. Our biological reductionism may lead us to see patients such as George as someone with overactive dopaminergic pathways in need of antidopaminergic antipsychotic. Unfortunately for many, biological reductionism often is based on unsubstantiated evidence.

George reminds me that life, including schizophrenia, is more interesting and complicated than a set of genes, pathways, neurons, or neurotransmitters. Our patients’ lives may be convoluted with delusions, often stemming from truth or impaired affects, which are nonetheless genuine. I don’t know what will happen to George, but his past 50 years suggest that he will continue to have friends, and he will continue to live without being impaired by his delusions. Strangely, I worry less about him than many of my other patients.

Many mental health providers have advocated for a wider and easier access to involuntarily medicate our patients. I think that there is a misguided belief that involuntary antipsychotic treatment will lead to a rise in their use. However, if Carl Rogers, PhD, and others were right in stating that our relationship with our patients was the ultimate factor in their recovery, at what cost are we willing to jeopardize this? My fear is that this cost will be the loss of trust, which is so necessary in treatment. I hope that my short relationship with George did not scare him from ever seeing a psychiatrist again. In some ways, I suspect that by simply listening to George and withholding forced treatment, he will be more inclined to seek treatment in the future.
 

 

 

Take-home points

  • Certain patients with psychosis have fairly high functioning.
  • Milieu therapy is, in certain cases, able to assuage some symptoms of psychosis.
  • Compulsory antipsychotic administration may not be ethical in certain cases of acute psychosis.
  • Biological reductionism may undermine a complete ethical understanding of psychosis.
  • Psychiatric disorders are etiologically complex and multifactorial.
  • Involuntary treatment may provide short-term gains, but prevent long-term trust between patient and provider.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre also mentors several residents on projects, including reduction in the use of solitary confinement of patients with mental illness, reduction in the use of involuntary treatment of the mentally ill, and examination of the mentally ill offender.

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Shinal v. Toms: It’s Now Harder to Get Informed Consent

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Question: Which of the following statements regarding Shinal v. Toms, a recent landmark decision on informed consent, is correct?:

A. The case was heard in the Pennsylvania Supreme Court and its decision is binding only in that state.

B. It held that obtaining informed consent is a doctor’s duty that is non-delegable.

C. The decision reversed the lower courts, which had held that the defendant’s qualified assistant could obtain consent.

D. An earlier case heard by the same court had ruled that doctors, not hospitals, owe the legal duty to obtain informed consent.

E. All are correct.

Answer: E.
 

On Nov. 26, 2007, Megan Shinal and Dr. Steven Toms met for a 20-minute initial consultation to discuss removing a recurrent craniopharyngioma.1 Years earlier, a surgeon had performed a transsphenoidal resection, but was unable to remove all of it. The residual portion of the tumor had increased in size and extended into vital structures of the brain, jeopardizing Mrs. Shinal’s eyesight and her carotid artery, causing headaches, and threatening to impact her pituitary function.

Dr. Toms testified that he reviewed with Mrs. Shinal the alternatives, risks, and benefits of total versus subtotal resection, and shared his opinion that, although a less aggressive approach to removing the tumor was safer in the short term, such an approach would increase the likelihood that the tumor would regrow. Dr. Toms was unable to recall many of the specifics, but he testified that he advised Mrs. Shinal that total surgical resection offered the highest chance for long-term survival. By the end of the visit, Mrs. Shinal had decided to undergo surgery. However, the type of surgery had not yet been determined.


Shortly thereafter, on Dec. 19, 2007, Mrs. Shinal had a telephone conversation with Dr. Toms’ physician assistant. Mrs. Shinal later testified that she asked the physician assistant about scarring that would likely result from surgery, whether radiation would be necessary, and about the date of surgery. The medical record of this telephone call indicated that Dr. Toms’ physician assistant also answered questions about the craniotomy incision. On Jan. 17, 2008, Mrs. Shinal met with the physician assistant at the Geisinger Medical Center’s neurosurgery clinic. The assistant obtained Mrs. Shinal’s medical history, conducted a physical, and provided Mrs. Shinal with information relating to the surgery. Mrs. Shinal signed an informed consent form.

On Jan. 31, 2008, Mrs. Shinal underwent an open craniotomy for a total resection of the pituitary tumor at Geisinger Medical Center. During the operation, Dr. Toms perforated Mrs. Shinal’s carotid artery, which resulted in hemorrhage, stroke, brain injury, and partial blindness.

Dr. S.Y. Tan


According to the Shinals’ complaint, Dr. Toms failed to explain the risks of surgery to Mrs. Shinal or to offer her the lower-risk surgical alternative of subtotal resection of the benign tumor, followed by radiation. At trial, Mrs. Shinal was unable to recall being informed of the relative risks of the surgery, other than coma and death. She testified that, had she known the alternative approaches to surgery, i.e., total versus subtotal resection, she would have chosen subtotal resection as the safer, less aggressive alternative.

The trial court instructed the jury with regard to Dr. Toms’ duty to obtain informed consent from Mrs. Shinal as follows: “[I]n considering whether [Dr. Toms] provided consent to [Mrs. Shinal], you may consider any relevant information you find was communicated to [Mrs. Shinal] by any qualified person acting as an assistant to [Dr. Toms].”

On April 21, 2014, the jury returned a verdict in favor of Dr. Toms.

The plaintiffs appealed to the Pennsylvania Superior Court, which affirmed the trial court’s judgment. It rejected the Shinals’ argument that the trial court’s informed consent charge, which permitted the jury to consider information provided by Dr. Toms’ physician assistant to Mrs. Shinal, was erroneous and prejudicial. The Superior Court relied upon two of its prior cases to opine that a qualified professional acting under the attending doctor’s supervision may convey information communicated to a patient for purposes of obtaining informed consent.

The trial court initially instructed the jury that, in assessing whether Dr. Toms obtained Mrs. Shinal’s informed consent, it could consider relevant information communicated by “any qualified person acting as an assistant” to Dr. Toms. The defendant doctor argued that while it is the physician’s duty to obtain the patient’s informed consent, the physician is not required to supply all of the information personally. It is the information conveyed, rather than the person conveying it that determines informed consent. Dr. Toms cited several older Pennsylvania Superior Court cases, which permitted a physician to fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.

The plaintiffs then appealed to the Pennsylvania Supreme Court, which led to a reversal. In a 4-3 decision, the court disagreed, citing their ruling in the 2002 case of Valles v. Albert Einstein Medical Center,2 where they held that the duty to obtain informed consent could not be imputed to a hospital. In Valles, the court held that the duty to obtain a patient’s informed consent is a nondelegable duty owed by the physician conducting the surgery or treatment, because obtaining informed consent results directly from the duty of disclosure, which lies solely with the physician, and a hospital therefore cannot be liable for a physician’s failure to obtain informed consent.

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Reasoning by extension, the court accordingly ruled that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. It declared: “Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.”

The court also held that “a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent. Without direct dialogue and a two-way exchange between the physician and patient, the physician cannot be confident that the patient comprehends the risks, benefits, likelihood of success, and alternatives. ... Informed consent is a product of the physician-patient relationship.

"The patient is in the vulnerable position of entrusting his or her care and well being to the physician based upon the physician’s education, training, and expertise," the court added. "It is incumbent upon the physician to cultivate a relationship with the patient and to familiarize himself or herself with the patient’s understanding and expectations. Were the law to permit physicians to delegate the provision of critical information to staff, it would undermine patient autonomy and bodily integrity by depriving the patient of the opportunity to engage in a dialogue with his or her chosen health care provider. A regime that would countenance delegation of the informed consent process would undermine the primacy of the physician-patient relationship. Only by personally satisfying the duty of disclosure may the physician ensure that consent truly is informed.”

The facts of the case appear straightforward, and its legal conclusion clear. Whether one agrees with the court’s decision is, however, another matter. The American Medical Association and the Pennsylvania Medical Society (PAMED) had submitted an amicus brief supporting Dr. Toms’ position, arguing that he had fulfilled his obligations under Pennsylvania’s Medical Care Availability and Reduction of Error Act, as well as common law established in previous Pennsylvania court rulings. The final appellate decision therefore came as a big disappointment. The PAMED website notes that the decision “could have significant ramifications for Pennsylvania physicians” in that they can “seemingly no longer rely on the aid of their qualified staff in the informed consent process.”3

The urgent question now is whether other jurisdictions will adopt this Pennsylvania rule that drastically changes the way doctors obtain informed consent from their patients.

 

 

 

 

 

 

 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Shinal v. Toms, J-106-2016, Supreme Court of Pennsylvania, Decided: June 20, 2017.

2. Valles v. Albert Einstein Medical Center, 805 A.2d (PA, 2002).

3. Informed-consent ruling may have “far-reaching, negative impact.” AMA Wire, Aug 8, 2017.


 

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Question: Which of the following statements regarding Shinal v. Toms, a recent landmark decision on informed consent, is correct?:

A. The case was heard in the Pennsylvania Supreme Court and its decision is binding only in that state.

B. It held that obtaining informed consent is a doctor’s duty that is non-delegable.

C. The decision reversed the lower courts, which had held that the defendant’s qualified assistant could obtain consent.

D. An earlier case heard by the same court had ruled that doctors, not hospitals, owe the legal duty to obtain informed consent.

E. All are correct.

Answer: E.
 

On Nov. 26, 2007, Megan Shinal and Dr. Steven Toms met for a 20-minute initial consultation to discuss removing a recurrent craniopharyngioma.1 Years earlier, a surgeon had performed a transsphenoidal resection, but was unable to remove all of it. The residual portion of the tumor had increased in size and extended into vital structures of the brain, jeopardizing Mrs. Shinal’s eyesight and her carotid artery, causing headaches, and threatening to impact her pituitary function.

Dr. Toms testified that he reviewed with Mrs. Shinal the alternatives, risks, and benefits of total versus subtotal resection, and shared his opinion that, although a less aggressive approach to removing the tumor was safer in the short term, such an approach would increase the likelihood that the tumor would regrow. Dr. Toms was unable to recall many of the specifics, but he testified that he advised Mrs. Shinal that total surgical resection offered the highest chance for long-term survival. By the end of the visit, Mrs. Shinal had decided to undergo surgery. However, the type of surgery had not yet been determined.


Shortly thereafter, on Dec. 19, 2007, Mrs. Shinal had a telephone conversation with Dr. Toms’ physician assistant. Mrs. Shinal later testified that she asked the physician assistant about scarring that would likely result from surgery, whether radiation would be necessary, and about the date of surgery. The medical record of this telephone call indicated that Dr. Toms’ physician assistant also answered questions about the craniotomy incision. On Jan. 17, 2008, Mrs. Shinal met with the physician assistant at the Geisinger Medical Center’s neurosurgery clinic. The assistant obtained Mrs. Shinal’s medical history, conducted a physical, and provided Mrs. Shinal with information relating to the surgery. Mrs. Shinal signed an informed consent form.

On Jan. 31, 2008, Mrs. Shinal underwent an open craniotomy for a total resection of the pituitary tumor at Geisinger Medical Center. During the operation, Dr. Toms perforated Mrs. Shinal’s carotid artery, which resulted in hemorrhage, stroke, brain injury, and partial blindness.

Dr. S.Y. Tan


According to the Shinals’ complaint, Dr. Toms failed to explain the risks of surgery to Mrs. Shinal or to offer her the lower-risk surgical alternative of subtotal resection of the benign tumor, followed by radiation. At trial, Mrs. Shinal was unable to recall being informed of the relative risks of the surgery, other than coma and death. She testified that, had she known the alternative approaches to surgery, i.e., total versus subtotal resection, she would have chosen subtotal resection as the safer, less aggressive alternative.

The trial court instructed the jury with regard to Dr. Toms’ duty to obtain informed consent from Mrs. Shinal as follows: “[I]n considering whether [Dr. Toms] provided consent to [Mrs. Shinal], you may consider any relevant information you find was communicated to [Mrs. Shinal] by any qualified person acting as an assistant to [Dr. Toms].”

On April 21, 2014, the jury returned a verdict in favor of Dr. Toms.

The plaintiffs appealed to the Pennsylvania Superior Court, which affirmed the trial court’s judgment. It rejected the Shinals’ argument that the trial court’s informed consent charge, which permitted the jury to consider information provided by Dr. Toms’ physician assistant to Mrs. Shinal, was erroneous and prejudicial. The Superior Court relied upon two of its prior cases to opine that a qualified professional acting under the attending doctor’s supervision may convey information communicated to a patient for purposes of obtaining informed consent.

The trial court initially instructed the jury that, in assessing whether Dr. Toms obtained Mrs. Shinal’s informed consent, it could consider relevant information communicated by “any qualified person acting as an assistant” to Dr. Toms. The defendant doctor argued that while it is the physician’s duty to obtain the patient’s informed consent, the physician is not required to supply all of the information personally. It is the information conveyed, rather than the person conveying it that determines informed consent. Dr. Toms cited several older Pennsylvania Superior Court cases, which permitted a physician to fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.

The plaintiffs then appealed to the Pennsylvania Supreme Court, which led to a reversal. In a 4-3 decision, the court disagreed, citing their ruling in the 2002 case of Valles v. Albert Einstein Medical Center,2 where they held that the duty to obtain informed consent could not be imputed to a hospital. In Valles, the court held that the duty to obtain a patient’s informed consent is a nondelegable duty owed by the physician conducting the surgery or treatment, because obtaining informed consent results directly from the duty of disclosure, which lies solely with the physician, and a hospital therefore cannot be liable for a physician’s failure to obtain informed consent.

Creative Commons


Reasoning by extension, the court accordingly ruled that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. It declared: “Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.”

The court also held that “a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent. Without direct dialogue and a two-way exchange between the physician and patient, the physician cannot be confident that the patient comprehends the risks, benefits, likelihood of success, and alternatives. ... Informed consent is a product of the physician-patient relationship.

"The patient is in the vulnerable position of entrusting his or her care and well being to the physician based upon the physician’s education, training, and expertise," the court added. "It is incumbent upon the physician to cultivate a relationship with the patient and to familiarize himself or herself with the patient’s understanding and expectations. Were the law to permit physicians to delegate the provision of critical information to staff, it would undermine patient autonomy and bodily integrity by depriving the patient of the opportunity to engage in a dialogue with his or her chosen health care provider. A regime that would countenance delegation of the informed consent process would undermine the primacy of the physician-patient relationship. Only by personally satisfying the duty of disclosure may the physician ensure that consent truly is informed.”

The facts of the case appear straightforward, and its legal conclusion clear. Whether one agrees with the court’s decision is, however, another matter. The American Medical Association and the Pennsylvania Medical Society (PAMED) had submitted an amicus brief supporting Dr. Toms’ position, arguing that he had fulfilled his obligations under Pennsylvania’s Medical Care Availability and Reduction of Error Act, as well as common law established in previous Pennsylvania court rulings. The final appellate decision therefore came as a big disappointment. The PAMED website notes that the decision “could have significant ramifications for Pennsylvania physicians” in that they can “seemingly no longer rely on the aid of their qualified staff in the informed consent process.”3

The urgent question now is whether other jurisdictions will adopt this Pennsylvania rule that drastically changes the way doctors obtain informed consent from their patients.

 

 

 

 

 

 

 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Shinal v. Toms, J-106-2016, Supreme Court of Pennsylvania, Decided: June 20, 2017.

2. Valles v. Albert Einstein Medical Center, 805 A.2d (PA, 2002).

3. Informed-consent ruling may have “far-reaching, negative impact.” AMA Wire, Aug 8, 2017.


 

 

Question: Which of the following statements regarding Shinal v. Toms, a recent landmark decision on informed consent, is correct?:

A. The case was heard in the Pennsylvania Supreme Court and its decision is binding only in that state.

B. It held that obtaining informed consent is a doctor’s duty that is non-delegable.

C. The decision reversed the lower courts, which had held that the defendant’s qualified assistant could obtain consent.

D. An earlier case heard by the same court had ruled that doctors, not hospitals, owe the legal duty to obtain informed consent.

E. All are correct.

Answer: E.
 

