Commentary

The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.

The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.

Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).

But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.

Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
 

Buried in paperwork

In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.

When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.

Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.

About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.

Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.

“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.

“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.

The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.

Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.

Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
 

Seeking better work-life balance

More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).

About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).

About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.

Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).

To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).

Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.

Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.

Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).

About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).

Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.

Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.

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

The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.

The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.

Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).

But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.

Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
 

Buried in paperwork

In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.

When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.

Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.

About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.

Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.

“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.

“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.

The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.

Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.

Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
 

Seeking better work-life balance

More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).

About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).

About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.

Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).

To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).

Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.

Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.

Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).

About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).

Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.

Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.

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

The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.

The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.

Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).

But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.

Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
 

Buried in paperwork

In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.

When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.

Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.

About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.

Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.

“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.

“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.

The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.

Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.

Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
 

Seeking better work-life balance

More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).

About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).

About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.

Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).

To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).

Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.

Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.

Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).

About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).

Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.

Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.

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

The COVID-19 pandemic has significantly impacted mental health. Adolescents, adults, and health care professionals (HCPs) report worsening mental health outcomes since the pandemic.^1-3 Anxiety rates have tripled, depression quadrupled, and substance and alcohol use also have increased.³ The World Health Organization (WHO) reported that during the COVID-19 pandemic, 93% of countries worldwide documented disruptions to mental health services.⁴ HCP shortages, worsened by the pandemic, have resulted in a mental health crisis. What can we do?

Over the past 20 years, pharmacists have assumed a more significant role in managing patients’ mental health conditions through multidisciplinary team engagement. Pharmacists’ training includes optimizing pharmacotherapy, identifying and managing adverse effects (AEs), improving medication adherence, and reducing unnecessary health care costs.⁵ Pharmacists have assumed pivotal roles in mental health management, including but not limited to screening, drug selection, medication management, and decision-making support for patients and HCPs. Pharmacist-provided services have led to improved medication therapy outcomes and patient satisfaction.⁶

According to the 2012 National Alliance on Mental Illness national survey, > 50% of patients treated for a mental health condition report having a strong relationship with their pharmacist.⁷ The US Department of Veterans Affairs (VA) has led the charge, engaging pharmacists in patient-oriented mental health care,including those specific to accessing mental health care (eg, fear of stigmatization).⁸ After obtaining a 4-year PharmD degree, psychiatric pharmacists receive additional postgraduate residency training (2 years) focused on direct patient care and then are eligible for board certification. There are about 2000 board-certified psychiatric pharmacists in the United States. Qualified psychiatric pharmacists, especially those in underresourced states, have increased the number of available patient-oriented mental health services.⁷ However, to continue expanding and improving access to care, we need more HCPs and pharmacists.

Mental health clinical pharmacy specialists (CPSs) within the VA work in a variety of settings, including but not limited to, the inpatient psychiatric unit; residential programs for posttraumatic stress disorder (PTSD) and substance misuse; as part of the Mental Health Intensive Case Management (MHICM) team; and in pain, telehealth, and other outpatient clinics. The VA’s mental health CPSs operate under an independent scope of practice (SOP) and manage a variety of mental health disorders. The SOP also allows pharmacists to independently manage medications for psychiatric conditions, request laboratory tests, and change therapy as needed based on patient response. The Table describes pharmacist-reported roles in a single VA facility in various mental health practice sites (eg, inpatient, outpatient, substance misuse). Pharmacist involvement in medication management with the interdisciplinary team improved symptoms, medication adherence, and reduced AEs for conditions such as depression.⁹

Within the VA, the outpatient mental health pharmacist works collaboratively with psychiatrists and HCPs to manage common psychiatric conditions on the phone and in person. VA pharmacists also are involved in the monitoring of patients on second-generation antipsychotics. Pharmacists assist with metabolic monitoring and assessing patients for movements disorders, using standardized rating scales. Pharmacists can manage complex psychiatric patients in collaboration with psychiatrists by providing medication management, laboratory test monitoring, medication counseling, and HCP referrals.

Pharmacists’ expertise is used in diverse ways in the VHA. At one facility, pharmacists functioned as interim prescribers when the facility experienced a turnover in behavioral health professionals. Pharmacists’ involvement decreased inappropriate use of psychiatric emergency services.¹⁰ VA pharmacists who manage patients’ mental health needs in primary care help achieve symptom improvement and medication adherence as well as lower referral rates for specialty mental health services.⁹ Pharmacist-managed electronic consult service provided a costs savings of about $40,000 a year.¹¹

Pharmacists have shown that they can expand their roles. Pharmacists are versatile HCPs, currently working and collaborating with other HCPs in various settings to provide mental health services. Health care systems need to continue to use and expand the number of pharmacists. Including pharmacists in the primary and specialty care teams can increase access to care and improve health outcomes during the pandemic and beyond. The American Association of Colleges of Pharmacy in partnership with the American Medical Association established a resource to support and guide institutions interested in embedding pharmacists into different clinical sites.¹² Opportunities for increased services by pharmacists can lead to improved outcomes, timely patient care, appropriate use of psychiatric medications and services, and cost savings.

Acknowledgments

We acknowledge the following Boise Veterans Affairs pharmacists: Paul Black, PharmD; Josh Gerving, PharmD; Kristin Helmboldt, PharmD; Samantha Patton, PharmD; Heather Walser, PharmD; and Andrea Winterswyk, PharmD, for contributing information about their practice roles and impact on patient care.

The COVID-19 pandemic has significantly impacted mental health. Adolescents, adults, and health care professionals (HCPs) report worsening mental health outcomes since the pandemic.^1-3 Anxiety rates have tripled, depression quadrupled, and substance and alcohol use also have increased.³ The World Health Organization (WHO) reported that during the COVID-19 pandemic, 93% of countries worldwide documented disruptions to mental health services.⁴ HCP shortages, worsened by the pandemic, have resulted in a mental health crisis. What can we do?

Over the past 20 years, pharmacists have assumed a more significant role in managing patients’ mental health conditions through multidisciplinary team engagement. Pharmacists’ training includes optimizing pharmacotherapy, identifying and managing adverse effects (AEs), improving medication adherence, and reducing unnecessary health care costs.⁵ Pharmacists have assumed pivotal roles in mental health management, including but not limited to screening, drug selection, medication management, and decision-making support for patients and HCPs. Pharmacist-provided services have led to improved medication therapy outcomes and patient satisfaction.⁶

According to the 2012 National Alliance on Mental Illness national survey, > 50% of patients treated for a mental health condition report having a strong relationship with their pharmacist.⁷ The US Department of Veterans Affairs (VA) has led the charge, engaging pharmacists in patient-oriented mental health care,including those specific to accessing mental health care (eg, fear of stigmatization).⁸ After obtaining a 4-year PharmD degree, psychiatric pharmacists receive additional postgraduate residency training (2 years) focused on direct patient care and then are eligible for board certification. There are about 2000 board-certified psychiatric pharmacists in the United States. Qualified psychiatric pharmacists, especially those in underresourced states, have increased the number of available patient-oriented mental health services.⁷ However, to continue expanding and improving access to care, we need more HCPs and pharmacists.

