Family separations and the intergenerational transmission of trauma

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Changed

 

Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

Growing up, I was always intrigued by the strong emotions that even the mildest separation evoked within me. As a psychiatrist, I now believe that these emotions were related to my family’s difficulty with separation, a concept likely transmitted from my grandmother’s sudden separation as a child.

The political circumstances of the “Kindertransport” and the recent family separation at the southern U.S. border differ, but the Kindertransport is a model for studying the effects of forced parent-child separation and its intergenerational transmission. As a rescue operation that took place immediately before World War II, the Kindertransport was the emigration of approximately 10,000 German Jewish children from Germany and Nazi-occupied countries to England. Even though they were not literally forced, the parents involved were compelled to separate from their children to give their children a chance to survive.

Dr. Sarah Reinstein


In a recent letter1 published in The New York Times, Eva Yachnes, herself a Kindertransport participant, reflected on the current situation at the southern U.S. border. She alluded to the lifelong effects of her own separation at the age of 6 when emigrating from Vienna to Germany. Personally, as a granddaughter of a Kindertransport participant, I am particularly concerned about the intergenerational transmission of the trauma of family separation.

Since early May 2018, more than 2,000 children have been forcibly separated from their parents after illegally crossing the border. As part of a “zero tolerance policy,” the separation was characterized by the Trump administration as a deterrent to illegal border crossings. Although many Americans are horrified by the news reports about family separation, psychiatrists in particular have expressed concern about this trauma. The American Psychiatric Association issued a statement2 warning that “any forced separation is highly stressful for children and can cause lifelong trauma.” Several weeks later, the APA joined several other mental health organizations in a letter3 calling for the immediate end of enforcement of those policies. In that letter, the organizations said forced separations can cause “an increased risk of ... mental illnesses such as depression, anxiety, and posttraumatic stress disorder.”

What must psychiatrists understand about the impact of childhood trauma? How can psychiatrists approach treatment of children separated from their parents? Are there ways to minimize the risk for intergenerational impact of this trauma?
 

What do we know?

Childhood trauma is influenced by multiple factors and can be expressed in several ways. According to research,4 the age of the child at the time of traumatic event, the frequency of traumatic experiences, and the degree to which the child’s caretakers were involved in the trauma are factors that influence the extent of psychological damage. This research also suggests that childhood trauma is associated with emotional dysregulation, aggression against self and others, difficulties in attention and dissociation, medical problems, and difficulty with navigating adult interpersonal relationships.

 

 

When viewed through the lens of attachment theory, the forced separation of a child from its caretakers is a potent form of childhood trauma. Joanna E. Chambers, MD, summarizes and explains John Bowlby’s attachment theory as a neurobiological system originating from an infant’s connection to the primary caretaker. This connection becomes a lifelong model for all subsequent relationships.

Any traumatic disruptions in the development of this system puts the child at risk of developing “insecure attachment.” This insecure attachment can lead to lifelong emotional problems for the child, affecting the quality of subsequent marital relationships, relationships to children, and the development of personality disorders.

In addition, it correlates to the development of psychiatric illnesses, specifically depression and anxiety. There is also a plausible biological basis for attachment theory. Both oxytocin, a hormone released in human bonding, and social interaction itself have been shown to decrease cortisol levels. Elevated cortisol has been found to negatively affect infant brain development, Dr. Chambers argued.5

Given those significant effects of childhood trauma, it is understandable that there exists a concept of “intergenerational transmission of trauma.” Originating from studies of Holocaust survivors and their descendants, researchers Amy Lehrner, PhD, and Rachel Yehuda, PhD, conceptualize intergenerational transmission of trauma as the intergenerational impact of prenatal PTSD.6 This impact is expressed as a predisposition in the offspring of Holocaust survivors to developing PTSD, difficulties in individuation and separation, higher rates of mood and anxiety disorders, and higher rates of physical health issues.

Although they are complex and clearly multidetermined, Dr. Yehuda and Dr. Lehrner also summarize plausible biological theories for the intergenerational transmission of trauma. Epigenetic differences in the hypothalamic-pituitary-adrenal axis, circadian rhythm, urinary and plasma cortisol levels, glucocorticoid sensitivity, and regulation of the glucocorticoid receptor gene all have been found in Holocaust offspring with parental PTSD, in contrast to offspring without parental PTSD.6

What can we as psychiatrists do?

We are uniquely equipped to take several concrete steps to help mitigate the effects of these traumatic events. Among them, we can:

  • Provide opportunities for the child and the family to process their experience. This can be profoundly healing and can help minimize the devastating psychological effects of this separation.
  • Become acquainted with the concept of intergenerational transmission of resilience.
  • Work with trauma survivors to develop their own personal narratives and cultural rituals surrounding the trauma.6
  • Encourage second- and third-generation descendants to engage in artistic expression of the trauma, visit places of importance to their parents, and engage in social and political activism. These are all expressions of resilience in the offspring of trauma victims.6

In summary, recent U.S. political events have caused thousands of children to be forcibly separated from their parents. Those separations are traumatic and can have lifelong psychological implications for the children and their offspring. It is important to provide quality mental health treatment to these children with a specific focus on treating PTSD and processing the traumatic experience. Psychological treatment can help mitigate the effects of the traumatic separation and create a sense of resiliency.
 

 

 

References

1. New York Times. June 20, 2018. “My separation trauma.”

2. American Psychiatric Association statement, May 30, 2018.

3. Letter to the departments of Justice, Health & Human Services, and Homeland Security, June 20, 2018.

4. Child Adolesc Psychiatric Clin N Am. 2003;(12.2):293-318.

5. Psychodynamic Psychiatry. 2017 Dec;45(4):542-63.

6. Psychological Trauma: Theory, Research, Practice, and Policy. 2018 Jan;10(1):22-9.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital of the Northwell Health System, Glen Oaks, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine after graduating from the Albert Einstein College of Medicine and Yeshiva University with a B.A. in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

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Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

Growing up, I was always intrigued by the strong emotions that even the mildest separation evoked within me. As a psychiatrist, I now believe that these emotions were related to my family’s difficulty with separation, a concept likely transmitted from my grandmother’s sudden separation as a child.

The political circumstances of the “Kindertransport” and the recent family separation at the southern U.S. border differ, but the Kindertransport is a model for studying the effects of forced parent-child separation and its intergenerational transmission. As a rescue operation that took place immediately before World War II, the Kindertransport was the emigration of approximately 10,000 German Jewish children from Germany and Nazi-occupied countries to England. Even though they were not literally forced, the parents involved were compelled to separate from their children to give their children a chance to survive.

Dr. Sarah Reinstein


In a recent letter1 published in The New York Times, Eva Yachnes, herself a Kindertransport participant, reflected on the current situation at the southern U.S. border. She alluded to the lifelong effects of her own separation at the age of 6 when emigrating from Vienna to Germany. Personally, as a granddaughter of a Kindertransport participant, I am particularly concerned about the intergenerational transmission of the trauma of family separation.

Since early May 2018, more than 2,000 children have been forcibly separated from their parents after illegally crossing the border. As part of a “zero tolerance policy,” the separation was characterized by the Trump administration as a deterrent to illegal border crossings. Although many Americans are horrified by the news reports about family separation, psychiatrists in particular have expressed concern about this trauma. The American Psychiatric Association issued a statement2 warning that “any forced separation is highly stressful for children and can cause lifelong trauma.” Several weeks later, the APA joined several other mental health organizations in a letter3 calling for the immediate end of enforcement of those policies. In that letter, the organizations said forced separations can cause “an increased risk of ... mental illnesses such as depression, anxiety, and posttraumatic stress disorder.”

What must psychiatrists understand about the impact of childhood trauma? How can psychiatrists approach treatment of children separated from their parents? Are there ways to minimize the risk for intergenerational impact of this trauma?
 

What do we know?

Childhood trauma is influenced by multiple factors and can be expressed in several ways. According to research,4 the age of the child at the time of traumatic event, the frequency of traumatic experiences, and the degree to which the child’s caretakers were involved in the trauma are factors that influence the extent of psychological damage. This research also suggests that childhood trauma is associated with emotional dysregulation, aggression against self and others, difficulties in attention and dissociation, medical problems, and difficulty with navigating adult interpersonal relationships.

 

 

When viewed through the lens of attachment theory, the forced separation of a child from its caretakers is a potent form of childhood trauma. Joanna E. Chambers, MD, summarizes and explains John Bowlby’s attachment theory as a neurobiological system originating from an infant’s connection to the primary caretaker. This connection becomes a lifelong model for all subsequent relationships.

Any traumatic disruptions in the development of this system puts the child at risk of developing “insecure attachment.” This insecure attachment can lead to lifelong emotional problems for the child, affecting the quality of subsequent marital relationships, relationships to children, and the development of personality disorders.

In addition, it correlates to the development of psychiatric illnesses, specifically depression and anxiety. There is also a plausible biological basis for attachment theory. Both oxytocin, a hormone released in human bonding, and social interaction itself have been shown to decrease cortisol levels. Elevated cortisol has been found to negatively affect infant brain development, Dr. Chambers argued.5

Given those significant effects of childhood trauma, it is understandable that there exists a concept of “intergenerational transmission of trauma.” Originating from studies of Holocaust survivors and their descendants, researchers Amy Lehrner, PhD, and Rachel Yehuda, PhD, conceptualize intergenerational transmission of trauma as the intergenerational impact of prenatal PTSD.6 This impact is expressed as a predisposition in the offspring of Holocaust survivors to developing PTSD, difficulties in individuation and separation, higher rates of mood and anxiety disorders, and higher rates of physical health issues.

Although they are complex and clearly multidetermined, Dr. Yehuda and Dr. Lehrner also summarize plausible biological theories for the intergenerational transmission of trauma. Epigenetic differences in the hypothalamic-pituitary-adrenal axis, circadian rhythm, urinary and plasma cortisol levels, glucocorticoid sensitivity, and regulation of the glucocorticoid receptor gene all have been found in Holocaust offspring with parental PTSD, in contrast to offspring without parental PTSD.6

What can we as psychiatrists do?

We are uniquely equipped to take several concrete steps to help mitigate the effects of these traumatic events. Among them, we can:

  • Provide opportunities for the child and the family to process their experience. This can be profoundly healing and can help minimize the devastating psychological effects of this separation.
  • Become acquainted with the concept of intergenerational transmission of resilience.
  • Work with trauma survivors to develop their own personal narratives and cultural rituals surrounding the trauma.6
  • Encourage second- and third-generation descendants to engage in artistic expression of the trauma, visit places of importance to their parents, and engage in social and political activism. These are all expressions of resilience in the offspring of trauma victims.6

In summary, recent U.S. political events have caused thousands of children to be forcibly separated from their parents. Those separations are traumatic and can have lifelong psychological implications for the children and their offspring. It is important to provide quality mental health treatment to these children with a specific focus on treating PTSD and processing the traumatic experience. Psychological treatment can help mitigate the effects of the traumatic separation and create a sense of resiliency.
 

 

 

References

1. New York Times. June 20, 2018. “My separation trauma.”

2. American Psychiatric Association statement, May 30, 2018.

3. Letter to the departments of Justice, Health & Human Services, and Homeland Security, June 20, 2018.

4. Child Adolesc Psychiatric Clin N Am. 2003;(12.2):293-318.

5. Psychodynamic Psychiatry. 2017 Dec;45(4):542-63.

6. Psychological Trauma: Theory, Research, Practice, and Policy. 2018 Jan;10(1):22-9.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital of the Northwell Health System, Glen Oaks, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine after graduating from the Albert Einstein College of Medicine and Yeshiva University with a B.A. in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

 

Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.

Growing up, I was always intrigued by the strong emotions that even the mildest separation evoked within me. As a psychiatrist, I now believe that these emotions were related to my family’s difficulty with separation, a concept likely transmitted from my grandmother’s sudden separation as a child.

The political circumstances of the “Kindertransport” and the recent family separation at the southern U.S. border differ, but the Kindertransport is a model for studying the effects of forced parent-child separation and its intergenerational transmission. As a rescue operation that took place immediately before World War II, the Kindertransport was the emigration of approximately 10,000 German Jewish children from Germany and Nazi-occupied countries to England. Even though they were not literally forced, the parents involved were compelled to separate from their children to give their children a chance to survive.

Dr. Sarah Reinstein


In a recent letter1 published in The New York Times, Eva Yachnes, herself a Kindertransport participant, reflected on the current situation at the southern U.S. border. She alluded to the lifelong effects of her own separation at the age of 6 when emigrating from Vienna to Germany. Personally, as a granddaughter of a Kindertransport participant, I am particularly concerned about the intergenerational transmission of the trauma of family separation.

Since early May 2018, more than 2,000 children have been forcibly separated from their parents after illegally crossing the border. As part of a “zero tolerance policy,” the separation was characterized by the Trump administration as a deterrent to illegal border crossings. Although many Americans are horrified by the news reports about family separation, psychiatrists in particular have expressed concern about this trauma. The American Psychiatric Association issued a statement2 warning that “any forced separation is highly stressful for children and can cause lifelong trauma.” Several weeks later, the APA joined several other mental health organizations in a letter3 calling for the immediate end of enforcement of those policies. In that letter, the organizations said forced separations can cause “an increased risk of ... mental illnesses such as depression, anxiety, and posttraumatic stress disorder.”

What must psychiatrists understand about the impact of childhood trauma? How can psychiatrists approach treatment of children separated from their parents? Are there ways to minimize the risk for intergenerational impact of this trauma?
 

What do we know?

Childhood trauma is influenced by multiple factors and can be expressed in several ways. According to research,4 the age of the child at the time of traumatic event, the frequency of traumatic experiences, and the degree to which the child’s caretakers were involved in the trauma are factors that influence the extent of psychological damage. This research also suggests that childhood trauma is associated with emotional dysregulation, aggression against self and others, difficulties in attention and dissociation, medical problems, and difficulty with navigating adult interpersonal relationships.

 

 

When viewed through the lens of attachment theory, the forced separation of a child from its caretakers is a potent form of childhood trauma. Joanna E. Chambers, MD, summarizes and explains John Bowlby’s attachment theory as a neurobiological system originating from an infant’s connection to the primary caretaker. This connection becomes a lifelong model for all subsequent relationships.