On Nov. 26, 2007, Megan Shinal and Dr. Steven Toms met for a 20-minute initial consultation to discuss removing a recurrent craniopharyngioma.1 Years earlier, a surgeon had performed a transsphenoidal resection, but was unable to remove all of it. The residual portion of the tumor had increased in size and extended into vital structures of the brain, jeopardizing Mrs. Shinal’s eyesight and her carotid artery, causing headaches, and threatening to impact her pituitary function.

Dr. Toms testified that he reviewed with Mrs. Shinal the alternatives, risks, and benefits of total versus subtotal resection, and shared his opinion that, although a less aggressive approach to removing the tumor was safer in the short term, such an approach would increase the likelihood that the tumor would regrow. Dr. Toms was unable to recall many of the specifics, but he testified that he advised Mrs. Shinal that total surgical resection offered the highest chance for long-term survival. By the end of the visit, Mrs. Shinal had decided to undergo surgery. However, the type of surgery had not yet been determined.


Shortly thereafter, on Dec. 19, 2007, Mrs. Shinal had a telephone conversation with Dr. Toms’ physician assistant. Mrs. Shinal later testified that she asked the physician assistant about scarring that would likely result from surgery, whether radiation would be necessary, and about the date of surgery. The medical record of this telephone call indicated that Dr. Toms’ physician assistant also answered questions about the craniotomy incision. On Jan. 17, 2008, Mrs. Shinal met with the physician assistant at the Geisinger Medical Center’s neurosurgery clinic. The assistant obtained Mrs. Shinal’s medical history, conducted a physical, and provided Mrs. Shinal with information relating to the surgery. Mrs. Shinal signed an informed consent form.

On Jan. 31, 2008, Mrs. Shinal underwent an open craniotomy for a total resection of the pituitary tumor at Geisinger Medical Center. During the operation, Dr. Toms perforated Mrs. Shinal’s carotid artery, which resulted in hemorrhage, stroke, brain injury, and partial blindness.

Dr. S.Y. Tan


According to the Shinals’ complaint, Dr. Toms failed to explain the risks of surgery to Mrs. Shinal or to offer her the lower-risk surgical alternative of subtotal resection of the benign tumor, followed by radiation. At trial, Mrs. Shinal was unable to recall being informed of the relative risks of the surgery, other than coma and death. She testified that, had she known the alternative approaches to surgery, i.e., total versus subtotal resection, she would have chosen subtotal resection as the safer, less aggressive alternative.

The trial court instructed the jury with regard to Dr. Toms’ duty to obtain informed consent from Mrs. Shinal as follows: “[I]n considering whether [Dr. Toms] provided consent to [Mrs. Shinal], you may consider any relevant information you find was communicated to [Mrs. Shinal] by any qualified person acting as an assistant to [Dr. Toms].”

On April 21, 2014, the jury returned a verdict in favor of Dr. Toms.

The plaintiffs appealed to the Pennsylvania Superior Court, which affirmed the trial court’s judgment. It rejected the Shinals’ argument that the trial court’s informed consent charge, which permitted the jury to consider information provided by Dr. Toms’ physician assistant to Mrs. Shinal, was erroneous and prejudicial. The Superior Court relied upon two of its prior cases to opine that a qualified professional acting under the attending doctor’s supervision may convey information communicated to a patient for purposes of obtaining informed consent.

The trial court initially instructed the jury that, in assessing whether Dr. Toms obtained Mrs. Shinal’s informed consent, it could consider relevant information communicated by “any qualified person acting as an assistant” to Dr. Toms. The defendant doctor argued that while it is the physician’s duty to obtain the patient’s informed consent, the physician is not required to supply all of the information personally. It is the information conveyed, rather than the person conveying it that determines informed consent. Dr. Toms cited several older Pennsylvania Superior Court cases, which permitted a physician to fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent.

The plaintiffs then appealed to the Pennsylvania Supreme Court, which led to a reversal. In a 4-3 decision, the court disagreed, citing their ruling in the 2002 case of Valles v. Albert Einstein Medical Center,2 where they held that the duty to obtain informed consent could not be imputed to a hospital. In Valles, the court held that the duty to obtain a patient’s informed consent is a nondelegable duty owed by the physician conducting the surgery or treatment, because obtaining informed consent results directly from the duty of disclosure, which lies solely with the physician, and a hospital therefore cannot be liable for a physician’s failure to obtain informed consent.

Creative Commons


Reasoning by extension, the court accordingly ruled that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. It declared: “Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.”

The court also held that “a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent. Without direct dialogue and a two-way exchange between the physician and patient, the physician cannot be confident that the patient comprehends the risks, benefits, likelihood of success, and alternatives. ... Informed consent is a product of the physician-patient relationship.

"The patient is in the vulnerable position of entrusting his or her care and well being to the physician based upon the physician’s education, training, and expertise," the court added. "It is incumbent upon the physician to cultivate a relationship with the patient and to familiarize himself or herself with the patient’s understanding and expectations. Were the law to permit physicians to delegate the provision of critical information to staff, it would undermine patient autonomy and bodily integrity by depriving the patient of the opportunity to engage in a dialogue with his or her chosen health care provider. A regime that would countenance delegation of the informed consent process would undermine the primacy of the physician-patient relationship. Only by personally satisfying the duty of disclosure may the physician ensure that consent truly is informed.”

The facts of the case appear straightforward, and its legal conclusion clear. Whether one agrees with the court’s decision is, however, another matter. The American Medical Association and the Pennsylvania Medical Society (PAMED) had submitted an amicus brief supporting Dr. Toms’ position, arguing that he had fulfilled his obligations under Pennsylvania’s Medical Care Availability and Reduction of Error Act, as well as common law established in previous Pennsylvania court rulings. The final appellate decision therefore came as a big disappointment. The PAMED website notes that the decision “could have significant ramifications for Pennsylvania physicians” in that they can “seemingly no longer rely on the aid of their qualified staff in the informed consent process.”3

The urgent question now is whether other jurisdictions will adopt this Pennsylvania rule that drastically changes the way doctors obtain informed consent from their patients.

 

 

 

 

 

 

 

 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Shinal v. Toms, J-106-2016, Supreme Court of Pennsylvania, Decided: June 20, 2017.

2. Valles v. Albert Einstein Medical Center, 805 A.2d (PA, 2002).

3. Informed-consent ruling may have “far-reaching, negative impact.” AMA Wire, Aug 8, 2017.


 

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Back to the Future, Part 2: Community Paramedicine

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Following the successful use of ambulances during the Civil War to transport wounded soldiers from the battlefield to safer and better equipped field hospital facilities, many communities adopted the practice for their civilian populations. Between the Civil War and World War II (WWII) "teaching hospitals" sent interns on their ambulances both to improve patient care at the scene, and to further their interns’ postgraduate education. However, as described by Ryan Corbett Bell in his book The Ambulance (Jefferson, NC: McFarland; 2009), by the 1930s, relatively poor reimbursement for ambulance calls followed by the severe doctor shortage due to WWII, effectively ended this practice. Though the interns were initially replaced by "ambulance attendants" or "orderlies," since the 1960s, ambulances have been staffed by trained EMTs and (later) paramedics to provide basic and advanced prehospital care both at the scene and during transport. For almost half a century, paramedics operating with standing protocols and physician medical control have conclusively demonstrated their ability to improve care and save lives.

At present, the increased demand for access to medical care brought about by the Affordable Care Act, an aging homebound population, overcrowded EDs, and inpatient services filled to capacity, along with, in some areas, insufficient numbers of visiting nurses, NPs, and PAs to provide needed home care services, prompted many to consider expanding the role of paramedics and EMTs to provide "community paramedicine," without afterward requiring them to transport patients to hospitals.

Community paramedicine was defined in 2012 by the US Department of Health and Human Services Administration as "an emerging field in health care where EMTs and Paramedics operate in expanded roles in an effort to connect underutilized resources to underserved populations" (https://www.hrsa.gov). A standard curriculum consisting of 114 hours of education in social determinants of health, public health, and tailored learning about chronic diseases, together with 200 hours of laboratory and clinical experiences has been developed and made available free of charge to colleges and universities (https://www.ruralhealthinfo.org).

Among the many individuals and organizations weighing in on the subject of community paramedicine, the American College of Emergency Physicians 2015 policy statement supports the development of properly designed expanded scope of practice programs for EMS personnel with medical oversight, that do not compromise existing emergency response systems (https://www.acep.org/). Dr Bryan Bledsoe, an editorial board member of JEMS (Journal of Emergency Medical Services), provides a thoughtful analysis of the pros and cons of community paramedicine (http://www.jems.com), hile Iyah K. Romm and colleagues, writing in the NEJM Catalyst, offer concrete evidence of the effectiveness of one such mobile integrated healthcare and community paramedicine program (http://catalyst.nejm.org).

Properly trained, experienced paramedics with careful supervision by emergency medical control physicians and consultation with the patients’ primary care physicians, supported by telemedicine and bedside diagnostic tests, can provide essential care in a patient’s home environment. Depending on local circumstances, EMTs and paramedics can provide that care 24/7, supplementing other available home health care to support posthospital-discharge care for congestive heart failure, wound healing, etc, obviating the need for repeated ED and clinic visits or hospitalizations.

In addition to patient benefits, community paramedicine offers an opportunity for experienced paramedics to extend their years of practice similar to the way urgent care clinics have enabled experienced EPs to extend theirs. For all of these reasons, we support an expanded role for EMTs and paramedics in safe, carefully planned community paramedicine programs.

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Following the successful use of ambulances during the Civil War to transport wounded soldiers from the battlefield to safer and better equipped field hospital facilities, many communities adopted the practice for their civilian populations. Between the Civil War and World War II (WWII) "teaching hospitals" sent interns on their ambulances both to improve patient care at the scene, and to further their interns’ postgraduate education. However, as described by Ryan Corbett Bell in his book The Ambulance (Jefferson, NC: McFarland; 2009), by the 1930s, relatively poor reimbursement for ambulance calls followed by the severe doctor shortage due to WWII, effectively ended this practice. Though the interns were initially replaced by "ambulance attendants" or "orderlies," since the 1960s, ambulances have been staffed by trained EMTs and (later) paramedics to provide basic and advanced prehospital care both at the scene and during transport. For almost half a century, paramedics operating with standing protocols and physician medical control have conclusively demonstrated their ability to improve care and save lives.

At present, the increased demand for access to medical care brought about by the Affordable Care Act, an aging homebound population, overcrowded EDs, and inpatient services filled to capacity, along with, in some areas, insufficient numbers of visiting nurses, NPs, and PAs to provide needed home care services, prompted many to consider expanding the role of paramedics and EMTs to provide "community paramedicine," without afterward requiring them to transport patients to hospitals.

Community paramedicine was defined in 2012 by the US Department of Health and Human Services Administration as "an emerging field in health care where EMTs and Paramedics operate in expanded roles in an effort to connect underutilized resources to underserved populations" (https://www.hrsa.gov). A standard curriculum consisting of 114 hours of education in social determinants of health, public health, and tailored learning about chronic diseases, together with 200 hours of laboratory and clinical experiences has been developed and made available free of charge to colleges and universities (https://www.ruralhealthinfo.org).

Among the many individuals and organizations weighing in on the subject of community paramedicine, the American College of Emergency Physicians 2015 policy statement supports the development of properly designed expanded scope of practice programs for EMS personnel with medical oversight, that do not compromise existing emergency response systems (https://www.acep.org/). Dr Bryan Bledsoe, an editorial board member of JEMS (Journal of Emergency Medical Services), provides a thoughtful analysis of the pros and cons of community paramedicine (http://www.jems.com), hile Iyah K. Romm and colleagues, writing in the NEJM Catalyst, offer concrete evidence of the effectiveness of one such mobile integrated healthcare and community paramedicine program (http://catalyst.nejm.org).

Properly trained, experienced paramedics with careful supervision by emergency medical control physicians and consultation with the patients’ primary care physicians, supported by telemedicine and bedside diagnostic tests, can provide essential care in a patient’s home environment. Depending on local circumstances, EMTs and paramedics can provide that care 24/7, supplementing other available home health care to support posthospital-discharge care for congestive heart failure, wound healing, etc, obviating the need for repeated ED and clinic visits or hospitalizations.

In addition to patient benefits, community paramedicine offers an opportunity for experienced paramedics to extend their years of practice similar to the way urgent care clinics have enabled experienced EPs to extend theirs. For all of these reasons, we support an expanded role for EMTs and paramedics in safe, carefully planned community paramedicine programs.

Following the successful use of ambulances during the Civil War to transport wounded soldiers from the battlefield to safer and better equipped field hospital facilities, many communities adopted the practice for their civilian populations. Between the Civil War and World War II (WWII) "teaching hospitals" sent interns on their ambulances both to improve patient care at the scene, and to further their interns’ postgraduate education. However, as described by Ryan Corbett Bell in his book The Ambulance (Jefferson, NC: McFarland; 2009), by the 1930s, relatively poor reimbursement for ambulance calls followed by the severe doctor shortage due to WWII, effectively ended this practice. Though the interns were initially replaced by "ambulance attendants" or "orderlies," since the 1960s, ambulances have been staffed by trained EMTs and (later) paramedics to provide basic and advanced prehospital care both at the scene and during transport. For almost half a century, paramedics operating with standing protocols and physician medical control have conclusively demonstrated their ability to improve care and save lives.

At present, the increased demand for access to medical care brought about by the Affordable Care Act, an aging homebound population, overcrowded EDs, and inpatient services filled to capacity, along with, in some areas, insufficient numbers of visiting nurses, NPs, and PAs to provide needed home care services, prompted many to consider expanding the role of paramedics and EMTs to provide "community paramedicine," without afterward requiring them to transport patients to hospitals.

Community paramedicine was defined in 2012 by the US Department of Health and Human Services Administration as "an emerging field in health care where EMTs and Paramedics operate in expanded roles in an effort to connect underutilized resources to underserved populations" (https://www.hrsa.gov). A standard curriculum consisting of 114 hours of education in social determinants of health, public health, and tailored learning about chronic diseases, together with 200 hours of laboratory and clinical experiences has been developed and made available free of charge to colleges and universities (https://www.ruralhealthinfo.org).

Among the many individuals and organizations weighing in on the subject of community paramedicine, the American College of Emergency Physicians 2015 policy statement supports the development of properly designed expanded scope of practice programs for EMS personnel with medical oversight, that do not compromise existing emergency response systems (https://www.acep.org/). Dr Bryan Bledsoe, an editorial board member of JEMS (Journal of Emergency Medical Services), provides a thoughtful analysis of the pros and cons of community paramedicine (http://www.jems.com), hile Iyah K. Romm and colleagues, writing in the NEJM Catalyst, offer concrete evidence of the effectiveness of one such mobile integrated healthcare and community paramedicine program (http://catalyst.nejm.org).

Properly trained, experienced paramedics with careful supervision by emergency medical control physicians and consultation with the patients’ primary care physicians, supported by telemedicine and bedside diagnostic tests, can provide essential care in a patient’s home environment. Depending on local circumstances, EMTs and paramedics can provide that care 24/7, supplementing other available home health care to support posthospital-discharge care for congestive heart failure, wound healing, etc, obviating the need for repeated ED and clinic visits or hospitalizations.

In addition to patient benefits, community paramedicine offers an opportunity for experienced paramedics to extend their years of practice similar to the way urgent care clinics have enabled experienced EPs to extend theirs. For all of these reasons, we support an expanded role for EMTs and paramedics in safe, carefully planned community paramedicine programs.