Mental health clinical pharmacy specialists (CPSs) within the VA work in a variety of settings, including but not limited to, the inpatient psychiatric unit; residential programs for posttraumatic stress disorder (PTSD) and substance misuse; as part of the Mental Health Intensive Case Management (MHICM) team; and in pain, telehealth, and other outpatient clinics. The VA’s mental health CPSs operate under an independent scope of practice (SOP) and manage a variety of mental health disorders. The SOP also allows pharmacists to independently manage medications for psychiatric conditions, request laboratory tests, and change therapy as needed based on patient response. The Table describes pharmacist-reported roles in a single VA facility in various mental health practice sites (eg, inpatient, outpatient, substance misuse). Pharmacist involvement in medication management with the interdisciplinary team improved symptoms, medication adherence, and reduced AEs for conditions such as depression.⁹

Within the VA, the outpatient mental health pharmacist works collaboratively with psychiatrists and HCPs to manage common psychiatric conditions on the phone and in person. VA pharmacists also are involved in the monitoring of patients on second-generation antipsychotics. Pharmacists assist with metabolic monitoring and assessing patients for movements disorders, using standardized rating scales. Pharmacists can manage complex psychiatric patients in collaboration with psychiatrists by providing medication management, laboratory test monitoring, medication counseling, and HCP referrals.

Pharmacists’ expertise is used in diverse ways in the VHA. At one facility, pharmacists functioned as interim prescribers when the facility experienced a turnover in behavioral health professionals. Pharmacists’ involvement decreased inappropriate use of psychiatric emergency services.¹⁰ VA pharmacists who manage patients’ mental health needs in primary care help achieve symptom improvement and medication adherence as well as lower referral rates for specialty mental health services.⁹ Pharmacist-managed electronic consult service provided a costs savings of about $40,000 a year.¹¹

Pharmacists have shown that they can expand their roles. Pharmacists are versatile HCPs, currently working and collaborating with other HCPs in various settings to provide mental health services. Health care systems need to continue to use and expand the number of pharmacists. Including pharmacists in the primary and specialty care teams can increase access to care and improve health outcomes during the pandemic and beyond. The American Association of Colleges of Pharmacy in partnership with the American Medical Association established a resource to support and guide institutions interested in embedding pharmacists into different clinical sites.¹² Opportunities for increased services by pharmacists can lead to improved outcomes, timely patient care, appropriate use of psychiatric medications and services, and cost savings.

Acknowledgments

We acknowledge the following Boise Veterans Affairs pharmacists: Paul Black, PharmD; Josh Gerving, PharmD; Kristin Helmboldt, PharmD; Samantha Patton, PharmD; Heather Walser, PharmD; and Andrea Winterswyk, PharmD, for contributing information about their practice roles and impact on patient care.

The COVID-19 pandemic has significantly impacted mental health. Adolescents, adults, and health care professionals (HCPs) report worsening mental health outcomes since the pandemic.^1-3 Anxiety rates have tripled, depression quadrupled, and substance and alcohol use also have increased.³ The World Health Organization (WHO) reported that during the COVID-19 pandemic, 93% of countries worldwide documented disruptions to mental health services.⁴ HCP shortages, worsened by the pandemic, have resulted in a mental health crisis. What can we do?

Over the past 20 years, pharmacists have assumed a more significant role in managing patients’ mental health conditions through multidisciplinary team engagement. Pharmacists’ training includes optimizing pharmacotherapy, identifying and managing adverse effects (AEs), improving medication adherence, and reducing unnecessary health care costs.⁵ Pharmacists have assumed pivotal roles in mental health management, including but not limited to screening, drug selection, medication management, and decision-making support for patients and HCPs. Pharmacist-provided services have led to improved medication therapy outcomes and patient satisfaction.⁶

According to the 2012 National Alliance on Mental Illness national survey, > 50% of patients treated for a mental health condition report having a strong relationship with their pharmacist.⁷ The US Department of Veterans Affairs (VA) has led the charge, engaging pharmacists in patient-oriented mental health care,including those specific to accessing mental health care (eg, fear of stigmatization).⁸ After obtaining a 4-year PharmD degree, psychiatric pharmacists receive additional postgraduate residency training (2 years) focused on direct patient care and then are eligible for board certification. There are about 2000 board-certified psychiatric pharmacists in the United States. Qualified psychiatric pharmacists, especially those in underresourced states, have increased the number of available patient-oriented mental health services.⁷ However, to continue expanding and improving access to care, we need more HCPs and pharmacists.

Mental health clinical pharmacy specialists (CPSs) within the VA work in a variety of settings, including but not limited to, the inpatient psychiatric unit; residential programs for posttraumatic stress disorder (PTSD) and substance misuse; as part of the Mental Health Intensive Case Management (MHICM) team; and in pain, telehealth, and other outpatient clinics. The VA’s mental health CPSs operate under an independent scope of practice (SOP) and manage a variety of mental health disorders. The SOP also allows pharmacists to independently manage medications for psychiatric conditions, request laboratory tests, and change therapy as needed based on patient response. The Table describes pharmacist-reported roles in a single VA facility in various mental health practice sites (eg, inpatient, outpatient, substance misuse). Pharmacist involvement in medication management with the interdisciplinary team improved symptoms, medication adherence, and reduced AEs for conditions such as depression.⁹

Within the VA, the outpatient mental health pharmacist works collaboratively with psychiatrists and HCPs to manage common psychiatric conditions on the phone and in person. VA pharmacists also are involved in the monitoring of patients on second-generation antipsychotics. Pharmacists assist with metabolic monitoring and assessing patients for movements disorders, using standardized rating scales. Pharmacists can manage complex psychiatric patients in collaboration with psychiatrists by providing medication management, laboratory test monitoring, medication counseling, and HCP referrals.

Pharmacists’ expertise is used in diverse ways in the VHA. At one facility, pharmacists functioned as interim prescribers when the facility experienced a turnover in behavioral health professionals. Pharmacists’ involvement decreased inappropriate use of psychiatric emergency services.¹⁰ VA pharmacists who manage patients’ mental health needs in primary care help achieve symptom improvement and medication adherence as well as lower referral rates for specialty mental health services.⁹ Pharmacist-managed electronic consult service provided a costs savings of about $40,000 a year.¹¹

Pharmacists have shown that they can expand their roles. Pharmacists are versatile HCPs, currently working and collaborating with other HCPs in various settings to provide mental health services. Health care systems need to continue to use and expand the number of pharmacists. Including pharmacists in the primary and specialty care teams can increase access to care and improve health outcomes during the pandemic and beyond. The American Association of Colleges of Pharmacy in partnership with the American Medical Association established a resource to support and guide institutions interested in embedding pharmacists into different clinical sites.¹² Opportunities for increased services by pharmacists can lead to improved outcomes, timely patient care, appropriate use of psychiatric medications and services, and cost savings.

Acknowledgments

We acknowledge the following Boise Veterans Affairs pharmacists: Paul Black, PharmD; Josh Gerving, PharmD; Kristin Helmboldt, PharmD; Samantha Patton, PharmD; Heather Walser, PharmD; and Andrea Winterswyk, PharmD, for contributing information about their practice roles and impact on patient care.

March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.² She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.³ She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.⁴

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.⁵ Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.⁵ But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.⁴

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.⁵

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.⁶ In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.^7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.^5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.² She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.³ She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.⁴

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.⁵ Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.⁵ But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.⁴

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.⁵

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.⁶ In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.^7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.^5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.² She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.³ She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.⁴

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.⁵ Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.⁵ But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.⁴

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.⁵

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.⁶ In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.^7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.^5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.

I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.

Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).

Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.

More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.

Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.

I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.

In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.

Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival? Given the cost of so many of these newer treatments, we should expect more than indirect, inferred benefits for patients.

At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.

I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?

We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.

Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.

In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.

I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.

Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).

Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.

More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.

Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.

I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.

In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.

Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival? Given the cost of so many of these newer treatments, we should expect more than indirect, inferred benefits for patients.

At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.

I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?

We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.

Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.

In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.

I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.

Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).

Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.

More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.

Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.

I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.

In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.

Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival? Given the cost of so many of these newer treatments, we should expect more than indirect, inferred benefits for patients.

At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.

I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?

We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.

Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

A 64-year-old woman is evaluated for fever, diarrhea, and abdominal pain. She was diagnosed with Clostridioides difficile 2 months ago and completed a 10-day course of vancomycin. Her stool toxin test is positive for Clostridioides difficile (C. diff). Based on the most recent Infectious Diseases Society of America (IDSA) guidelines, what would be the preferred therapy?

A) Metronidazole

B) Fidaxomicin + bezlotoxumab

C) Vancomycin

D) Fecal microbiota transplant

The recommendations from the 2021 guidelines would be to treat with fidaxomicin and add bezlotoxumab.¹ The guidelines highlight the following changes:

• In patients with an initial Clostridioides difficile infections (CDI) fidaxomicin is preferred over vancomycin.
• In patients with a recurrent CDI episode, fidaxomicin is favored over vancomycin. For patients with multiple recurrences, vancomycin in a tapered and pulsed regimen, vancomycin followed by rifaximin, and fecal microbiota transplantation are options in addition to fidaxomicin.
• Addition of bezlotoxumab to standard of care antibiotics is recommended for recurrence of CDI within the first 6 months over standard of care antibiotics alone

The feasibility of these recommendations is up for debate. The cost of a course of fidaxomicin is $2,800, and the cost of bezlotoxumab is about $4,500. Cost effectiveness studies that helped drive the recommendations show a savings by reducing future hospitalizations for C. diff.² Unfortunately, this enthusiasm is not shared by many insurance companies for outpatient treatment.

Knee osteoarthritis

I will save you the excitement of the new acromegaly guidelines and focus on something we see all the time: knee osteoarthritis. The American Academy of Orthopedic Surgeons has released guidelines for this condition.³ The useful points I found were as follows:

• Topical application of nonsteroidal anti-inflammatory drugs (e.g., diclofenac) should be used to improve function and quality of life in patients with knee osteoarthritis.
• Exercise routines (i.e, supervised, unsupervised, and/or aquatic) are recommended versus no exercise for improving pain and function in patients with knee osteoarthritis.
• Not recommended is the use of oral narcotics (including tramadol), as they are not effective at improving pain or function, and their use results in a significant increased risk of adverse events.
• Not recommended for routine use in symptomatic knee osteoarthritis is intra-articular injection of hyaluronic acid.

I was happy to see topical NSAIDS recommended, as they are a much safer option in older patients than oral NSAIDS (which were also recommended). The recommendation against narcotics, including tramadol, is a shift from the recommendation of tramadol in the 2013 guidelines.⁴ Acetaminophen was enthusiastically recommended, and is still worth a try.

Sexually transmitted infections

• The dosing for the treatment of gonorrhea has increased to 500 mg of ceftriaxone (was 250 mg in 2015 guidelines), with a dose of 1 gram for patients who weigh more than 150 kg.
• Chlamydia infections should be treated with a 7-day course of doxycycline as the preferred antibiotic, except in pregnant women (where azithromycin is recommended).
• Herpes simplex virus 2 recurrences can be treated with twice-daily dosing of 800 mg of acyclovir for 5 days, or acyclovir 800 mg three times a day for 2 days. The shortest course for recurrence is famciclovir 1 gram twice a day for 1 day.
• The Centers for Disease Control and Prevention has removed the recommendation for avoidance of alcohol when taking metronidazole.

I hope these highlights of guidelines for common issues we see are helpful!

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Johnson S et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile Infection in adults. Clin Infect Dis. 2021 Sep 7;73(5):e1029-e1044.

2. Pabhu VS et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018 Feb 1;66(3):355-62.

3. American Academy of Orthopaedic Surgeons: Management of osteoarthritis of the knee (non-arthroplasty) – Evidence-based clinical practice guideline (2021 Aug 31. https://www.aaos.org/oak3cpg).

4. Jevsevar DS. Treatment of osteoarthritis of the knee: Evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013: Sep;21(9):571-6.

5. Sexually transmitted infections treatment guidelines, 2021 recommendations and reports. MMWR 2021 Jul 23;70(4):1-187.

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

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

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

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

Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.

The common element among these very different legal issues is that physicians typically have no idea what to do when they find themselves potentially in trouble, but how they choose to deal with the issue can have significant consequences.

In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.

More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.

Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.

Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.

There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.

In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.

If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).

• Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
• If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
• Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
• Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
• Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
• Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
• If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
• Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
• If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
• If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
• Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.

There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.

Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.

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

In patients with persistent atopic dermatitis (AD) who are taking dupilumab, is there benefit of patch testing to determine if allergic contact dermatitis (ACD) also is contributing to their disease? Results of patch testing are likely be influenced by the immunomodulatory effects of dupilumab. Similar to the recommendation for patients to refrain from using topical or systemic corticosteroids for 1 week or more prior to patch testing to eliminate false negatives, we reviewed the literature to create practice guidelines for dermatologists regarding patch testing while a patient is taking dupilumab.

Pathophysiology and Pathomechanism

Dupilumab functions through the blockade of T helper 2 (T_H2) cells; ACD is propagated through the T helper 1 (T_H1) cellular pathway. However, patients with ACD that is unresponsive to allergen avoidance and traditional therapies, such as topical and oral corticosteroids, have responded to dupilumab. The more common reports of this responsiveness are with fragrances; multiple case series described patients with ACD to fragrance mix I¹ and balsam of Peru^1,2 who improved on dupilumab when other treatments failed. There also are reports of response when ACD was secondary to nickel,^2,3p-phenylenediamine,¹ Compositae,⁴ and non–formaldehyde-releasing preservatives (non-FRPs).⁵ Therefore, not all ACD is propagated through the T_H1 cellular pathway.

As noted in these cases, ACD can be a response to an allergen whose pathogenesis involves the T_H2 pathway or when patient characteristics favor a T_H2 response. It has been suggested that AD patients are more susceptible to T_H2-mediated contact sensitization to less-potent allergens, such as fragrances.⁶

Patch Test Results

Positive patch test results for allergens have been reported while patients are on dupilumab therapy, including a few studies in which results prior to starting dupilumab were compared with those while patients were on dupilumab therapy. In a retrospective chart review of 48 patients on dupilumab for AD with persistent disease, 23 patients were patch tested before and during dupilumab therapy. In these patients, the majority of contact allergies were persistent and only 10% (13/125) of patch test–positive results resolved on dupilumab therapy.⁷ Contact allergies that resolved included those to emulsifiers (propylene glycol, Amerchol L101 [lanolin-containing products found in cosmetics and other goods], dimethylaminopropylamine), fragrances (fragrance mix I, balsam of Peru), sunscreens (sulisobenzone, phenylbenzimidazole-5-sulfonic acid), and metals (vanadium chloride, phenylmercuric acetate).⁷ The following results observed in individual cases demonstrated conflicting findings: persistence of allergy to non-FRPs (methylisothiazolinone [MI]) but resolution of allergy to formaldehyde⁸; persistence of allergy to corticosteroids (budesonide and alclometasone)⁹; persistence of allergy to an antibiotic (neomycin sulfate) but resolution of allergies to a different antibiotic (bacitracin), glues (ethyl acrylate), bleach, and glutaraldehyde⁹; persistence of nickel allergy but resolution of allergies to fragrances (cinnamic aldehyde, balsam of Peru) and non-FRPs (methylchloroisothiazolinone or MI)¹⁰; and persistence of allergies to non-FRPs (MI) and FRPs (bronopol) but resolution of allergies to nickel, fragrances (hydroperoxides of linalool), and Compositae.¹¹ Additional case reports of positive patch test results while on dupilumab but with no pretreatment results for comparison include allergies to rubber additives,^12-14 nickel,¹⁴ textile dyes,¹⁴ cosmetic and hair care additives,^12,14,15 corticosteroids,¹⁵ FRPs,¹⁵ fragrances,^15,16 emulsifiers,¹⁶ and non-FRPs.¹⁷

An evident theme in the dupilumab patch-testing literature has been that results are variable and case specific: a given patient with ACD to an allergen will respond to dupilumab treatment and have subsequent negative patch testing, while another patient will not respond to dupilumab treatment and have persistent positive patch testing. This is likely because, in certain individuals, the allergen-immune system combination shifts ACD pathogenesis from a purely T_H1 response to at least a partial T_H2 response, thus allowing for benefit from dupilumab therapy. T helper 1 cell–mediated ACD should not be affected by dupilumab; therefore, reliable results can be elucidated from patch testing despite the drug.