Any traumatic disruptions in the development of this system puts the child at risk of developing “insecure attachment.” This insecure attachment can lead to lifelong emotional problems for the child, affecting the quality of subsequent marital relationships, relationships to children, and the development of personality disorders.

In addition, it correlates to the development of psychiatric illnesses, specifically depression and anxiety. There is also a plausible biological basis for attachment theory. Both oxytocin, a hormone released in human bonding, and social interaction itself have been shown to decrease cortisol levels. Elevated cortisol has been found to negatively affect infant brain development, Dr. Chambers argued.5

Given those significant effects of childhood trauma, it is understandable that there exists a concept of “intergenerational transmission of trauma.” Originating from studies of Holocaust survivors and their descendants, researchers Amy Lehrner, PhD, and Rachel Yehuda, PhD, conceptualize intergenerational transmission of trauma as the intergenerational impact of prenatal PTSD.6 This impact is expressed as a predisposition in the offspring of Holocaust survivors to developing PTSD, difficulties in individuation and separation, higher rates of mood and anxiety disorders, and higher rates of physical health issues.

Although they are complex and clearly multidetermined, Dr. Yehuda and Dr. Lehrner also summarize plausible biological theories for the intergenerational transmission of trauma. Epigenetic differences in the hypothalamic-pituitary-adrenal axis, circadian rhythm, urinary and plasma cortisol levels, glucocorticoid sensitivity, and regulation of the glucocorticoid receptor gene all have been found in Holocaust offspring with parental PTSD, in contrast to offspring without parental PTSD.6

What can we as psychiatrists do?

We are uniquely equipped to take several concrete steps to help mitigate the effects of these traumatic events. Among them, we can:

  • Provide opportunities for the child and the family to process their experience. This can be profoundly healing and can help minimize the devastating psychological effects of this separation.
  • Become acquainted with the concept of intergenerational transmission of resilience.
  • Work with trauma survivors to develop their own personal narratives and cultural rituals surrounding the trauma.6
  • Encourage second- and third-generation descendants to engage in artistic expression of the trauma, visit places of importance to their parents, and engage in social and political activism. These are all expressions of resilience in the offspring of trauma victims.6

In summary, recent U.S. political events have caused thousands of children to be forcibly separated from their parents. Those separations are traumatic and can have lifelong psychological implications for the children and their offspring. It is important to provide quality mental health treatment to these children with a specific focus on treating PTSD and processing the traumatic experience. Psychological treatment can help mitigate the effects of the traumatic separation and create a sense of resiliency.
 

 

 

References

1. New York Times. June 20, 2018. “My separation trauma.”

2. American Psychiatric Association statement, May 30, 2018.

3. Letter to the departments of Justice, Health & Human Services, and Homeland Security, June 20, 2018.

4. Child Adolesc Psychiatric Clin N Am. 2003;(12.2):293-318.

5. Psychodynamic Psychiatry. 2017 Dec;45(4):542-63.

6. Psychological Trauma: Theory, Research, Practice, and Policy. 2018 Jan;10(1):22-9.
 

Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital of the Northwell Health System, Glen Oaks, New York. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine after graduating from the Albert Einstein College of Medicine and Yeshiva University with a B.A. in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.

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Damned documentation

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Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images
Tracy teaches kindergarten in what was once a working-class neighborhood, now populated by biotech types with PhDs and lots of dough.

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

 

 


“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Alan Rockoff
Sounds about as useful as Medicare Wellness Visit forms.

It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?

We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.

There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.

Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.

As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

Publications
Topics
Sections

 

Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images
Tracy teaches kindergarten in what was once a working-class neighborhood, now populated by biotech types with PhDs and lots of dough.

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

 

 


“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Alan Rockoff
Sounds about as useful as Medicare Wellness Visit forms.

It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?

We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.

There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.

Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.

As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

 

Documentation got you down? Feel like you’re turning into a data entry clerk?

Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.

1. Tiers for Tots

PRImageFactory/iStock/Getty Images
Tracy teaches kindergarten in what was once a working-class neighborhood, now populated by biotech types with PhDs and lots of dough.

“What are the parents like?” I ask.

“They’re great!” Tracy says. “They want their kids to be creative and play.”

She frowns. “But my boss insists I give him data.”

“Data? What data?”

“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”

“And what if the kids flub letter recognition?”

Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”

“Good grief! What is a Tier 2 intervention?”

“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”

Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!

2. Filing for firefighters

Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.

“The paperwork is driving me crazy,” he says.

“What paperwork?”

“In between calls, we spend hours filling out forms,” he says.

“Which forms?”

“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.

“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”

“And now?”

“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”

And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.

3. Your personal banker doesn’t know you!

Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”

I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”

“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”

“Sounds reasonable.”

 

 


“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”

“Do the regulators ever ask?”

“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”

Dr. Alan Rockoff
Sounds about as useful as Medicare Wellness Visit forms.

It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?

We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.

There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.

Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.

As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

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Hands-on surgical training is incomparable

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Hands-on surgical training is incomparable

I am not one to critique new technology or new technique. The article on use of virtual reality to not only teach technique but also to grade it caught my attention. I work in a small hospital without a million-dollar robot. Very complicated cases are sent out to larger hospitals. We have 2 new graduates who, like most new grads, have little experience with many surgical techniques. Dr. Lenihan and I were resident classmates, so I know he understands the rigors of a no-hour limit residency. Even with our residency, when we got out we relied on our partners to assist us until they knew we could do cases with a surgical assistant (SA) or a less experienced helper.

We are asking too much of our new graduates. It is up to us to provide the help and assistance with surgeries that they are not comfortable doing. While virtual reality training is great for teaching robotics and some laparoscopic techniques, it cannot teach things such as anterior and posterior repairs, tension-free vaginal tape procedures, and enterocoele repair. We can all watch YouTube tutorials, but actually doing surgery is very different. We owe it to our new graduates to provide mentoring and encouragement with their surgical cases. At our hospital, mentoring the first 10 cases performed by a new physician (new grad or otherwise) used to be required, but that requirement is gone. Our service is one of the few that still has 2 physicians at every major case. We have an SA available, but we prefer to assist each other. This makes our laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy cases a 30- to 35-minute case. It allows us to teach anterior and posterior repair technique.

The involvement in surgical improvement is hands-on, and virtual reality training will never replace it.

Anthony J. Lemanski, MD
Kingman, Arizona

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Hands-on surgical training is incomparable

I am not one to critique new technology or new technique. The article on use of virtual reality to not only teach technique but also to grade it caught my attention. I work in a small hospital without a million-dollar robot. Very complicated cases are sent out to larger hospitals. We have 2 new graduates who, like most new grads, have little experience with many surgical techniques. Dr. Lenihan and I were resident classmates, so I know he understands the rigors of a no-hour limit residency. Even with our residency, when we got out we relied on our partners to assist us until they knew we could do cases with a surgical assistant (SA) or a less experienced helper.

We are asking too much of our new graduates. It is up to us to provide the help and assistance with surgeries that they are not comfortable doing. While virtual reality training is great for teaching robotics and some laparoscopic techniques, it cannot teach things such as anterior and posterior repairs, tension-free vaginal tape procedures, and enterocoele repair. We can all watch YouTube tutorials, but actually doing surgery is very different. We owe it to our new graduates to provide mentoring and encouragement with their surgical cases. At our hospital, mentoring the first 10 cases performed by a new physician (new grad or otherwise) used to be required, but that requirement is gone. Our service is one of the few that still has 2 physicians at every major case. We have an SA available, but we prefer to assist each other. This makes our laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy cases a 30- to 35-minute case. It allows us to teach anterior and posterior repair technique.

The involvement in surgical improvement is hands-on, and virtual reality training will never replace it.

Anthony J. Lemanski, MD
Kingman, Arizona

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Hands-on surgical training is incomparable

I am not one to critique new technology or new technique. The article on use of virtual reality to not only teach technique but also to grade it caught my attention. I work in a small hospital without a million-dollar robot. Very complicated cases are sent out to larger hospitals. We have 2 new graduates who, like most new grads, have little experience with many surgical techniques. Dr. Lenihan and I were resident classmates, so I know he understands the rigors of a no-hour limit residency. Even with our residency, when we got out we relied on our partners to assist us until they knew we could do cases with a surgical assistant (SA) or a less experienced helper.

We are asking too much of our new graduates. It is up to us to provide the help and assistance with surgeries that they are not comfortable doing. While virtual reality training is great for teaching robotics and some laparoscopic techniques, it cannot teach things such as anterior and posterior repairs, tension-free vaginal tape procedures, and enterocoele repair. We can all watch YouTube tutorials, but actually doing surgery is very different. We owe it to our new graduates to provide mentoring and encouragement with their surgical cases. At our hospital, mentoring the first 10 cases performed by a new physician (new grad or otherwise) used to be required, but that requirement is gone. Our service is one of the few that still has 2 physicians at every major case. We have an SA available, but we prefer to assist each other. This makes our laparoscopic-assisted vaginal hysterectomy, bilateral salpingo-oophorectomy cases a 30- to 35-minute case. It allows us to teach anterior and posterior repair technique.

The involvement in surgical improvement is hands-on, and virtual reality training will never replace it.

Anthony J. Lemanski, MD
Kingman, Arizona

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Hypertensive crisis of pregnancy must be treated with all urgency

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Hypertensive crisis of pregnancy must be treated with all urgency

The following happened approximately 27 years ago when I worked as an attending at a regional level 2 hospital in Puerto Rico. One afternoon I received a call from the emergency department that they had been managing a patient (G4P3) at 33 weeks of gestation for about 4 hours. The patient was consulted for hypertension when she went into a hypertensive encephalopathic coma. The patient was brought back to the birth center. Apresoline was given but did not bring the blood pressure down. Magnesium sulfate also was started at that time. I called a colleague from internal medicine and started to give nitroprusside.

Every time the patient’s blood pressure dropped from 120 mm Hg diastolic, she would become conscious and speak with us. As soon as her blood pressure went up, she would go into a coma. The patient was then transferred to a tertiary center in as stable a condition as possible. Cesarean delivery was performed, and the baby did not survive. The mother had an intracerebral hemorrhage. She was transferred to the supra-tertiary center in San Juan where she later passed away from complications of the hypertensive crisis. If the emergency physician had called me earlier, more could have been done.

This event is always fresh I my mind when I manage my patients in Ohio. Thank God for the newer medications we have available and the protocols to manage hypertensive crisis in pregnancy. I hope this experience heightens awareness of how deadly this condition can be.

David A. Rosado, MD
Celina, Ohio

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Hypertensive crisis of pregnancy must be treated with all urgency

The following happened approximately 27 years ago when I worked as an attending at a regional level 2 hospital in Puerto Rico. One afternoon I received a call from the emergency department that they had been managing a patient (G4P3) at 33 weeks of gestation for about 4 hours. The patient was consulted for hypertension when she went into a hypertensive encephalopathic coma. The patient was brought back to the birth center. Apresoline was given but did not bring the blood pressure down. Magnesium sulfate also was started at that time. I called a colleague from internal medicine and started to give nitroprusside.

Every time the patient’s blood pressure dropped from 120 mm Hg diastolic, she would become conscious and speak with us. As soon as her blood pressure went up, she would go into a coma. The patient was then transferred to a tertiary center in as stable a condition as possible. Cesarean delivery was performed, and the baby did not survive. The mother had an intracerebral hemorrhage. She was transferred to the supra-tertiary center in San Juan where she later passed away from complications of the hypertensive crisis. If the emergency physician had called me earlier, more could have been done.

This event is always fresh I my mind when I manage my patients in Ohio. Thank God for the newer medications we have available and the protocols to manage hypertensive crisis in pregnancy. I hope this experience heightens awareness of how deadly this condition can be.

David A. Rosado, MD
Celina, Ohio

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Hypertensive crisis of pregnancy must be treated with all urgency

The following happened approximately 27 years ago when I worked as an attending at a regional level 2 hospital in Puerto Rico. One afternoon I received a call from the emergency department that they had been managing a patient (G4P3) at 33 weeks of gestation for about 4 hours. The patient was consulted for hypertension when she went into a hypertensive encephalopathic coma. The patient was brought back to the birth center. Apresoline was given but did not bring the blood pressure down. Magnesium sulfate also was started at that time. I called a colleague from internal medicine and started to give nitroprusside.

Every time the patient’s blood pressure dropped from 120 mm Hg diastolic, she would become conscious and speak with us. As soon as her blood pressure went up, she would go into a coma. The patient was then transferred to a tertiary center in as stable a condition as possible. Cesarean delivery was performed, and the baby did not survive. The mother had an intracerebral hemorrhage. She was transferred to the supra-tertiary center in San Juan where she later passed away from complications of the hypertensive crisis. If the emergency physician had called me earlier, more could have been done.

This event is always fresh I my mind when I manage my patients in Ohio. Thank God for the newer medications we have available and the protocols to manage hypertensive crisis in pregnancy. I hope this experience heightens awareness of how deadly this condition can be.

David A. Rosado, MD
Celina, Ohio

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

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Buckwheat Extract

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Native to North and East Asia, buckwheat has been grown in China for more than 2,000 years and has been used in traditional medicine to treat varicose veins.1,2 This highly adaptable plant – the most common species of which are Fagopyrum esculentum (common buckwheat or sweet buckwheat), and F. tataricum (which grows in more mountainous regions) – has acclimated to cultivation in North America, as well.1 Increasingly popular as a healthy grain option, buckwheat flour has been touted for beneficial effects on diabetes, obesity, hypertension, hypercholesterolemia, and constipation.1 It has also gained attention for its association with some allergic reactions.

SandraKavas/iStock /Getty Images Plus
The reputed antioxidant and photoprotective properties of the botanical, in particular, have led to greater scientific scrutiny. Indeed, buckwheat contains an abundance of flavonoids, as well as flavones, phytosterols, and thiamin-binding proteins, many of which are well known to exhibit antioxidant activity.3 Rutin, the primary flavonoid in F. esculentum, has been demonstrated to decrease total leg volume in venous insufficiency patients.2 Chlorogenic acid and hyperoside are also key constituents of buckwheat, as are the flavonoids quercetin, orientin, vitexin, isoorientin, and isovitexin.3,4 In this column, the focus is on research indicating dermatologic applications for this ancient botanical ingredient.
 

