Commentary

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

It’s election season again. Every 4 years, October becomes the purgatory month of politics. But this year, it’s even more complicated, being juxtaposed against a chaotic mosaic of a viral pandemic, economic travails, social upheaval, and exceptionally toxic political hyperpartisanship.

The widespread expectation is that citizens will vote for their party’s candidates, but there is now a body of evidence suggesting that our brains may be pre-wired to be liberal or conservative.

Enter neuro-politics. This discipline is younger than neuro-economics, neuro-law, neuro-ethics, neuro-marketing, neuro-art, neuro-culture, or neuro-esthetics. Neuro-politics focuses on the intersection of politics with neuroscience.¹ However, there are many antecedents to neuro-politics reflected in the writings of Plato, Aristotle, Niccolò Machiavelli, John Locke, Baruch Spinoza, Henri Bergson, William James, and others.

Neuro-politics attempts to generate data to answer a variety of questions about political behavior, such as:

• Is political orientation associated with differences in certain brain regions?
• Are there reliable neural biomarkers of political orientation?
• Is political orientation modifiable, and if so, why are some individuals ferociously entrenched to one political dogma while others are able to untether themselves and adopt another political doctrine?
• What are the brain characteristics of “swing voters” who may align themselves with different parties in different election cycles?
• Is there a “religification” of politics among the ardent fanatics who regard the tenets of their political beliefs as “articles of faith?”
• Is the brain modified by certain attributes (such as educational level, age, sex, marital status, race, ethnicity, and religious affiliation) that translate to political decision-making?
• Can neuro-politics explain the sprouting of psychiatric symptoms such as obsessions, anxiety, irritability, anger, hatred, and conspiracy theories?
• Is political extremism driven by cortical structures, limbic structures, or both?

Politics and the brain

Here is a brief review of some studies that examined the relationship of political orientation or voting behavior with brain structure and function:

1. Roger Sperry, the 1981 Nobel Laureate (for his studies on split-brain patients) reported that in patients who underwent callosotomy, both cerebral hemispheres gave the same ratings of politicians when their photos were shown to each hemisphere separately.²

2. A functional magnetic resonance imaging (fMRI) study found that the faces of candidates activated participants’ ventromedial and anterior prefrontal cortices. Amygdala activation was associated with the intensity of the emotion.³

Continue to: A skin conductance...

3. A skin conductance study reported that politically liberal individuals had low reactivity to sudden noises and threatening stimuli, while conservative counterparts demonstrated high physiological reactions to noises and stimuli.⁴

4. Images of a losing candidate elicited greater activation on fMRI in the insula and ventral anterior cingulate compared to no activation by exposure to an image of the winning candidate.⁵

5. Another fMRI study found that “individualism” was associated with activation of the medial prefrontal cortex and temporo-parietal junction when participants listened to a set of political statements. On the other hand, “conservatism” activated the dorsolateral prefrontal cortex, while “radicalism” activated the ventral striatum and posterior cingulate.⁶

6. An EEG activity study of healthy individuals revealed desynchronization in the alpha band related to the politicians who lost simulated elections and were judged as “less trustworthy” when the participant watched their faces.⁷

7. A structural MRI study of young adults reported that liberalism was associated with increased gray matter volume in the anterior cingulate, while conservatism was associated with increased volume of the right amygdala. The authors replicated their findings and concluded there is a possible link between brain structure and psychological mechanisms that mediate political attitudes.⁸

Continue to: To examine the effect of...

8. To examine the effect of a “first impression” based on the physical appearance of candidates, researchers compared individuals with damage to the lateral orbitofrontal cortex (OFC) with a group that had frontal damage that spared the lateral OFC and another group of matched healthy volunteers. They used a simulated elections paradigm in which participants voted based solely on photographs of the candidates’ faces. Only the group with OFC damage was influenced by attractiveness, while those with an intact frontal lobe or non-OFC frontal damage relied on other data, such as competence.⁹ These researchers concluded that an intact OFC is necessary for political decision-making.

9. A study using cognitive tasks reported that liberals are more adept at dealing with novel information than conservatives.¹⁰

What part of your brain will you use?

Regardless of the data generated by the neuro-politics studies, the bottom line is: What part of your brain do you use when you cast your vote for an issue, a representative, a senator, or a president? Is it a purely intellectual decision (ie, cortical), or is it driven by visceral emotions (ie, limbic)? Do you believe that every single item in your party’s platform is right and virtuous, while every item in the other party’s platform is wrong and evil? Can you think of any redeeming feature of the candidate you hate or the party you despise?