Final Thoughts

We propose that AD patients with residual disease after taking dupilumab undergo patch testing. Positive results indicate allergens that are not inhibited by the drug. Patients will need to follow strict allergen avoidance to resolve this component of their disease; failure to improve might suggest the result was a nonrelevant positive.

If patch testing is negative, an alternative cause for residual disease must be sought. We do not recommend stopping dupilumab prior to patch testing to avoid a disease flare from AD or possible T_H2-mediated ACD.

In patients with persistent atopic dermatitis (AD) who are taking dupilumab, is there benefit of patch testing to determine if allergic contact dermatitis (ACD) also is contributing to their disease? Results of patch testing are likely be influenced by the immunomodulatory effects of dupilumab. Similar to the recommendation for patients to refrain from using topical or systemic corticosteroids for 1 week or more prior to patch testing to eliminate false negatives, we reviewed the literature to create practice guidelines for dermatologists regarding patch testing while a patient is taking dupilumab.

Pathophysiology and Pathomechanism

Dupilumab functions through the blockade of T helper 2 (T_H2) cells; ACD is propagated through the T helper 1 (T_H1) cellular pathway. However, patients with ACD that is unresponsive to allergen avoidance and traditional therapies, such as topical and oral corticosteroids, have responded to dupilumab. The more common reports of this responsiveness are with fragrances; multiple case series described patients with ACD to fragrance mix I¹ and balsam of Peru^1,2 who improved on dupilumab when other treatments failed. There also are reports of response when ACD was secondary to nickel,^2,3p-phenylenediamine,¹ Compositae,⁴ and non–formaldehyde-releasing preservatives (non-FRPs).⁵ Therefore, not all ACD is propagated through the T_H1 cellular pathway.

As noted in these cases, ACD can be a response to an allergen whose pathogenesis involves the T_H2 pathway or when patient characteristics favor a T_H2 response. It has been suggested that AD patients are more susceptible to T_H2-mediated contact sensitization to less-potent allergens, such as fragrances.⁶

Patch Test Results

Positive patch test results for allergens have been reported while patients are on dupilumab therapy, including a few studies in which results prior to starting dupilumab were compared with those while patients were on dupilumab therapy. In a retrospective chart review of 48 patients on dupilumab for AD with persistent disease, 23 patients were patch tested before and during dupilumab therapy. In these patients, the majority of contact allergies were persistent and only 10% (13/125) of patch test–positive results resolved on dupilumab therapy.⁷ Contact allergies that resolved included those to emulsifiers (propylene glycol, Amerchol L101 [lanolin-containing products found in cosmetics and other goods], dimethylaminopropylamine), fragrances (fragrance mix I, balsam of Peru), sunscreens (sulisobenzone, phenylbenzimidazole-5-sulfonic acid), and metals (vanadium chloride, phenylmercuric acetate).⁷ The following results observed in individual cases demonstrated conflicting findings: persistence of allergy to non-FRPs (methylisothiazolinone [MI]) but resolution of allergy to formaldehyde⁸; persistence of allergy to corticosteroids (budesonide and alclometasone)⁹; persistence of allergy to an antibiotic (neomycin sulfate) but resolution of allergies to a different antibiotic (bacitracin), glues (ethyl acrylate), bleach, and glutaraldehyde⁹; persistence of nickel allergy but resolution of allergies to fragrances (cinnamic aldehyde, balsam of Peru) and non-FRPs (methylchloroisothiazolinone or MI)¹⁰; and persistence of allergies to non-FRPs (MI) and FRPs (bronopol) but resolution of allergies to nickel, fragrances (hydroperoxides of linalool), and Compositae.¹¹ Additional case reports of positive patch test results while on dupilumab but with no pretreatment results for comparison include allergies to rubber additives,^12-14 nickel,¹⁴ textile dyes,¹⁴ cosmetic and hair care additives,^12,14,15 corticosteroids,¹⁵ FRPs,¹⁵ fragrances,^15,16 emulsifiers,¹⁶ and non-FRPs.¹⁷

An evident theme in the dupilumab patch-testing literature has been that results are variable and case specific: a given patient with ACD to an allergen will respond to dupilumab treatment and have subsequent negative patch testing, while another patient will not respond to dupilumab treatment and have persistent positive patch testing. This is likely because, in certain individuals, the allergen-immune system combination shifts ACD pathogenesis from a purely T_H1 response to at least a partial T_H2 response, thus allowing for benefit from dupilumab therapy. T helper 1 cell–mediated ACD should not be affected by dupilumab; therefore, reliable results can be elucidated from patch testing despite the drug.

Final Thoughts

We propose that AD patients with residual disease after taking dupilumab undergo patch testing. Positive results indicate allergens that are not inhibited by the drug. Patients will need to follow strict allergen avoidance to resolve this component of their disease; failure to improve might suggest the result was a nonrelevant positive.

If patch testing is negative, an alternative cause for residual disease must be sought. We do not recommend stopping dupilumab prior to patch testing to avoid a disease flare from AD or possible T_H2-mediated ACD.

In patients with persistent atopic dermatitis (AD) who are taking dupilumab, is there benefit of patch testing to determine if allergic contact dermatitis (ACD) also is contributing to their disease? Results of patch testing are likely be influenced by the immunomodulatory effects of dupilumab. Similar to the recommendation for patients to refrain from using topical or systemic corticosteroids for 1 week or more prior to patch testing to eliminate false negatives, we reviewed the literature to create practice guidelines for dermatologists regarding patch testing while a patient is taking dupilumab.

Pathophysiology and Pathomechanism

Dupilumab functions through the blockade of T helper 2 (T_H2) cells; ACD is propagated through the T helper 1 (T_H1) cellular pathway. However, patients with ACD that is unresponsive to allergen avoidance and traditional therapies, such as topical and oral corticosteroids, have responded to dupilumab. The more common reports of this responsiveness are with fragrances; multiple case series described patients with ACD to fragrance mix I¹ and balsam of Peru^1,2 who improved on dupilumab when other treatments failed. There also are reports of response when ACD was secondary to nickel,^2,3p-phenylenediamine,¹ Compositae,⁴ and non–formaldehyde-releasing preservatives (non-FRPs).⁵ Therefore, not all ACD is propagated through the T_H1 cellular pathway.