Wound Healing

In 2008, van den Berg et al. performed an in vitro investigation of the antioxidant and anti-inflammatory qualities of buckwheat honey for consideration in wound healing. American buckwheat honey from New York was found to be the source of the most salient activities, with such properties attributed to its abundant phenolic components. The researchers suggested that these phenols might impart antibacterial activity, while the low pH and high free acid content of the buckwheat honey could contribute to healing wounds.4

Antioxidant Activity

The antioxidant capacity, along with other traits, characterizing the sprouts of common buckwheat (F. esculentum) and tartary buckwheat (F. tataricum) was evaluated by Liu et al. in 2008. Rutin is the main flavonoid found in both species, with fivefold higher levels identified in tartary buckwheat in this study. Ethanol extracts of tartary buckwheat also exhibited greater free radical scavenging activity and superoxide scavenging activity, compared with common buckwheat. Both buckwheat species displayed antioxidant activity on human hepatoma HepG2 cells, with tartary buckwheat more effective in diminishing cellular oxidative stress, which the authors attributed to its greater rutin and quercetin levels.5

Zhou et al. studied the protective effects of buckwheat honey on hydroxyl radical-induced DNA damage in 2012, finding that all studied honeys more effectively protected DNA in non–site specific rather than site-specific systems.6

Photoprotection

In a 2005 screening of 47 antioxidant substances and study of their effects on UV-induced lipid peroxidation, Trommer and Neubert reported that buckwheat extract significantly lowered radiation levels, as did extracts of St. John’s Wort, melissa, and sage. They concluded that their in vitro findings supported the inclusion of such ingredients in photoprotective cosmetic formulations or sunscreens pending the results of in vivo experiments with these compounds.7

In 2006, Hinneburg et al. evaluated the antioxidant and photoprotective activity of a buckwheat herb extract, also comparing its photoprotective characteristics to those of a commercial UV absorber. In an assay with 1,1-diphenyl-2-picryl-hydrazyl radical (DPPH), buckwheat extract exhibited significantly more antioxidant activity than did pure rutin, with buckwheat observed to more effectively block UV-induced peroxidation of linoleic acid as compared with rutin and the commercial UV absorber. The researchers concluded that including antioxidants such as buckwheat extract in photoprotective formulations may serve to maximize skin protection in such products.8

 

 

Buckwheat Sensitivity

Dr. Leslie S. Baumann
Notably, Geiselhart et al. set out in 2017 to characterize concomitant sensitivities in patients allergic to buckwheat. They divided subjects selected by positive skin prick tests into a group sensitive to buckwheat without clinical signs and an allergic group, finding that patients with clinical symptoms presented with a distinct allergen recognition pattern. Specifically, the researchers noted that a new allergen, Fag e 4, which may cross react with latex, warranted addition to the allergen panel of buckwheat and that concomitant sensitization to legumin, Fag e 2 and Fag e 5 predicts buckwheat allergy.9

Conclusion

Because it is a popular component in many diets around the world, especially Japan, Korea, Russia, and Poland, as well as other Asian and European countries, South Africa, Australia, and North America,4 it is reasonable to expect that we’ll see more research on buckwheat. For now, there are indications to suggest that more investigations are warranted to determine whether this botanical agent will have a meaningful role in the dermatologic armamentarium.

References

1. Li SQ et al. Crit Rev Food Sci Nutr. 2001 Sep;41(6):451-64.

2. Dattner AM. Dermatol Ther. 2003;16(2):106-13.

3. Hinneburg I et al. J Agric Food Chem. 2005 Jan 12;53(1):3-7.

4. van den Berg AJ et al. J Wound Care. 2008 Apr;17(4):172-4, 176-8.

5. Liu CL et al. J Agric Food Chem. 2008 Jan 9;56(1):173-8.

6. Zhou J et al. Food Chem Toxicol. 2012 Aug;50(8):2766-73.

7. Trommer H et al. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

8. Hinneburg I et al. Pharmazie. 2006 Mar;61(3):237-40.

9. Geiselhart S et al. Clin Exp Allergy. 2018 Feb;48(2):217-24.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014); she also authored a New York Times Best Seller for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance Therapeutics. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

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Native to North and East Asia, buckwheat has been grown in China for more than 2,000 years and has been used in traditional medicine to treat varicose veins.1,2 This highly adaptable plant – the most common species of which are Fagopyrum esculentum (common buckwheat or sweet buckwheat), and F. tataricum (which grows in more mountainous regions) – has acclimated to cultivation in North America, as well.1 Increasingly popular as a healthy grain option, buckwheat flour has been touted for beneficial effects on diabetes, obesity, hypertension, hypercholesterolemia, and constipation.1 It has also gained attention for its association with some allergic reactions.

SandraKavas/iStock /Getty Images Plus
The reputed antioxidant and photoprotective properties of the botanical, in particular, have led to greater scientific scrutiny. Indeed, buckwheat contains an abundance of flavonoids, as well as flavones, phytosterols, and thiamin-binding proteins, many of which are well known to exhibit antioxidant activity.3 Rutin, the primary flavonoid in F. esculentum, has been demonstrated to decrease total leg volume in venous insufficiency patients.2 Chlorogenic acid and hyperoside are also key constituents of buckwheat, as are the flavonoids quercetin, orientin, vitexin, isoorientin, and isovitexin.3,4 In this column, the focus is on research indicating dermatologic applications for this ancient botanical ingredient.
 

Wound Healing

In 2008, van den Berg et al. performed an in vitro investigation of the antioxidant and anti-inflammatory qualities of buckwheat honey for consideration in wound healing. American buckwheat honey from New York was found to be the source of the most salient activities, with such properties attributed to its abundant phenolic components. The researchers suggested that these phenols might impart antibacterial activity, while the low pH and high free acid content of the buckwheat honey could contribute to healing wounds.4

Antioxidant Activity

The antioxidant capacity, along with other traits, characterizing the sprouts of common buckwheat (F. esculentum) and tartary buckwheat (F. tataricum) was evaluated by Liu et al. in 2008. Rutin is the main flavonoid found in both species, with fivefold higher levels identified in tartary buckwheat in this study. Ethanol extracts of tartary buckwheat also exhibited greater free radical scavenging activity and superoxide scavenging activity, compared with common buckwheat. Both buckwheat species displayed antioxidant activity on human hepatoma HepG2 cells, with tartary buckwheat more effective in diminishing cellular oxidative stress, which the authors attributed to its greater rutin and quercetin levels.5

Zhou et al. studied the protective effects of buckwheat honey on hydroxyl radical-induced DNA damage in 2012, finding that all studied honeys more effectively protected DNA in non–site specific rather than site-specific systems.6

Photoprotection

In a 2005 screening of 47 antioxidant substances and study of their effects on UV-induced lipid peroxidation, Trommer and Neubert reported that buckwheat extract significantly lowered radiation levels, as did extracts of St. John’s Wort, melissa, and sage. They concluded that their in vitro findings supported the inclusion of such ingredients in photoprotective cosmetic formulations or sunscreens pending the results of in vivo experiments with these compounds.7

In 2006, Hinneburg et al. evaluated the antioxidant and photoprotective activity of a buckwheat herb extract, also comparing its photoprotective characteristics to those of a commercial UV absorber. In an assay with 1,1-diphenyl-2-picryl-hydrazyl radical (DPPH), buckwheat extract exhibited significantly more antioxidant activity than did pure rutin, with buckwheat observed to more effectively block UV-induced peroxidation of linoleic acid as compared with rutin and the commercial UV absorber. The researchers concluded that including antioxidants such as buckwheat extract in photoprotective formulations may serve to maximize skin protection in such products.8

 

 

Buckwheat Sensitivity

Dr. Leslie S. Baumann
Notably, Geiselhart et al. set out in 2017 to characterize concomitant sensitivities in patients allergic to buckwheat. They divided subjects selected by positive skin prick tests into a group sensitive to buckwheat without clinical signs and an allergic group, finding that patients with clinical symptoms presented with a distinct allergen recognition pattern. Specifically, the researchers noted that a new allergen, Fag e 4, which may cross react with latex, warranted addition to the allergen panel of buckwheat and that concomitant sensitization to legumin, Fag e 2 and Fag e 5 predicts buckwheat allergy.9

Conclusion

Because it is a popular component in many diets around the world, especially Japan, Korea, Russia, and Poland, as well as other Asian and European countries, South Africa, Australia, and North America,4 it is reasonable to expect that we’ll see more research on buckwheat. For now, there are indications to suggest that more investigations are warranted to determine whether this botanical agent will have a meaningful role in the dermatologic armamentarium.

References

1. Li SQ et al. Crit Rev Food Sci Nutr. 2001 Sep;41(6):451-64.

2. Dattner AM. Dermatol Ther. 2003;16(2):106-13.

3. Hinneburg I et al. J Agric Food Chem. 2005 Jan 12;53(1):3-7.

4. van den Berg AJ et al. J Wound Care. 2008 Apr;17(4):172-4, 176-8.

5. Liu CL et al. J Agric Food Chem. 2008 Jan 9;56(1):173-8.

6. Zhou J et al. Food Chem Toxicol. 2012 Aug;50(8):2766-73.

7. Trommer H et al. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

8. Hinneburg I et al. Pharmazie. 2006 Mar;61(3):237-40.

9. Geiselhart S et al. Clin Exp Allergy. 2018 Feb;48(2):217-24.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014); she also authored a New York Times Best Seller for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance Therapeutics. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

 

Native to North and East Asia, buckwheat has been grown in China for more than 2,000 years and has been used in traditional medicine to treat varicose veins.1,2 This highly adaptable plant – the most common species of which are Fagopyrum esculentum (common buckwheat or sweet buckwheat), and F. tataricum (which grows in more mountainous regions) – has acclimated to cultivation in North America, as well.1 Increasingly popular as a healthy grain option, buckwheat flour has been touted for beneficial effects on diabetes, obesity, hypertension, hypercholesterolemia, and constipation.1 It has also gained attention for its association with some allergic reactions.

SandraKavas/iStock /Getty Images Plus
The reputed antioxidant and photoprotective properties of the botanical, in particular, have led to greater scientific scrutiny. Indeed, buckwheat contains an abundance of flavonoids, as well as flavones, phytosterols, and thiamin-binding proteins, many of which are well known to exhibit antioxidant activity.3 Rutin, the primary flavonoid in F. esculentum, has been demonstrated to decrease total leg volume in venous insufficiency patients.2 Chlorogenic acid and hyperoside are also key constituents of buckwheat, as are the flavonoids quercetin, orientin, vitexin, isoorientin, and isovitexin.3,4 In this column, the focus is on research indicating dermatologic applications for this ancient botanical ingredient.
 

Wound Healing

In 2008, van den Berg et al. performed an in vitro investigation of the antioxidant and anti-inflammatory qualities of buckwheat honey for consideration in wound healing. American buckwheat honey from New York was found to be the source of the most salient activities, with such properties attributed to its abundant phenolic components. The researchers suggested that these phenols might impart antibacterial activity, while the low pH and high free acid content of the buckwheat honey could contribute to healing wounds.4

Antioxidant Activity

The antioxidant capacity, along with other traits, characterizing the sprouts of common buckwheat (F. esculentum) and tartary buckwheat (F. tataricum) was evaluated by Liu et al. in 2008. Rutin is the main flavonoid found in both species, with fivefold higher levels identified in tartary buckwheat in this study. Ethanol extracts of tartary buckwheat also exhibited greater free radical scavenging activity and superoxide scavenging activity, compared with common buckwheat. Both buckwheat species displayed antioxidant activity on human hepatoma HepG2 cells, with tartary buckwheat more effective in diminishing cellular oxidative stress, which the authors attributed to its greater rutin and quercetin levels.5

Zhou et al. studied the protective effects of buckwheat honey on hydroxyl radical-induced DNA damage in 2012, finding that all studied honeys more effectively protected DNA in non–site specific rather than site-specific systems.6

Photoprotection

In a 2005 screening of 47 antioxidant substances and study of their effects on UV-induced lipid peroxidation, Trommer and Neubert reported that buckwheat extract significantly lowered radiation levels, as did extracts of St. John’s Wort, melissa, and sage. They concluded that their in vitro findings supported the inclusion of such ingredients in photoprotective cosmetic formulations or sunscreens pending the results of in vivo experiments with these compounds.7

In 2006, Hinneburg et al. evaluated the antioxidant and photoprotective activity of a buckwheat herb extract, also comparing its photoprotective characteristics to those of a commercial UV absorber. In an assay with 1,1-diphenyl-2-picryl-hydrazyl radical (DPPH), buckwheat extract exhibited significantly more antioxidant activity than did pure rutin, with buckwheat observed to more effectively block UV-induced peroxidation of linoleic acid as compared with rutin and the commercial UV absorber. The researchers concluded that including antioxidants such as buckwheat extract in photoprotective formulations may serve to maximize skin protection in such products.8

 

 

Buckwheat Sensitivity

Dr. Leslie S. Baumann
Notably, Geiselhart et al. set out in 2017 to characterize concomitant sensitivities in patients allergic to buckwheat. They divided subjects selected by positive skin prick tests into a group sensitive to buckwheat without clinical signs and an allergic group, finding that patients with clinical symptoms presented with a distinct allergen recognition pattern. Specifically, the researchers noted that a new allergen, Fag e 4, which may cross react with latex, warranted addition to the allergen panel of buckwheat and that concomitant sensitization to legumin, Fag e 2 and Fag e 5 predicts buckwheat allergy.9

Conclusion

Because it is a popular component in many diets around the world, especially Japan, Korea, Russia, and Poland, as well as other Asian and European countries, South Africa, Australia, and North America,4 it is reasonable to expect that we’ll see more research on buckwheat. For now, there are indications to suggest that more investigations are warranted to determine whether this botanical agent will have a meaningful role in the dermatologic armamentarium.