One attribute that we psychiatrists possess by virtue of our training and clinical work is that we are able to transcend dichotomies and to perceive nuances and shades of gray about controversial issues. So I hope we employ the circuits of our brain where wisdom putatively resides¹¹ and which may develop further (via neuroplasticity) with the conduct of psychotherapy.¹² Those brain circuits include:

• prefrontal cortex (for emotional regulation, decision-making, and value relativism)
• lateral prefrontal cortex (to facilitate calculated, reason-based decision-making)
• medial prefrontal cortex (for emotional valence and pro-social attitudes and behaviors).

However, being human, it is quite likely that our amygdala may “seep through” and color our judgment and decisions. But let us try to cast a vote that is not only good for the country but also good for our patients, many of whom may not even be able to vote. Election season is a time to make a positive difference in our patients’ lives, not just ours. Let’s hope our brains exploit this unique opportunity.

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

I had been in practice only 6 or 7 years when I got the itch to do some writing. I had been exchanging letters with my father since I left for college. He was a professional writer but I had never done more than was required to get through school. What motivated me to sit down at the keyboard of his old hand-me-down portable typewriter was my frustration with grandmothers, as nearly every day I found myself struggling to counter some grandmother’s well-intentioned but somewhat off-the-mark childrearing advice.

supersizer/Getty Images

Occasionally this would be during a face-to-face encounter with a grandmother who had tagged along to the well-baby visit. More often, I was trying to arm a mother or father with the “facts” (at least as I understood them) that they could carry home and use to defend my position as the child care expert for the family.

These were not knock-down-drag-out disagreements but I always felt badly that I might be tarnishing a grandmother’s reputation. Grandfathers seemed to have learned it was best to keep silent on childrearing. I knew from my own family that most grandmothers had years of experience raising children that, if properly delivered, could make childrearing a more positive experience for new parents. My father, whose mother was widowed when he was an infant, was raised by his grandmother. However, too often I found that grandmotherly advice came packaged with just enough old wives’ tales and factually incorrect medical information to be dangerous.

The title of my opus would be “The Good Grandmother Handbook” and it would be an effort to update grandmothers with the latest information on childrearing from a recently trained and cocky board-certified pediatrician with only 6 years’ practice under his belt. The book would reassure grandmothers that, although some of the things they had done as parents are now frowned upon, most of what they did has stood the test of time and probably is worth sharing.

The final chapter of the book would be about grandparent etiquette. How to deal with the fact that there is another set of grandparents who have opinions and would like to have time with their grandchildren. When and how to give advice: Basically, only if asked or you feel your grandchild’s life is at stake. And, finally, how to deal with the disappointment of not being asked for advice and not being involved.

Not surprisingly that sophomoric and condescending effort never got further than the first draft. It reflected my early experiences in a minimally diverse and relatively affluent community. As my world view broadened, I realized that for many families it’s not a question of how to deal with a grandmother’s unsolicited advice. There are numerous grandparents who have been forced to become safe havens in which a family in distress can ride out the turbulent economic times and societal upheaval. In many cases, grandmothers are essential workers – not just occasional babysitters – but surrogate parents.

A Pediatrics article estimates that 2% of children in this country are being raised by their grandparents. And, it turns out that grandparents are doing a surprisingly good job. The researchers concluded that: “Despite caring for children with greater developmental problems and poorer temperament grandparent caregivers seem to cope with parenting about as well as parents.”

As pediatricians we must continue to reach out to grandmothers and grandfathers who are caring for some of our most challenged patients. They need our medical advice but even more they need our compassion and emotional support. Over the last 5 decades I’ve come to learn that, although there are some grandmothers who can be meddlesome dispensers of old wives’ tales, many are the backbone of families in need.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?

For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”

Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.

At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?

One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, it can be hard to break out from the middle and bottom groups without a strong advocate or opportunities to demonstrate exceptional proficiency.

Below are three recommendations to consider for improving mentorship within departments:

1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.

2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.

3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.

If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.

Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

1. Include and integrate pregnant women and lactating women in the clinical research agenda.

2. Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.

3. Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.

4. Remove regulatory barriers to research in pregnant women.

5. Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.

6. Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.

7. Develop separate programs to study therapeutic products used off patent in pregnant women and lactating women using the National Institute of Health Best Pharmaceuticals for Children Act (BPCA) as a model.

8. Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.

9. Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.

10. Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.

11. Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.

12. Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.

13. Optimize registries for pregnancy and lactation.

14. The Department of Health & Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.

15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

Source: Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].

I have had friends and colleagues visibly shrink away when I say that my work involves the study of medication safety in pregnancy. “Yikes! I would never let my daughter participate in a clinical study if she was pregnant!” I hear. It’s an interesting response. Understandably protective of a loved one, except that the loved one is an adult woman who presumably can make her own choices. And the response reveals an assumption that medications are tested in all populations before approval for market. Sadly, the response is ill-informed given that pregnant women are still excluded from most if not all clinical research. My work, by the way, is focused on postapproval studies.