As noted in these cases, ACD can be a response to an allergen whose pathogenesis involves the T_H2 pathway or when patient characteristics favor a T_H2 response. It has been suggested that AD patients are more susceptible to T_H2-mediated contact sensitization to less-potent allergens, such as fragrances.⁶

Patch Test Results

Positive patch test results for allergens have been reported while patients are on dupilumab therapy, including a few studies in which results prior to starting dupilumab were compared with those while patients were on dupilumab therapy. In a retrospective chart review of 48 patients on dupilumab for AD with persistent disease, 23 patients were patch tested before and during dupilumab therapy. In these patients, the majority of contact allergies were persistent and only 10% (13/125) of patch test–positive results resolved on dupilumab therapy.⁷ Contact allergies that resolved included those to emulsifiers (propylene glycol, Amerchol L101 [lanolin-containing products found in cosmetics and other goods], dimethylaminopropylamine), fragrances (fragrance mix I, balsam of Peru), sunscreens (sulisobenzone, phenylbenzimidazole-5-sulfonic acid), and metals (vanadium chloride, phenylmercuric acetate).⁷ The following results observed in individual cases demonstrated conflicting findings: persistence of allergy to non-FRPs (methylisothiazolinone [MI]) but resolution of allergy to formaldehyde⁸; persistence of allergy to corticosteroids (budesonide and alclometasone)⁹; persistence of allergy to an antibiotic (neomycin sulfate) but resolution of allergies to a different antibiotic (bacitracin), glues (ethyl acrylate), bleach, and glutaraldehyde⁹; persistence of nickel allergy but resolution of allergies to fragrances (cinnamic aldehyde, balsam of Peru) and non-FRPs (methylchloroisothiazolinone or MI)¹⁰; and persistence of allergies to non-FRPs (MI) and FRPs (bronopol) but resolution of allergies to nickel, fragrances (hydroperoxides of linalool), and Compositae.¹¹ Additional case reports of positive patch test results while on dupilumab but with no pretreatment results for comparison include allergies to rubber additives,^12-14 nickel,¹⁴ textile dyes,¹⁴ cosmetic and hair care additives,^12,14,15 corticosteroids,¹⁵ FRPs,¹⁵ fragrances,^15,16 emulsifiers,¹⁶ and non-FRPs.¹⁷

An evident theme in the dupilumab patch-testing literature has been that results are variable and case specific: a given patient with ACD to an allergen will respond to dupilumab treatment and have subsequent negative patch testing, while another patient will not respond to dupilumab treatment and have persistent positive patch testing. This is likely because, in certain individuals, the allergen-immune system combination shifts ACD pathogenesis from a purely T_H1 response to at least a partial T_H2 response, thus allowing for benefit from dupilumab therapy. T helper 1 cell–mediated ACD should not be affected by dupilumab; therefore, reliable results can be elucidated from patch testing despite the drug.

Final Thoughts

We propose that AD patients with residual disease after taking dupilumab undergo patch testing. Positive results indicate allergens that are not inhibited by the drug. Patients will need to follow strict allergen avoidance to resolve this component of their disease; failure to improve might suggest the result was a nonrelevant positive.

If patch testing is negative, an alternative cause for residual disease must be sought. We do not recommend stopping dupilumab prior to patch testing to avoid a disease flare from AD or possible T_H2-mediated ACD.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder affecting 7% of adults and 13% of children in the United States.^1,2 Atopic dermatitis is characterized by pruritus, dry skin, and pain, all of which can negatively impact quality of life and put patients at higher risk for psychiatric comorbidities such as anxiety and depression.³ The pathogenesis of AD is multifactorial, involving genetics, epidermal barrier dysfunction, and immune dysregulation. Overactivation of helper T cell (T_H2) pathway cytokines, including IL-4, IL-13, and IL-31, is thought to propagate both inflammation and pruritus, which are central to AD. The JAK-STAT signaling pathway plays a pivotal role in the immune system dysregulation and exaggeration of T_H2 cell response, making JAK-STAT inhibitors (or JAK inhibitors) strong theoretical candidates for the treatment of AD.⁴ In humans, the Janus kinases are composed of 4 different members—JAK1, JAK2, JAK3, and tyrosine kinase 2—all of which can be targeted by JAK inhibitors.⁵

JAK inhibitors such as tofacitinib have already been approved by the US Food and Drug Administration (FDA) to treat various inflammatory conditions, including rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis; other JAK inhibitors such as baricitinib are only approved for patients with rheumatoid arthritis.^6,7 The success of these small molecule inhibitors in these immune-mediated conditions make them attractive candidates for the treatment of AD. Several JAK inhibitors are in phase 2 and phase 3 clinical trials as oral therapies (moderate to severe AD) or as topical treatments (mild to moderate AD). Currently, ruxolitinib (RUX) is the only topical JAK inhibitor that is FDA approved for the treatment of AD in the United States.⁸ In this editorial, we focus on recent trials of JAK inhibitors tested in patients with AD, including topical RUX, as well as oral abrocitinib, upadacitinib, and baricitinib.

Topical RUX in AD

Ruxolitinib is a topical JAK1/2 small molecule inhibitor approved by the FDA for the treatment of AD in 2021. In a randomized trial by Kim et al⁹ in 2020, all tested regimens of RUX demonstrated significant improvement in eczema area and severity index (EASI) scores vs vehicle; notably, RUX cream 1.5% applied twice daily achieved the greatest mean percentage change in baseline EASI score vs vehicle at 4 weeks (76.1% vs 15.5%; P<.0001). Ruxolitinib cream was well tolerated through week 8 of the trial, and all adverse events (AEs) were mild to moderate in severity and comparable to those in the vehicle group.⁹

Topical JAK inhibitors appear to be effective for mild to moderate AD and have had an acceptable safety profile in clinical trials thus far. Although topical corticosteroids and calcineurin inhibitors can have great clinical benefit in AD, they are recommended for short-term use given side effects such as thinning of the skin, burning, or telangiectasia formation.^10,11 The hope is that topical JAK inhibitors may be an alternative to standard topical treatments for AD, as they can be used for longer periods due to a safer side-effect profile.

Oral JAK Inhibitors in AD

Several oral JAK inhibitors are undergoing investigation for the systemic treatment of moderate to severe AD. Abrocitinib is an oral JAK1 inhibitor that has demonstrated efficacy in several phase 3 trials in patients with moderate to severe AD. In a 2021 trial, patients were randomized in a 2:2:2:1 ratio to receive abrocitinib 200 mg daily, abrocitinib 100 mg daily, subcutaneous dupilumab 300 mg every other week, or placebo, respectively.¹² Patients in both abrocitinib groups showed significant improvement in AD vs placebo, and EASI-75 response was achieved in 70.3%, 58.7%, 58.1%, and 27.1% of patients, respectively (P<.001 for both abrocitinib doses vs placebo). Adverse events occurred more frequently in the abrocitinib 200-mg group vs placebo. Nausea, acne, nasopharyngitis, and headache were the most frequently reported AEs with abrocitinib.¹² Another phase 3 trial by Silverberg et al¹³ (N=391) had similar treatment results, with 38.1% of participants receiving abrocitinib 200 mg and 28.4% of participants receiving abrocitinib 100 mg achieving investigator global assessment scores of 0 (clear) or 1 (almost clear) vs 9.1% of participants receiving placebo (P<.001). Abrocitinib was well tolerated in this trial with few serious AEs (ie, herpangina [0.6%], pneumonia [0.6%]).¹³ In both trials, there were rare instances of laboratory values indicating thrombocytopenia with the 200-mg dose (0.9%¹² and 3.2%¹³) without any clinical manifestations. Although a decrease in platelets was observed, no thrombocytopenia occurred in the abrocitinib 100-mg group in the latter trial.¹³

Baricitinib is another oral inhibitor of JAK1 and JAK2 with potential for the treatment of AD. One randomized trial (N=329) demonstrated its efficacy in combination with a topical corticosteroid (TCS). At 16 weeks, a higher number of participants treated with baricitinib and TCS achieved investigator global assessment scores of 0 (clear) or 1 (almost clear) compared to those who received placebo and TCS (31% with baricitinib 4 mg + TCS, 24% with baricitinib 2 mg + TCS, and 15% with placebo + TCS).¹⁴ Similarly, in BREEZE-AD5,another phase 3 trial (N=440), baricitinib monotherapy demonstrated a higher rate of treatment success vs placebo.¹⁵ Specifically, 13% of patients treated with baricitinib 1 mg and 30% of those treated with baricitinib 2 mg achieved 75% or greater reduction in EASI scores compared to 8% in the placebo group. The most common AEs associated with baricitinib were nasopharyngitis and headache. Adverse events occurred with similar frequency across both experimental and control groups.¹⁵ Reich et al¹⁴ demonstrated a higher overall rate of AEs—most commonly nasopharyngitis, upper respiratory tract infections, and folliculitis—in baricitinib-treated patients; however, serious AEs occurred with similar frequency across all groups, including the control group.