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The Atopic Dermatitis Biologic Era Has Begun

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Atopic dermatitis (AD) is a vexing multisystem disorder characterized by frequently recurrent, intrusive, and sometimes disabling itch and dermatitis. The itch may be present throughout the day but crescendos at bedtime or 1 to 2 hours after sleep initiation, resulting in disrupted sleep cycles, lack of rest, more hours scratching, daytime somnolence, poor work attendance and performance, and poor school attendance and performance.1

Atopic dermatitis is a lifelong disease that only remits in approximately half of patients.2 There is a need for a disease-specific systemic drug in AD. Phototherapy, cyclosporine, methotrexate, and azathioprine are nonspecific immunosuppressive agents that can be used off label for AD but may or may not be effective.3 Oral or intramuscular corticosteroids are associated with problematic side effects such as weight gain, osteoporosis, fractures, psychological problems, striae, buffalo hump, and steroid withdrawal symptoms and disease aggravation upon withdrawal (ie, flaring to a state worse than prior to steroid initiation).3,4

A biologic medication for AD has been long overdue. Psoriatic biologic medications have been tried in AD with occasional benefit in case reports but no major response in larger trials. Belloni et al5 reviewed early data on off-label usage of biologics approved by the US Food and Drug Administration for psoriasis or other indications applied to AD patients. In their review of cases, they make the point that results are variable and anti-B-cell activity may hold the greatest promise.5 On the other hand, a recent series of 3 patients showed limited response to rituximab in chronic AD,6 while a combination of omalizumab, an anti-IgE medication, and rituximab was helpful in some patients.7 Ultimately, the issue is that nonspecific biologics may or may not address the underlying disease factors in AD. Therefore, there has been a true need for biologic intervention targeted directly at the pathogenic mechanism of AD. Furthermore, the desire for a biologic targeted at AD is paired with the true need to have a medication so targeted that the drug would have little effect on the rest of the immune system, resulting in targeted immunomodulation without secondary risk of infections.

Wait no longer, that era arrived a few months ago with the rapid US Food and Drug Administration approval of dupilumab, an injectable medication used every 2 weeks for the therapy of moderate to severe AD. This fully human monoclonal antibody against the IL-4Rα subunit blocks IL-4 and IL-13, key inflammatory agents in the triggering of production of IgE and eosinophil activation. Even better than the fact that it is targeted are the excellent outcomes in the therapy of moderate to severe AD in adults and the minimal side-effect profile resulting in no requirements for laboratory screening or ongoing monitoring.8

Dupilumab seems to perform well, both clinically and in improving the lives of AD patients. Meta-analysis of trials involving dupilumab has shown improved health-related quality of life outcomes.9,10 Usage of dupilumab alone in clinical trials for 16 weeks (SOLO 1 and SOLO 2) has resulted in stunning reduction in disease severity with a limited side-effect profile, with patients most commonly reporting conjunctivitis.11 In real-world models where dupilumab is added into a regimen of topical corticosteroid usage (LIBERTY AD CHRONOS trial), patients fared even better with the combination, highlighting that this medication may best be used adjunctively to our skin care guidance as dermatologists.12

A new era for AD patients has arrived and we as practitioners are now fortunate to be able to therapeutically reach the worst cases of AD. The new era has only begun with dozens of new agents addressing a variety of interleukin pathways including IL-17 and IL-22 still under development. Ultimately, we hope that ongoing pediatric trials will allow us to glean the role of early disease intervention at the root cause of AD and address our abilities to prevent comorbidities and disease persistence. Will we be able to avert years of disabling disease? The future holds immense hope.

References
  1. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
  2. Somanunt S, Chinratanapisit S, Pacharn P, et al. The natural history of atopic dermatitis and its association with Atopic March [published online Dec 12, 2016]. Asian Pac J Allergy Immunol. doi:10.12932/AP0825.
  3. Sidbury R, Davis DM, Cohen DE, et al; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3. management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71:327-349.
  4. Hajar T, Leshem YA, Hanifin JM, et al; the National Eczema Association Task Force. A systematic review of topical corticosteroid withdrawal ("steroid addiction") in patients with atopic dermatitis and other dermatoses [published online January 13, 2015]. J Am Acad Dermatol. 2015;72:541.e2-549.e2.
  5. Belloni B, Andres C, Ollert M, et al. Novel immunological approaches in the treatment of atopic eczema. Curr Opin Allergy Clin Immunol. 2008;8:423-427.
  6. McDonald BS, Jones J, Rustin M. Rituximab as a treatment for severe atopic eczema: failure to improve in three consecutive patients. Clin Exp Dermatol. 2016;41:45-47.  
  7. Sánchez-Ramón S, Eguíluz-Gracia I, Rodríguez-Mazariego ME, et al. Sequential combined therapy with omalizumab and rituximab: a new approach to severe atopic dermatitis. J Investig Allergol Clin Immunol. 2013;23:190-196.
  8. D'Erme AM, Romanelli M, Chiricozzi A. Spotlight on dupilumab in the treatment of atopic dermatitis: design, development, and potential place in therapy. Drug Des Devel Ther. 2017;11:1473-1480.  
  9. Han Y, Chen Y, Liu X, et al. Efficacy and safety of dupilumab for the treatment of adult atopic dermatitis: a meta-analysis of randomized clinical trials [published online May 4, 2017]. J Allergy Clin Immunol. doi:10.1016/j.jaci.2017.04.015.
  10. Simpson EL. Dupilumab improves general health-related quality-of-life in patients with moderate-to-severe atopic dermatitis: pooled results from two randomized, controlled phase 3 clinical trials. Dermatol Ther (Heidelb). 2017;7:243-248.  
  11. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis [published online Sep 30, 2016]. N Engl J Med. 2016;375:2335-2348.  
  12. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [published online May 4, 2017]. Lancet. 2017;389:2287-2303.
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Dr. N.B. Silverberg is from the Department of Dermatology, Mt Sinai West of the Icahn School of Medicine, New York, New York. Dr. J.I. Silverberg is from the Departments of Dermatology, Preventive Medicine, and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Dr. N.B. Silverberg is on the advisory board for and has received honoraria from Pfizer Inc. She also is an investigator for Regeneron Pharmaceuticals, Inc. Dr. J.I. Silverberg reports no conflict of interest.

Correspondence: Nanette B. Silverberg, MD, Mt Sinai West, 425 W 59th St, Ste 8B, New York, NY 10019 ([email protected]).

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Dr. N.B. Silverberg is from the Department of Dermatology, Mt Sinai West of the Icahn School of Medicine, New York, New York. Dr. J.I. Silverberg is from the Departments of Dermatology, Preventive Medicine, and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Dr. N.B. Silverberg is on the advisory board for and has received honoraria from Pfizer Inc. She also is an investigator for Regeneron Pharmaceuticals, Inc. Dr. J.I. Silverberg reports no conflict of interest.

Correspondence: Nanette B. Silverberg, MD, Mt Sinai West, 425 W 59th St, Ste 8B, New York, NY 10019 ([email protected]).

Author and Disclosure Information

Dr. N.B. Silverberg is from the Department of Dermatology, Mt Sinai West of the Icahn School of Medicine, New York, New York. Dr. J.I. Silverberg is from the Departments of Dermatology, Preventive Medicine, and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Dr. N.B. Silverberg is on the advisory board for and has received honoraria from Pfizer Inc. She also is an investigator for Regeneron Pharmaceuticals, Inc. Dr. J.I. Silverberg reports no conflict of interest.

Correspondence: Nanette B. Silverberg, MD, Mt Sinai West, 425 W 59th St, Ste 8B, New York, NY 10019 ([email protected]).

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Atopic dermatitis (AD) is a vexing multisystem disorder characterized by frequently recurrent, intrusive, and sometimes disabling itch and dermatitis. The itch may be present throughout the day but crescendos at bedtime or 1 to 2 hours after sleep initiation, resulting in disrupted sleep cycles, lack of rest, more hours scratching, daytime somnolence, poor work attendance and performance, and poor school attendance and performance.1

Atopic dermatitis is a lifelong disease that only remits in approximately half of patients.2 There is a need for a disease-specific systemic drug in AD. Phototherapy, cyclosporine, methotrexate, and azathioprine are nonspecific immunosuppressive agents that can be used off label for AD but may or may not be effective.3 Oral or intramuscular corticosteroids are associated with problematic side effects such as weight gain, osteoporosis, fractures, psychological problems, striae, buffalo hump, and steroid withdrawal symptoms and disease aggravation upon withdrawal (ie, flaring to a state worse than prior to steroid initiation).3,4

A biologic medication for AD has been long overdue. Psoriatic biologic medications have been tried in AD with occasional benefit in case reports but no major response in larger trials. Belloni et al5 reviewed early data on off-label usage of biologics approved by the US Food and Drug Administration for psoriasis or other indications applied to AD patients. In their review of cases, they make the point that results are variable and anti-B-cell activity may hold the greatest promise.5 On the other hand, a recent series of 3 patients showed limited response to rituximab in chronic AD,6 while a combination of omalizumab, an anti-IgE medication, and rituximab was helpful in some patients.7 Ultimately, the issue is that nonspecific biologics may or may not address the underlying disease factors in AD. Therefore, there has been a true need for biologic intervention targeted directly at the pathogenic mechanism of AD. Furthermore, the desire for a biologic targeted at AD is paired with the true need to have a medication so targeted that the drug would have little effect on the rest of the immune system, resulting in targeted immunomodulation without secondary risk of infections.

Wait no longer, that era arrived a few months ago with the rapid US Food and Drug Administration approval of dupilumab, an injectable medication used every 2 weeks for the therapy of moderate to severe AD. This fully human monoclonal antibody against the IL-4Rα subunit blocks IL-4 and IL-13, key inflammatory agents in the triggering of production of IgE and eosinophil activation. Even better than the fact that it is targeted are the excellent outcomes in the therapy of moderate to severe AD in adults and the minimal side-effect profile resulting in no requirements for laboratory screening or ongoing monitoring.8

Dupilumab seems to perform well, both clinically and in improving the lives of AD patients. Meta-analysis of trials involving dupilumab has shown improved health-related quality of life outcomes.9,10 Usage of dupilumab alone in clinical trials for 16 weeks (SOLO 1 and SOLO 2) has resulted in stunning reduction in disease severity with a limited side-effect profile, with patients most commonly reporting conjunctivitis.11 In real-world models where dupilumab is added into a regimen of topical corticosteroid usage (LIBERTY AD CHRONOS trial), patients fared even better with the combination, highlighting that this medication may best be used adjunctively to our skin care guidance as dermatologists.12

A new era for AD patients has arrived and we as practitioners are now fortunate to be able to therapeutically reach the worst cases of AD. The new era has only begun with dozens of new agents addressing a variety of interleukin pathways including IL-17 and IL-22 still under development. Ultimately, we hope that ongoing pediatric trials will allow us to glean the role of early disease intervention at the root cause of AD and address our abilities to prevent comorbidities and disease persistence. Will we be able to avert years of disabling disease? The future holds immense hope.

Atopic dermatitis (AD) is a vexing multisystem disorder characterized by frequently recurrent, intrusive, and sometimes disabling itch and dermatitis. The itch may be present throughout the day but crescendos at bedtime or 1 to 2 hours after sleep initiation, resulting in disrupted sleep cycles, lack of rest, more hours scratching, daytime somnolence, poor work attendance and performance, and poor school attendance and performance.1

Atopic dermatitis is a lifelong disease that only remits in approximately half of patients.2 There is a need for a disease-specific systemic drug in AD. Phototherapy, cyclosporine, methotrexate, and azathioprine are nonspecific immunosuppressive agents that can be used off label for AD but may or may not be effective.3 Oral or intramuscular corticosteroids are associated with problematic side effects such as weight gain, osteoporosis, fractures, psychological problems, striae, buffalo hump, and steroid withdrawal symptoms and disease aggravation upon withdrawal (ie, flaring to a state worse than prior to steroid initiation).3,4

A biologic medication for AD has been long overdue. Psoriatic biologic medications have been tried in AD with occasional benefit in case reports but no major response in larger trials. Belloni et al5 reviewed early data on off-label usage of biologics approved by the US Food and Drug Administration for psoriasis or other indications applied to AD patients. In their review of cases, they make the point that results are variable and anti-B-cell activity may hold the greatest promise.5 On the other hand, a recent series of 3 patients showed limited response to rituximab in chronic AD,6 while a combination of omalizumab, an anti-IgE medication, and rituximab was helpful in some patients.7 Ultimately, the issue is that nonspecific biologics may or may not address the underlying disease factors in AD. Therefore, there has been a true need for biologic intervention targeted directly at the pathogenic mechanism of AD. Furthermore, the desire for a biologic targeted at AD is paired with the true need to have a medication so targeted that the drug would have little effect on the rest of the immune system, resulting in targeted immunomodulation without secondary risk of infections.

Wait no longer, that era arrived a few months ago with the rapid US Food and Drug Administration approval of dupilumab, an injectable medication used every 2 weeks for the therapy of moderate to severe AD. This fully human monoclonal antibody against the IL-4Rα subunit blocks IL-4 and IL-13, key inflammatory agents in the triggering of production of IgE and eosinophil activation. Even better than the fact that it is targeted are the excellent outcomes in the therapy of moderate to severe AD in adults and the minimal side-effect profile resulting in no requirements for laboratory screening or ongoing monitoring.8

Dupilumab seems to perform well, both clinically and in improving the lives of AD patients. Meta-analysis of trials involving dupilumab has shown improved health-related quality of life outcomes.9,10 Usage of dupilumab alone in clinical trials for 16 weeks (SOLO 1 and SOLO 2) has resulted in stunning reduction in disease severity with a limited side-effect profile, with patients most commonly reporting conjunctivitis.11 In real-world models where dupilumab is added into a regimen of topical corticosteroid usage (LIBERTY AD CHRONOS trial), patients fared even better with the combination, highlighting that this medication may best be used adjunctively to our skin care guidance as dermatologists.12

A new era for AD patients has arrived and we as practitioners are now fortunate to be able to therapeutically reach the worst cases of AD. The new era has only begun with dozens of new agents addressing a variety of interleukin pathways including IL-17 and IL-22 still under development. Ultimately, we hope that ongoing pediatric trials will allow us to glean the role of early disease intervention at the root cause of AD and address our abilities to prevent comorbidities and disease persistence. Will we be able to avert years of disabling disease? The future holds immense hope.