Antonio_Diaz/Thinkstock

Translating the above response to a larger picture, health care providers and pharmaceutical manufacturers also have their concerns about pregnant women and lactating women participating in clinical research. Along with the patient and her loved ones, all parties’ concerns are valid. However, there is a harsh reality: According to a study in the American Journal of Obstetrics & Gynecology, an estimated 50% of U.S. women take one or more prescription medications during pregnancy. Once marketed, therapies are prescribed to pregnant women, knowingly and unknowingly, and without evidence-based knowledge of their safety. If postapproval safety studies are undertaken, decades may pass as data accrue and before results become available. In general, even less is known about the safety of medications in breastmilk.

Without a path forward that includes pregnant women and lactating women in clinical research, we will remain without timely knowledge of medication safety. Further, our understanding of efficacy will be based on clinical studies of nonpregnant women. Recognizing the need for this information, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) was convened in 2017 and tasked with determining this path forward.

The PRGLAC was established by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health, the PRGLAC is made up of representatives of all federal agencies with responsibilities for women’s health and research, as well as clinicians, industry experts, and other experts. The PRGLAC’s work has been conducted in two phases.

In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018, and submitted their conclusions to Congress and the Secretary of Health & Human Services in a publicly available report. The report provides 15 specific recommendations, several of which are directly relevant to obstetricians: No. 3 recommends expanding the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology, No. 6 recommends the development and implementation of evidence-based communication strategies with health care providers, and No. 13 recommends optimization of registries for pregnancy and lactation. Obstetricians can make a positive contribution to accruing medication safety data by being aware of pregnancy registries and indicating their availability to eligible patients.

In the spring of 2019, the PRGLAC reconvened with a 2-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. Four working groups (WGs) were identified to address the recommendations of the report: WG1 Research and Training, WG2 Regulatory, WG3 Communication and Registries, and WG4 Discovery. The four groups have deliberated, and a new report is being finalized. The PRGLAC’s efforts provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. Once available, the final report will be posted on the PRGLAC website.

The recommendations in this report, when implemented, are directly relevant to patient care and clinician training and will provide a path forward for the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
 

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology. She also represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy disclosed she has worked with multiple pharmaceutical manufacturers regarding medication safety studies in pregnancy, most recently Biohaven. Email her at [email protected].

Spending on medications is expected to grow from $344 billion in 2018 to $420 billion in 2023, largely driven by the introduction of new branded drugs.¹ These costs place substantial financial burden on patients, with nearly 30% of patients not taking their prescriptions as directed because of costs. Although many new medications have transformed how we care for patients, others may not offer meaningful benefit over existing less-costly alternatives that are supported by declining effect sizes of conventional placebo-controlled trials.² Most medications are approved based on placebo-controlled trial data that does not include an arm comparing the new drug to standard of care, leaving clinicians and patients unable to make meaningful comparisons when deciding on the most appropriate or cost-effective treatment. We consider ways in which clinicians, patients, payers, and regulators could compel more meaningful trials from industry.

Although we often look to the US Food and Drug Administration (FDA) to ensure rigorous and appropriate testing of new medications, the primary mission of the FDA is to ensure efficacy and safety. As a result, pharmaceutical companies seeking approval in the United States have little incentive to go beyond providing the minimal level of evidence required: placebo-controlled randomized trials. Although these trials provide important data on whether a treatment works and its associated risks, they do not provide data on comparative effectiveness. When relevant inexpensive medications are already on the market for the same indication, these placebo-controlled trials provide inadequate evidence to guide clinical decision-making. This issue is particularly relevant in dermatology given how easily topical medications can be combined or reformulated to pursue additional market exclusivity. The addition of an active comparator arm represents an important opportunity to improve the value of these studies.

In the pivotal trials of clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel for the treatment of acne, the experimental group was not only compared to vehicle but also the active comparator arms of clindamycin alone and benzoyl peroxide alone. The mean percentage change in total lesions was 47.9% with clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel, 41.6% with the active comparator arm of benzoyl peroxide alone, 40.4% with the active comparator arm of clindamycin alone, and 26.2% for vehicle.³ With these data in mind, clinicians and patients can decide whether the additional benefit of this new product over benzoyl peroxide alone is worth the increased cost.