References

1. Li SQ et al. Crit Rev Food Sci Nutr. 2001 Sep;41(6):451-64.

2. Dattner AM. Dermatol Ther. 2003;16(2):106-13.

3. Hinneburg I et al. J Agric Food Chem. 2005 Jan 12;53(1):3-7.

4. van den Berg AJ et al. J Wound Care. 2008 Apr;17(4):172-4, 176-8.

5. Liu CL et al. J Agric Food Chem. 2008 Jan 9;56(1):173-8.

6. Zhou J et al. Food Chem Toxicol. 2012 Aug;50(8):2766-73.

7. Trommer H et al. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

8. Hinneburg I et al. Pharmazie. 2006 Mar;61(3):237-40.

9. Geiselhart S et al. Clin Exp Allergy. 2018 Feb;48(2):217-24.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014); she also authored a New York Times Best Seller for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance Therapeutics. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

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Extreme heat and mental health: Protecting patients

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Now that the summer is in full swing, it is incumbent upon the psychiatric and mental health community to learn about the specific effects on behavior, psychiatric risks, and outcomes – and to plan for ways to protect our patients and communities.

Extreme heat has significant effects on mental health and behavior. Research shows1 that the number of people exposed to extreme heat is expected to rise in many American cities, particularly across the southern United States. Records were set in May 2018 across the United States and around the world. In the United States, those May temperatures were the warmest ever recorded, representing the hottest spring ever.2 Around the world, the warmer-than-average conditions that engulfed much of the land and sea surfaces made May the fourth-warmest since records started being kept in 1880.2

In short, these trends are not remitting. Extreme heat and climate disruption are the new normal.

Extreme heat makes many people cranky, agitated, or listless. However, heat waves are not benign, uncomfortable periods; they have profound health risks tied to increasing rates of anxiety, depression, posttraumatic stress disorder, and even death. In fact, extreme heat is now considered to be the single largest weather-related cause of death, exceeding hurricanes, lightning, tornadoes, floods, and earthquakes combined. The Centers for Disease Control and Prevention reports 7,800 deaths attributable to extreme heat between 1999 and 2009 – and predicts more frequent and extreme heat.3

rdegrie/iStockphoto.com

In addition, extreme heat has been linked to increases in aggression and violence. One standard deviation of temperature increase and rainfall is associated with a 4% increase in interpersonal violence and 14% increase in intergroup violence.4 Anecdotal stories underscore the well known lore among prison staff of increased inmate violence during heat waves.5

Complex cognitive tasks such as working memory (spatial span test, pattern recognition) have been observed to be significantly impaired through heat stress.6 Increased heat also contributes to insomnia and worsens with increased humidity.7 A study in England and Wales showed a link between a possible association between hot weather and an increased risk of suicide.8 People with mental illness and those who abuse substances are considered an especially vulnerable population to the impacts of extreme heat and other climate change–related events. Co-occurring variables such as poverty, substandard housing, and lack of access to cool environments all contribute to this increased vulnerability. Homeless mentally ill have little control over their environments and have very limited ability to protect themselves from heat exposures and therefore are at extreme risk.The most protective tool against heat stress/stroke is the availability of functioning air conditioners. Regretfully, these kinds of cooling systems are out of reach for many people who live on the margins of society.

Furthermore, patients with severe psychotic or mood disorders, substance abuse disorders, and cognitive impairments who are able to compensate with marginal executive functioning during periods of normal weather are challenged during intense heat, and can lose their fragile ability to make plans, have good judgment, and care effectively for themselves. These patients are more likely to experience heat stroke and other heat-related morbidity.

Here is evidence that supports the greater impact of extreme heat on psychiatric patients:

 

 

  • Increased emergency department and hospitalization for patients with preexisting psychiatric illness during heat waves.10,11
  • Preexisting mental illness alone increases the risk of mortality during extreme heat events by 2 to 3 times.12,13
  • Patients with schizophrenia might have underlying impairments in thermoregulation that are intrinsic to the disease. Such impairments would explain the perplexing sight of psychotic patients bundled up in layers on hot days.14
  • Psychiatric medications (antipsychotics, anticholinergics, and antidepressants) have the potential to impair the body’s heat regulatory functioning; lithium affects fluid homeostasis.15

Dr. Robin Cooper

The negative effects of climate change are not equally distributed, and people with mental illness are among the most vulnerable. Given the predictable future of extreme heat waves (potentially increasing the population exposure by four- to sixfold by midcentury),1 we must do everything we can to educate our patients so that they take preventive measures to protect themselves from the adverse effects of extreme heat.
 

References

1. Nature Climate Change. 2015 May 18;5:652-5.

2. National Oceanic and Atmospheric Administration Global Climate Report. May 2018.

3. “Climate Change and Extreme Heat Events.” Centers for Disease Control and Prevention.

4. Science. 2013 Sep 13;341(6151).

5. Personal communication.

6. Int J Hyperthermia. 2003 May-Jun;19(3):355-72.

7. J Physiol Anthropol. 2012 May 31;31(14).

8. Br J Psychiatry. 2007 Aug;191:106-12.

9. U.S. Global Change Research Program, 2016. “The Impacts of Climate Change on Human Health in the United States: A Scientific Assessment.” Chapters 8 and 9.

10. J Affect Disord. 2014 Feb;155:154-61.

11. Environ Health Perspect. 2008 Oct;116(10):1369-75.

12. Psychiatr Serv. 1998 Aug;49(8):1088-90.

13. Arch Intern Med. 2007 Nov. 12;167(20):2170-6.

14. Schizophr Res. 2004 Aug 1;69(2-3):149-57.

15. Eur Psychiatry. 2007 Sep;22(6):335-8.



Strategies for patients, communities

Part of the job of mental health professionals is psychoeducation, or teaching patients and families about the health risks tied to the psychological and physical impacts of heat exposure. Also, we should provide advice about effective management of psychiatric medications – such as monitoring lithium levels and considering medication dose adjustments – to reduce risks. Another key step is engaging caregivers, case managers, visiting nurses, and family members so that they closely monitor vulnerable populations. Providing information about the availability of respite care and cooling centers is another concrete step clinicians can take to help minimize the impact of extreme heat on patients.

Information that can be shared with patients about the threat include:

Dr. Cooper is in private practice and is affiliated with the department of psychiatry at the University of California, San Francisco. She is a Distinguished Life Fellow of the American Psychiatric Association.

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Now that the summer is in full swing, it is incumbent upon the psychiatric and mental health community to learn about the specific effects on behavior, psychiatric risks, and outcomes – and to plan for ways to protect our patients and communities.

Extreme heat has significant effects on mental health and behavior. Research shows1 that the number of people exposed to extreme heat is expected to rise in many American cities, particularly across the southern United States. Records were set in May 2018 across the United States and around the world. In the United States, those May temperatures were the warmest ever recorded, representing the hottest spring ever.2 Around the world, the warmer-than-average conditions that engulfed much of the land and sea surfaces made May the fourth-warmest since records started being kept in 1880.2

In short, these trends are not remitting. Extreme heat and climate disruption are the new normal.

Extreme heat makes many people cranky, agitated, or listless. However, heat waves are not benign, uncomfortable periods; they have profound health risks tied to increasing rates of anxiety, depression, posttraumatic stress disorder, and even death. In fact, extreme heat is now considered to be the single largest weather-related cause of death, exceeding hurricanes, lightning, tornadoes, floods, and earthquakes combined. The Centers for Disease Control and Prevention reports 7,800 deaths attributable to extreme heat between 1999 and 2009 – and predicts more frequent and extreme heat.3

rdegrie/iStockphoto.com

In addition, extreme heat has been linked to increases in aggression and violence. One standard deviation of temperature increase and rainfall is associated with a 4% increase in interpersonal violence and 14% increase in intergroup violence.4 Anecdotal stories underscore the well known lore among prison staff of increased inmate violence during heat waves.5

Complex cognitive tasks such as working memory (spatial span test, pattern recognition) have been observed to be significantly impaired through heat stress.6 Increased heat also contributes to insomnia and worsens with increased humidity.7 A study in England and Wales showed a link between a possible association between hot weather and an increased risk of suicide.8 People with mental illness and those who abuse substances are considered an especially vulnerable population to the impacts of extreme heat and other climate change–related events. Co-occurring variables such as poverty, substandard housing, and lack of access to cool environments all contribute to this increased vulnerability. Homeless mentally ill have little control over their environments and have very limited ability to protect themselves from heat exposures and therefore are at extreme risk.The most protective tool against heat stress/stroke is the availability of functioning air conditioners. Regretfully, these kinds of cooling systems are out of reach for many people who live on the margins of society.

Furthermore, patients with severe psychotic or mood disorders, substance abuse disorders, and cognitive impairments who are able to compensate with marginal executive functioning during periods of normal weather are challenged during intense heat, and can lose their fragile ability to make plans, have good judgment, and care effectively for themselves. These patients are more likely to experience heat stroke and other heat-related morbidity.

Here is evidence that supports the greater impact of extreme heat on psychiatric patients:

 

 

  • Increased emergency department and hospitalization for patients with preexisting psychiatric illness during heat waves.10,11
  • Preexisting mental illness alone increases the risk of mortality during extreme heat events by 2 to 3 times.12,13
  • Patients with schizophrenia might have underlying impairments in thermoregulation that are intrinsic to the disease. Such impairments would explain the perplexing sight of psychotic patients bundled up in layers on hot days.14
  • Psychiatric medications (antipsychotics, anticholinergics, and antidepressants) have the potential to impair the body’s heat regulatory functioning; lithium affects fluid homeostasis.15

Dr. Robin Cooper

The negative effects of climate change are not equally distributed, and people with mental illness are among the most vulnerable. Given the predictable future of extreme heat waves (potentially increasing the population exposure by four- to sixfold by midcentury),1 we must do everything we can to educate our patients so that they take preventive measures to protect themselves from the adverse effects of extreme heat.
 

References

1. Nature Climate Change. 2015 May 18;5:652-5.

2. National Oceanic and Atmospheric Administration Global Climate Report. May 2018.

3. “Climate Change and Extreme Heat Events.” Centers for Disease Control and Prevention.

4. Science. 2013 Sep 13;341(6151).

5. Personal communication.

6. Int J Hyperthermia. 2003 May-Jun;19(3):355-72.

7. J Physiol Anthropol. 2012 May 31;31(14).

8. Br J Psychiatry. 2007 Aug;191:106-12.

9. U.S. Global Change Research Program, 2016. “The Impacts of Climate Change on Human Health in the United States: A Scientific Assessment.” Chapters 8 and 9.

10. J Affect Disord. 2014 Feb;155:154-61.

11. Environ Health Perspect. 2008 Oct;116(10):1369-75.

12. Psychiatr Serv. 1998 Aug;49(8):1088-90.

13. Arch Intern Med. 2007 Nov. 12;167(20):2170-6.

14. Schizophr Res. 2004 Aug 1;69(2-3):149-57.

15. Eur Psychiatry. 2007 Sep;22(6):335-8.



Strategies for patients, communities

Part of the job of mental health professionals is psychoeducation, or teaching patients and families about the health risks tied to the psychological and physical impacts of heat exposure. Also, we should provide advice about effective management of psychiatric medications – such as monitoring lithium levels and considering medication dose adjustments – to reduce risks. Another key step is engaging caregivers, case managers, visiting nurses, and family members so that they closely monitor vulnerable populations. Providing information about the availability of respite care and cooling centers is another concrete step clinicians can take to help minimize the impact of extreme heat on patients.

Information that can be shared with patients about the threat include:

Dr. Cooper is in private practice and is affiliated with the department of psychiatry at the University of California, San Francisco. She is a Distinguished Life Fellow of the American Psychiatric Association.

 

Now that the summer is in full swing, it is incumbent upon the psychiatric and mental health community to learn about the specific effects on behavior, psychiatric risks, and outcomes – and to plan for ways to protect our patients and communities.

Extreme heat has significant effects on mental health and behavior. Research shows1 that the number of people exposed to extreme heat is expected to rise in many American cities, particularly across the southern United States. Records were set in May 2018 across the United States and around the world. In the United States, those May temperatures were the warmest ever recorded, representing the hottest spring ever.2 Around the world, the warmer-than-average conditions that engulfed much of the land and sea surfaces made May the fourth-warmest since records started being kept in 1880.2

In short, these trends are not remitting. Extreme heat and climate disruption are the new normal.

Extreme heat makes many people cranky, agitated, or listless. However, heat waves are not benign, uncomfortable periods; they have profound health risks tied to increasing rates of anxiety, depression, posttraumatic stress disorder, and even death. In fact, extreme heat is now considered to be the single largest weather-related cause of death, exceeding hurricanes, lightning, tornadoes, floods, and earthquakes combined. The Centers for Disease Control and Prevention reports 7,800 deaths attributable to extreme heat between 1999 and 2009 – and predicts more frequent and extreme heat.3

rdegrie/iStockphoto.com

In addition, extreme heat has been linked to increases in aggression and violence. One standard deviation of temperature increase and rainfall is associated with a 4% increase in interpersonal violence and 14% increase in intergroup violence.4 Anecdotal stories underscore the well known lore among prison staff of increased inmate violence during heat waves.5

Complex cognitive tasks such as working memory (spatial span test, pattern recognition) have been observed to be significantly impaired through heat stress.6 Increased heat also contributes to insomnia and worsens with increased humidity.7 A study in England and Wales showed a link between a possible association between hot weather and an increased risk of suicide.8 People with mental illness and those who abuse substances are considered an especially vulnerable population to the impacts of extreme heat and other climate change–related events. Co-occurring variables such as poverty, substandard housing, and lack of access to cool environments all contribute to this increased vulnerability. Homeless mentally ill have little control over their environments and have very limited ability to protect themselves from heat exposures and therefore are at extreme risk.The most protective tool against heat stress/stroke is the availability of functioning air conditioners. Regretfully, these kinds of cooling systems are out of reach for many people who live on the margins of society.

Furthermore, patients with severe psychotic or mood disorders, substance abuse disorders, and cognitive impairments who are able to compensate with marginal executive functioning during periods of normal weather are challenged during intense heat, and can lose their fragile ability to make plans, have good judgment, and care effectively for themselves. These patients are more likely to experience heat stroke and other heat-related morbidity.