References
  1. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
  2. Somanunt S, Chinratanapisit S, Pacharn P, et al. The natural history of atopic dermatitis and its association with Atopic March [published online Dec 12, 2016]. Asian Pac J Allergy Immunol. doi:10.12932/AP0825.
  3. Sidbury R, Davis DM, Cohen DE, et al; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3. management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71:327-349.
  4. Hajar T, Leshem YA, Hanifin JM, et al; the National Eczema Association Task Force. A systematic review of topical corticosteroid withdrawal ("steroid addiction") in patients with atopic dermatitis and other dermatoses [published online January 13, 2015]. J Am Acad Dermatol. 2015;72:541.e2-549.e2.
  5. Belloni B, Andres C, Ollert M, et al. Novel immunological approaches in the treatment of atopic eczema. Curr Opin Allergy Clin Immunol. 2008;8:423-427.
  6. McDonald BS, Jones J, Rustin M. Rituximab as a treatment for severe atopic eczema: failure to improve in three consecutive patients. Clin Exp Dermatol. 2016;41:45-47.  
  7. Sánchez-Ramón S, Eguíluz-Gracia I, Rodríguez-Mazariego ME, et al. Sequential combined therapy with omalizumab and rituximab: a new approach to severe atopic dermatitis. J Investig Allergol Clin Immunol. 2013;23:190-196.
  8. D'Erme AM, Romanelli M, Chiricozzi A. Spotlight on dupilumab in the treatment of atopic dermatitis: design, development, and potential place in therapy. Drug Des Devel Ther. 2017;11:1473-1480.  
  9. Han Y, Chen Y, Liu X, et al. Efficacy and safety of dupilumab for the treatment of adult atopic dermatitis: a meta-analysis of randomized clinical trials [published online May 4, 2017]. J Allergy Clin Immunol. doi:10.1016/j.jaci.2017.04.015.
  10. Simpson EL. Dupilumab improves general health-related quality-of-life in patients with moderate-to-severe atopic dermatitis: pooled results from two randomized, controlled phase 3 clinical trials. Dermatol Ther (Heidelb). 2017;7:243-248.  
  11. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis [published online Sep 30, 2016]. N Engl J Med. 2016;375:2335-2348.  
  12. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [published online May 4, 2017]. Lancet. 2017;389:2287-2303.
References
  1. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-351.
  2. Somanunt S, Chinratanapisit S, Pacharn P, et al. The natural history of atopic dermatitis and its association with Atopic March [published online Dec 12, 2016]. Asian Pac J Allergy Immunol. doi:10.12932/AP0825.
  3. Sidbury R, Davis DM, Cohen DE, et al; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3. management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71:327-349.
  4. Hajar T, Leshem YA, Hanifin JM, et al; the National Eczema Association Task Force. A systematic review of topical corticosteroid withdrawal ("steroid addiction") in patients with atopic dermatitis and other dermatoses [published online January 13, 2015]. J Am Acad Dermatol. 2015;72:541.e2-549.e2.
  5. Belloni B, Andres C, Ollert M, et al. Novel immunological approaches in the treatment of atopic eczema. Curr Opin Allergy Clin Immunol. 2008;8:423-427.
  6. McDonald BS, Jones J, Rustin M. Rituximab as a treatment for severe atopic eczema: failure to improve in three consecutive patients. Clin Exp Dermatol. 2016;41:45-47.  
  7. Sánchez-Ramón S, Eguíluz-Gracia I, Rodríguez-Mazariego ME, et al. Sequential combined therapy with omalizumab and rituximab: a new approach to severe atopic dermatitis. J Investig Allergol Clin Immunol. 2013;23:190-196.
  8. D'Erme AM, Romanelli M, Chiricozzi A. Spotlight on dupilumab in the treatment of atopic dermatitis: design, development, and potential place in therapy. Drug Des Devel Ther. 2017;11:1473-1480.  
  9. Han Y, Chen Y, Liu X, et al. Efficacy and safety of dupilumab for the treatment of adult atopic dermatitis: a meta-analysis of randomized clinical trials [published online May 4, 2017]. J Allergy Clin Immunol. doi:10.1016/j.jaci.2017.04.015.
  10. Simpson EL. Dupilumab improves general health-related quality-of-life in patients with moderate-to-severe atopic dermatitis: pooled results from two randomized, controlled phase 3 clinical trials. Dermatol Ther (Heidelb). 2017;7:243-248.  
  11. Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis [published online Sep 30, 2016]. N Engl J Med. 2016;375:2335-2348.  
  12. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [published online May 4, 2017]. Lancet. 2017;389:2287-2303.
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When the waters recede: Hurricane Harvey and PTSD through indirect trauma

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It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

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It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

 

It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

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The Disease for Which There Is No Cure and Not Enough Conversation

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If I simply let the title of this column stand alone, I suspect most readers of Federal Practitioner would fill in the blank with diseases, such as cancer, HIV, or even devastating genetic conditions, just as I would if presented with the statement without explication.

I read the sentence several weeks ago on a website for caregivers of patients with dementia while browsing for quite a different purpose, and it has haunted me ever since. As a consultation psychiatrist who has spent my career as a VA hospitalist, I am well aware of the sad reality of dementia, but against the backdrop of the aging veteran population, the poignancy of the human tragedy overwhelmed me.

Almost every day on the medical and surgical wards of the VA hospital where I have worked for nearly 2 decades, I see an aging veteran population. There are days when the average age of inpatients is pushing 70 years, and there are many patients in their 80s and 90s. The statistics show that my facility is by no means unique in the VA. Data from the American Community Survey Profile of veterans in 2015 indicate that the median age of veterans is 64 years whereas that of nonveterans is 41.1 The survey emphasized that this age factor has a rippling effect on many other demographic parameters, such as disability, income, and employment, all, in turn, impact the epidemiology of health and illness.1

It is not just age that increases the likelihood that a veteran will develop dementia: Research has identified several aspects of military service that raise the risk of being diagnosed with major neurocognitive disorder, the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition designation for dementia. Many families, patients, and even a few health care professionals may not realize that major neurocognitive disorder is the new neuropsychiatric term for dementia.

Also, many health care professionals do not realize that dementia is the sixth leading cause of death in the U.S.2 Traumatic brain injury, posttraumatic stress disorder, and depression are identified as potential contributors to a higher incidence of dementia in service men and women often with onset at an earlier age.3 Given the prevalence of these comorbidities in persons who were in the military, the VA and DoD will face the medical and psychosocial challenges of providing not only clinical treatment, but also a range of social services for military personnel and veterans. Indeed, federal institutions like the GRECC (Geriatric Research Education and Clinical Center) already are engaged in cutting edge research, delivering high-quality medical treatment, and specialized geriatric and dementia care education and support.

Despite these impressive efforts, too often families ask me 2 crucial questions when a patient is already at a moderate or severe stage of the disease: Is there a cure, and will they get better with or without treatment? This lack of knowledge and understanding is by no means confined to federal health care.

A 2015 report from the Alzheimer’s Association found that 45% of patients with Alzheimer disease or their caregivers were not told about the diagnosis by the doctor.2 Doctors reported that they were more likely to have informed the family of a cancer diagnosis at least in part because they felt there were treatments available and in some cases a cure.

Families ask these questions of me and other health care professionals in the hope of finding guidance. Often the veteran has been hospitalized after behavioral disturbances or wandering have made it impossible to care for the loved elder at home. The family is faced with a double blow: learning the patient has an incurable terminal disease and having to make the decision to place a grandmother or father in a nursing facility. Granted this woeful decision may have to be made even when the family has been fully informed at the time of diagnosis, but it is more distressing when the decision is needed immediately based on safety.

Husbands and wives of 50 years or more and adult children, graying themselves, often ask the second question about improvement. Although treatments exist that can help relieve symptoms and slow progression temporarily, the inexorable and tragic course of the wiping away of memory cannot be reversed or halted.

Not surprisingly, practitioners avoid telling patients and families about a dementia diagnosis because those conversations are painful and difficult. However, the news is much less agonizing to hear when there is time to enjoy the good days that remain and to make arrangements for finances and families. For these important reasons, VA emphasizes shared decision making as the cornerstone of geriatric care. Yet there can be no shared decisions without the compassionate and truthful telling about the diagnosis and the prognosis.

References

1. U.S. Department of Veterans Affairs National Ce- nter for Veterans Analytics and Statistics. Profile of veterans: 2015 data from the American Community Survey. https://www.va.gov/vetdata/docs/Specia lReports/Profile_of_Veterans_2015.pdf. Published March 2017. Accessed August 22, 2017.

2. Alzheimer’s Association. 2015 Alzheimer’s disease facts and figures. Alzheimers Dement. 2015;11(3):332-384.

3. Weiner MW, Friedl KE, Pacifico A, et al. Military risk factors for Alzheimer’s disease. Alzheimers Dement. 2013;9(4):445-451.

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If I simply let the title of this column stand alone, I suspect most readers of Federal Practitioner would fill in the blank with diseases, such as cancer, HIV, or even devastating genetic conditions, just as I would if presented with the statement without explication.

I read the sentence several weeks ago on a website for caregivers of patients with dementia while browsing for quite a different purpose, and it has haunted me ever since. As a consultation psychiatrist who has spent my career as a VA hospitalist, I am well aware of the sad reality of dementia, but against the backdrop of the aging veteran population, the poignancy of the human tragedy overwhelmed me.

Almost every day on the medical and surgical wards of the VA hospital where I have worked for nearly 2 decades, I see an aging veteran population. There are days when the average age of inpatients is pushing 70 years, and there are many patients in their 80s and 90s. The statistics show that my facility is by no means unique in the VA. Data from the American Community Survey Profile of veterans in 2015 indicate that the median age of veterans is 64 years whereas that of nonveterans is 41.1 The survey emphasized that this age factor has a rippling effect on many other demographic parameters, such as disability, income, and employment, all, in turn, impact the epidemiology of health and illness.1

It is not just age that increases the likelihood that a veteran will develop dementia: Research has identified several aspects of military service that raise the risk of being diagnosed with major neurocognitive disorder, the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition designation for dementia. Many families, patients, and even a few health care professionals may not realize that major neurocognitive disorder is the new neuropsychiatric term for dementia.

Also, many health care professionals do not realize that dementia is the sixth leading cause of death in the U.S.2 Traumatic brain injury, posttraumatic stress disorder, and depression are identified as potential contributors to a higher incidence of dementia in service men and women often with onset at an earlier age.3 Given the prevalence of these comorbidities in persons who were in the military, the VA and DoD will face the medical and psychosocial challenges of providing not only clinical treatment, but also a range of social services for military personnel and veterans. Indeed, federal institutions like the GRECC (Geriatric Research Education and Clinical Center) already are engaged in cutting edge research, delivering high-quality medical treatment, and specialized geriatric and dementia care education and support.

Despite these impressive efforts, too often families ask me 2 crucial questions when a patient is already at a moderate or severe stage of the disease: Is there a cure, and will they get better with or without treatment? This lack of knowledge and understanding is by no means confined to federal health care.

A 2015 report from the Alzheimer’s Association found that 45% of patients with Alzheimer disease or their caregivers were not told about the diagnosis by the doctor.2 Doctors reported that they were more likely to have informed the family of a cancer diagnosis at least in part because they felt there were treatments available and in some cases a cure.

Families ask these questions of me and other health care professionals in the hope of finding guidance. Often the veteran has been hospitalized after behavioral disturbances or wandering have made it impossible to care for the loved elder at home. The family is faced with a double blow: learning the patient has an incurable terminal disease and having to make the decision to place a grandmother or father in a nursing facility. Granted this woeful decision may have to be made even when the family has been fully informed at the time of diagnosis, but it is more distressing when the decision is needed immediately based on safety.

Husbands and wives of 50 years or more and adult children, graying themselves, often ask the second question about improvement. Although treatments exist that can help relieve symptoms and slow progression temporarily, the inexorable and tragic course of the wiping away of memory cannot be reversed or halted.

Not surprisingly, practitioners avoid telling patients and families about a dementia diagnosis because those conversations are painful and difficult. However, the news is much less agonizing to hear when there is time to enjoy the good days that remain and to make arrangements for finances and families. For these important reasons, VA emphasizes shared decision making as the cornerstone of geriatric care. Yet there can be no shared decisions without the compassionate and truthful telling about the diagnosis and the prognosis.

If I simply let the title of this column stand alone, I suspect most readers of Federal Practitioner would fill in the blank with diseases, such as cancer, HIV, or even devastating genetic conditions, just as I would if presented with the statement without explication.

I read the sentence several weeks ago on a website for caregivers of patients with dementia while browsing for quite a different purpose, and it has haunted me ever since. As a consultation psychiatrist who has spent my career as a VA hospitalist, I am well aware of the sad reality of dementia, but against the backdrop of the aging veteran population, the poignancy of the human tragedy overwhelmed me.

Almost every day on the medical and surgical wards of the VA hospital where I have worked for nearly 2 decades, I see an aging veteran population. There are days when the average age of inpatients is pushing 70 years, and there are many patients in their 80s and 90s. The statistics show that my facility is by no means unique in the VA. Data from the American Community Survey Profile of veterans in 2015 indicate that the median age of veterans is 64 years whereas that of nonveterans is 41.1 The survey emphasized that this age factor has a rippling effect on many other demographic parameters, such as disability, income, and employment, all, in turn, impact the epidemiology of health and illness.1

It is not just age that increases the likelihood that a veteran will develop dementia: Research has identified several aspects of military service that raise the risk of being diagnosed with major neurocognitive disorder, the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition designation for dementia. Many families, patients, and even a few health care professionals may not realize that major neurocognitive disorder is the new neuropsychiatric term for dementia.

Also, many health care professionals do not realize that dementia is the sixth leading cause of death in the U.S.2 Traumatic brain injury, posttraumatic stress disorder, and depression are identified as potential contributors to a higher incidence of dementia in service men and women often with onset at an earlier age.3 Given the prevalence of these comorbidities in persons who were in the military, the VA and DoD will face the medical and psychosocial challenges of providing not only clinical treatment, but also a range of social services for military personnel and veterans. Indeed, federal institutions like the GRECC (Geriatric Research Education and Clinical Center) already are engaged in cutting edge research, delivering high-quality medical treatment, and specialized geriatric and dementia care education and support.

Despite these impressive efforts, too often families ask me 2 crucial questions when a patient is already at a moderate or severe stage of the disease: Is there a cure, and will they get better with or without treatment? This lack of knowledge and understanding is by no means confined to federal health care.

A 2015 report from the Alzheimer’s Association found that 45% of patients with Alzheimer disease or their caregivers were not told about the diagnosis by the doctor.2 Doctors reported that they were more likely to have informed the family of a cancer diagnosis at least in part because they felt there were treatments available and in some cases a cure.

Families ask these questions of me and other health care professionals in the hope of finding guidance. Often the veteran has been hospitalized after behavioral disturbances or wandering have made it impossible to care for the loved elder at home. The family is faced with a double blow: learning the patient has an incurable terminal disease and having to make the decision to place a grandmother or father in a nursing facility. Granted this woeful decision may have to be made even when the family has been fully informed at the time of diagnosis, but it is more distressing when the decision is needed immediately based on safety.

Husbands and wives of 50 years or more and adult children, graying themselves, often ask the second question about improvement. Although treatments exist that can help relieve symptoms and slow progression temporarily, the inexorable and tragic course of the wiping away of memory cannot be reversed or halted.

Not surprisingly, practitioners avoid telling patients and families about a dementia diagnosis because those conversations are painful and difficult. However, the news is much less agonizing to hear when there is time to enjoy the good days that remain and to make arrangements for finances and families. For these important reasons, VA emphasizes shared decision making as the cornerstone of geriatric care. Yet there can be no shared decisions without the compassionate and truthful telling about the diagnosis and the prognosis.

References

1. U.S. Department of Veterans Affairs National Ce- nter for Veterans Analytics and Statistics. Profile of veterans: 2015 data from the American Community Survey. https://www.va.gov/vetdata/docs/Specia lReports/Profile_of_Veterans_2015.pdf. Published March 2017. Accessed August 22, 2017.

2. Alzheimer’s Association. 2015 Alzheimer’s disease facts and figures. Alzheimers Dement. 2015;11(3):332-384.

3. Weiner MW, Friedl KE, Pacifico A, et al. Military risk factors for Alzheimer’s disease. Alzheimers Dement. 2013;9(4):445-451.

References

1. U.S. Department of Veterans Affairs National Ce- nter for Veterans Analytics and Statistics. Profile of veterans: 2015 data from the American Community Survey. https://www.va.gov/vetdata/docs/Specia lReports/Profile_of_Veterans_2015.pdf. Published March 2017. Accessed August 22, 2017.

2. Alzheimer’s Association. 2015 Alzheimer’s disease facts and figures. Alzheimers Dement. 2015;11(3):332-384.

3. Weiner MW, Friedl KE, Pacifico A, et al. Military risk factors for Alzheimer’s disease. Alzheimers Dement. 2013;9(4):445-451.

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Noxious Nocebos in Dermatology

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The medical dictum primum non nocere (first, do no harm) is a fundamental rule by which physicians have lived for centuries.1 Physicians are familiar with the term placebo (I shall please) and the placebo effect of improvement based on expectation of positive results; however, many are not familiar with the term nocebo (I shall harm) and the nocebo effect of lack of improvement or deterioration based on the expectation of negative results. The patient’s expectation of being pleased and/or being harmed may be on the conscious level and/or on one or more subconscious and unconscious levels.

Words can have as much of an impact on some patients as medications or procedures. Rudyard Kipling said, “Words are, of course, the most powerful drug used by mankind.” The words that a dermatologist chooses to use can have either a placebo or a nocebo effect on the patient. The purpose of this commentary is to elevate awareness that there are positive alternatives to unintended negative suggestions that are commonly used in dermatologic practice.

A search of PubMed articles indexed for MEDLINE and Scopus published from January 1966 through July 28, 2016, was conducted using the terms placebo or nocebo and cutaneous or skin. Prior publications in this area related specifically to dermatology include those of Poletti2 and Sonthalia et al.3A more general search also was performed through the same dates using just the terms placebo or nocebo to see whether mention of specific skin diseases occurred in the text, with no additional findings.