In contrast, the trials of dapsone gel 7.5% for the treatment of acne did not include an active comparator. The mean percentage change in total lesions was 48.9% for dapsone gel and 43.2% for vehicle.⁴ Given these data, it is possible that dapsone gel may be no more effective, or possibly less effective, than alternatives such as benzoyl peroxide or other topical antibiotics. Nevertheless, dapsone annual sales were more than $200 million in 2016,⁵ suggesting that effectively marketed new products can achieve high sales even without convincing evidence of their value compared to standard of care. Although dapsone may be a useful treatment, we cannot effectively make patient-centered clinical decisions given the lack of an active comparator trial design.

This issue is not limited to acne. Phase 3 trials of halobetasol propionate foam 0.05% for psoriasis and crisaborole for atopic dermatitis also did not include an active comparator arm.^6,7 Given that topical steroids—and calcineurin inhibitors for atopic dermatitis—are mainstays of treatment for each condition, it is difficult to determine whether these new treatments offer meaningful advantages over existing options and how to incorporate them into our management strategies.

Unfortunately, expensive new medications that are adopted without convincing evidence of their benefit above standard of care can put patients at risk for financial toxicity, either directly through higher out-of-pocket costs or indirectly through higher premiums. Given the impact of rising medication costs on clinicians, patients, and payers, we propose several approaches these stakeholders could adopt to encourage the use of active comparator trial designs.

Clinicians and patients can encourage these trials by remaining skeptical of new treatments that were only compared to vehicle or placebo. Because new medications often are more expensive, clinicians and patients could avoid using these treatments without evidence of either increased efficacy or improved safety and tolerability. In addition, health care institutions should consider reducing pharmaceutical representatives’ access to clinicians to encourage treatment decisions based on the published literature and comparative effectiveness data rather than marketing.

Payers, such as Medicare, also could play a role by requiring active comparator trials for coverage of new medications, particularly when there are already other effective treatments available or other medications in the same class. Payers also could give preferred coverage tier or step therapy status to medications that demonstrate value over existing options.

Although regulatory approaches to increase use of active comparator designs may be more politically challenging to introduce, these options would be more administratively robust. The FDA or a novel regulatory body could require that new treatments demonstrate value in addition to safety and efficacy. This approach would be similar to the role of The National Institute for Health and Care Excellence in the United Kingdom or the recommendations of the European Medicines Agency. Such a group also could provide independent adjudication to ensure appropriate selection of a relevant active comparator. Another approach would be to give extended market exclusivity to medications that are approved based on trials including an additional active comparator arm, an approach used by the European Medicines Agency.

Any approach that encourages increased use of active comparator trials is not without potential downsides. It will be important to avoid unintended consequences of reduced research for rare diseases with smaller markets that may not be able to support the increased cost of these trials. As a result, it would be reasonable to forgo active comparator designs for mediations indicated for rare and orphan diseases or for medications with novel mechanisms of action.

Another argument against including an active comparator arm is that it may stifle innovation by driving up the cost of conducting trials; however, if a product is so marginally innovative that it cannot demonstrate superior safety or efficacy to an existing product, such a new treatment may not be worth the increased cost. In addition, patients provide a notable contribution by participating in these trials, and it is important to ensure that their efforts result in the highest-quality data possible. Furthermore, given the adverse physical and psychosocial impact of a wide variety of dermatologic diseases, the inclusion of an active comparator arm reduces the likelihood that patients will receive placebo, which will make these trials more ethical when effective treatments are available.⁸ By raising the bar, we can encourage pharmaceutical companies to pursue novel approaches that are more likely to have a revolutionary impact rather than minor modifications or formulations that offer little to no benefit at substantially increased cost.

Although some recent clinical trials in dermatology have included active comparators, many new medications continue to be introduced without any evidence of how they compare to existing standards of care. Until clinicians, patients, payers, and regulators demand that pharmaceutical companies conduct the necessary trials to not only demonstrate whether a treatment is effective and safe but also how it provides value, there will be continued introduction of marginal innovations rather than revolutionary treatments that improve patients’ lives. The next time a new medication is approved, as clinicians, patients, and payers, we must ask ourselves, is this treatment worth it?

Spending on medications is expected to grow from $344 billion in 2018 to $420 billion in 2023, largely driven by the introduction of new branded drugs.¹ These costs place substantial financial burden on patients, with nearly 30% of patients not taking their prescriptions as directed because of costs. Although many new medications have transformed how we care for patients, others may not offer meaningful benefit over existing less-costly alternatives that are supported by declining effect sizes of conventional placebo-controlled trials.² Most medications are approved based on placebo-controlled trial data that does not include an arm comparing the new drug to standard of care, leaving clinicians and patients unable to make meaningful comparisons when deciding on the most appropriate or cost-effective treatment. We consider ways in which clinicians, patients, payers, and regulators could compel more meaningful trials from industry.

