Opinion

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

Because of physiological changes with aging and differences in cancer biology, caring for older adults (OAs) with cancer requires careful assessment and planning.

Clark Dumontier, MD, of Brigham and Women’s Hospital in Boston, and colleagues sought to define the meaning of the terms “undertreatment” and “overtreatment” for OAs with cancer in a scoping literature review published in the Journal of Clinical Oncology.

Though OAs are typically defined as adults aged 65 years and older, in this review, the authors defined OAs as patients aged 60 years and older.

The authors theorized that a scoping review of papers about this patient population could provide clues about limitations in the oncology literature and guidance about patient management and future research. Despite comprising the majority of cancer patients, OAs are underrepresented in clinical trials.
 

About scoping reviews

Scoping reviews are used to identify existing evidence in a field, clarify concepts or definitions in the literature, survey how research on a topic is conducted, and identify knowledge gaps. In addition, scoping reviews summarize available evidence without answering a discrete research question.

Industry standards for scoping reviews have been established by the Johanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. According to these standards, scoping reviews should:

• Establish eligibility criteria with a rationale for each criterion clearly explained
• Search multiple databases in multiple languages
• Include “gray literature,” defined as studies that are unpublished or difficult to locate
• Have several independent reviewers screen titles and abstracts
• Ask multiple independent reviewers to review full text articles
• Present results with charts or diagrams that align with the review’s objective
• Graphically depict the decision process for including/excluding sources
• Identify implications for further research.

In their review, Dr. DuMontier and colleagues fulfilled many of the aforementioned criteria. The team searched three English-language databases for titles and abstracts that included the terms undertreatment and/or overtreatment, and were related to OAs with cancer, inclusive of all types of articles, cancer types, and treatments.

Definitions of undertreatment and overtreatment were extracted, and categories underlying these definitions were derived. Within a random subset of articles, two coauthors independently determined final categories of definitions and independently assigned those categories.
 

Findings and implications

To define OA, Dr. DuMontier and colleagues used a cutoff of 60 years or older. Articles mentioning undertreatment (n = 236), overtreatment (n = 71), or both (n = 51) met criteria for inclusion (n = 256), but only 14 articles (5.5%) explicitly provided formal definitions.

For most of the reviewed articles, the authors judged definitions from the surrounding context. In a random subset of 50 articles, there was a high level of agreement (87.1%; κ = 0.81) between two coauthors in independently assigning categories of definitions.

Undertreatment was applied to therapy that was less than recommended (148 articles; 62.7%) or less than recommended with worse outcomes (88 articles; 37.3%).

Overtreatment most commonly denoted intensive treatment of an OA in whom harms outweighed the benefits of treatment (38 articles; 53.5%) or intensive treatment of a cancer not expected to affect the OA during the patient’s remaining life (33 articles; 46.5%).

Overall, the authors found that undertreatment and overtreatment of OAs with cancer are imprecisely defined concepts. Formal geriatric assessment was recommended in just over half of articles, and only 26.2% recommended formal assessments of age-related vulnerabilities for management. The authors proposed definitions that accounted for both oncologic factors and geriatric domains.
 

Care of individual patients and clinical research

National Comprehensive Cancer Network (NCCN) guidelines for OAs with cancer recommend initial consideration of overall life expectancy. If a patient is a candidate for cancer treatment on that basis, the next recommended assessment is that of the patient’s capacity to understand the relevant information, appreciate the underlying values and overall medical situation, reason through decisions, and communicate a choice that is consistent with the patient’s articulated goals.

In the pretreatment evaluation of OAs in whom there are no concerns about tolerance to antineoplastic therapy, NCCN guidelines suggest geriatric screening with standardized tools and, if abnormal, comprehensive geriatric screening. The guidelines recommend considering alternative treatment options if nonmodifiable abnormalities are identified.

Referral to a geriatric clinical specialist, use of the Cancer and Aging Research Group’s Chemo Toxicity Calculator, and calculation of Chemotherapy Risk Assessment Scale for High-Age Patients score are specifically suggested if high-risk procedures (such as chemotherapy, radiation, or complex surgery, which most oncologists would consider to be “another day in the office”) are contemplated.

The American Society of Clinical Oncology (ASCO) guidelines for geriatric oncology are similarly detailed and endorse similar evaluations and management.

Employing disease-centric and geriatric domains

Dr. DuMontier and colleagues noted that, for OAs with comorbidity or psychosocial challenges, surrogate survival endpoints are unrelated to quality of life (QOL) outcomes. Nonetheless, QOL is valued by OAs at least as much as survival improvement.