Here is evidence that supports the greater impact of extreme heat on psychiatric patients:

 

 

  • Increased emergency department and hospitalization for patients with preexisting psychiatric illness during heat waves.10,11
  • Preexisting mental illness alone increases the risk of mortality during extreme heat events by 2 to 3 times.12,13
  • Patients with schizophrenia might have underlying impairments in thermoregulation that are intrinsic to the disease. Such impairments would explain the perplexing sight of psychotic patients bundled up in layers on hot days.14
  • Psychiatric medications (antipsychotics, anticholinergics, and antidepressants) have the potential to impair the body’s heat regulatory functioning; lithium affects fluid homeostasis.15

Dr. Robin Cooper

The negative effects of climate change are not equally distributed, and people with mental illness are among the most vulnerable. Given the predictable future of extreme heat waves (potentially increasing the population exposure by four- to sixfold by midcentury),1 we must do everything we can to educate our patients so that they take preventive measures to protect themselves from the adverse effects of extreme heat.
 

References

1. Nature Climate Change. 2015 May 18;5:652-5.

2. National Oceanic and Atmospheric Administration Global Climate Report. May 2018.

3. “Climate Change and Extreme Heat Events.” Centers for Disease Control and Prevention.

4. Science. 2013 Sep 13;341(6151).

5. Personal communication.

6. Int J Hyperthermia. 2003 May-Jun;19(3):355-72.

7. J Physiol Anthropol. 2012 May 31;31(14).

8. Br J Psychiatry. 2007 Aug;191:106-12.

9. U.S. Global Change Research Program, 2016. “The Impacts of Climate Change on Human Health in the United States: A Scientific Assessment.” Chapters 8 and 9.

10. J Affect Disord. 2014 Feb;155:154-61.

11. Environ Health Perspect. 2008 Oct;116(10):1369-75.

12. Psychiatr Serv. 1998 Aug;49(8):1088-90.

13. Arch Intern Med. 2007 Nov. 12;167(20):2170-6.

14. Schizophr Res. 2004 Aug 1;69(2-3):149-57.

15. Eur Psychiatry. 2007 Sep;22(6):335-8.



Strategies for patients, communities

Part of the job of mental health professionals is psychoeducation, or teaching patients and families about the health risks tied to the psychological and physical impacts of heat exposure. Also, we should provide advice about effective management of psychiatric medications – such as monitoring lithium levels and considering medication dose adjustments – to reduce risks. Another key step is engaging caregivers, case managers, visiting nurses, and family members so that they closely monitor vulnerable populations. Providing information about the availability of respite care and cooling centers is another concrete step clinicians can take to help minimize the impact of extreme heat on patients.

Information that can be shared with patients about the threat include:

Dr. Cooper is in private practice and is affiliated with the department of psychiatry at the University of California, San Francisco. She is a Distinguished Life Fellow of the American Psychiatric Association.

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Significant figures: The honesty in being precise

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Physicists have strict rules about significant figures. Medical journals lack this professional discipline and it produces distortions that mislead readers.

Whenever you measure and report something in physics, the precision of the measurement is reflected in how the value is written. Writing a result with more digits implies that a higher precision was achieved. If that wasn’t the case, you are falsely claiming skill and accomplishment. You’ve entered the zone of post-truth.

This point was taught by my high school physics teacher, Mr. Gunnar Overgaard, may he rest in peace. Suppose we measured the length of the lab table with the meter stick. We repeated the action three times. We computed an average. Our table was 243.7 cm long. If we wrote 243.73 or 243.73333 we got a lower grade. Meter sticks only have markings of 0.1 cm. So the precision of the reported measurement should properly reflect that limitation.

Researchers in medicine seem to have skipped that lesson in physics lab. In medical journals, the default seems to be to report measurements with two decimal points, such as 16.67%, which is a gross distortion of the precision when I know that that really means 2 out of 12 patients had the finding.

This issue of precision came up recently in two papers published about the number of deaths caused by Hurricane Maria in Puerto Rico. The official death toll was 64. This number became a political hot potato when President Trump cited it as if it was evidence that he and the current local government had managed the emergency response better than George W. Bush did for Katrina.

On May 29, 2018, some researchers at the Harvard School of Public Health, a prestigious institution, published an article in The New England Journal of Medicine, a prestigious journal. You would presume that pair could report properly. The abstract said “This rate yielded a total of 4,645 excess deaths during this period (95% CI, 793 to 8,498).”1 Many newspapers published the number 4,645 in a headline. Most newspapers didn’t include all of the scientific mumbo jumbo about bias and confidence intervals.

Georgijevic/E+/Getty Images


However, the number 4,645 did not pass the sniff test at many newspapers, including the Washington Post. Their headline began “Harvard study estimates thousands died”2 and that story went on to clarify that “The Harvard study’s statistical analysis found that deaths related to the hurricane fell within a range of about 800 to more than 8,000.” That is one significant digit. Then the fact checkers went to work on it. They didn’t issue a Pinocchio score, but under a headline of “Did exactly 4,645 people die in Hurricane Maria? Nope”3 the fact checkers concluded that “it’s an egregious example of false precision to cite the ‘4,645’ number without explaining how fuzzy the number really is.”

The situation was compounded 3 days later when another news report had the Puerto Rico Department of Public Health putting the death toll at 1,397. Many assumptions go into determining what an excess death is. If the false precision makes it appear the scientists have a political agenda, it casts shade on whether the assumptions they made are objective and unbiased.

The result on social media was predictable. Outrage was expressed, as always. Lawsuits have been filed. The reputations of all scientists have been impugned. The implication is that, depending on your political polarization, you can choose the number 64, 1,000, 1,400, or 4,645 and any number is just as true as another. Worse, instead of focusing on the severity of the catastrophe and how we might have responded better then and better now and with better planning for the future, the debate has focused on alternative facts and fake scientific news. Thanks, Harvard.

Dr. Kevin T. Powell

So in the spirit of thinking globally but acting locally, what can I do? I love my editor. I have hinted before about how much easier it is to read, as well as more accurate scientifically, to round the numbers that we report. We've done it a few times recently, but now that the Washington Post has done it on a major news story, should this practice become the norm for journalism? If medical journal editors won't handle precision honestly, other journalists must step up. I'm distressed when I review an article that says 14.6% agreed and 79.2% strongly agreed and I know those percentages with 3 digits really mean 7/48 and 38/48, so they should be rounded to two significant figures. And isn’t it easier to read and comprehend if reporting that three treatment groups had positive findings of 4.25%, 12.08%, and 9.84% when rounded to 4%, 12%, and 10%?

Scientists using this false precision (and peer reviewers who allow it) need to be corrected. They are trying to sell their research as a Louis Vuitton handbag when we all know it is only a cheap knockoff.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected]

References

1. N Eng J Med. 2018 May 29. doi: 10.1056/NEJMsa1803972

2. “Harvard study estimates thousands died in Puerto Rico because of Hurricane Maria,” by Arelis R. Hernández and Laurie McGinley, The Washington Post, May 29, 2018.

3. “Did exactly 4,645 people die in Hurricane Maria? Nope.” by Glenn Kessler, The Washington Post, June 1, 2018.

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Physicists have strict rules about significant figures. Medical journals lack this professional discipline and it produces distortions that mislead readers.

Whenever you measure and report something in physics, the precision of the measurement is reflected in how the value is written. Writing a result with more digits implies that a higher precision was achieved. If that wasn’t the case, you are falsely claiming skill and accomplishment. You’ve entered the zone of post-truth.

This point was taught by my high school physics teacher, Mr. Gunnar Overgaard, may he rest in peace. Suppose we measured the length of the lab table with the meter stick. We repeated the action three times. We computed an average. Our table was 243.7 cm long. If we wrote 243.73 or 243.73333 we got a lower grade. Meter sticks only have markings of 0.1 cm. So the precision of the reported measurement should properly reflect that limitation.

Researchers in medicine seem to have skipped that lesson in physics lab. In medical journals, the default seems to be to report measurements with two decimal points, such as 16.67%, which is a gross distortion of the precision when I know that that really means 2 out of 12 patients had the finding.

This issue of precision came up recently in two papers published about the number of deaths caused by Hurricane Maria in Puerto Rico. The official death toll was 64. This number became a political hot potato when President Trump cited it as if it was evidence that he and the current local government had managed the emergency response better than George W. Bush did for Katrina.

On May 29, 2018, some researchers at the Harvard School of Public Health, a prestigious institution, published an article in The New England Journal of Medicine, a prestigious journal. You would presume that pair could report properly. The abstract said “This rate yielded a total of 4,645 excess deaths during this period (95% CI, 793 to 8,498).”1 Many newspapers published the number 4,645 in a headline. Most newspapers didn’t include all of the scientific mumbo jumbo about bias and confidence intervals.

Georgijevic/E+/Getty Images


However, the number 4,645 did not pass the sniff test at many newspapers, including the Washington Post. Their headline began “Harvard study estimates thousands died”2 and that story went on to clarify that “The Harvard study’s statistical analysis found that deaths related to the hurricane fell within a range of about 800 to more than 8,000.” That is one significant digit. Then the fact checkers went to work on it. They didn’t issue a Pinocchio score, but under a headline of “Did exactly 4,645 people die in Hurricane Maria? Nope”3 the fact checkers concluded that “it’s an egregious example of false precision to cite the ‘4,645’ number without explaining how fuzzy the number really is.”

The situation was compounded 3 days later when another news report had the Puerto Rico Department of Public Health putting the death toll at 1,397. Many assumptions go into determining what an excess death is. If the false precision makes it appear the scientists have a political agenda, it casts shade on whether the assumptions they made are objective and unbiased.

The result on social media was predictable. Outrage was expressed, as always. Lawsuits have been filed. The reputations of all scientists have been impugned. The implication is that, depending on your political polarization, you can choose the number 64, 1,000, 1,400, or 4,645 and any number is just as true as another. Worse, instead of focusing on the severity of the catastrophe and how we might have responded better then and better now and with better planning for the future, the debate has focused on alternative facts and fake scientific news. Thanks, Harvard.

Dr. Kevin T. Powell

So in the spirit of thinking globally but acting locally, what can I do? I love my editor. I have hinted before about how much easier it is to read, as well as more accurate scientifically, to round the numbers that we report. We've done it a few times recently, but now that the Washington Post has done it on a major news story, should this practice become the norm for journalism? If medical journal editors won't handle precision honestly, other journalists must step up. I'm distressed when I review an article that says 14.6% agreed and 79.2% strongly agreed and I know those percentages with 3 digits really mean 7/48 and 38/48, so they should be rounded to two significant figures. And isn’t it easier to read and comprehend if reporting that three treatment groups had positive findings of 4.25%, 12.08%, and 9.84% when rounded to 4%, 12%, and 10%?

Scientists using this false precision (and peer reviewers who allow it) need to be corrected. They are trying to sell their research as a Louis Vuitton handbag when we all know it is only a cheap knockoff.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected]

References

1. N Eng J Med. 2018 May 29. doi: 10.1056/NEJMsa1803972

2. “Harvard study estimates thousands died in Puerto Rico because of Hurricane Maria,” by Arelis R. Hernández and Laurie McGinley, The Washington Post, May 29, 2018.

3. “Did exactly 4,645 people die in Hurricane Maria? Nope.” by Glenn Kessler, The Washington Post, June 1, 2018.

Physicists have strict rules about significant figures. Medical journals lack this professional discipline and it produces distortions that mislead readers.

Whenever you measure and report something in physics, the precision of the measurement is reflected in how the value is written. Writing a result with more digits implies that a higher precision was achieved. If that wasn’t the case, you are falsely claiming skill and accomplishment. You’ve entered the zone of post-truth.

This point was taught by my high school physics teacher, Mr. Gunnar Overgaard, may he rest in peace. Suppose we measured the length of the lab table with the meter stick. We repeated the action three times. We computed an average. Our table was 243.7 cm long. If we wrote 243.73 or 243.73333 we got a lower grade. Meter sticks only have markings of 0.1 cm. So the precision of the reported measurement should properly reflect that limitation.

Researchers in medicine seem to have skipped that lesson in physics lab. In medical journals, the default seems to be to report measurements with two decimal points, such as 16.67%, which is a gross distortion of the precision when I know that that really means 2 out of 12 patients had the finding.

This issue of precision came up recently in two papers published about the number of deaths caused by Hurricane Maria in Puerto Rico. The official death toll was 64. This number became a political hot potato when President Trump cited it as if it was evidence that he and the current local government had managed the emergency response better than George W. Bush did for Katrina.

On May 29, 2018, some researchers at the Harvard School of Public Health, a prestigious institution, published an article in The New England Journal of Medicine, a prestigious journal. You would presume that pair could report properly. The abstract said “This rate yielded a total of 4,645 excess deaths during this period (95% CI, 793 to 8,498).”1 Many newspapers published the number 4,645 in a headline. Most newspapers didn’t include all of the scientific mumbo jumbo about bias and confidence intervals.

Georgijevic/E+/Getty Images


However, the number 4,645 did not pass the sniff test at many newspapers, including the Washington Post. Their headline began “Harvard study estimates thousands died”2 and that story went on to clarify that “The Harvard study’s statistical analysis found that deaths related to the hurricane fell within a range of about 800 to more than 8,000.” That is one significant digit. Then the fact checkers went to work on it. They didn’t issue a Pinocchio score, but under a headline of “Did exactly 4,645 people die in Hurricane Maria? Nope”3 the fact checkers concluded that “it’s an egregious example of false precision to cite the ‘4,645’ number without explaining how fuzzy the number really is.”

The situation was compounded 3 days later when another news report had the Puerto Rico Department of Public Health putting the death toll at 1,397. Many assumptions go into determining what an excess death is. If the false precision makes it appear the scientists have a political agenda, it casts shade on whether the assumptions they made are objective and unbiased.

The result on social media was predictable. Outrage was expressed, as always. Lawsuits have been filed. The reputations of all scientists have been impugned. The implication is that, depending on your political polarization, you can choose the number 64, 1,000, 1,400, or 4,645 and any number is just as true as another. Worse, instead of focusing on the severity of the catastrophe and how we might have responded better then and better now and with better planning for the future, the debate has focused on alternative facts and fake scientific news. Thanks, Harvard.