Although we often look to the US Food and Drug Administration (FDA) to ensure rigorous and appropriate testing of new medications, the primary mission of the FDA is to ensure efficacy and safety. As a result, pharmaceutical companies seeking approval in the United States have little incentive to go beyond providing the minimal level of evidence required: placebo-controlled randomized trials. Although these trials provide important data on whether a treatment works and its associated risks, they do not provide data on comparative effectiveness. When relevant inexpensive medications are already on the market for the same indication, these placebo-controlled trials provide inadequate evidence to guide clinical decision-making. This issue is particularly relevant in dermatology given how easily topical medications can be combined or reformulated to pursue additional market exclusivity. The addition of an active comparator arm represents an important opportunity to improve the value of these studies.

In the pivotal trials of clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel for the treatment of acne, the experimental group was not only compared to vehicle but also the active comparator arms of clindamycin alone and benzoyl peroxide alone. The mean percentage change in total lesions was 47.9% with clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel, 41.6% with the active comparator arm of benzoyl peroxide alone, 40.4% with the active comparator arm of clindamycin alone, and 26.2% for vehicle.³ With these data in mind, clinicians and patients can decide whether the additional benefit of this new product over benzoyl peroxide alone is worth the increased cost.

In contrast, the trials of dapsone gel 7.5% for the treatment of acne did not include an active comparator. The mean percentage change in total lesions was 48.9% for dapsone gel and 43.2% for vehicle.⁴ Given these data, it is possible that dapsone gel may be no more effective, or possibly less effective, than alternatives such as benzoyl peroxide or other topical antibiotics. Nevertheless, dapsone annual sales were more than $200 million in 2016,⁵ suggesting that effectively marketed new products can achieve high sales even without convincing evidence of their value compared to standard of care. Although dapsone may be a useful treatment, we cannot effectively make patient-centered clinical decisions given the lack of an active comparator trial design.

This issue is not limited to acne. Phase 3 trials of halobetasol propionate foam 0.05% for psoriasis and crisaborole for atopic dermatitis also did not include an active comparator arm.^6,7 Given that topical steroids—and calcineurin inhibitors for atopic dermatitis—are mainstays of treatment for each condition, it is difficult to determine whether these new treatments offer meaningful advantages over existing options and how to incorporate them into our management strategies.

Unfortunately, expensive new medications that are adopted without convincing evidence of their benefit above standard of care can put patients at risk for financial toxicity, either directly through higher out-of-pocket costs or indirectly through higher premiums. Given the impact of rising medication costs on clinicians, patients, and payers, we propose several approaches these stakeholders could adopt to encourage the use of active comparator trial designs.

Clinicians and patients can encourage these trials by remaining skeptical of new treatments that were only compared to vehicle or placebo. Because new medications often are more expensive, clinicians and patients could avoid using these treatments without evidence of either increased efficacy or improved safety and tolerability. In addition, health care institutions should consider reducing pharmaceutical representatives’ access to clinicians to encourage treatment decisions based on the published literature and comparative effectiveness data rather than marketing.

Payers, such as Medicare, also could play a role by requiring active comparator trials for coverage of new medications, particularly when there are already other effective treatments available or other medications in the same class. Payers also could give preferred coverage tier or step therapy status to medications that demonstrate value over existing options.

Although regulatory approaches to increase use of active comparator designs may be more politically challenging to introduce, these options would be more administratively robust. The FDA or a novel regulatory body could require that new treatments demonstrate value in addition to safety and efficacy. This approach would be similar to the role of The National Institute for Health and Care Excellence in the United Kingdom or the recommendations of the European Medicines Agency. Such a group also could provide independent adjudication to ensure appropriate selection of a relevant active comparator. Another approach would be to give extended market exclusivity to medications that are approved based on trials including an additional active comparator arm, an approach used by the European Medicines Agency.

Any approach that encourages increased use of active comparator trials is not without potential downsides. It will be important to avoid unintended consequences of reduced research for rare diseases with smaller markets that may not be able to support the increased cost of these trials. As a result, it would be reasonable to forgo active comparator designs for mediations indicated for rare and orphan diseases or for medications with novel mechanisms of action.

Another argument against including an active comparator arm is that it may stifle innovation by driving up the cost of conducting trials; however, if a product is so marginally innovative that it cannot demonstrate superior safety or efficacy to an existing product, such a new treatment may not be worth the increased cost. In addition, patients provide a notable contribution by participating in these trials, and it is important to ensure that their efforts result in the highest-quality data possible. Furthermore, given the adverse physical and psychosocial impact of a wide variety of dermatologic diseases, the inclusion of an active comparator arm reduces the likelihood that patients will receive placebo, which will make these trials more ethical when effective treatments are available.⁸ By raising the bar, we can encourage pharmaceutical companies to pursue novel approaches that are more likely to have a revolutionary impact rather than minor modifications or formulations that offer little to no benefit at substantially increased cost.