The selective JAK1 inhibitor upadacitinib also is undergoing testing in treating moderate to severe AD. In one trial, 167 patients were randomized to once daily oral upadacitinib 7.5 mg, 15 mg, or 30 mg or placebo.¹⁶ All doses of upadacitinib demonstrated considerably higher percentage improvements from baseline in EASI scores compared to placebo at 16 weeks with a clear dose-response relationship (39%, 62%, and 74% vs 23%, respectively). In this trial, there were no dose-limiting safety events. Serious AEs were infrequent, occurring in 4.8%, 2.4%, and 0% of upadacitinib groups vs 2.5% for placebo. The serious AEs observed with upadacitinib were 1 case of appendicitis, lower jaw pericoronitis in a patient with a history of repeated tooth infections, and an exacerbation of AD.¹⁶

Tofacitinib, another JAK inhibitor, has been shown to increase the risk for blood clots and death in a large trial in the treatment of rheumatoid arthritis. Following this study, the FDA is requiring black box warnings for tofacitinib and also for the 2 JAK inhibitors baricitinib and upadacitinib regarding the risks for heart-related events, cancer, blood clots, and death. Given that these medications share a similar mechanism of action to tofacitinib, they may have similar risks, though they have not yet been fully evaluated in large safety trials.¹⁷

With more recent investigation into novel therapeutics for AD, oral JAK inhibitors may play an important role in the future to treat patients with moderate to severe AD with inadequate response or contraindications to other systemic therapies. In trials thus far, oral JAK inhibitors have exhibited acceptable safety profiles and have demonstrated treatment success in AD. More randomized, controlled, phase 3 studies with larger patient populations are required to confirm their potential as effective treatments and elucidate their long-term safety.

Deucravacitinib in Psoriasis

Deucravacitinib is a first-in-class, oral, selective TYK2 inhibitor currently undergoing testing for the treatment of psoriasis. A randomized phase 2 trial (N=267) found that deucravacitinib was more effective than placebo in treating chronic plaque psoriasis at doses of 3 to 12 mg daily.¹⁸ The percentage of participants with a 75% or greater reduction from baseline in the psoriasis area and severity index score was 7% with placebo, 9% with deucravacitinib 3 mg every other day (P=.49 vs placebo), 39% with 3 mg once daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). The most commonly reported AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection. Adverse events occurred in 51% of participants in the control group and in 55% to 80% of those in the experimental groups. Additionally, there was 1 reported case of melanoma (stage 0) 96 days after the start of treatment in a patient in the 3-mg once-daily group. Serious AEs occurred in only 0% to 2% of participants who received deucravacitinib.¹⁸

Two phase 3 trials—POETYK PSO-1 and POETYK PSO-2 (N=1686)—found deucravacitinib to be notably more effective than both placebo and apremilast in treating psoriasis.¹⁹ Among participants receiving deucravacitinib 6 mg daily, 58.7% and 53.6% in the 2 respective trials achieved psoriasis area and severity index 75 response vs 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving apremilast. Overall, the treatment was well tolerated, with a low rate of discontinuation of deucravacitinib due to AEs (2.4% of patients on deucravacitinib compared to 3.8% on placebo and 5.2% on apremilast). The most frequently observed AEs with deucravacitinib were nasopharyngitis and upper respiratory tract infection. The full results of these trials are expected to be published soon.^19,20

Final Thoughts

Overall, JAK inhibitors are a novel class of therapeutics that may have further success in the treatment of other dermatologic conditions that negatively affect patients’ quality of life and productivity. We should look forward to additional successful trials with these promising medications.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder affecting 7% of adults and 13% of children in the United States.^1,2 Atopic dermatitis is characterized by pruritus, dry skin, and pain, all of which can negatively impact quality of life and put patients at higher risk for psychiatric comorbidities such as anxiety and depression.³ The pathogenesis of AD is multifactorial, involving genetics, epidermal barrier dysfunction, and immune dysregulation. Overactivation of helper T cell (T_H2) pathway cytokines, including IL-4, IL-13, and IL-31, is thought to propagate both inflammation and pruritus, which are central to AD. The JAK-STAT signaling pathway plays a pivotal role in the immune system dysregulation and exaggeration of T_H2 cell response, making JAK-STAT inhibitors (or JAK inhibitors) strong theoretical candidates for the treatment of AD.⁴ In humans, the Janus kinases are composed of 4 different members—JAK1, JAK2, JAK3, and tyrosine kinase 2—all of which can be targeted by JAK inhibitors.⁵

JAK inhibitors such as tofacitinib have already been approved by the US Food and Drug Administration (FDA) to treat various inflammatory conditions, including rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis; other JAK inhibitors such as baricitinib are only approved for patients with rheumatoid arthritis.^6,7 The success of these small molecule inhibitors in these immune-mediated conditions make them attractive candidates for the treatment of AD. Several JAK inhibitors are in phase 2 and phase 3 clinical trials as oral therapies (moderate to severe AD) or as topical treatments (mild to moderate AD). Currently, ruxolitinib (RUX) is the only topical JAK inhibitor that is FDA approved for the treatment of AD in the United States.⁸ In this editorial, we focus on recent trials of JAK inhibitors tested in patients with AD, including topical RUX, as well as oral abrocitinib, upadacitinib, and baricitinib.

Topical RUX in AD

Ruxolitinib is a topical JAK1/2 small molecule inhibitor approved by the FDA for the treatment of AD in 2021. In a randomized trial by Kim et al⁹ in 2020, all tested regimens of RUX demonstrated significant improvement in eczema area and severity index (EASI) scores vs vehicle; notably, RUX cream 1.5% applied twice daily achieved the greatest mean percentage change in baseline EASI score vs vehicle at 4 weeks (76.1% vs 15.5%; P<.0001). Ruxolitinib cream was well tolerated through week 8 of the trial, and all adverse events (AEs) were mild to moderate in severity and comparable to those in the vehicle group.⁹

Topical JAK inhibitors appear to be effective for mild to moderate AD and have had an acceptable safety profile in clinical trials thus far. Although topical corticosteroids and calcineurin inhibitors can have great clinical benefit in AD, they are recommended for short-term use given side effects such as thinning of the skin, burning, or telangiectasia formation.^10,11 The hope is that topical JAK inhibitors may be an alternative to standard topical treatments for AD, as they can be used for longer periods due to a safer side-effect profile.