Patient expectations play an important role in both positive and negative treatment outcomes. Patient-physician communication can moderate these effects both positively and negatively.4 Nocebo effects can substantially reduce treatment efficacy and patient compliance. Patient expectations of negative results or side effects of a treatment or medication can be self-induced or can be induced by inappropriate physician-patient communication, drug information leaflets, influence of family or peers, or discovery of reported adverse effects through reading materials on the Internet.4 Expectation of negative effects can reduce patient adherence and compliance with treatment, reducing treatment efficacy. The psychosocial context around the patient and the treatment may change the neuronal biochemistry and circuitry in the patient’s brain, and the central and peripheral mechanisms activated by placebos and nocebos have been found to be the same as those activated by the medications, suggesting cognitive/affective enhancing or impeding of drug action.5

The subconscious and unconscious habitual automated parts of the brain hear words on the level of a 5- or 6-year-old child with literal unconscious cognitive interpretation of the words. These parts also do not connect words in a sentence with each other.5 For example, if the dermatologist or nurse says “This will not hurt,” the unconscious brain hears not and hurt but does not connect the two. On the other hand, if the dermatologist or nurse says “ You may experience some discomfort,” the unconscious brain hears comfort. Telling the patient “Don’t scratch” may be heard unconsciously as scratch. See the Table for suggested rephrasing of common nocebos used in dermatology. The conscious parts of the brain help determine cognitions influenced by associated unconscious memories, positive or negative. Both the conscious and unconscious parts of the brain influence affect or emotion. The conscious parts of the brain have been compared to a slow walnut-sized computer, while the unconscious parts have anecdotally been compared to a watermelon-sized supercomputer. When a person reacts, the much quicker and larger unconscious response generally wins out over the smaller and slower conscious response. The polyvagal theory of Porges6 describes the evolutionary development of the autonomic nervous system and how it influences behavior and feelings. The phylogenetically oldest portion, associated with the dorsal nucleus parasympathetic nervous system, involves the body at rest, activation of digestion, and when under strong stress the freeze response whereby the body stays stationary and does not move at all. The middle portion, the sympathetic nervous system, involves fight or flight responses. The phylogenetically newest portion, associated with the ventral nucleus parasympathetic nervous system, involves vocal tone, facial expression, and socialization.6

When excess stress occurs, there is a natural shift downward from social communicative newer parasympathetic nervous system to fight or flight sympathetic nervous system, and possibly further shift to the freeze response of older parasympathetic nervous system dominance. Memories that are associated with a strong surge of norepinephrine tend to be much more strongly fixed in the memory than ordinary memories and frequently are associated with overwhelming traumatic experiences. When a threat is perceived, negative interpretations and perceptions generally win out over positive interpretations and perceptions. Unconscious fears generally prevail over conscious thoughts, and stronger emotions generally prevail over weaker emotions. Anxiety often is associated with rapid breathing and activation of the sympathetic nervous system. It can be countered by slow breathing to a rate of approximately 6 breaths per minute, helping to bring back more parasympathetic balance. Pacing a patient’s breathing to slow it and using a soothing tone of voice can help reduce patient anxiety. Reducing anxiety can decrease the patient’s tendency to jump to negative conclusions or have negative perceptions or emotions that can invoke the nocebo effect.

For the dermatologist, as for the patient, changing an old habit and creating a new habit requires repeating something differently and consistently 20 to 40 times. Becoming more conscious of the effects of language on the patient is an important part of the art of medicine. By carefully choosing words, intonation, and body language, it is possible to enhance the placebo effect and decrease the nocebo effect for the benefit of the patient. When describing possible adverse effects of treatments or medications, if the dermatologist says that most people do fine with the treatment but a few can experience the described adverse effect, it usually takes the edge off the potential suggested nocebo effect.

In conclusion, primum non nocere includes careful consideration and use of language, tone, and body language to maximize the placebo effect and minimize the nocebo effect.

References
  1. Hippocrates. Epidemics. Jones WHS, trans. Loeb Classical Library: Hippocrates. Vol 1. Cambridge, MA: Harvard University Press; 1923:164-165.
  2. Poletti ED. El efecto nocebo in dermatología. Dermatol Cosmet Quirg. 2007;5:74.
  3. Sonthalia S, Sahaya K, Arora R, et al. Nocebo effect in dermatology. Indian J Dermatol Venereol Leprol. 2015;81:242-250.
  4. Bingel U. Avoiding nocebo effects to optimize treatment outcomes. JAMA. 2014;312:693-694.
  5. Greenwald AG. New look 3: unconscious cognition reclaimed. Am Psychol. 1992;47:766-779.
  6. Porges SW. The Polyvagal Theory: Neurophysiological Foundations of Emotions, Attachment, Communication, and Self-regulation. New York, NY: W.W. Norton & Co; 2011.
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Correspondence: Philip D. Shenefelt, MD, MS, Department of Dermatology and Cutaneous Surgery, MDC 079, College of Medicine, University of South Florida, 12901 Bruce B. Downs Blvd, Tampa, FL 33612 ([email protected]).

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The medical dictum primum non nocere (first, do no harm) is a fundamental rule by which physicians have lived for centuries.1 Physicians are familiar with the term placebo (I shall please) and the placebo effect of improvement based on expectation of positive results; however, many are not familiar with the term nocebo (I shall harm) and the nocebo effect of lack of improvement or deterioration based on the expectation of negative results. The patient’s expectation of being pleased and/or being harmed may be on the conscious level and/or on one or more subconscious and unconscious levels.

Words can have as much of an impact on some patients as medications or procedures. Rudyard Kipling said, “Words are, of course, the most powerful drug used by mankind.” The words that a dermatologist chooses to use can have either a placebo or a nocebo effect on the patient. The purpose of this commentary is to elevate awareness that there are positive alternatives to unintended negative suggestions that are commonly used in dermatologic practice.

A search of PubMed articles indexed for MEDLINE and Scopus published from January 1966 through July 28, 2016, was conducted using the terms placebo or nocebo and cutaneous or skin. Prior publications in this area related specifically to dermatology include those of Poletti2 and Sonthalia et al.3A more general search also was performed through the same dates using just the terms placebo or nocebo to see whether mention of specific skin diseases occurred in the text, with no additional findings.

Patient expectations play an important role in both positive and negative treatment outcomes. Patient-physician communication can moderate these effects both positively and negatively.4 Nocebo effects can substantially reduce treatment efficacy and patient compliance. Patient expectations of negative results or side effects of a treatment or medication can be self-induced or can be induced by inappropriate physician-patient communication, drug information leaflets, influence of family or peers, or discovery of reported adverse effects through reading materials on the Internet.4 Expectation of negative effects can reduce patient adherence and compliance with treatment, reducing treatment efficacy. The psychosocial context around the patient and the treatment may change the neuronal biochemistry and circuitry in the patient’s brain, and the central and peripheral mechanisms activated by placebos and nocebos have been found to be the same as those activated by the medications, suggesting cognitive/affective enhancing or impeding of drug action.5

The subconscious and unconscious habitual automated parts of the brain hear words on the level of a 5- or 6-year-old child with literal unconscious cognitive interpretation of the words. These parts also do not connect words in a sentence with each other.5 For example, if the dermatologist or nurse says “This will not hurt,” the unconscious brain hears not and hurt but does not connect the two. On the other hand, if the dermatologist or nurse says “ You may experience some discomfort,” the unconscious brain hears comfort. Telling the patient “Don’t scratch” may be heard unconsciously as scratch. See the Table for suggested rephrasing of common nocebos used in dermatology. The conscious parts of the brain help determine cognitions influenced by associated unconscious memories, positive or negative. Both the conscious and unconscious parts of the brain influence affect or emotion. The conscious parts of the brain have been compared to a slow walnut-sized computer, while the unconscious parts have anecdotally been compared to a watermelon-sized supercomputer. When a person reacts, the much quicker and larger unconscious response generally wins out over the smaller and slower conscious response. The polyvagal theory of Porges6 describes the evolutionary development of the autonomic nervous system and how it influences behavior and feelings. The phylogenetically oldest portion, associated with the dorsal nucleus parasympathetic nervous system, involves the body at rest, activation of digestion, and when under strong stress the freeze response whereby the body stays stationary and does not move at all. The middle portion, the sympathetic nervous system, involves fight or flight responses. The phylogenetically newest portion, associated with the ventral nucleus parasympathetic nervous system, involves vocal tone, facial expression, and socialization.6

When excess stress occurs, there is a natural shift downward from social communicative newer parasympathetic nervous system to fight or flight sympathetic nervous system, and possibly further shift to the freeze response of older parasympathetic nervous system dominance. Memories that are associated with a strong surge of norepinephrine tend to be much more strongly fixed in the memory than ordinary memories and frequently are associated with overwhelming traumatic experiences. When a threat is perceived, negative interpretations and perceptions generally win out over positive interpretations and perceptions. Unconscious fears generally prevail over conscious thoughts, and stronger emotions generally prevail over weaker emotions. Anxiety often is associated with rapid breathing and activation of the sympathetic nervous system. It can be countered by slow breathing to a rate of approximately 6 breaths per minute, helping to bring back more parasympathetic balance. Pacing a patient’s breathing to slow it and using a soothing tone of voice can help reduce patient anxiety. Reducing anxiety can decrease the patient’s tendency to jump to negative conclusions or have negative perceptions or emotions that can invoke the nocebo effect.

For the dermatologist, as for the patient, changing an old habit and creating a new habit requires repeating something differently and consistently 20 to 40 times. Becoming more conscious of the effects of language on the patient is an important part of the art of medicine. By carefully choosing words, intonation, and body language, it is possible to enhance the placebo effect and decrease the nocebo effect for the benefit of the patient. When describing possible adverse effects of treatments or medications, if the dermatologist says that most people do fine with the treatment but a few can experience the described adverse effect, it usually takes the edge off the potential suggested nocebo effect.

In conclusion, primum non nocere includes careful consideration and use of language, tone, and body language to maximize the placebo effect and minimize the nocebo effect.

The medical dictum primum non nocere (first, do no harm) is a fundamental rule by which physicians have lived for centuries.1 Physicians are familiar with the term placebo (I shall please) and the placebo effect of improvement based on expectation of positive results; however, many are not familiar with the term nocebo (I shall harm) and the nocebo effect of lack of improvement or deterioration based on the expectation of negative results. The patient’s expectation of being pleased and/or being harmed may be on the conscious level and/or on one or more subconscious and unconscious levels.

Words can have as much of an impact on some patients as medications or procedures. Rudyard Kipling said, “Words are, of course, the most powerful drug used by mankind.” The words that a dermatologist chooses to use can have either a placebo or a nocebo effect on the patient. The purpose of this commentary is to elevate awareness that there are positive alternatives to unintended negative suggestions that are commonly used in dermatologic practice.

A search of PubMed articles indexed for MEDLINE and Scopus published from January 1966 through July 28, 2016, was conducted using the terms placebo or nocebo and cutaneous or skin. Prior publications in this area related specifically to dermatology include those of Poletti2 and Sonthalia et al.3A more general search also was performed through the same dates using just the terms placebo or nocebo to see whether mention of specific skin diseases occurred in the text, with no additional findings.

Patient expectations play an important role in both positive and negative treatment outcomes. Patient-physician communication can moderate these effects both positively and negatively.4 Nocebo effects can substantially reduce treatment efficacy and patient compliance. Patient expectations of negative results or side effects of a treatment or medication can be self-induced or can be induced by inappropriate physician-patient communication, drug information leaflets, influence of family or peers, or discovery of reported adverse effects through reading materials on the Internet.4 Expectation of negative effects can reduce patient adherence and compliance with treatment, reducing treatment efficacy. The psychosocial context around the patient and the treatment may change the neuronal biochemistry and circuitry in the patient’s brain, and the central and peripheral mechanisms activated by placebos and nocebos have been found to be the same as those activated by the medications, suggesting cognitive/affective enhancing or impeding of drug action.5

The subconscious and unconscious habitual automated parts of the brain hear words on the level of a 5- or 6-year-old child with literal unconscious cognitive interpretation of the words. These parts also do not connect words in a sentence with each other.5 For example, if the dermatologist or nurse says “This will not hurt,” the unconscious brain hears not and hurt but does not connect the two. On the other hand, if the dermatologist or nurse says “ You may experience some discomfort,” the unconscious brain hears comfort. Telling the patient “Don’t scratch” may be heard unconsciously as scratch. See the Table for suggested rephrasing of common nocebos used in dermatology. The conscious parts of the brain help determine cognitions influenced by associated unconscious memories, positive or negative. Both the conscious and unconscious parts of the brain influence affect or emotion. The conscious parts of the brain have been compared to a slow walnut-sized computer, while the unconscious parts have anecdotally been compared to a watermelon-sized supercomputer. When a person reacts, the much quicker and larger unconscious response generally wins out over the smaller and slower conscious response. The polyvagal theory of Porges6 describes the evolutionary development of the autonomic nervous system and how it influences behavior and feelings. The phylogenetically oldest portion, associated with the dorsal nucleus parasympathetic nervous system, involves the body at rest, activation of digestion, and when under strong stress the freeze response whereby the body stays stationary and does not move at all. The middle portion, the sympathetic nervous system, involves fight or flight responses. The phylogenetically newest portion, associated with the ventral nucleus parasympathetic nervous system, involves vocal tone, facial expression, and socialization.6

When excess stress occurs, there is a natural shift downward from social communicative newer parasympathetic nervous system to fight or flight sympathetic nervous system, and possibly further shift to the freeze response of older parasympathetic nervous system dominance. Memories that are associated with a strong surge of norepinephrine tend to be much more strongly fixed in the memory than ordinary memories and frequently are associated with overwhelming traumatic experiences. When a threat is perceived, negative interpretations and perceptions generally win out over positive interpretations and perceptions. Unconscious fears generally prevail over conscious thoughts, and stronger emotions generally prevail over weaker emotions. Anxiety often is associated with rapid breathing and activation of the sympathetic nervous system. It can be countered by slow breathing to a rate of approximately 6 breaths per minute, helping to bring back more parasympathetic balance. Pacing a patient’s breathing to slow it and using a soothing tone of voice can help reduce patient anxiety. Reducing anxiety can decrease the patient’s tendency to jump to negative conclusions or have negative perceptions or emotions that can invoke the nocebo effect.

For the dermatologist, as for the patient, changing an old habit and creating a new habit requires repeating something differently and consistently 20 to 40 times. Becoming more conscious of the effects of language on the patient is an important part of the art of medicine. By carefully choosing words, intonation, and body language, it is possible to enhance the placebo effect and decrease the nocebo effect for the benefit of the patient. When describing possible adverse effects of treatments or medications, if the dermatologist says that most people do fine with the treatment but a few can experience the described adverse effect, it usually takes the edge off the potential suggested nocebo effect.

In conclusion, primum non nocere includes careful consideration and use of language, tone, and body language to maximize the placebo effect and minimize the nocebo effect.

References
  1. Hippocrates. Epidemics. Jones WHS, trans. Loeb Classical Library: Hippocrates. Vol 1. Cambridge, MA: Harvard University Press; 1923:164-165.
  2. Poletti ED. El efecto nocebo in dermatología. Dermatol Cosmet Quirg. 2007;5:74.
  3. Sonthalia S, Sahaya K, Arora R, et al. Nocebo effect in dermatology. Indian J Dermatol Venereol Leprol. 2015;81:242-250.
  4. Bingel U. Avoiding nocebo effects to optimize treatment outcomes. JAMA. 2014;312:693-694.
  5. Greenwald AG. New look 3: unconscious cognition reclaimed. Am Psychol. 1992;47:766-779.
  6. Porges SW. The Polyvagal Theory: Neurophysiological Foundations of Emotions, Attachment, Communication, and Self-regulation. New York, NY: W.W. Norton & Co; 2011.
References
  1. Hippocrates. Epidemics. Jones WHS, trans. Loeb Classical Library: Hippocrates. Vol 1. Cambridge, MA: Harvard University Press; 1923:164-165.
  2. Poletti ED. El efecto nocebo in dermatología. Dermatol Cosmet Quirg. 2007;5:74.
  3. Sonthalia S, Sahaya K, Arora R, et al. Nocebo effect in dermatology. Indian J Dermatol Venereol Leprol. 2015;81:242-250.
  4. Bingel U. Avoiding nocebo effects to optimize treatment outcomes. JAMA. 2014;312:693-694.
  5. Greenwald AG. New look 3: unconscious cognition reclaimed. Am Psychol. 1992;47:766-779.
  6. Porges SW. The Polyvagal Theory: Neurophysiological Foundations of Emotions, Attachment, Communication, and Self-regulation. New York, NY: W.W. Norton & Co; 2011.
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Are Aspartame’s Benefits Sugarcoated?