Although some recent clinical trials in dermatology have included active comparators, many new medications continue to be introduced without any evidence of how they compare to existing standards of care. Until clinicians, patients, payers, and regulators demand that pharmaceutical companies conduct the necessary trials to not only demonstrate whether a treatment is effective and safe but also how it provides value, there will be continued introduction of marginal innovations rather than revolutionary treatments that improve patients’ lives. The next time a new medication is approved, as clinicians, patients, and payers, we must ask ourselves, is this treatment worth it?

Spending on medications is expected to grow from $344 billion in 2018 to $420 billion in 2023, largely driven by the introduction of new branded drugs.¹ These costs place substantial financial burden on patients, with nearly 30% of patients not taking their prescriptions as directed because of costs. Although many new medications have transformed how we care for patients, others may not offer meaningful benefit over existing less-costly alternatives that are supported by declining effect sizes of conventional placebo-controlled trials.² Most medications are approved based on placebo-controlled trial data that does not include an arm comparing the new drug to standard of care, leaving clinicians and patients unable to make meaningful comparisons when deciding on the most appropriate or cost-effective treatment. We consider ways in which clinicians, patients, payers, and regulators could compel more meaningful trials from industry.

Although we often look to the US Food and Drug Administration (FDA) to ensure rigorous and appropriate testing of new medications, the primary mission of the FDA is to ensure efficacy and safety. As a result, pharmaceutical companies seeking approval in the United States have little incentive to go beyond providing the minimal level of evidence required: placebo-controlled randomized trials. Although these trials provide important data on whether a treatment works and its associated risks, they do not provide data on comparative effectiveness. When relevant inexpensive medications are already on the market for the same indication, these placebo-controlled trials provide inadequate evidence to guide clinical decision-making. This issue is particularly relevant in dermatology given how easily topical medications can be combined or reformulated to pursue additional market exclusivity. The addition of an active comparator arm represents an important opportunity to improve the value of these studies.

In the pivotal trials of clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel for the treatment of acne, the experimental group was not only compared to vehicle but also the active comparator arms of clindamycin alone and benzoyl peroxide alone. The mean percentage change in total lesions was 47.9% with clindamycin phosphate 1.2%–benzoyl peroxide 2.5% gel, 41.6% with the active comparator arm of benzoyl peroxide alone, 40.4% with the active comparator arm of clindamycin alone, and 26.2% for vehicle.³ With these data in mind, clinicians and patients can decide whether the additional benefit of this new product over benzoyl peroxide alone is worth the increased cost.

In contrast, the trials of dapsone gel 7.5% for the treatment of acne did not include an active comparator. The mean percentage change in total lesions was 48.9% for dapsone gel and 43.2% for vehicle.⁴ Given these data, it is possible that dapsone gel may be no more effective, or possibly less effective, than alternatives such as benzoyl peroxide or other topical antibiotics. Nevertheless, dapsone annual sales were more than $200 million in 2016,⁵ suggesting that effectively marketed new products can achieve high sales even without convincing evidence of their value compared to standard of care. Although dapsone may be a useful treatment, we cannot effectively make patient-centered clinical decisions given the lack of an active comparator trial design.

This issue is not limited to acne. Phase 3 trials of halobetasol propionate foam 0.05% for psoriasis and crisaborole for atopic dermatitis also did not include an active comparator arm.^6,7 Given that topical steroids—and calcineurin inhibitors for atopic dermatitis—are mainstays of treatment for each condition, it is difficult to determine whether these new treatments offer meaningful advantages over existing options and how to incorporate them into our management strategies.

Unfortunately, expensive new medications that are adopted without convincing evidence of their benefit above standard of care can put patients at risk for financial toxicity, either directly through higher out-of-pocket costs or indirectly through higher premiums. Given the impact of rising medication costs on clinicians, patients, and payers, we propose several approaches these stakeholders could adopt to encourage the use of active comparator trial designs.

Clinicians and patients can encourage these trials by remaining skeptical of new treatments that were only compared to vehicle or placebo. Because new medications often are more expensive, clinicians and patients could avoid using these treatments without evidence of either increased efficacy or improved safety and tolerability. In addition, health care institutions should consider reducing pharmaceutical representatives’ access to clinicians to encourage treatment decisions based on the published literature and comparative effectiveness data rather than marketing.

Payers, such as Medicare, also could play a role by requiring active comparator trials for coverage of new medications, particularly when there are already other effective treatments available or other medications in the same class. Payers also could give preferred coverage tier or step therapy status to medications that demonstrate value over existing options.