Oral JAK Inhibitors in AD

Several oral JAK inhibitors are undergoing investigation for the systemic treatment of moderate to severe AD. Abrocitinib is an oral JAK1 inhibitor that has demonstrated efficacy in several phase 3 trials in patients with moderate to severe AD. In a 2021 trial, patients were randomized in a 2:2:2:1 ratio to receive abrocitinib 200 mg daily, abrocitinib 100 mg daily, subcutaneous dupilumab 300 mg every other week, or placebo, respectively.¹² Patients in both abrocitinib groups showed significant improvement in AD vs placebo, and EASI-75 response was achieved in 70.3%, 58.7%, 58.1%, and 27.1% of patients, respectively (P<.001 for both abrocitinib doses vs placebo). Adverse events occurred more frequently in the abrocitinib 200-mg group vs placebo. Nausea, acne, nasopharyngitis, and headache were the most frequently reported AEs with abrocitinib.¹² Another phase 3 trial by Silverberg et al¹³ (N=391) had similar treatment results, with 38.1% of participants receiving abrocitinib 200 mg and 28.4% of participants receiving abrocitinib 100 mg achieving investigator global assessment scores of 0 (clear) or 1 (almost clear) vs 9.1% of participants receiving placebo (P<.001). Abrocitinib was well tolerated in this trial with few serious AEs (ie, herpangina [0.6%], pneumonia [0.6%]).¹³ In both trials, there were rare instances of laboratory values indicating thrombocytopenia with the 200-mg dose (0.9%¹² and 3.2%¹³) without any clinical manifestations. Although a decrease in platelets was observed, no thrombocytopenia occurred in the abrocitinib 100-mg group in the latter trial.¹³

Baricitinib is another oral inhibitor of JAK1 and JAK2 with potential for the treatment of AD. One randomized trial (N=329) demonstrated its efficacy in combination with a topical corticosteroid (TCS). At 16 weeks, a higher number of participants treated with baricitinib and TCS achieved investigator global assessment scores of 0 (clear) or 1 (almost clear) compared to those who received placebo and TCS (31% with baricitinib 4 mg + TCS, 24% with baricitinib 2 mg + TCS, and 15% with placebo + TCS).¹⁴ Similarly, in BREEZE-AD5,another phase 3 trial (N=440), baricitinib monotherapy demonstrated a higher rate of treatment success vs placebo.¹⁵ Specifically, 13% of patients treated with baricitinib 1 mg and 30% of those treated with baricitinib 2 mg achieved 75% or greater reduction in EASI scores compared to 8% in the placebo group. The most common AEs associated with baricitinib were nasopharyngitis and headache. Adverse events occurred with similar frequency across both experimental and control groups.¹⁵ Reich et al¹⁴ demonstrated a higher overall rate of AEs—most commonly nasopharyngitis, upper respiratory tract infections, and folliculitis—in baricitinib-treated patients; however, serious AEs occurred with similar frequency across all groups, including the control group.

The selective JAK1 inhibitor upadacitinib also is undergoing testing in treating moderate to severe AD. In one trial, 167 patients were randomized to once daily oral upadacitinib 7.5 mg, 15 mg, or 30 mg or placebo.¹⁶ All doses of upadacitinib demonstrated considerably higher percentage improvements from baseline in EASI scores compared to placebo at 16 weeks with a clear dose-response relationship (39%, 62%, and 74% vs 23%, respectively). In this trial, there were no dose-limiting safety events. Serious AEs were infrequent, occurring in 4.8%, 2.4%, and 0% of upadacitinib groups vs 2.5% for placebo. The serious AEs observed with upadacitinib were 1 case of appendicitis, lower jaw pericoronitis in a patient with a history of repeated tooth infections, and an exacerbation of AD.¹⁶

Tofacitinib, another JAK inhibitor, has been shown to increase the risk for blood clots and death in a large trial in the treatment of rheumatoid arthritis. Following this study, the FDA is requiring black box warnings for tofacitinib and also for the 2 JAK inhibitors baricitinib and upadacitinib regarding the risks for heart-related events, cancer, blood clots, and death. Given that these medications share a similar mechanism of action to tofacitinib, they may have similar risks, though they have not yet been fully evaluated in large safety trials.¹⁷

With more recent investigation into novel therapeutics for AD, oral JAK inhibitors may play an important role in the future to treat patients with moderate to severe AD with inadequate response or contraindications to other systemic therapies. In trials thus far, oral JAK inhibitors have exhibited acceptable safety profiles and have demonstrated treatment success in AD. More randomized, controlled, phase 3 studies with larger patient populations are required to confirm their potential as effective treatments and elucidate their long-term safety.

Deucravacitinib in Psoriasis

Deucravacitinib is a first-in-class, oral, selective TYK2 inhibitor currently undergoing testing for the treatment of psoriasis. A randomized phase 2 trial (N=267) found that deucravacitinib was more effective than placebo in treating chronic plaque psoriasis at doses of 3 to 12 mg daily.¹⁸ The percentage of participants with a 75% or greater reduction from baseline in the psoriasis area and severity index score was 7% with placebo, 9% with deucravacitinib 3 mg every other day (P=.49 vs placebo), 39% with 3 mg once daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). The most commonly reported AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection. Adverse events occurred in 51% of participants in the control group and in 55% to 80% of those in the experimental groups. Additionally, there was 1 reported case of melanoma (stage 0) 96 days after the start of treatment in a patient in the 3-mg once-daily group. Serious AEs occurred in only 0% to 2% of participants who received deucravacitinib.¹⁸

Two phase 3 trials—POETYK PSO-1 and POETYK PSO-2 (N=1686)—found deucravacitinib to be notably more effective than both placebo and apremilast in treating psoriasis.¹⁹ Among participants receiving deucravacitinib 6 mg daily, 58.7% and 53.6% in the 2 respective trials achieved psoriasis area and severity index 75 response vs 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving apremilast. Overall, the treatment was well tolerated, with a low rate of discontinuation of deucravacitinib due to AEs (2.4% of patients on deucravacitinib compared to 3.8% on placebo and 5.2% on apremilast). The most frequently observed AEs with deucravacitinib were nasopharyngitis and upper respiratory tract infection. The full results of these trials are expected to be published soon.^19,20

Final Thoughts

Overall, JAK inhibitors are a novel class of therapeutics that may have further success in the treatment of other dermatologic conditions that negatively affect patients’ quality of life and productivity. We should look forward to additional successful trials with these promising medications.

Atopic dermatitis (AD) is a chronic inflammatory skin disorder affecting 7% of adults and 13% of children in the United States.^1,2 Atopic dermatitis is characterized by pruritus, dry skin, and pain, all of which can negatively impact quality of life and put patients at higher risk for psychiatric comorbidities such as anxiety and depression.³ The pathogenesis of AD is multifactorial, involving genetics, epidermal barrier dysfunction, and immune dysregulation. Overactivation of helper T cell (T_H2) pathway cytokines, including IL-4, IL-13, and IL-31, is thought to propagate both inflammation and pruritus, which are central to AD. The JAK-STAT signaling pathway plays a pivotal role in the immune system dysregulation and exaggeration of T_H2 cell response, making JAK-STAT inhibitors (or JAK inhibitors) strong theoretical candidates for the treatment of AD.⁴ In humans, the Janus kinases are composed of 4 different members—JAK1, JAK2, JAK3, and tyrosine kinase 2—all of which can be targeted by JAK inhibitors.⁵

JAK inhibitors such as tofacitinib have already been approved by the US Food and Drug Administration (FDA) to treat various inflammatory conditions, including rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis; other JAK inhibitors such as baricitinib are only approved for patients with rheumatoid arthritis.^6,7 The success of these small molecule inhibitors in these immune-mediated conditions make them attractive candidates for the treatment of AD. Several JAK inhibitors are in phase 2 and phase 3 clinical trials as oral therapies (moderate to severe AD) or as topical treatments (mild to moderate AD). Currently, ruxolitinib (RUX) is the only topical JAK inhibitor that is FDA approved for the treatment of AD in the United States.⁸ In this editorial, we focus on recent trials of JAK inhibitors tested in patients with AD, including topical RUX, as well as oral abrocitinib, upadacitinib, and baricitinib.