Dr. Kevin T. Powell

So in the spirit of thinking globally but acting locally, what can I do? I love my editor. I have hinted before about how much easier it is to read, as well as more accurate scientifically, to round the numbers that we report. We've done it a few times recently, but now that the Washington Post has done it on a major news story, should this practice become the norm for journalism? If medical journal editors won't handle precision honestly, other journalists must step up. I'm distressed when I review an article that says 14.6% agreed and 79.2% strongly agreed and I know those percentages with 3 digits really mean 7/48 and 38/48, so they should be rounded to two significant figures. And isn’t it easier to read and comprehend if reporting that three treatment groups had positive findings of 4.25%, 12.08%, and 9.84% when rounded to 4%, 12%, and 10%?

Scientists using this false precision (and peer reviewers who allow it) need to be corrected. They are trying to sell their research as a Louis Vuitton handbag when we all know it is only a cheap knockoff.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected]

References

1. N Eng J Med. 2018 May 29. doi: 10.1056/NEJMsa1803972

2. “Harvard study estimates thousands died in Puerto Rico because of Hurricane Maria,” by Arelis R. Hernández and Laurie McGinley, The Washington Post, May 29, 2018.

3. “Did exactly 4,645 people die in Hurricane Maria? Nope.” by Glenn Kessler, The Washington Post, June 1, 2018.

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Advocate for your LGBTQ patients

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June 28, 1969, is the day that many consider to be the origin of the modern LGBTQ (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning) movement.1 At that time, it was not uncommon for police officers to conduct raids on bars frequented by LGBTQ patrons, but this night was different. This night the patrons of the Stonewall Inn fought back. The subsequent violent clashes fueled the national organization of groups concentrated on the goal of advocating for LGBTQ rights. On June 28th, 1970, protests to commemorate the events at Stonewall occurred; many refer to these as the first Pride events. Since then the month of June has been seen as the unofficial Pride month for the LGBTQ community. These events began as demonstrations for equal rights and protections for LGBTQ individuals, but over time, events have grown also to become a celebration of queer lives and sexuality.2

Josve05a/Getty Images
These events are important and affirming to many of the LGBTQ youth for whom we care. For some, it may be the only time they feel that their identities are recognized, accepted, and celebrated. When these youth attend a Pride event and see LGBTQ people and allies of all ages and backgrounds participating, it can be reassuring and help lessen the feelings of isolation that they may experience in other spaces.

I attended my first Pride event over 10 years ago in support of a friend who had recently come out. He told me that the event was a place where he could proudly be his full self, something that he felt was not safe to do at school or work. When I participated at that event years ago, I began to understand my straight, cisgender privilege: I could walk down the street holding hands with my partner, discuss the details of a first date with colleagues at work, and wear the clothes that aligned with my gender identity without fear of being harassed or attacked. This, I realized, was not the case for everyone. Since attending that Pride event, I have had the opportunity to attend and volunteer at many local Pride events. Some have been in pouring rain, some have been in scorching heat, but all have been rejuvenating, inspiring, and fun! They have been opportunities for me to visibly show support for the local LGBTQ community and meet with other LGBTQ-serving organizations and allies.
 

Ways to get involved

Find out about local Pride events in your community and consider attending or volunteering. One of the contributing factors to LGBTQ health disparities is limited access to competent care. Many LGBTQ youth and adults have reported experiences of discrimination in the health care setting.3,4 When we, as health care providers, are visible at Pride events, we can have important effects on our local communities by showing them that we recognize and affirm LGBTQ identities.

Consider asking your organization or institution to provide support at local Pride events, post messages of support during Pride month, or host educational sessions about the care of LGBTQ youth.

Advocate for your patients. Remember the origins of Pride events. Remember that Pride started as an event to advocate for the rights of LGBTQ individuals. Continue to advocate for your patients in your institutions and communities year round by educating your staff and colleagues about care of this population and contacting your elected representatives regarding legislation to improve health care.

 

 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at [email protected].

Resources

Human Rights Campaign/Pride: You can learn more about the history of Pride and events in your state and community at www.hrc.org/pride.

How to contact your elected officials: You can find contact information for your local, state, and federal government representatives at www.usa.gov/elected-officials.

National LGBT Health Education Center: You can find educational resources to help optimize care of LGBT patients at www.lgbthealtheducation.org/.

U.S. Transgender Survey: You can read the report from a survey of almost 28,000 transgender respondents in the U.S. Specific information is available about experiences with health care; state level reports also available at www.ustranssurvey.org/reports/.
 

References

1. GLAAD Pride Month Resource Kit for Jounalists: www.glaad.org/publications/pridekit

2. Human Rights Campaign: History of LGBT Pride. www.hrc.org/blog/the-history-of-lgbt-pride-from-1970-to-now

3. The Report of the 2015 U.S. Transgender Survey (Washington, DC: National Center for Transgender Equality, 2016).

4. Healthy People 2020: Lesbian, Gay, Bisexual and Transgender Health.

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June 28, 1969, is the day that many consider to be the origin of the modern LGBTQ (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning) movement.1 At that time, it was not uncommon for police officers to conduct raids on bars frequented by LGBTQ patrons, but this night was different. This night the patrons of the Stonewall Inn fought back. The subsequent violent clashes fueled the national organization of groups concentrated on the goal of advocating for LGBTQ rights. On June 28th, 1970, protests to commemorate the events at Stonewall occurred; many refer to these as the first Pride events. Since then the month of June has been seen as the unofficial Pride month for the LGBTQ community. These events began as demonstrations for equal rights and protections for LGBTQ individuals, but over time, events have grown also to become a celebration of queer lives and sexuality.2

Josve05a/Getty Images
These events are important and affirming to many of the LGBTQ youth for whom we care. For some, it may be the only time they feel that their identities are recognized, accepted, and celebrated. When these youth attend a Pride event and see LGBTQ people and allies of all ages and backgrounds participating, it can be reassuring and help lessen the feelings of isolation that they may experience in other spaces.

I attended my first Pride event over 10 years ago in support of a friend who had recently come out. He told me that the event was a place where he could proudly be his full self, something that he felt was not safe to do at school or work. When I participated at that event years ago, I began to understand my straight, cisgender privilege: I could walk down the street holding hands with my partner, discuss the details of a first date with colleagues at work, and wear the clothes that aligned with my gender identity without fear of being harassed or attacked. This, I realized, was not the case for everyone. Since attending that Pride event, I have had the opportunity to attend and volunteer at many local Pride events. Some have been in pouring rain, some have been in scorching heat, but all have been rejuvenating, inspiring, and fun! They have been opportunities for me to visibly show support for the local LGBTQ community and meet with other LGBTQ-serving organizations and allies.
 

Ways to get involved

Find out about local Pride events in your community and consider attending or volunteering. One of the contributing factors to LGBTQ health disparities is limited access to competent care. Many LGBTQ youth and adults have reported experiences of discrimination in the health care setting.3,4 When we, as health care providers, are visible at Pride events, we can have important effects on our local communities by showing them that we recognize and affirm LGBTQ identities.

Consider asking your organization or institution to provide support at local Pride events, post messages of support during Pride month, or host educational sessions about the care of LGBTQ youth.

Advocate for your patients. Remember the origins of Pride events. Remember that Pride started as an event to advocate for the rights of LGBTQ individuals. Continue to advocate for your patients in your institutions and communities year round by educating your staff and colleagues about care of this population and contacting your elected representatives regarding legislation to improve health care.

 

 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at [email protected].

Resources

Human Rights Campaign/Pride: You can learn more about the history of Pride and events in your state and community at www.hrc.org/pride.

How to contact your elected officials: You can find contact information for your local, state, and federal government representatives at www.usa.gov/elected-officials.

National LGBT Health Education Center: You can find educational resources to help optimize care of LGBT patients at www.lgbthealtheducation.org/.

U.S. Transgender Survey: You can read the report from a survey of almost 28,000 transgender respondents in the U.S. Specific information is available about experiences with health care; state level reports also available at www.ustranssurvey.org/reports/.
 

References

1. GLAAD Pride Month Resource Kit for Jounalists: www.glaad.org/publications/pridekit

2. Human Rights Campaign: History of LGBT Pride. www.hrc.org/blog/the-history-of-lgbt-pride-from-1970-to-now

3. The Report of the 2015 U.S. Transgender Survey (Washington, DC: National Center for Transgender Equality, 2016).

4. Healthy People 2020: Lesbian, Gay, Bisexual and Transgender Health.

 

June 28, 1969, is the day that many consider to be the origin of the modern LGBTQ (Lesbian, Gay, Bisexual, Transgender, Queer/Questioning) movement.1 At that time, it was not uncommon for police officers to conduct raids on bars frequented by LGBTQ patrons, but this night was different. This night the patrons of the Stonewall Inn fought back. The subsequent violent clashes fueled the national organization of groups concentrated on the goal of advocating for LGBTQ rights. On June 28th, 1970, protests to commemorate the events at Stonewall occurred; many refer to these as the first Pride events. Since then the month of June has been seen as the unofficial Pride month for the LGBTQ community. These events began as demonstrations for equal rights and protections for LGBTQ individuals, but over time, events have grown also to become a celebration of queer lives and sexuality.2

Josve05a/Getty Images
These events are important and affirming to many of the LGBTQ youth for whom we care. For some, it may be the only time they feel that their identities are recognized, accepted, and celebrated. When these youth attend a Pride event and see LGBTQ people and allies of all ages and backgrounds participating, it can be reassuring and help lessen the feelings of isolation that they may experience in other spaces.

I attended my first Pride event over 10 years ago in support of a friend who had recently come out. He told me that the event was a place where he could proudly be his full self, something that he felt was not safe to do at school or work. When I participated at that event years ago, I began to understand my straight, cisgender privilege: I could walk down the street holding hands with my partner, discuss the details of a first date with colleagues at work, and wear the clothes that aligned with my gender identity without fear of being harassed or attacked. This, I realized, was not the case for everyone. Since attending that Pride event, I have had the opportunity to attend and volunteer at many local Pride events. Some have been in pouring rain, some have been in scorching heat, but all have been rejuvenating, inspiring, and fun! They have been opportunities for me to visibly show support for the local LGBTQ community and meet with other LGBTQ-serving organizations and allies.
 

Ways to get involved

Find out about local Pride events in your community and consider attending or volunteering. One of the contributing factors to LGBTQ health disparities is limited access to competent care. Many LGBTQ youth and adults have reported experiences of discrimination in the health care setting.3,4 When we, as health care providers, are visible at Pride events, we can have important effects on our local communities by showing them that we recognize and affirm LGBTQ identities.

Consider asking your organization or institution to provide support at local Pride events, post messages of support during Pride month, or host educational sessions about the care of LGBTQ youth.

Advocate for your patients. Remember the origins of Pride events. Remember that Pride started as an event to advocate for the rights of LGBTQ individuals. Continue to advocate for your patients in your institutions and communities year round by educating your staff and colleagues about care of this population and contacting your elected representatives regarding legislation to improve health care.

 

 

Dr. Chelvakumar is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She said she had no relevant financial disclosures. Email her at [email protected].

Resources

Human Rights Campaign/Pride: You can learn more about the history of Pride and events in your state and community at www.hrc.org/pride.

How to contact your elected officials: You can find contact information for your local, state, and federal government representatives at www.usa.gov/elected-officials.

National LGBT Health Education Center: You can find educational resources to help optimize care of LGBT patients at www.lgbthealtheducation.org/.

U.S. Transgender Survey: You can read the report from a survey of almost 28,000 transgender respondents in the U.S. Specific information is available about experiences with health care; state level reports also available at www.ustranssurvey.org/reports/.
 

References

1. GLAAD Pride Month Resource Kit for Jounalists: www.glaad.org/publications/pridekit

2. Human Rights Campaign: History of LGBT Pride. www.hrc.org/blog/the-history-of-lgbt-pride-from-1970-to-now

3. The Report of the 2015 U.S. Transgender Survey (Washington, DC: National Center for Transgender Equality, 2016).

4. Healthy People 2020: Lesbian, Gay, Bisexual and Transgender Health.

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Family separations could lead to irreversible health outcomes

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The recent crises of the separation of stressed children from their equally stressed parents at this country’s southern border raises the specter of emotional and cognitive reactions within these children – the negative ramifications of which will manifest themselves for years to come.

Stress is ubiquitous. Children experience stress in the normal everyday frustrations that come their way: going to day care for a few hours and leaving mommy, the tripping and falling as they learn to walk, a toy breaking. These stresses help a child develop the capacity for emotional regulation and are termed “tolerable stress.” There is, however, a big difference between tolerable stress and toxic stress.

Dr. Aradhana Bela Sood

When the stress reaction in response to perceived or actual danger is beyond tolerable levels by virtue of its quality, intensity, and longevity, it saps the body’s ability to rally or handle the trauma that is being faced because of depleted neurotransmitters that normally assist the body to fight or flee from danger. Unfortunately, that’s not the end of the story: As the stressor persists, it has the capacity to produce long-term alterations in the resilience of the brain and body of the young child. This change often is irreversible.

Scientists and the lay public have begun to actively discuss the impact of adverse childhood experiences and their causal link to irreversible negative adult health outcomes. We now know without a doubt the impact of toxic versus tolerable stress on the hypothalamic-pituitary-adrenal axis of the young child. We are aware that the brain of a young child is particularly vulnerable to stress during critical and sensitive periods of development and that downstream effects of early trauma show up as disorganized behavior and cognitive underperformance.

Development plays a central role in children’s behavioral response to separation from parents. Infants develop a sense of stranger anxiety and the primacy of one central figure between ages 8 and 10 months. The baby chooses the parent over strangers for comfort and care. Roughly between ages 3 and 4, a child develops an internal representation of the parent as the primary figure in their lives so that they can tolerate short periods of being away from the primary caregiver for, let’s say, half a day. They depend on the parent for all their physical and emotional needs, which includes the need for a stable, nurturing, and predictable presence.