Through no fault of their own, the authors’ conclusion that undertreatment and overtreatment are imperfectly defined concepts has a certain neutrality to it. However, the terms undertreatment and overtreatment are commonly used to signify that inappropriate treatment decisions were made. Therefore, the terms are inherently negative and pejorative.

As with most emotionally charged issues in oncology, it is ideal for professionals in our field to take charge when deficiencies exist. ASCO, NCCN, and the authors of this scoping review have provided a conceptual basis for doing so.

An integrated oncologist-geriatrician approach was shown to be effective in the randomized INTEGERATE trial, showing improved QOL, reduced hospital admissions, and reduced early treatment discontinuation from adverse events (ASCO 2020, Abstract 12011).

Therefore, those clinicians who have not formally, systematically, and routinely supplemented the traditional disease-centric endpoints with patient-centered criteria need to do so.

Similarly, a retrospective study published in JAMA Network Open demonstrated that geriatric and surgical comanagement of OAs with cancer was associated with significantly lower 90-day postoperative mortality and receipt of more supportive care services (physical therapy, occupational therapy, speech and swallow rehabilitation, and nutrition services), in comparison with management from the surgical service only.

These clinical and administrative changes will not only enhance patient management but also facilitate the clinical trials required to clarify optimal treatment intensity. As that occurs, we will be able to apply as much precision to the care of OAs with cancer as we do in other areas of cancer treatment.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Dumontier C et al. J Clin Oncol. 2020 Aug 1;38(22):2558-2569.

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

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

Recently I was in a minor car accident. No injuries, just some bent metal and scratched paint from a low-speed parking lot mishap.

The other driver and I got out of our cars, made sure we were both okay, and then I said “Let’s exchange insurance information.” We got our insurance cards out; I took a picture of her card, and she wrote down my info. Then we drove off and went on with our days. The whole thing took a few minutes.

Why am I writing about this?

Because it was all handled very politely. There were no angry words, name calling, or heated exchanges. We checked the damage, made sure the other was okay, and exchanged insurance cards ... without a single impolite phrase or gesture.

To me this is a good thing. In a world in which people yell (and sometimes brandish weapons) over imagined and minor offenses, in which political candidates exchange crude insults rather then debate policy, and in which an opposing viewpoint is treated as blasphemy rather than an honest difference of opinion, it was nice to have a polite, adult, exchange under unpleasant circumstances.

Perhaps it’s sad to find relief in such a minor event, but it’s also reassuring. In medicine (especially hospital work) we often see people at their very worst, and dealing with them can be a challenge. We live in a world of at-times seemingly endless rudeness, one-upping, and “problem-solving” with yelling, threats, and intimidation.

So I was glad the minor incident resulted in nothing more serious at the time than a brief, polite, conversation. It’s nice to know many people out there still subscribe to civil ideas and polite behavior, even when the circumstances are difficult.

Dr. Block has a solo neurology practice in Scottsdale, Arizona. He has nothing to disclose.

HM20 Virtual session title

When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics
 

Presenter

Kimberly Manning, MD, FACP, FAAP
 

Session summary

Dr. Kimberly Manning, associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, masterfully discussed the dual pandemics of COVID-19 and racism that we are currently experiencing and tried to describe the unique perspective of Black Americans.

Though it is easy to see that COVID-19 is a pandemic, racism is not always seen in this way. Dr. Manning demonstrated that when a pandemic is defined as “that which occurs over a wide geographic area and affects a high proportion of the population,” racism is absolutely a pandemic. She gave a great analogy: when sticking your hand into a bowl of Lucky Charms cereal, you do not expect to always end up with marshmallows alone, yet repeatedly, we see that Black Americans have been disproportionately affected by COVID-19. We often hear that we are in unprecedented times but as far as racism is concerned, there is nothing new about this.

Dr. Manning discussed the life stories of her grandfather, her father, and even her own life’s milestones such as starting college, getting into medical school, finishing residency – all the way to becoming a full professor. She described how each of these instances, though marked by something beautiful, was also marked by something truly awful. Each time she had a reason to smile and laugh, there was something awful happening in the country simultaneously that showed us how racism was still present. Though this was one person’s story, all Black Americans, not just those working in health care, can recount similar stories, emotions, and feelings of grief.

Dr. Manning concluded by telling us how we can “Do the Work” to combat the pandemic of racism:

• Broaden your fund of knowledge: Read books, listen to podcasts, watch documentaries.
• Remember that people are grieving.
• Explore your implicit biases.
• Be a brave bystander.
• Avoid performative allyship.