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Since my high school days, I have used some form of artificial sweetener in lieu of sugar. Long believing that sugar avoidance was the key to weight maintenance, I didn’t give much thought to the published ill effects of sugar substitutes—after all, I wasn’t a mouse, and I wasn’t consuming mass doses. Did the artificial sweeteners assist in controlling my weight? Quite honestly, I doubt it—but I was so used to being “sugar free” that I was habituated to using these products.

Several years ago at a luncheon, I was reaching for a packet of artificial sweetener to pour into my iced tea when an NP friend stopped me. She and her husband (a pharmacist) had sworn off these products after noting that he was having issues with his cognition and experiencing increased irritability. With no obvious cause for these symptoms, they investigated his diet. He had, over the previous year, increased his use of aspartame. They found research supporting an association between aspartame and changes in behavior and cognition. When he stopped using the product, they both noticed a return to his former jovial, intellectual self. I acknowledged their research conclusion as an “n = 1” but gave it no further credence.

More recently, friends who had adopted an “all-natural” diet chastised me for drinking sugar-free seltzer. I had switched years ago from diet sodas to this beverage as my primary source of hydration. What could be wrong? It had zero calories, no sodium, and no sugar. Ah, but it contained aspartame! Since switching to a food plan without aspartame, my friends had observed that they were feeling better and more alert. Hmm, sounded familiar … maybe there was something to these claims after all. I did a little research of my own, and was I surprised!

On the exterior, aspartame is a highly studied food additive with decades of research demonstrating its safety for human consumption.1 But what exactly happens when this sweetener is ingested? First, aspartame breaks down into amino acids and methanol (ie, wood alcohol). The methanol continues to break down into formaldehyde and formic acid, a substance commonly found in bee and ant venom (see Figure). And if that weren’t enough, a potential brain tumor agent (aspartylphenylalanine diketopiperazine) is also a residual byproduct.2,3 As you might expect, these components and byproducts come with varying adverse effects and potential health risks.

The majority of artificially sweetened beverages (ASBs) contain aspartame. As early as 1984—a mere six months after aspartame was approved for use in soft drinks—the FDA, with the assistance of the CDC, undertook an investigation of consumer complaints related to its use. The research team interviewed 517 complainants; 346 (67%) reported neurologic/behavioral symptoms, including headache, dizziness, and mood alteration.4 Despite that statistic, however, the researchers reported no evidence for the existence of serious, widespread, adverse health consequences resulting from aspartame consumption.4

Reading these reports reminded me of my friends’ comments and strongly suggested to me that soft drinks containing aspartame may be hard on the brain. Further to this point, a recent study found that ASB consumption is associated with an increased risk for stroke and dementia.5

 

 

 

Additional studies—including evaluations of possible associations between aspartame and headaches, seizures, behavior, cognition, and mood, as well as allergic-type reactions and use by potentially sensitive subpopulations—have been conducted. The verdict? Scientists maintain that aspartame is safe and that there are no unresolved questions regarding its safety when used as intended.6 Some researchers question the validity of the link between ASB consumption and negative health consequences, suggesting that individuals in worse health consume diet beverages in an effort to slow health deterioration or to lose weight.7 Yet, the debate about the effects of aspartame on our organs continues.

The number of epidemiologic studies that document strong associations between frequent ASB consumption and illness suggests that substituting or promoting artificial sweeteners as “healthy alternatives” to sugar may not be advisable.8 In fact, the most recent studies indicate that artificial sweeteners—the very compounds marketed to assist with weight control—can lead to weight gain, as they trick our brains into craving high-calorie foods. Moreover, ASB consumption is associated with a 21% increased risk for type 2 diabetes.9 Azad and colleagues found that evidence does not clearly support the use of nonnutritive sweeteners for weight management; they recommend using caution with these products until the long-term risks and benefits are fully understood.7

Is satisfying your sweet tooth with sugar alternatives worth the potential risk? Most of the studies conducted to support or refute aspartame-related health concerns prove correlation, not causality. A purist might point out that many of the studies have limitations that can lead to faulty conclusions. Be that as it may, it still gives one pause.

Small doses of aspartame each day might not be a tipping point toward the documented health complaints, but the consistent concerns about its effects were enough for me to make the switch to plain water, and sugar for my coffee. I do believe that Mary Poppins was correct—a spoonful of sugar does help—and I, for one, am following her lead.

What do you think? Are these concerns unfounded, or are we sweetening our road to poor health? Share your thoughts with me at [email protected]

References

1. Novella S. Aspartame: truth vs. fiction. https://sciencebasedmedicine.org/aspartame-truth-vs-fiction/. Accessed August 1, 2017.
2. Barua J, Bal A. Emerging facts about aspartame. www.manningsscience.com/uploads/8/6/8/1/8681125/article-on-aspartame.pdf. Accessed August 1, 2017.
3. Supersweet blog. Learning about sweeteners. https://supersweetblog.wordpress.com/aspartame/. Accessed August 1, 2017.
4. CDC. Evaluation of consumer complaints related to aspartame use. MMWR Morb Mortal Wkly Rep. 1984;33(43):605-607.
5. Pase MP, Himali JJ, Beiser AS, et al. Sugar- and artificially sweetened beverages and the risks of incident stroke and dementia: a prospective cohort study. Stroke. 2017;48(5): 1139-1146.
6. Butchko HH, Stargel WW, Comer CP, et al. Aspartame: review of safety. Regul Toxicol Pharmacol. 2002;35(2):S1- S93.
7. Azad MB, Abou-Setta AM, Chauhan BF, et al. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ. 2017;189(28): E929-E939.
8. Wersching H, Gardener H, Sacco L. Sugar-sweetened and artificially sweetened beverages in relation to stroke and dementia. Stroke. 2017;48(5):1129-1131.
9. Huang M, Quddus A, Stinson L, et al. Artificially sweetened beverages, sugar-sweetened beverages, plain water, and incident diabetes mellitus in postmenopausal women: the prospective Women’s Health Initiative observational study. Am J Clin Nutr. 2017;106:614-622.

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Since my high school days, I have used some form of artificial sweetener in lieu of sugar. Long believing that sugar avoidance was the key to weight maintenance, I didn’t give much thought to the published ill effects of sugar substitutes—after all, I wasn’t a mouse, and I wasn’t consuming mass doses. Did the artificial sweeteners assist in controlling my weight? Quite honestly, I doubt it—but I was so used to being “sugar free” that I was habituated to using these products.

Several years ago at a luncheon, I was reaching for a packet of artificial sweetener to pour into my iced tea when an NP friend stopped me. She and her husband (a pharmacist) had sworn off these products after noting that he was having issues with his cognition and experiencing increased irritability. With no obvious cause for these symptoms, they investigated his diet. He had, over the previous year, increased his use of aspartame. They found research supporting an association between aspartame and changes in behavior and cognition. When he stopped using the product, they both noticed a return to his former jovial, intellectual self. I acknowledged their research conclusion as an “n = 1” but gave it no further credence.

More recently, friends who had adopted an “all-natural” diet chastised me for drinking sugar-free seltzer. I had switched years ago from diet sodas to this beverage as my primary source of hydration. What could be wrong? It had zero calories, no sodium, and no sugar. Ah, but it contained aspartame! Since switching to a food plan without aspartame, my friends had observed that they were feeling better and more alert. Hmm, sounded familiar … maybe there was something to these claims after all. I did a little research of my own, and was I surprised!

On the exterior, aspartame is a highly studied food additive with decades of research demonstrating its safety for human consumption.1 But what exactly happens when this sweetener is ingested? First, aspartame breaks down into amino acids and methanol (ie, wood alcohol). The methanol continues to break down into formaldehyde and formic acid, a substance commonly found in bee and ant venom (see Figure). And if that weren’t enough, a potential brain tumor agent (aspartylphenylalanine diketopiperazine) is also a residual byproduct.2,3 As you might expect, these components and byproducts come with varying adverse effects and potential health risks.

The majority of artificially sweetened beverages (ASBs) contain aspartame. As early as 1984—a mere six months after aspartame was approved for use in soft drinks—the FDA, with the assistance of the CDC, undertook an investigation of consumer complaints related to its use. The research team interviewed 517 complainants; 346 (67%) reported neurologic/behavioral symptoms, including headache, dizziness, and mood alteration.4 Despite that statistic, however, the researchers reported no evidence for the existence of serious, widespread, adverse health consequences resulting from aspartame consumption.4

Reading these reports reminded me of my friends’ comments and strongly suggested to me that soft drinks containing aspartame may be hard on the brain. Further to this point, a recent study found that ASB consumption is associated with an increased risk for stroke and dementia.5

 

 

 

Additional studies—including evaluations of possible associations between aspartame and headaches, seizures, behavior, cognition, and mood, as well as allergic-type reactions and use by potentially sensitive subpopulations—have been conducted. The verdict? Scientists maintain that aspartame is safe and that there are no unresolved questions regarding its safety when used as intended.6 Some researchers question the validity of the link between ASB consumption and negative health consequences, suggesting that individuals in worse health consume diet beverages in an effort to slow health deterioration or to lose weight.7 Yet, the debate about the effects of aspartame on our organs continues.

The number of epidemiologic studies that document strong associations between frequent ASB consumption and illness suggests that substituting or promoting artificial sweeteners as “healthy alternatives” to sugar may not be advisable.8 In fact, the most recent studies indicate that artificial sweeteners—the very compounds marketed to assist with weight control—can lead to weight gain, as they trick our brains into craving high-calorie foods. Moreover, ASB consumption is associated with a 21% increased risk for type 2 diabetes.9 Azad and colleagues found that evidence does not clearly support the use of nonnutritive sweeteners for weight management; they recommend using caution with these products until the long-term risks and benefits are fully understood.7

Is satisfying your sweet tooth with sugar alternatives worth the potential risk? Most of the studies conducted to support or refute aspartame-related health concerns prove correlation, not causality. A purist might point out that many of the studies have limitations that can lead to faulty conclusions. Be that as it may, it still gives one pause.

Small doses of aspartame each day might not be a tipping point toward the documented health complaints, but the consistent concerns about its effects were enough for me to make the switch to plain water, and sugar for my coffee. I do believe that Mary Poppins was correct—a spoonful of sugar does help—and I, for one, am following her lead.

What do you think? Are these concerns unfounded, or are we sweetening our road to poor health? Share your thoughts with me at [email protected]

 

Since my high school days, I have used some form of artificial sweetener in lieu of sugar. Long believing that sugar avoidance was the key to weight maintenance, I didn’t give much thought to the published ill effects of sugar substitutes—after all, I wasn’t a mouse, and I wasn’t consuming mass doses. Did the artificial sweeteners assist in controlling my weight? Quite honestly, I doubt it—but I was so used to being “sugar free” that I was habituated to using these products.

Several years ago at a luncheon, I was reaching for a packet of artificial sweetener to pour into my iced tea when an NP friend stopped me. She and her husband (a pharmacist) had sworn off these products after noting that he was having issues with his cognition and experiencing increased irritability. With no obvious cause for these symptoms, they investigated his diet. He had, over the previous year, increased his use of aspartame. They found research supporting an association between aspartame and changes in behavior and cognition. When he stopped using the product, they both noticed a return to his former jovial, intellectual self. I acknowledged their research conclusion as an “n = 1” but gave it no further credence.

More recently, friends who had adopted an “all-natural” diet chastised me for drinking sugar-free seltzer. I had switched years ago from diet sodas to this beverage as my primary source of hydration. What could be wrong? It had zero calories, no sodium, and no sugar. Ah, but it contained aspartame! Since switching to a food plan without aspartame, my friends had observed that they were feeling better and more alert. Hmm, sounded familiar … maybe there was something to these claims after all. I did a little research of my own, and was I surprised!

On the exterior, aspartame is a highly studied food additive with decades of research demonstrating its safety for human consumption.1 But what exactly happens when this sweetener is ingested? First, aspartame breaks down into amino acids and methanol (ie, wood alcohol). The methanol continues to break down into formaldehyde and formic acid, a substance commonly found in bee and ant venom (see Figure). And if that weren’t enough, a potential brain tumor agent (aspartylphenylalanine diketopiperazine) is also a residual byproduct.2,3 As you might expect, these components and byproducts come with varying adverse effects and potential health risks.

The majority of artificially sweetened beverages (ASBs) contain aspartame. As early as 1984—a mere six months after aspartame was approved for use in soft drinks—the FDA, with the assistance of the CDC, undertook an investigation of consumer complaints related to its use. The research team interviewed 517 complainants; 346 (67%) reported neurologic/behavioral symptoms, including headache, dizziness, and mood alteration.4 Despite that statistic, however, the researchers reported no evidence for the existence of serious, widespread, adverse health consequences resulting from aspartame consumption.4

Reading these reports reminded me of my friends’ comments and strongly suggested to me that soft drinks containing aspartame may be hard on the brain. Further to this point, a recent study found that ASB consumption is associated with an increased risk for stroke and dementia.5

 

 

 

Additional studies—including evaluations of possible associations between aspartame and headaches, seizures, behavior, cognition, and mood, as well as allergic-type reactions and use by potentially sensitive subpopulations—have been conducted. The verdict? Scientists maintain that aspartame is safe and that there are no unresolved questions regarding its safety when used as intended.6 Some researchers question the validity of the link between ASB consumption and negative health consequences, suggesting that individuals in worse health consume diet beverages in an effort to slow health deterioration or to lose weight.7 Yet, the debate about the effects of aspartame on our organs continues.

The number of epidemiologic studies that document strong associations between frequent ASB consumption and illness suggests that substituting or promoting artificial sweeteners as “healthy alternatives” to sugar may not be advisable.8 In fact, the most recent studies indicate that artificial sweeteners—the very compounds marketed to assist with weight control—can lead to weight gain, as they trick our brains into craving high-calorie foods. Moreover, ASB consumption is associated with a 21% increased risk for type 2 diabetes.9 Azad and colleagues found that evidence does not clearly support the use of nonnutritive sweeteners for weight management; they recommend using caution with these products until the long-term risks and benefits are fully understood.7

Is satisfying your sweet tooth with sugar alternatives worth the potential risk? Most of the studies conducted to support or refute aspartame-related health concerns prove correlation, not causality. A purist might point out that many of the studies have limitations that can lead to faulty conclusions. Be that as it may, it still gives one pause.

Small doses of aspartame each day might not be a tipping point toward the documented health complaints, but the consistent concerns about its effects were enough for me to make the switch to plain water, and sugar for my coffee. I do believe that Mary Poppins was correct—a spoonful of sugar does help—and I, for one, am following her lead.