Familiarity of the environment, family rituals, consistency of daily routines provided by the parent help neural pathways responsible for the biologic unfolding of developmental milestones. Only recently, the science of early brain development and the role of early childhood trauma on brain biology has caught up with the longitudinal observational studies of bereaved children who lost their parents under circumstances of acute stress (the blitzkrieg, the Yom Kippur War, the Hungarian orphans) followed by the chronic stress phase of no primary caregiver for months to years. These observational studies coupled by the emerging neuroscience of early brain development and trauma are powerful informants of what is tolerable stress for children and what is not.

As a psychiatrist and expert in early child development, I am concerned about these long-term effects on migrant children. Research shows that young children who are nonverbal react to the stress of separation by death or absence of parents with anxiety; frantically seeking the parent/comforting familiar caregiver. Gradually as that possibility fades, with their limited ability to verbalize needs, episodic weeping can give way to disorganized behavior, despondence, and finally apathy and regression of milestones and cognitive abilities already achieved. The separation is merely the proxy face of other disasters that are probably co-occurring for the child/family and multiplies the dose of the stress: loss of siblings, loss of familiar physical elements of the landscape, loss of adequate physical sustenance, loss of routine, loss of consistency, increased vulnerability for physical illness, and the list goes on.

By age 2 and above, children are more vocal in their desire for reunification and will weep inconsolably upon separation. At this time their bodies and the psychological lens through which they view the world is changing irrevocably. Stress hormones, noxious at high levels such as cortisol/adrenocorticotropic hormone and glutamate rise to levels that no longer respond to the traditional negative feedback loop of the body and reach levels that lead to cell death in areas of the brain responsible for modulating emotions that can permanently change brain architecture.

Psychologically, the child seeks out the parent by any means (crying, flailing, tantruming). When no positive outcome occurs, this is replaced by an unwillingness to engage with the world, or the child engages but by behavior that is aggressive, disorganized, and regressed. In their own way, young children’s mistrust of the world leads to a variety of behaviors that impede normal development: rejection of others, disengagement from social connections by quietly sitting in a corner, being unwilling to eat or sleeping fitfully.

As separation from the primary caregiver continues, there is a deepening sense of hopelessness. Generally, no amount of physical props (toys, playgrounds) without the human familiar faces can rectify the feeling of abandonment and hopelessness that children in these conditions face. Assuming they are no strangers to trauma experienced through the lives of their asylum-seeking parents, this separation refreshes all the wounds of days gone by. At least in those moments of initial trauma, they had the parent as a buffer. But with this new separation, they are left to emotionally fend for themselves with no tools to manage their emotions.

We have to deal with the aftereffects of so many natural disasters that cannot be avoided: earthquakes, tornadoes, tsunamis that displace children and families with horrific outcomes. Did we really need a man-made disaster that will irrevocably change the brains and behaviors of a generation of children who just happen to be on our southern borders because of an accident of birth? If parents abandoned their children this way it would be called child abuse. Deliberate policy decisions that have such dire effects on children also take on the label of child abuse.

Although images of my years as a young parent of three boys are turning a sepia color in faded memory, in my new role as a grandmother observing my son and his wife so in love with their 2-year-old reinforces how much mutual dependency of a child and parent on each other strengthens the very fabric of life. Children are our future and are the building blocks of a just and humane society.

As of this writing, the administration has vowed to end these separations. But how will children who have been separated be reunited with their families?

The education of decision makers about the far-reaching emotional and physical consequences on normative childhood development must be a top priority for all scientists and professionals interested in kids and families: I think that means all of us.
 

Dr. Sood is professor of psychiatry and pediatrics, and senior professor of child mental health policy at the Virginia Treatment Center at Virginia Commonwealth University, Richmond. She also is affiliated with the department of psychiatry at VCU and Children’s Hospital of Richmond.

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The recent crises of the separation of stressed children from their equally stressed parents at this country’s southern border raises the specter of emotional and cognitive reactions within these children – the negative ramifications of which will manifest themselves for years to come.

Stress is ubiquitous. Children experience stress in the normal everyday frustrations that come their way: going to day care for a few hours and leaving mommy, the tripping and falling as they learn to walk, a toy breaking. These stresses help a child develop the capacity for emotional regulation and are termed “tolerable stress.” There is, however, a big difference between tolerable stress and toxic stress.

Dr. Aradhana Bela Sood

When the stress reaction in response to perceived or actual danger is beyond tolerable levels by virtue of its quality, intensity, and longevity, it saps the body’s ability to rally or handle the trauma that is being faced because of depleted neurotransmitters that normally assist the body to fight or flee from danger. Unfortunately, that’s not the end of the story: As the stressor persists, it has the capacity to produce long-term alterations in the resilience of the brain and body of the young child. This change often is irreversible.

Scientists and the lay public have begun to actively discuss the impact of adverse childhood experiences and their causal link to irreversible negative adult health outcomes. We now know without a doubt the impact of toxic versus tolerable stress on the hypothalamic-pituitary-adrenal axis of the young child. We are aware that the brain of a young child is particularly vulnerable to stress during critical and sensitive periods of development and that downstream effects of early trauma show up as disorganized behavior and cognitive underperformance.

Development plays a central role in children’s behavioral response to separation from parents. Infants develop a sense of stranger anxiety and the primacy of one central figure between ages 8 and 10 months. The baby chooses the parent over strangers for comfort and care. Roughly between ages 3 and 4, a child develops an internal representation of the parent as the primary figure in their lives so that they can tolerate short periods of being away from the primary caregiver for, let’s say, half a day. They depend on the parent for all their physical and emotional needs, which includes the need for a stable, nurturing, and predictable presence.

Familiarity of the environment, family rituals, consistency of daily routines provided by the parent help neural pathways responsible for the biologic unfolding of developmental milestones. Only recently, the science of early brain development and the role of early childhood trauma on brain biology has caught up with the longitudinal observational studies of bereaved children who lost their parents under circumstances of acute stress (the blitzkrieg, the Yom Kippur War, the Hungarian orphans) followed by the chronic stress phase of no primary caregiver for months to years. These observational studies coupled by the emerging neuroscience of early brain development and trauma are powerful informants of what is tolerable stress for children and what is not.

As a psychiatrist and expert in early child development, I am concerned about these long-term effects on migrant children. Research shows that young children who are nonverbal react to the stress of separation by death or absence of parents with anxiety; frantically seeking the parent/comforting familiar caregiver. Gradually as that possibility fades, with their limited ability to verbalize needs, episodic weeping can give way to disorganized behavior, despondence, and finally apathy and regression of milestones and cognitive abilities already achieved. The separation is merely the proxy face of other disasters that are probably co-occurring for the child/family and multiplies the dose of the stress: loss of siblings, loss of familiar physical elements of the landscape, loss of adequate physical sustenance, loss of routine, loss of consistency, increased vulnerability for physical illness, and the list goes on.

By age 2 and above, children are more vocal in their desire for reunification and will weep inconsolably upon separation. At this time their bodies and the psychological lens through which they view the world is changing irrevocably. Stress hormones, noxious at high levels such as cortisol/adrenocorticotropic hormone and glutamate rise to levels that no longer respond to the traditional negative feedback loop of the body and reach levels that lead to cell death in areas of the brain responsible for modulating emotions that can permanently change brain architecture.

Psychologically, the child seeks out the parent by any means (crying, flailing, tantruming). When no positive outcome occurs, this is replaced by an unwillingness to engage with the world, or the child engages but by behavior that is aggressive, disorganized, and regressed. In their own way, young children’s mistrust of the world leads to a variety of behaviors that impede normal development: rejection of others, disengagement from social connections by quietly sitting in a corner, being unwilling to eat or sleeping fitfully.

As separation from the primary caregiver continues, there is a deepening sense of hopelessness. Generally, no amount of physical props (toys, playgrounds) without the human familiar faces can rectify the feeling of abandonment and hopelessness that children in these conditions face. Assuming they are no strangers to trauma experienced through the lives of their asylum-seeking parents, this separation refreshes all the wounds of days gone by. At least in those moments of initial trauma, they had the parent as a buffer. But with this new separation, they are left to emotionally fend for themselves with no tools to manage their emotions.

We have to deal with the aftereffects of so many natural disasters that cannot be avoided: earthquakes, tornadoes, tsunamis that displace children and families with horrific outcomes. Did we really need a man-made disaster that will irrevocably change the brains and behaviors of a generation of children who just happen to be on our southern borders because of an accident of birth? If parents abandoned their children this way it would be called child abuse. Deliberate policy decisions that have such dire effects on children also take on the label of child abuse.

Although images of my years as a young parent of three boys are turning a sepia color in faded memory, in my new role as a grandmother observing my son and his wife so in love with their 2-year-old reinforces how much mutual dependency of a child and parent on each other strengthens the very fabric of life. Children are our future and are the building blocks of a just and humane society.

As of this writing, the administration has vowed to end these separations. But how will children who have been separated be reunited with their families?

The education of decision makers about the far-reaching emotional and physical consequences on normative childhood development must be a top priority for all scientists and professionals interested in kids and families: I think that means all of us.
 

Dr. Sood is professor of psychiatry and pediatrics, and senior professor of child mental health policy at the Virginia Treatment Center at Virginia Commonwealth University, Richmond. She also is affiliated with the department of psychiatry at VCU and Children’s Hospital of Richmond.

 

The recent crises of the separation of stressed children from their equally stressed parents at this country’s southern border raises the specter of emotional and cognitive reactions within these children – the negative ramifications of which will manifest themselves for years to come.

Stress is ubiquitous. Children experience stress in the normal everyday frustrations that come their way: going to day care for a few hours and leaving mommy, the tripping and falling as they learn to walk, a toy breaking. These stresses help a child develop the capacity for emotional regulation and are termed “tolerable stress.” There is, however, a big difference between tolerable stress and toxic stress.

Dr. Aradhana Bela Sood

When the stress reaction in response to perceived or actual danger is beyond tolerable levels by virtue of its quality, intensity, and longevity, it saps the body’s ability to rally or handle the trauma that is being faced because of depleted neurotransmitters that normally assist the body to fight or flee from danger. Unfortunately, that’s not the end of the story: As the stressor persists, it has the capacity to produce long-term alterations in the resilience of the brain and body of the young child. This change often is irreversible.

Scientists and the lay public have begun to actively discuss the impact of adverse childhood experiences and their causal link to irreversible negative adult health outcomes. We now know without a doubt the impact of toxic versus tolerable stress on the hypothalamic-pituitary-adrenal axis of the young child. We are aware that the brain of a young child is particularly vulnerable to stress during critical and sensitive periods of development and that downstream effects of early trauma show up as disorganized behavior and cognitive underperformance.

Development plays a central role in children’s behavioral response to separation from parents. Infants develop a sense of stranger anxiety and the primacy of one central figure between ages 8 and 10 months. The baby chooses the parent over strangers for comfort and care. Roughly between ages 3 and 4, a child develops an internal representation of the parent as the primary figure in their lives so that they can tolerate short periods of being away from the primary caregiver for, let’s say, half a day. They depend on the parent for all their physical and emotional needs, which includes the need for a stable, nurturing, and predictable presence.

Familiarity of the environment, family rituals, consistency of daily routines provided by the parent help neural pathways responsible for the biologic unfolding of developmental milestones. Only recently, the science of early brain development and the role of early childhood trauma on brain biology has caught up with the longitudinal observational studies of bereaved children who lost their parents under circumstances of acute stress (the blitzkrieg, the Yom Kippur War, the Hungarian orphans) followed by the chronic stress phase of no primary caregiver for months to years. These observational studies coupled by the emerging neuroscience of early brain development and trauma are powerful informants of what is tolerable stress for children and what is not.

As a psychiatrist and expert in early child development, I am concerned about these long-term effects on migrant children. Research shows that young children who are nonverbal react to the stress of separation by death or absence of parents with anxiety; frantically seeking the parent/comforting familiar caregiver. Gradually as that possibility fades, with their limited ability to verbalize needs, episodic weeping can give way to disorganized behavior, despondence, and finally apathy and regression of milestones and cognitive abilities already achieved. The separation is merely the proxy face of other disasters that are probably co-occurring for the child/family and multiplies the dose of the stress: loss of siblings, loss of familiar physical elements of the landscape, loss of adequate physical sustenance, loss of routine, loss of consistency, increased vulnerability for physical illness, and the list goes on.

By age 2 and above, children are more vocal in their desire for reunification and will weep inconsolably upon separation. At this time their bodies and the psychological lens through which they view the world is changing irrevocably. Stress hormones, noxious at high levels such as cortisol/adrenocorticotropic hormone and glutamate rise to levels that no longer respond to the traditional negative feedback loop of the body and reach levels that lead to cell death in areas of the brain responsible for modulating emotions that can permanently change brain architecture.

Psychologically, the child seeks out the parent by any means (crying, flailing, tantruming). When no positive outcome occurs, this is replaced by an unwillingness to engage with the world, or the child engages but by behavior that is aggressive, disorganized, and regressed. In their own way, young children’s mistrust of the world leads to a variety of behaviors that impede normal development: rejection of others, disengagement from social connections by quietly sitting in a corner, being unwilling to eat or sleeping fitfully.

As separation from the primary caregiver continues, there is a deepening sense of hopelessness. Generally, no amount of physical props (toys, playgrounds) without the human familiar faces can rectify the feeling of abandonment and hopelessness that children in these conditions face. Assuming they are no strangers to trauma experienced through the lives of their asylum-seeking parents, this separation refreshes all the wounds of days gone by. At least in those moments of initial trauma, they had the parent as a buffer. But with this new separation, they are left to emotionally fend for themselves with no tools to manage their emotions.

We have to deal with the aftereffects of so many natural disasters that cannot be avoided: earthquakes, tornadoes, tsunamis that displace children and families with horrific outcomes. Did we really need a man-made disaster that will irrevocably change the brains and behaviors of a generation of children who just happen to be on our southern borders because of an accident of birth? If parents abandoned their children this way it would be called child abuse. Deliberate policy decisions that have such dire effects on children also take on the label of child abuse.

Although images of my years as a young parent of three boys are turning a sepia color in faded memory, in my new role as a grandmother observing my son and his wife so in love with their 2-year-old reinforces how much mutual dependency of a child and parent on each other strengthens the very fabric of life. Children are our future and are the building blocks of a just and humane society.