Key takeaways

• Though the COVID-19 pandemic is unprecedented, the pandemic of racism is not.
• The story of COVID-19 is the story of social determinants of health.
• We all must “Do the Work” to combat everyday racism and be cognizant of what our Black colleagues are going through every day.

Dr. Doraiswamy is an assistant professor of medicine and pediatrics and a med-peds hospitalist at The Ohio State University and Nationwide Children’s Hospital, Columbus.

HM20 Virtual session title

When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics
 

Presenter

Kimberly Manning, MD, FACP, FAAP
 

Session summary

Dr. Kimberly Manning, associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, masterfully discussed the dual pandemics of COVID-19 and racism that we are currently experiencing and tried to describe the unique perspective of Black Americans.

Though it is easy to see that COVID-19 is a pandemic, racism is not always seen in this way. Dr. Manning demonstrated that when a pandemic is defined as “that which occurs over a wide geographic area and affects a high proportion of the population,” racism is absolutely a pandemic. She gave a great analogy: when sticking your hand into a bowl of Lucky Charms cereal, you do not expect to always end up with marshmallows alone, yet repeatedly, we see that Black Americans have been disproportionately affected by COVID-19. We often hear that we are in unprecedented times but as far as racism is concerned, there is nothing new about this.

Dr. Manning discussed the life stories of her grandfather, her father, and even her own life’s milestones such as starting college, getting into medical school, finishing residency – all the way to becoming a full professor. She described how each of these instances, though marked by something beautiful, was also marked by something truly awful. Each time she had a reason to smile and laugh, there was something awful happening in the country simultaneously that showed us how racism was still present. Though this was one person’s story, all Black Americans, not just those working in health care, can recount similar stories, emotions, and feelings of grief.

Dr. Manning concluded by telling us how we can “Do the Work” to combat the pandemic of racism:

• Broaden your fund of knowledge: Read books, listen to podcasts, watch documentaries.
• Remember that people are grieving.
• Explore your implicit biases.
• Be a brave bystander.
• Avoid performative allyship.

Key takeaways

• Though the COVID-19 pandemic is unprecedented, the pandemic of racism is not.
• The story of COVID-19 is the story of social determinants of health.
• We all must “Do the Work” to combat everyday racism and be cognizant of what our Black colleagues are going through every day.

Dr. Doraiswamy is an assistant professor of medicine and pediatrics and a med-peds hospitalist at The Ohio State University and Nationwide Children’s Hospital, Columbus.

HM20 Virtual session title

When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics
 

Presenter

Kimberly Manning, MD, FACP, FAAP
 

Session summary

Dr. Kimberly Manning, associate vice chair of diversity, equity, and inclusion at Emory University, Atlanta, masterfully discussed the dual pandemics of COVID-19 and racism that we are currently experiencing and tried to describe the unique perspective of Black Americans.

Though it is easy to see that COVID-19 is a pandemic, racism is not always seen in this way. Dr. Manning demonstrated that when a pandemic is defined as “that which occurs over a wide geographic area and affects a high proportion of the population,” racism is absolutely a pandemic. She gave a great analogy: when sticking your hand into a bowl of Lucky Charms cereal, you do not expect to always end up with marshmallows alone, yet repeatedly, we see that Black Americans have been disproportionately affected by COVID-19. We often hear that we are in unprecedented times but as far as racism is concerned, there is nothing new about this.

Dr. Manning discussed the life stories of her grandfather, her father, and even her own life’s milestones such as starting college, getting into medical school, finishing residency – all the way to becoming a full professor. She described how each of these instances, though marked by something beautiful, was also marked by something truly awful. Each time she had a reason to smile and laugh, there was something awful happening in the country simultaneously that showed us how racism was still present. Though this was one person’s story, all Black Americans, not just those working in health care, can recount similar stories, emotions, and feelings of grief.

Dr. Manning concluded by telling us how we can “Do the Work” to combat the pandemic of racism:

• Broaden your fund of knowledge: Read books, listen to podcasts, watch documentaries.
• Remember that people are grieving.
• Explore your implicit biases.
• Be a brave bystander.
• Avoid performative allyship.

Key takeaways

• Though the COVID-19 pandemic is unprecedented, the pandemic of racism is not.
• The story of COVID-19 is the story of social determinants of health.
• We all must “Do the Work” to combat everyday racism and be cognizant of what our Black colleagues are going through every day.

Dr. Doraiswamy is an assistant professor of medicine and pediatrics and a med-peds hospitalist at The Ohio State University and Nationwide Children’s Hospital, Columbus.

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].

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.