What do you think? Are these concerns unfounded, or are we sweetening our road to poor health? Share your thoughts with me at [email protected]

References

1. Novella S. Aspartame: truth vs. fiction. https://sciencebasedmedicine.org/aspartame-truth-vs-fiction/. Accessed August 1, 2017.
2. Barua J, Bal A. Emerging facts about aspartame. www.manningsscience.com/uploads/8/6/8/1/8681125/article-on-aspartame.pdf. Accessed August 1, 2017.
3. Supersweet blog. Learning about sweeteners. https://supersweetblog.wordpress.com/aspartame/. Accessed August 1, 2017.
4. CDC. Evaluation of consumer complaints related to aspartame use. MMWR Morb Mortal Wkly Rep. 1984;33(43):605-607.
5. Pase MP, Himali JJ, Beiser AS, et al. Sugar- and artificially sweetened beverages and the risks of incident stroke and dementia: a prospective cohort study. Stroke. 2017;48(5): 1139-1146.
6. Butchko HH, Stargel WW, Comer CP, et al. Aspartame: review of safety. Regul Toxicol Pharmacol. 2002;35(2):S1- S93.
7. Azad MB, Abou-Setta AM, Chauhan BF, et al. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ. 2017;189(28): E929-E939.
8. Wersching H, Gardener H, Sacco L. Sugar-sweetened and artificially sweetened beverages in relation to stroke and dementia. Stroke. 2017;48(5):1129-1131.
9. Huang M, Quddus A, Stinson L, et al. Artificially sweetened beverages, sugar-sweetened beverages, plain water, and incident diabetes mellitus in postmenopausal women: the prospective Women’s Health Initiative observational study. Am J Clin Nutr. 2017;106:614-622.

References

1. Novella S. Aspartame: truth vs. fiction. https://sciencebasedmedicine.org/aspartame-truth-vs-fiction/. Accessed August 1, 2017.
2. Barua J, Bal A. Emerging facts about aspartame. www.manningsscience.com/uploads/8/6/8/1/8681125/article-on-aspartame.pdf. Accessed August 1, 2017.
3. Supersweet blog. Learning about sweeteners. https://supersweetblog.wordpress.com/aspartame/. Accessed August 1, 2017.
4. CDC. Evaluation of consumer complaints related to aspartame use. MMWR Morb Mortal Wkly Rep. 1984;33(43):605-607.
5. Pase MP, Himali JJ, Beiser AS, et al. Sugar- and artificially sweetened beverages and the risks of incident stroke and dementia: a prospective cohort study. Stroke. 2017;48(5): 1139-1146.
6. Butchko HH, Stargel WW, Comer CP, et al. Aspartame: review of safety. Regul Toxicol Pharmacol. 2002;35(2):S1- S93.
7. Azad MB, Abou-Setta AM, Chauhan BF, et al. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. CMAJ. 2017;189(28): E929-E939.
8. Wersching H, Gardener H, Sacco L. Sugar-sweetened and artificially sweetened beverages in relation to stroke and dementia. Stroke. 2017;48(5):1129-1131.
9. Huang M, Quddus A, Stinson L, et al. Artificially sweetened beverages, sugar-sweetened beverages, plain water, and incident diabetes mellitus in postmenopausal women: the prospective Women’s Health Initiative observational study. Am J Clin Nutr. 2017;106:614-622.

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Practice Makes Perfect?

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It is human nature to practice things that we are already good at doing. If you’re a golfer, then you know what I’m talking about. I hit the driver over and over again on the range, but never practice hitting the bad lie in the bunker, or the half-swing wedge from a tight lie. I sink hundreds of 3 footers, but can’t putt into this range from 50 feet. I’ve gotten much better at golf since I started playing, but my scores have hardly gone down.

Why? It’s the things I never practice that usually come back to bite me during the round, making it impossible to avoid double bogeys and driving up my score. It’s these areas where I have the most room for improvement, and if I simply made the effort to practice them, I could see a real impact on my handicap.

I think a similar thing happens in our orthopedic practices. I read everything I can on the anterior cruciate ligament, yet I already feel comfortable with my reconstruction technique. I skim, or avoid reading altogether, articles about topics I don’t like to treat, like the hand or spine. Yet, I still see these things every day in my practice and on call. If my depth of knowledge in these areas was as good as it is in sports medicine, I could provide better, more immediate care to my patients, rather than refer them to subspecialists.

A perfect orthopedic example would be the patellofemoral joint. One of the least enjoyable patient encounters for me is the young adult with normal alignment and intractable anterior knee pain that does not respond to nonoperative treatment. I’m concerned any surgical intervention may make them worse and I’m often left without much to offer the patient.

It’s for this reason AJO has partnered with Dr. Jack Farr to produce the patellofemoral issue; to provide a comprehensive guide to the latest thinking in the treatment of patellofemoral disorders (see the March/April 2017 issue). We solicited so much outstanding content, that a single issue could not hold all of the articles. In this issue, our patellofemoral series continues with 3 outstanding articles. Magnussen presents "Patella Alta Sees You, Do You See It?" and Hinckel and colleagues have authored a guide to patellofemoral cartilage restoration. Unal and colleagues follow-up with a review of the lateral retinaculum.

In our "Codes to Know" section, we reexamine diagnostic arthroscopy, a code most of us have billed infrequently. New technologies, however, have made it possible to peer into the joint in the office, and McMillan and colleagues teach us how to make it economically feasible, even for employed physicians.

Finally, we have a number of great articles on difficult problems—the stiff elbow, complex distal radius fractures, and intraoperative acetabular fractures during total hip arthroplasty.

Please enjoy this issue and think about what topics you tend to shy away from. I’m willing to bet you can add the most to your practice by studying up on these topics. As always, please provide your feedback to our editorial team so that we can continue to make improvements to our journal. We envision a change in the way orthopedists utilize a journal in their practice, and are continuously looking for ways to make AJO a more relevant tool for improving your patient care and workflow. We are working hard to give our readers the journal they deserve, but in my spare time, I’ll be brushing up on trochleoplasties and half-swing wedges.

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It is human nature to practice things that we are already good at doing. If you’re a golfer, then you know what I’m talking about. I hit the driver over and over again on the range, but never practice hitting the bad lie in the bunker, or the half-swing wedge from a tight lie. I sink hundreds of 3 footers, but can’t putt into this range from 50 feet. I’ve gotten much better at golf since I started playing, but my scores have hardly gone down.

Why? It’s the things I never practice that usually come back to bite me during the round, making it impossible to avoid double bogeys and driving up my score. It’s these areas where I have the most room for improvement, and if I simply made the effort to practice them, I could see a real impact on my handicap.

I think a similar thing happens in our orthopedic practices. I read everything I can on the anterior cruciate ligament, yet I already feel comfortable with my reconstruction technique. I skim, or avoid reading altogether, articles about topics I don’t like to treat, like the hand or spine. Yet, I still see these things every day in my practice and on call. If my depth of knowledge in these areas was as good as it is in sports medicine, I could provide better, more immediate care to my patients, rather than refer them to subspecialists.

A perfect orthopedic example would be the patellofemoral joint. One of the least enjoyable patient encounters for me is the young adult with normal alignment and intractable anterior knee pain that does not respond to nonoperative treatment. I’m concerned any surgical intervention may make them worse and I’m often left without much to offer the patient.

It’s for this reason AJO has partnered with Dr. Jack Farr to produce the patellofemoral issue; to provide a comprehensive guide to the latest thinking in the treatment of patellofemoral disorders (see the March/April 2017 issue). We solicited so much outstanding content, that a single issue could not hold all of the articles. In this issue, our patellofemoral series continues with 3 outstanding articles. Magnussen presents "Patella Alta Sees You, Do You See It?" and Hinckel and colleagues have authored a guide to patellofemoral cartilage restoration. Unal and colleagues follow-up with a review of the lateral retinaculum.

In our "Codes to Know" section, we reexamine diagnostic arthroscopy, a code most of us have billed infrequently. New technologies, however, have made it possible to peer into the joint in the office, and McMillan and colleagues teach us how to make it economically feasible, even for employed physicians.

Finally, we have a number of great articles on difficult problems—the stiff elbow, complex distal radius fractures, and intraoperative acetabular fractures during total hip arthroplasty.

Please enjoy this issue and think about what topics you tend to shy away from. I’m willing to bet you can add the most to your practice by studying up on these topics. As always, please provide your feedback to our editorial team so that we can continue to make improvements to our journal. We envision a change in the way orthopedists utilize a journal in their practice, and are continuously looking for ways to make AJO a more relevant tool for improving your patient care and workflow. We are working hard to give our readers the journal they deserve, but in my spare time, I’ll be brushing up on trochleoplasties and half-swing wedges.

It is human nature to practice things that we are already good at doing. If you’re a golfer, then you know what I’m talking about. I hit the driver over and over again on the range, but never practice hitting the bad lie in the bunker, or the half-swing wedge from a tight lie. I sink hundreds of 3 footers, but can’t putt into this range from 50 feet. I’ve gotten much better at golf since I started playing, but my scores have hardly gone down.

Why? It’s the things I never practice that usually come back to bite me during the round, making it impossible to avoid double bogeys and driving up my score. It’s these areas where I have the most room for improvement, and if I simply made the effort to practice them, I could see a real impact on my handicap.

I think a similar thing happens in our orthopedic practices. I read everything I can on the anterior cruciate ligament, yet I already feel comfortable with my reconstruction technique. I skim, or avoid reading altogether, articles about topics I don’t like to treat, like the hand or spine. Yet, I still see these things every day in my practice and on call. If my depth of knowledge in these areas was as good as it is in sports medicine, I could provide better, more immediate care to my patients, rather than refer them to subspecialists.

A perfect orthopedic example would be the patellofemoral joint. One of the least enjoyable patient encounters for me is the young adult with normal alignment and intractable anterior knee pain that does not respond to nonoperative treatment. I’m concerned any surgical intervention may make them worse and I’m often left without much to offer the patient.

It’s for this reason AJO has partnered with Dr. Jack Farr to produce the patellofemoral issue; to provide a comprehensive guide to the latest thinking in the treatment of patellofemoral disorders (see the March/April 2017 issue). We solicited so much outstanding content, that a single issue could not hold all of the articles. In this issue, our patellofemoral series continues with 3 outstanding articles. Magnussen presents "Patella Alta Sees You, Do You See It?" and Hinckel and colleagues have authored a guide to patellofemoral cartilage restoration. Unal and colleagues follow-up with a review of the lateral retinaculum.

In our "Codes to Know" section, we reexamine diagnostic arthroscopy, a code most of us have billed infrequently. New technologies, however, have made it possible to peer into the joint in the office, and McMillan and colleagues teach us how to make it economically feasible, even for employed physicians.

Finally, we have a number of great articles on difficult problems—the stiff elbow, complex distal radius fractures, and intraoperative acetabular fractures during total hip arthroplasty.

Please enjoy this issue and think about what topics you tend to shy away from. I’m willing to bet you can add the most to your practice by studying up on these topics. As always, please provide your feedback to our editorial team so that we can continue to make improvements to our journal. We envision a change in the way orthopedists utilize a journal in their practice, and are continuously looking for ways to make AJO a more relevant tool for improving your patient care and workflow. We are working hard to give our readers the journal they deserve, but in my spare time, I’ll be brushing up on trochleoplasties and half-swing wedges.

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Should psychologists be allowed to prescribe?

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In response to Dr. Nasrallah’s editorial “Prescribing is the culmination of extensive medical training and psychologists don’t qualify” (From the Editor, Current Psychiatry. June 2017, p. 11-12,14-16): I have mixed feelings about prescription privileges for psychologists, and I am not pursuing them. But Dr. Nasrallah’s manner of arguing with anecdotes and unsubstantiated opinion is undeserving of publication. He notes that psychologists with further training now have prescription privileges in several states and warns of the possible dangers of such practices. However, he did not bother to describe the training psychologists receive or report on the psychiatrists who helped develop that curriculum. Dr. Nasrallah did not present any empirical evidence to indicate that any actual harm has resulted from psychologists having prescription privileges or compare that with the harm from the prescription privileges of psychiatrists, other physicians, physician assistants, nurse practitioners, naturopaths, etc. He implies that only psychiatrists can properly prescribe psychiatric medications, which would certainly be a minority opinion. He offers no alternative solution to the current public health problems.

Tedd Judd, PhD, ABPP-CN
Diplomate in Clinical Neuropsychology
Certified Hispanic Mental Health Specialist
Cross-Cultural Specialist
Bellingham, Washington

I read Dr. Nasrallah’s editorial with a critical eye. As a psychologist in private clinical and forensic practice for more than 30 years, it is disheartening that you toe the politico-economic line proffered over the decades that establishes and buoys a clash between our helping professions in the hoary guise of protecting the consuming public.

It is disingenuous and misleading for you to cite “28,000 hours of training… 8 years of medical school” as a prerequisite for having adequate “psycho­pharmacological skills.”

Psychologists and psychiatrists can learn the same necessary and comprehensive skills to perform competent and equivalent prescription duties in succinct, operational ways.

It is about time the welfare of the consuming public be served instead of territorial profiteering. Perhaps you should focus more on the dwindling numbers of psychiatrists who perform psychotherapy in conjunction with psychopharmacology than on limiting the pool of providers who are qualified by training to do both. How many of those 28,000 hours are dedicated to training your psychiatrists in psychotherapy?

Norman R. Klein, PhD
Licensed Psychologist
Westport, Connecticut


Dr. Nasrallah wrote an unsurprisingly eloquent and passionate editorial and argues a cogent case for restricting prescription privileges to medically trained professionals. I wonder, though, if public health statistics of outcomes among mental health patients in states where clinical psychologists have been licensed to prescribe, such as New Mexico and Hawaii, bear out any of Dr. Nasrallah’s concerns.

Ole J. Thienhaus, MD, MBA
Department Head and Professor of Psychiatry
University of Arizona
College of Medicine-Tucson
Tucson, Arizona
 

 

 

 

Dr. Nasrallah responds

I am not surprised by Dr. Judd’s or Dr. Klein’s disagreement with my editorial asserting that psycho­logists do not receive the medical training that qualifies them to prescribe. They side with their fellow psychologists, just as psychiatrists agree with me. After all, those of us who have had the extensive training of psychiatric physicians know the abundance of medical skills needed for competent prescribing and find it preposterous that psychologists, who have a PhD and are acknowledged for their psychotherapy and psychometric skills, can take a drastic shortcut by getting politicians to give them the right to prescribe. Dr. Klein has no idea how much training it takes to become a competent prescriber, so his comments that both psychiatrists and psych­ologists can be similarly trained cannot be taken seriously. Even after 4 years of psychiatric residency with daily psychopharmacology teaching and training psychiatrists still feel they have much more to learn. It is dangerous hubris to think that even without the vital medical school foundation prior to psychiatric training that psychologists can enroll in a course and practicum and become psychopharmacologists.

Here, I provide a description of one state’s proposed the training that psycho­logists would receive. I hope that Drs. Judd and Klein will recognize the dangerously inadequate training recently proposed for psychologists to become “prescribers.”

Proposed curriculum for psychologists

1. Online instruction, not face-to-face classroom experience

2. Many courses are prerecorded

3. Instructors are psychologists, not psychiatrists

4. Psychologists can complete the program at their own pace, which can be done in a few weeks

5. Hours of instruction range between 306 to 468 hours, compared with 500 hours required for massage therapists

6. A minimum of 40 hours of “basic training on clinical assessment” is required, compared with 60 hours for electrologists

7. The “graduate” must pass a test prepared by the American Psychological Association, which advocates for prescriptive authority and is not an independent testing organization

8. There is no minimum of requirements of an undergraduate biomedical prerequisite course—the work that is required for all medical students, physician assistants, and nursing students—which includes chemistry or biochemistry (with laboratory experience), human anatomy, physiology, general biology, microbiology (with laboratory experience), cell biology, and molecular biology

9. Recommended number of patient encounters is anemic: 600 encounters, which can be 10 encounters with 60 patients or 15 encounters with 40 patients. This is far below what is required of psychiatric residents

 

 

10. The proposed training requires treating a minimum of 75 patients over 2 years. A typical third-year psychiatric resident sees 75 patients every month. Each first- and second-year resident works up and treats >600 inpatients in <1 year

11. At the end of the practicum, applicants must demonstrate competency in 9 milestones, but competency is not defined. In contrast, psychiatric residency programs have mandates from the Accreditation Council for Graduate Medical Education requiring that residents be graded every 6 months on 23 milestones, with specific anchor points provided

12. Only 25% of the practicum occurs on psychiatric inpatient wards or outpatient clinics. One wonders where the patients who need psychopharmacology would be

13. Supervision is inadequate. There is no requirement for supervision by psychiatrists, whose training and experience make them qualified psychopharmacologists

14. There is no guidance on the frequency or intensity of supervision. In psychiatry, residents are supervised with each patient encounter over 4 years. Should psychologists without medical training be held to a lesser standard?