Although regulatory approaches to increase use of active comparator designs may be more politically challenging to introduce, these options would be more administratively robust. The FDA or a novel regulatory body could require that new treatments demonstrate value in addition to safety and efficacy. This approach would be similar to the role of The National Institute for Health and Care Excellence in the United Kingdom or the recommendations of the European Medicines Agency. Such a group also could provide independent adjudication to ensure appropriate selection of a relevant active comparator. Another approach would be to give extended market exclusivity to medications that are approved based on trials including an additional active comparator arm, an approach used by the European Medicines Agency.

Any approach that encourages increased use of active comparator trials is not without potential downsides. It will be important to avoid unintended consequences of reduced research for rare diseases with smaller markets that may not be able to support the increased cost of these trials. As a result, it would be reasonable to forgo active comparator designs for mediations indicated for rare and orphan diseases or for medications with novel mechanisms of action.

Another argument against including an active comparator arm is that it may stifle innovation by driving up the cost of conducting trials; however, if a product is so marginally innovative that it cannot demonstrate superior safety or efficacy to an existing product, such a new treatment may not be worth the increased cost. In addition, patients provide a notable contribution by participating in these trials, and it is important to ensure that their efforts result in the highest-quality data possible. Furthermore, given the adverse physical and psychosocial impact of a wide variety of dermatologic diseases, the inclusion of an active comparator arm reduces the likelihood that patients will receive placebo, which will make these trials more ethical when effective treatments are available.⁸ By raising the bar, we can encourage pharmaceutical companies to pursue novel approaches that are more likely to have a revolutionary impact rather than minor modifications or formulations that offer little to no benefit at substantially increased cost.

Although some recent clinical trials in dermatology have included active comparators, many new medications continue to be introduced without any evidence of how they compare to existing standards of care. Until clinicians, patients, payers, and regulators demand that pharmaceutical companies conduct the necessary trials to not only demonstrate whether a treatment is effective and safe but also how it provides value, there will be continued introduction of marginal innovations rather than revolutionary treatments that improve patients’ lives. The next time a new medication is approved, as clinicians, patients, and payers, we must ask ourselves, is this treatment worth it?

Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Let me tell you about Tim Ferriss. A few years ago, I started reading his best-selling book, The 4-Hour Body. Ferris detailed how he made himself into a one-man experiment – he’d make changes to his diet, checked his weight and his labs, maybe he even had metabolic studies done.

Courtesy Taylor Prinsen

He’d take these measures after soaking in hot baths, then ice baths, and while I admired his discipline, he did lose me during the chapter where he was using steroids. In the end, he advised a dairy-free, low-carbohydrate diet of green vegetables, beans or lentils, and protein for four meals a day, 6 days a week, with free-for-all eating on the 7th day. Then, there was a weight-lifting routine with kettle bells and ice packs to be placed on your shoulders for a set amount of time each day.

I may not remember the program’s details, but something about Ferris fascinated me. He brands himself as being a “human guinea pig,” about “lifestyle design,” and whatever that is, I like it. Perhaps I am attracted to the idea that we might control the trajectories of our generally uncontrollable lives.

Tim Ferriss graduated from Princeton, he’s written five best-selling books and has a popular podcast, he’s been a TED speaker, and he’s been on Fortune’s “40 under 40” list – and there’s so much more. Ferriss is brilliant, innovative, handsome, charismatic, prolific, extraordinarily athletic. I may have forgotten to mention that he was the National Chinese Kickboxing Champion and was a semifinalist in the World Champion Tango competition in Buenos Aires. He’s adventuresome and fearless, and if that isn’t enough, he speaks five languages. In the genetic dice roll, Mr. Ferriss did well, and he’s a driven and energetic hard worker who is open to new experiences.

I subscribe to the Tim Ferriss podcast – as of this writing, there are 466 episodes, with an incredible lineup of interviews with famous and successful guests. I also subscribe to his “5-Bullet Friday” email list where he mentions the interesting things he is reading, watching, learning about, or eating, and the products he is trying – single-ply toilet paper gets a thumbs down – then ends with a thought-provoking quote. This gentleman spends a tremendous amount of time searching and striving, working on himself and his own emotional growth and self-improvement, and yet he still has time for incredible explorations and experiences.

A search for psychic peace

Honestly, were it not for a few little details, I would like to be Tim Ferriss. Who wouldn’t? But what stops me from actually wanting to be Ferriss is that early on while listening to him, I realized that his drive has been fueled by intense psychic pain. He talks openly about being very close to suicide in college, about a tormenting mood disorder, demons to tame, and productivity as an antidote to a fear of failure, not always as a joy for life. There are moments that I have felt so sad for this remarkable stranger. Tim Ferriss is a searcher and what I believe he searches for most is his own psychic peace.