As of this writing, the administration has vowed to end these separations. But how will children who have been separated be reunited with their families?

The education of decision makers about the far-reaching emotional and physical consequences on normative childhood development must be a top priority for all scientists and professionals interested in kids and families: I think that means all of us.
 

Dr. Sood is professor of psychiatry and pediatrics, and senior professor of child mental health policy at the Virginia Treatment Center at Virginia Commonwealth University, Richmond. She also is affiliated with the department of psychiatry at VCU and Children’s Hospital of Richmond.

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Right to Try: Mission accomplished?

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On May 30, 2018, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, guaranteeing patients with terminal illnesses the right to seek access to investigational drugs which have passed at least phase 1 testing. As he signed the bipartisan-backed bill into law, the president said he believes it will ultimately save “hundreds of thousands” of lives, scoring an apparent win-win-win for the president, for Congress, and for patients. A critical appraisal of the law – and of the supposition that patients will reap great benefit from it – requires that we ask two questions: Does the law degrade measures originally put in place to protect patients, and does it actually improve access to potentially life-saving drugs?

As a hematologist with about 2 decades of experience conducting clinical research involving patients with incurable cancer, I want as many patients as possible to have access to promising new therapies. Clinical trials, as the sole means of determining a candidate drug’s safety and efficacy, are conducted in a systematic fashion, with phase 1 trials focusing predominantly on safety. As any experienced researcher is aware, however, a phase 1 trial only provides a basic sense of a drug’s safety. It would be unimaginable (and unethical) to conduct subsequent phase 2 and 3 trials without including rigorous ongoing monitoring for adverse effects.

Dr. Jeffrey A. Zonder
Some critics of the Right to Try law feel that it potentially weakens landmark legislation originally put into place to protect the public from fraudulent and/or dangerous drugs, by permitting access before efficacy and safety is really established. When considering trends in phase 1 trials in oncology, at least, this concern might be tempered. In an analysis of all phase 1 trials originally submitted for presentation at the annual meetings of the American Society of Clinical Oncology between 1991 and 2002 (involving more than 6,000 individual patients being treated with drugs that had not been approved by the Food and Drug Administration at the time of abstract presentation), the treatment-related death rate was only 0.54%.1

A later study evaluating all nonpediatric phase 1 trials sponsored by the National Cancer Institute’s Cancer Therapy Evaluation Program between 2001 and 2012, which included more than 8,300 patients, found the therapy-related death rate to be similarly low – approximately 1%.2

It is distinctly possible that the same drugs used in the analyzed trials would have been more toxic to patients who, for one reason or another, would not have met enrollment criteria. It is impossible to precisely quantify the degree to which risk may be increased under the Right to Try law, but even if it were tripled or quadrupled, compared with these historical expectations, the absolute risk of treatment-related death remains low. It should be noted that the incidence of nonfatal grade 3-4 adverse events in the same analyses was 10%-20% so a similar proportional increase in these events would impact a larger number of patients. Overall, it is difficult to know the degree to which Right to Try impacts the safety of fragile patients with terminal illnesses.

The answer to the second question – Is access to life-saving drugs improved? – is much easier to answer: No.

One reason is that these patients already have the right to seek access to investigational drugs through the FDA’s Expanded Access Program. An overview of the Expanded Access Program reported that approximately 11,000 patients over a period of 10 years submitted requests for access to investigational drugs and that 99% of the requests were granted.3

Proponents of the Right to Try law argue that the new law somehow simplifies the request process, but it is difficult to understand exactly how. Further, in a position paper on the topic of Right to Try policy, Lisa Kearns and Alison Bateman-House, PhD, of New York University, wrote, “In the more than 2½ years since the first [individual state right to try] law was signed, there have been no documented cases of anyone receiving access, because of a right to try law, to an experimental product that would not have been available via the FDA’s Expanded Access Program.”4

Finally, and most importantly, neither the existing Expanded Access Program nor the newly enacted Right to Try law require that pharmaceutical companies actually provide the requested drugs. Industry leaders, in testimony before Congress, have cited patient safety, costs, drug supply, and negative impact on existing clinical trial accrual as reasons pharmaceutical companies commonly deny requests for access to investigational products.

The bottom line is that the Right to Try law really lacks teeth. Despite the favorable optics for the president and Congress, it is virtually certain that Right to Try will never save hundreds of thousands of lives, and the suggestion that it will is either disingenuous or uninformed. Hopefully, though, Congress’s passage of Right to Try is indicative of a more general interest in bipartisan cooperation to improve access to affordable, high-quality health care.
 
 

 

Dr. Zonder is a professor in the department of oncology at the Barbara Ann Karmanos Cancer Institute and Wayne State University in Detroit. He is the leader of the KCI Myeloma and Amyloidosis Team. He is also a member of the Hematology News Editorial Advisory Board. He reported having no relevant financial disclosures.

References

1. Roberts TG Jr. et al. JAMA. 2004 Nov 3;292(17):2130-40.

2. Fukada YK et al. J Clin Oncol. 2014 May 20. doi: 10.1200/jco.2014.32.15_suppl.2552.

3. Jarow JP et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):177-9.

4. Kearns L et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):170-6.
 

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On May 30, 2018, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, guaranteeing patients with terminal illnesses the right to seek access to investigational drugs which have passed at least phase 1 testing. As he signed the bipartisan-backed bill into law, the president said he believes it will ultimately save “hundreds of thousands” of lives, scoring an apparent win-win-win for the president, for Congress, and for patients. A critical appraisal of the law – and of the supposition that patients will reap great benefit from it – requires that we ask two questions: Does the law degrade measures originally put in place to protect patients, and does it actually improve access to potentially life-saving drugs?

As a hematologist with about 2 decades of experience conducting clinical research involving patients with incurable cancer, I want as many patients as possible to have access to promising new therapies. Clinical trials, as the sole means of determining a candidate drug’s safety and efficacy, are conducted in a systematic fashion, with phase 1 trials focusing predominantly on safety. As any experienced researcher is aware, however, a phase 1 trial only provides a basic sense of a drug’s safety. It would be unimaginable (and unethical) to conduct subsequent phase 2 and 3 trials without including rigorous ongoing monitoring for adverse effects.

Dr. Jeffrey A. Zonder
Some critics of the Right to Try law feel that it potentially weakens landmark legislation originally put into place to protect the public from fraudulent and/or dangerous drugs, by permitting access before efficacy and safety is really established. When considering trends in phase 1 trials in oncology, at least, this concern might be tempered. In an analysis of all phase 1 trials originally submitted for presentation at the annual meetings of the American Society of Clinical Oncology between 1991 and 2002 (involving more than 6,000 individual patients being treated with drugs that had not been approved by the Food and Drug Administration at the time of abstract presentation), the treatment-related death rate was only 0.54%.1

A later study evaluating all nonpediatric phase 1 trials sponsored by the National Cancer Institute’s Cancer Therapy Evaluation Program between 2001 and 2012, which included more than 8,300 patients, found the therapy-related death rate to be similarly low – approximately 1%.2

It is distinctly possible that the same drugs used in the analyzed trials would have been more toxic to patients who, for one reason or another, would not have met enrollment criteria. It is impossible to precisely quantify the degree to which risk may be increased under the Right to Try law, but even if it were tripled or quadrupled, compared with these historical expectations, the absolute risk of treatment-related death remains low. It should be noted that the incidence of nonfatal grade 3-4 adverse events in the same analyses was 10%-20% so a similar proportional increase in these events would impact a larger number of patients. Overall, it is difficult to know the degree to which Right to Try impacts the safety of fragile patients with terminal illnesses.

The answer to the second question – Is access to life-saving drugs improved? – is much easier to answer: No.

One reason is that these patients already have the right to seek access to investigational drugs through the FDA’s Expanded Access Program. An overview of the Expanded Access Program reported that approximately 11,000 patients over a period of 10 years submitted requests for access to investigational drugs and that 99% of the requests were granted.3

Proponents of the Right to Try law argue that the new law somehow simplifies the request process, but it is difficult to understand exactly how. Further, in a position paper on the topic of Right to Try policy, Lisa Kearns and Alison Bateman-House, PhD, of New York University, wrote, “In the more than 2½ years since the first [individual state right to try] law was signed, there have been no documented cases of anyone receiving access, because of a right to try law, to an experimental product that would not have been available via the FDA’s Expanded Access Program.”4

Finally, and most importantly, neither the existing Expanded Access Program nor the newly enacted Right to Try law require that pharmaceutical companies actually provide the requested drugs. Industry leaders, in testimony before Congress, have cited patient safety, costs, drug supply, and negative impact on existing clinical trial accrual as reasons pharmaceutical companies commonly deny requests for access to investigational products.

The bottom line is that the Right to Try law really lacks teeth. Despite the favorable optics for the president and Congress, it is virtually certain that Right to Try will never save hundreds of thousands of lives, and the suggestion that it will is either disingenuous or uninformed. Hopefully, though, Congress’s passage of Right to Try is indicative of a more general interest in bipartisan cooperation to improve access to affordable, high-quality health care.
 
 

 

Dr. Zonder is a professor in the department of oncology at the Barbara Ann Karmanos Cancer Institute and Wayne State University in Detroit. He is the leader of the KCI Myeloma and Amyloidosis Team. He is also a member of the Hematology News Editorial Advisory Board. He reported having no relevant financial disclosures.

References

1. Roberts TG Jr. et al. JAMA. 2004 Nov 3;292(17):2130-40.

2. Fukada YK et al. J Clin Oncol. 2014 May 20. doi: 10.1200/jco.2014.32.15_suppl.2552.

3. Jarow JP et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):177-9.

4. Kearns L et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):170-6.
 

 

On May 30, 2018, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, guaranteeing patients with terminal illnesses the right to seek access to investigational drugs which have passed at least phase 1 testing. As he signed the bipartisan-backed bill into law, the president said he believes it will ultimately save “hundreds of thousands” of lives, scoring an apparent win-win-win for the president, for Congress, and for patients. A critical appraisal of the law – and of the supposition that patients will reap great benefit from it – requires that we ask two questions: Does the law degrade measures originally put in place to protect patients, and does it actually improve access to potentially life-saving drugs?

As a hematologist with about 2 decades of experience conducting clinical research involving patients with incurable cancer, I want as many patients as possible to have access to promising new therapies. Clinical trials, as the sole means of determining a candidate drug’s safety and efficacy, are conducted in a systematic fashion, with phase 1 trials focusing predominantly on safety. As any experienced researcher is aware, however, a phase 1 trial only provides a basic sense of a drug’s safety. It would be unimaginable (and unethical) to conduct subsequent phase 2 and 3 trials without including rigorous ongoing monitoring for adverse effects.

Dr. Jeffrey A. Zonder
Some critics of the Right to Try law feel that it potentially weakens landmark legislation originally put into place to protect the public from fraudulent and/or dangerous drugs, by permitting access before efficacy and safety is really established. When considering trends in phase 1 trials in oncology, at least, this concern might be tempered. In an analysis of all phase 1 trials originally submitted for presentation at the annual meetings of the American Society of Clinical Oncology between 1991 and 2002 (involving more than 6,000 individual patients being treated with drugs that had not been approved by the Food and Drug Administration at the time of abstract presentation), the treatment-related death rate was only 0.54%.1

A later study evaluating all nonpediatric phase 1 trials sponsored by the National Cancer Institute’s Cancer Therapy Evaluation Program between 2001 and 2012, which included more than 8,300 patients, found the therapy-related death rate to be similarly low – approximately 1%.2

It is distinctly possible that the same drugs used in the analyzed trials would have been more toxic to patients who, for one reason or another, would not have met enrollment criteria. It is impossible to precisely quantify the degree to which risk may be increased under the Right to Try law, but even if it were tripled or quadrupled, compared with these historical expectations, the absolute risk of treatment-related death remains low. It should be noted that the incidence of nonfatal grade 3-4 adverse events in the same analyses was 10%-20% so a similar proportional increase in these events would impact a larger number of patients. Overall, it is difficult to know the degree to which Right to Try impacts the safety of fragile patients with terminal illnesses.

The answer to the second question – Is access to life-saving drugs improved? – is much easier to answer: No.

One reason is that these patients already have the right to seek access to investigational drugs through the FDA’s Expanded Access Program. An overview of the Expanded Access Program reported that approximately 11,000 patients over a period of 10 years submitted requests for access to investigational drugs and that 99% of the requests were granted.3

Proponents of the Right to Try law argue that the new law somehow simplifies the request process, but it is difficult to understand exactly how. Further, in a position paper on the topic of Right to Try policy, Lisa Kearns and Alison Bateman-House, PhD, of New York University, wrote, “In the more than 2½ years since the first [individual state right to try] law was signed, there have been no documented cases of anyone receiving access, because of a right to try law, to an experimental product that would not have been available via the FDA’s Expanded Access Program.”4

Finally, and most importantly, neither the existing Expanded Access Program nor the newly enacted Right to Try law require that pharmaceutical companies actually provide the requested drugs. Industry leaders, in testimony before Congress, have cited patient safety, costs, drug supply, and negative impact on existing clinical trial accrual as reasons pharmaceutical companies commonly deny requests for access to investigational products.

The bottom line is that the Right to Try law really lacks teeth. Despite the favorable optics for the president and Congress, it is virtually certain that Right to Try will never save hundreds of thousands of lives, and the suggestion that it will is either disingenuous or uninformed. Hopefully, though, Congress’s passage of Right to Try is indicative of a more general interest in bipartisan cooperation to improve access to affordable, high-quality health care.
 
 

 

Dr. Zonder is a professor in the department of oncology at the Barbara Ann Karmanos Cancer Institute and Wayne State University in Detroit. He is the leader of the KCI Myeloma and Amyloidosis Team. He is also a member of the Hematology News Editorial Advisory Board. He reported having no relevant financial disclosures.

References

1. Roberts TG Jr. et al. JAMA. 2004 Nov 3;292(17):2130-40.

2. Fukada YK et al. J Clin Oncol. 2014 May 20. doi: 10.1200/jco.2014.32.15_suppl.2552.

3. Jarow JP et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):177-9.

4. Kearns L et al. Ther Innov Regul Sci. 2017 Mar 1;51(2):170-6.
 

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