15. There are no specifications of continuing medical education, ongoing supervision, or outcomes

16. The potential dangers of psycho­tropics are not emphasized. For example:

• permanent or life-threatening adverse effects, such as tardive dyskinesia or agranulocytosis
• addiction potential, such as with stimulants or benzodiazepines
• potentially fatal drug interactions with monoamine oxidase inhibitors and meperidine or serotonin syndrome, or cardiac arrests with overdoses of tricyclic antidepressants

17. Many medications require on­going monitoring. Some involve physical examination (extrapyramidal side effects, metabolic syndrome) or laboratory tests (lithium, carbamazepine, clozapine, valproate, renal and hepatic functions, metabolic profile for all antipsychotics). Failure to monitor may lead to fatal outcomes. Some medications are considered unsafe during pregnancy or breast-feeding.

Psychologists do a great service for patients with mental illness by providing evidence-based psycho­therapies, such as cognitive-behavioral, dialectical-behavioral, interpersonal, and behavioral therapy. They complement what psychiatrists and nurse practitioners do with pharmaco­therapy. Many patients with mild or moderate psychiatric disorders improve significantly with psychotherapy without the use of psychotropics. Psychologists should focus on what they were trained to do because they can benefit numerous patients. That is much better than trying to become prescribers and practice mediocre psychopharmacology without the requisite medical training. Patients with mental illness deserve no less.
 

Henry A. Nasrallah, MD
Professor and Chair
Department of Psychiatry and Behavioral Neuroscience
Saint Louis University School of Medicine
St. Louis, Missouri

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In response to Dr. Nasrallah’s editorial “Prescribing is the culmination of extensive medical training and psychologists don’t qualify” (From the Editor, Current Psychiatry. June 2017, p. 11-12,14-16): I have mixed feelings about prescription privileges for psychologists, and I am not pursuing them. But Dr. Nasrallah’s manner of arguing with anecdotes and unsubstantiated opinion is undeserving of publication. He notes that psychologists with further training now have prescription privileges in several states and warns of the possible dangers of such practices. However, he did not bother to describe the training psychologists receive or report on the psychiatrists who helped develop that curriculum. Dr. Nasrallah did not present any empirical evidence to indicate that any actual harm has resulted from psychologists having prescription privileges or compare that with the harm from the prescription privileges of psychiatrists, other physicians, physician assistants, nurse practitioners, naturopaths, etc. He implies that only psychiatrists can properly prescribe psychiatric medications, which would certainly be a minority opinion. He offers no alternative solution to the current public health problems.

Tedd Judd, PhD, ABPP-CN
Diplomate in Clinical Neuropsychology
Certified Hispanic Mental Health Specialist
Cross-Cultural Specialist
Bellingham, Washington

I read Dr. Nasrallah’s editorial with a critical eye. As a psychologist in private clinical and forensic practice for more than 30 years, it is disheartening that you toe the politico-economic line proffered over the decades that establishes and buoys a clash between our helping professions in the hoary guise of protecting the consuming public.

It is disingenuous and misleading for you to cite “28,000 hours of training… 8 years of medical school” as a prerequisite for having adequate “psycho­pharmacological skills.”

Psychologists and psychiatrists can learn the same necessary and comprehensive skills to perform competent and equivalent prescription duties in succinct, operational ways.

It is about time the welfare of the consuming public be served instead of territorial profiteering. Perhaps you should focus more on the dwindling numbers of psychiatrists who perform psychotherapy in conjunction with psychopharmacology than on limiting the pool of providers who are qualified by training to do both. How many of those 28,000 hours are dedicated to training your psychiatrists in psychotherapy?

Norman R. Klein, PhD
Licensed Psychologist
Westport, Connecticut


Dr. Nasrallah wrote an unsurprisingly eloquent and passionate editorial and argues a cogent case for restricting prescription privileges to medically trained professionals. I wonder, though, if public health statistics of outcomes among mental health patients in states where clinical psychologists have been licensed to prescribe, such as New Mexico and Hawaii, bear out any of Dr. Nasrallah’s concerns.

Ole J. Thienhaus, MD, MBA
Department Head and Professor of Psychiatry
University of Arizona
College of Medicine-Tucson
Tucson, Arizona
 

 

 

 

Dr. Nasrallah responds

I am not surprised by Dr. Judd’s or Dr. Klein’s disagreement with my editorial asserting that psycho­logists do not receive the medical training that qualifies them to prescribe. They side with their fellow psychologists, just as psychiatrists agree with me. After all, those of us who have had the extensive training of psychiatric physicians know the abundance of medical skills needed for competent prescribing and find it preposterous that psychologists, who have a PhD and are acknowledged for their psychotherapy and psychometric skills, can take a drastic shortcut by getting politicians to give them the right to prescribe. Dr. Klein has no idea how much training it takes to become a competent prescriber, so his comments that both psychiatrists and psych­ologists can be similarly trained cannot be taken seriously. Even after 4 years of psychiatric residency with daily psychopharmacology teaching and training psychiatrists still feel they have much more to learn. It is dangerous hubris to think that even without the vital medical school foundation prior to psychiatric training that psychologists can enroll in a course and practicum and become psychopharmacologists.

Here, I provide a description of one state’s proposed the training that psycho­logists would receive. I hope that Drs. Judd and Klein will recognize the dangerously inadequate training recently proposed for psychologists to become “prescribers.”

Proposed curriculum for psychologists

1. Online instruction, not face-to-face classroom experience

2. Many courses are prerecorded

3. Instructors are psychologists, not psychiatrists

4. Psychologists can complete the program at their own pace, which can be done in a few weeks

5. Hours of instruction range between 306 to 468 hours, compared with 500 hours required for massage therapists

6. A minimum of 40 hours of “basic training on clinical assessment” is required, compared with 60 hours for electrologists

7. The “graduate” must pass a test prepared by the American Psychological Association, which advocates for prescriptive authority and is not an independent testing organization

8. There is no minimum of requirements of an undergraduate biomedical prerequisite course—the work that is required for all medical students, physician assistants, and nursing students—which includes chemistry or biochemistry (with laboratory experience), human anatomy, physiology, general biology, microbiology (with laboratory experience), cell biology, and molecular biology

9. Recommended number of patient encounters is anemic: 600 encounters, which can be 10 encounters with 60 patients or 15 encounters with 40 patients. This is far below what is required of psychiatric residents

 

 

10. The proposed training requires treating a minimum of 75 patients over 2 years. A typical third-year psychiatric resident sees 75 patients every month. Each first- and second-year resident works up and treats >600 inpatients in <1 year

11. At the end of the practicum, applicants must demonstrate competency in 9 milestones, but competency is not defined. In contrast, psychiatric residency programs have mandates from the Accreditation Council for Graduate Medical Education requiring that residents be graded every 6 months on 23 milestones, with specific anchor points provided

12. Only 25% of the practicum occurs on psychiatric inpatient wards or outpatient clinics. One wonders where the patients who need psychopharmacology would be

13. Supervision is inadequate. There is no requirement for supervision by psychiatrists, whose training and experience make them qualified psychopharmacologists

14. There is no guidance on the frequency or intensity of supervision. In psychiatry, residents are supervised with each patient encounter over 4 years. Should psychologists without medical training be held to a lesser standard?

15. There are no specifications of continuing medical education, ongoing supervision, or outcomes

16. The potential dangers of psycho­tropics are not emphasized. For example:

• permanent or life-threatening adverse effects, such as tardive dyskinesia or agranulocytosis
• addiction potential, such as with stimulants or benzodiazepines
• potentially fatal drug interactions with monoamine oxidase inhibitors and meperidine or serotonin syndrome, or cardiac arrests with overdoses of tricyclic antidepressants

17. Many medications require on­going monitoring. Some involve physical examination (extrapyramidal side effects, metabolic syndrome) or laboratory tests (lithium, carbamazepine, clozapine, valproate, renal and hepatic functions, metabolic profile for all antipsychotics). Failure to monitor may lead to fatal outcomes. Some medications are considered unsafe during pregnancy or breast-feeding.

Psychologists do a great service for patients with mental illness by providing evidence-based psycho­therapies, such as cognitive-behavioral, dialectical-behavioral, interpersonal, and behavioral therapy. They complement what psychiatrists and nurse practitioners do with pharmaco­therapy. Many patients with mild or moderate psychiatric disorders improve significantly with psychotherapy without the use of psychotropics. Psychologists should focus on what they were trained to do because they can benefit numerous patients. That is much better than trying to become prescribers and practice mediocre psychopharmacology without the requisite medical training. Patients with mental illness deserve no less.
 

Henry A. Nasrallah, MD
Professor and Chair
Department of Psychiatry and Behavioral Neuroscience
Saint Louis University School of Medicine
St. Louis, Missouri

 

In response to Dr. Nasrallah’s editorial “Prescribing is the culmination of extensive medical training and psychologists don’t qualify” (From the Editor, Current Psychiatry. June 2017, p. 11-12,14-16): I have mixed feelings about prescription privileges for psychologists, and I am not pursuing them. But Dr. Nasrallah’s manner of arguing with anecdotes and unsubstantiated opinion is undeserving of publication. He notes that psychologists with further training now have prescription privileges in several states and warns of the possible dangers of such practices. However, he did not bother to describe the training psychologists receive or report on the psychiatrists who helped develop that curriculum. Dr. Nasrallah did not present any empirical evidence to indicate that any actual harm has resulted from psychologists having prescription privileges or compare that with the harm from the prescription privileges of psychiatrists, other physicians, physician assistants, nurse practitioners, naturopaths, etc. He implies that only psychiatrists can properly prescribe psychiatric medications, which would certainly be a minority opinion. He offers no alternative solution to the current public health problems.

Tedd Judd, PhD, ABPP-CN
Diplomate in Clinical Neuropsychology
Certified Hispanic Mental Health Specialist
Cross-Cultural Specialist
Bellingham, Washington

I read Dr. Nasrallah’s editorial with a critical eye. As a psychologist in private clinical and forensic practice for more than 30 years, it is disheartening that you toe the politico-economic line proffered over the decades that establishes and buoys a clash between our helping professions in the hoary guise of protecting the consuming public.

It is disingenuous and misleading for you to cite “28,000 hours of training… 8 years of medical school” as a prerequisite for having adequate “psycho­pharmacological skills.”

Psychologists and psychiatrists can learn the same necessary and comprehensive skills to perform competent and equivalent prescription duties in succinct, operational ways.

It is about time the welfare of the consuming public be served instead of territorial profiteering. Perhaps you should focus more on the dwindling numbers of psychiatrists who perform psychotherapy in conjunction with psychopharmacology than on limiting the pool of providers who are qualified by training to do both. How many of those 28,000 hours are dedicated to training your psychiatrists in psychotherapy?

Norman R. Klein, PhD
Licensed Psychologist
Westport, Connecticut


Dr. Nasrallah wrote an unsurprisingly eloquent and passionate editorial and argues a cogent case for restricting prescription privileges to medically trained professionals. I wonder, though, if public health statistics of outcomes among mental health patients in states where clinical psychologists have been licensed to prescribe, such as New Mexico and Hawaii, bear out any of Dr. Nasrallah’s concerns.

Ole J. Thienhaus, MD, MBA
Department Head and Professor of Psychiatry
University of Arizona
College of Medicine-Tucson
Tucson, Arizona
 

 

 

 

Dr. Nasrallah responds

I am not surprised by Dr. Judd’s or Dr. Klein’s disagreement with my editorial asserting that psycho­logists do not receive the medical training that qualifies them to prescribe. They side with their fellow psychologists, just as psychiatrists agree with me. After all, those of us who have had the extensive training of psychiatric physicians know the abundance of medical skills needed for competent prescribing and find it preposterous that psychologists, who have a PhD and are acknowledged for their psychotherapy and psychometric skills, can take a drastic shortcut by getting politicians to give them the right to prescribe. Dr. Klein has no idea how much training it takes to become a competent prescriber, so his comments that both psychiatrists and psych­ologists can be similarly trained cannot be taken seriously. Even after 4 years of psychiatric residency with daily psychopharmacology teaching and training psychiatrists still feel they have much more to learn. It is dangerous hubris to think that even without the vital medical school foundation prior to psychiatric training that psychologists can enroll in a course and practicum and become psychopharmacologists.

Here, I provide a description of one state’s proposed the training that psycho­logists would receive. I hope that Drs. Judd and Klein will recognize the dangerously inadequate training recently proposed for psychologists to become “prescribers.”

Proposed curriculum for psychologists

1. Online instruction, not face-to-face classroom experience

2. Many courses are prerecorded

3. Instructors are psychologists, not psychiatrists

4. Psychologists can complete the program at their own pace, which can be done in a few weeks

5. Hours of instruction range between 306 to 468 hours, compared with 500 hours required for massage therapists

6. A minimum of 40 hours of “basic training on clinical assessment” is required, compared with 60 hours for electrologists

7. The “graduate” must pass a test prepared by the American Psychological Association, which advocates for prescriptive authority and is not an independent testing organization

8. There is no minimum of requirements of an undergraduate biomedical prerequisite course—the work that is required for all medical students, physician assistants, and nursing students—which includes chemistry or biochemistry (with laboratory experience), human anatomy, physiology, general biology, microbiology (with laboratory experience), cell biology, and molecular biology

9. Recommended number of patient encounters is anemic: 600 encounters, which can be 10 encounters with 60 patients or 15 encounters with 40 patients. This is far below what is required of psychiatric residents

 

 

10. The proposed training requires treating a minimum of 75 patients over 2 years. A typical third-year psychiatric resident sees 75 patients every month. Each first- and second-year resident works up and treats >600 inpatients in <1 year

11. At the end of the practicum, applicants must demonstrate competency in 9 milestones, but competency is not defined. In contrast, psychiatric residency programs have mandates from the Accreditation Council for Graduate Medical Education requiring that residents be graded every 6 months on 23 milestones, with specific anchor points provided

12. Only 25% of the practicum occurs on psychiatric inpatient wards or outpatient clinics. One wonders where the patients who need psychopharmacology would be

13. Supervision is inadequate. There is no requirement for supervision by psychiatrists, whose training and experience make them qualified psychopharmacologists

14. There is no guidance on the frequency or intensity of supervision. In psychiatry, residents are supervised with each patient encounter over 4 years. Should psychologists without medical training be held to a lesser standard?

15. There are no specifications of continuing medical education, ongoing supervision, or outcomes

16. The potential dangers of psycho­tropics are not emphasized. For example:

• permanent or life-threatening adverse effects, such as tardive dyskinesia or agranulocytosis
• addiction potential, such as with stimulants or benzodiazepines
• potentially fatal drug interactions with monoamine oxidase inhibitors and meperidine or serotonin syndrome, or cardiac arrests with overdoses of tricyclic antidepressants

17. Many medications require on­going monitoring. Some involve physical examination (extrapyramidal side effects, metabolic syndrome) or laboratory tests (lithium, carbamazepine, clozapine, valproate, renal and hepatic functions, metabolic profile for all antipsychotics). Failure to monitor may lead to fatal outcomes. Some medications are considered unsafe during pregnancy or breast-feeding.

Psychologists do a great service for patients with mental illness by providing evidence-based psycho­therapies, such as cognitive-behavioral, dialectical-behavioral, interpersonal, and behavioral therapy. They complement what psychiatrists and nurse practitioners do with pharmaco­therapy. Many patients with mild or moderate psychiatric disorders improve significantly with psychotherapy without the use of psychotropics. Psychologists should focus on what they were trained to do because they can benefit numerous patients. That is much better than trying to become prescribers and practice mediocre psychopharmacology without the requisite medical training. Patients with mental illness deserve no less.
 

Henry A. Nasrallah, MD
Professor and Chair
Department of Psychiatry and Behavioral Neuroscience
Saint Louis University School of Medicine
St. Louis, Missouri

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