In a forum for psychiatrists, I wish I could write that Ferriss has found solace with our Food and Drug Administration–approved pharmaceuticals and with psychotherapy, but that’s not what he says. What Ferriss has found helpful, however, is psychedelics, and a wide variety of psychological and philosophical teachings ranging from meditation to Stoicism. And most notably, Ferriss has been an advocate for using hallucinogens as a legal medical intervention. Ferriss was one of four philanthropists who donated a total of $17 million to fund the Johns Hopkins Center for Psychedelic & Consciousness Research. He’s helped to move this field forward and to improve its credibility.

On Sept. 14, 2020, Tim Ferriss released a podcast he recorded with his dance partner and close friend, Debbie Millman, and when he recorded it, he was not certain he would release it. None of his usual sponsors endorsed during the podcast. He starts Episode #464 with, “For me, this is the most important podcast episode I’ve ever published. In it, I describe the most life-shaping, certainly the most difficult, and certainly the most transformative journey of my 43 years on this planet. I’ve never shared it before.”

I applaud Mr. Ferriss for going through with posting the podcast, a confessional about how he was repeatedly sexually molested over a 2-year period as a young child by a babysitter’s son. He worried about how this would affect his family, if they would be left feeling guilty or devastated. He says, “Please note that I expect to be completely overwhelmed emotionally and otherwise when this is published and please understand if I’m not able to reply to any outreach.”

Ferriss and Millman had a long discussion about their sexual abuse as children. Millman was abused by her stepfather at the age of 9, and she talks about confronting him many years later. Ferriss has not confronted his perpetrator, though he has contemplated doing so.

Sexual violence and violation at any age leaves people scarred. In a recent letter to the New York Times in response to President Trump’s words of support to Ghislaine Maxwell, the woman who helped Jeffrey Epstein find his victims, Baltimore psychiatrist Robin Weiss wrote, “Thirty-eight years ago, when I was 32, I was raped. I was married, I was a doctor – you might say I was in pretty stable shape. Yet the shame and guilt I felt were overwhelming. Why didn’t I fight harder? How did I let this happen? I knew better, yet it took me years to overcome those irrational feelings.” These feelings of shame, guilt, self-doubt, and self-blame are nearly universal in survivors of sexual trauma. In children, they can be even worse, as children often don’t have an understanding that what is being done to them is wrong. They lack the language and the maturity to process the events, and ongoing abuse may be accompanied by threats to life of the child or their family members if they tell others, as was the case with Millman. She chose to process her abuse and the consequent difficulties she had by seeking psychiatric care. She took antidepressants and has been in psychoanalysis, both of which she has found to be helpful. Her treatment has tamed her demons, it is ongoing decades later and those demons have not vanished.
 

Abuse comes back in ‘a tidal wave’

Not surprisingly, Ferriss struggled with whether to make these events public. While so much of his story feels familiar to those of us who help patients process their trauma, it’s not completely typical. Ferriss remembered these episodes of sexual abuse “in high resolution,” while using ayahuasca, a hallucinogen, about 5 years ago. He describes suppressing and discounting these memories until he attended a 10-day silent retreat where he used psilocybin. I found it interesting that Ferriss fasted for 5 days before attending the retreat “to increase the depth of the experience.” He goes on to say, “Around day 6 of this silent retreat, all of this abuse came back to me like a tidal wave and it was replaying as if I was wearing a virtual reality headset. I was immersed, I wasn’t an observer, it was as though I was being traumatized and retraumatized 24/7.” He describes an excruciating and horrifying experience and he referred to it as a “psychotic break.”

Ferriss goes on to talk about how bringing these memories to light has affected him, how it’s explained many of his behaviors and ways of relating in a way that has helped him organize and understand his life.

“It was at the tail end of the retreat that I realized that these 17 seemingly inexplicable behaviors of mine – these vicious cycles or triggers that I had been treating like separate problems to be solved, were all downstream of this trauma. Oh, now that you click that puzzle piece into place, these really strange behaviors – this self-loathing, this rage that was seemingly so exaggerated and disproportionate – leading to the near-suicide I had in college – all these things fell into places making sense.” It gave him a sense of relief but was simultaneously overwhelming.

Both Ferriss and Millman talk about books and treatments that have been helpful to them. Their knowledge of trauma treatments and resources is impressive and can be found at: Tim Ferriss – My Healing Journey After Childhood Abuse (Includes Extensive Resource List). Their wish is to share their suffering as a way to help others, impart hope, and better connect.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatry Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.