Topical RUX in AD

Ruxolitinib is a topical JAK1/2 small molecule inhibitor approved by the FDA for the treatment of AD in 2021. In a randomized trial by Kim et al⁹ in 2020, all tested regimens of RUX demonstrated significant improvement in eczema area and severity index (EASI) scores vs vehicle; notably, RUX cream 1.5% applied twice daily achieved the greatest mean percentage change in baseline EASI score vs vehicle at 4 weeks (76.1% vs 15.5%; P<.0001). Ruxolitinib cream was well tolerated through week 8 of the trial, and all adverse events (AEs) were mild to moderate in severity and comparable to those in the vehicle group.⁹

Topical JAK inhibitors appear to be effective for mild to moderate AD and have had an acceptable safety profile in clinical trials thus far. Although topical corticosteroids and calcineurin inhibitors can have great clinical benefit in AD, they are recommended for short-term use given side effects such as thinning of the skin, burning, or telangiectasia formation.^10,11 The hope is that topical JAK inhibitors may be an alternative to standard topical treatments for AD, as they can be used for longer periods due to a safer side-effect profile.

Oral JAK Inhibitors in AD

Several oral JAK inhibitors are undergoing investigation for the systemic treatment of moderate to severe AD. Abrocitinib is an oral JAK1 inhibitor that has demonstrated efficacy in several phase 3 trials in patients with moderate to severe AD. In a 2021 trial, patients were randomized in a 2:2:2:1 ratio to receive abrocitinib 200 mg daily, abrocitinib 100 mg daily, subcutaneous dupilumab 300 mg every other week, or placebo, respectively.¹² Patients in both abrocitinib groups showed significant improvement in AD vs placebo, and EASI-75 response was achieved in 70.3%, 58.7%, 58.1%, and 27.1% of patients, respectively (P<.001 for both abrocitinib doses vs placebo). Adverse events occurred more frequently in the abrocitinib 200-mg group vs placebo. Nausea, acne, nasopharyngitis, and headache were the most frequently reported AEs with abrocitinib.¹² Another phase 3 trial by Silverberg et al¹³ (N=391) had similar treatment results, with 38.1% of participants receiving abrocitinib 200 mg and 28.4% of participants receiving abrocitinib 100 mg achieving investigator global assessment scores of 0 (clear) or 1 (almost clear) vs 9.1% of participants receiving placebo (P<.001). Abrocitinib was well tolerated in this trial with few serious AEs (ie, herpangina [0.6%], pneumonia [0.6%]).¹³ In both trials, there were rare instances of laboratory values indicating thrombocytopenia with the 200-mg dose (0.9%¹² and 3.2%¹³) without any clinical manifestations. Although a decrease in platelets was observed, no thrombocytopenia occurred in the abrocitinib 100-mg group in the latter trial.¹³

Baricitinib is another oral inhibitor of JAK1 and JAK2 with potential for the treatment of AD. One randomized trial (N=329) demonstrated its efficacy in combination with a topical corticosteroid (TCS). At 16 weeks, a higher number of participants treated with baricitinib and TCS achieved investigator global assessment scores of 0 (clear) or 1 (almost clear) compared to those who received placebo and TCS (31% with baricitinib 4 mg + TCS, 24% with baricitinib 2 mg + TCS, and 15% with placebo + TCS).¹⁴ Similarly, in BREEZE-AD5,another phase 3 trial (N=440), baricitinib monotherapy demonstrated a higher rate of treatment success vs placebo.¹⁵ Specifically, 13% of patients treated with baricitinib 1 mg and 30% of those treated with baricitinib 2 mg achieved 75% or greater reduction in EASI scores compared to 8% in the placebo group. The most common AEs associated with baricitinib were nasopharyngitis and headache. Adverse events occurred with similar frequency across both experimental and control groups.¹⁵ Reich et al¹⁴ demonstrated a higher overall rate of AEs—most commonly nasopharyngitis, upper respiratory tract infections, and folliculitis—in baricitinib-treated patients; however, serious AEs occurred with similar frequency across all groups, including the control group.

The selective JAK1 inhibitor upadacitinib also is undergoing testing in treating moderate to severe AD. In one trial, 167 patients were randomized to once daily oral upadacitinib 7.5 mg, 15 mg, or 30 mg or placebo.¹⁶ All doses of upadacitinib demonstrated considerably higher percentage improvements from baseline in EASI scores compared to placebo at 16 weeks with a clear dose-response relationship (39%, 62%, and 74% vs 23%, respectively). In this trial, there were no dose-limiting safety events. Serious AEs were infrequent, occurring in 4.8%, 2.4%, and 0% of upadacitinib groups vs 2.5% for placebo. The serious AEs observed with upadacitinib were 1 case of appendicitis, lower jaw pericoronitis in a patient with a history of repeated tooth infections, and an exacerbation of AD.¹⁶

Tofacitinib, another JAK inhibitor, has been shown to increase the risk for blood clots and death in a large trial in the treatment of rheumatoid arthritis. Following this study, the FDA is requiring black box warnings for tofacitinib and also for the 2 JAK inhibitors baricitinib and upadacitinib regarding the risks for heart-related events, cancer, blood clots, and death. Given that these medications share a similar mechanism of action to tofacitinib, they may have similar risks, though they have not yet been fully evaluated in large safety trials.¹⁷

With more recent investigation into novel therapeutics for AD, oral JAK inhibitors may play an important role in the future to treat patients with moderate to severe AD with inadequate response or contraindications to other systemic therapies. In trials thus far, oral JAK inhibitors have exhibited acceptable safety profiles and have demonstrated treatment success in AD. More randomized, controlled, phase 3 studies with larger patient populations are required to confirm their potential as effective treatments and elucidate their long-term safety.

Deucravacitinib in Psoriasis

Deucravacitinib is a first-in-class, oral, selective TYK2 inhibitor currently undergoing testing for the treatment of psoriasis. A randomized phase 2 trial (N=267) found that deucravacitinib was more effective than placebo in treating chronic plaque psoriasis at doses of 3 to 12 mg daily.¹⁸ The percentage of participants with a 75% or greater reduction from baseline in the psoriasis area and severity index score was 7% with placebo, 9% with deucravacitinib 3 mg every other day (P=.49 vs placebo), 39% with 3 mg once daily (P<.001 vs placebo), 69% with 3 mg twice daily (P<.001 vs placebo), 67% with 6 mg twice daily (P<.001 vs placebo), and 75% with 12 mg once daily (P<.001 vs placebo). The most commonly reported AEs were nasopharyngitis, headache, diarrhea, nausea, and upper respiratory tract infection. Adverse events occurred in 51% of participants in the control group and in 55% to 80% of those in the experimental groups. Additionally, there was 1 reported case of melanoma (stage 0) 96 days after the start of treatment in a patient in the 3-mg once-daily group. Serious AEs occurred in only 0% to 2% of participants who received deucravacitinib.¹⁸

Two phase 3 trials—POETYK PSO-1 and POETYK PSO-2 (N=1686)—found deucravacitinib to be notably more effective than both placebo and apremilast in treating psoriasis.¹⁹ Among participants receiving deucravacitinib 6 mg daily, 58.7% and 53.6% in the 2 respective trials achieved psoriasis area and severity index 75 response vs 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving apremilast. Overall, the treatment was well tolerated, with a low rate of discontinuation of deucravacitinib due to AEs (2.4% of patients on deucravacitinib compared to 3.8% on placebo and 5.2% on apremilast). The most frequently observed AEs with deucravacitinib were nasopharyngitis and upper respiratory tract infection. The full results of these trials are expected to be published soon.^19,20

Final Thoughts

Overall, JAK inhibitors are a novel class of therapeutics that may have further success in the treatment of other dermatologic conditions that negatively affect patients’ quality of life and productivity. We should look forward to additional successful trials with these promising medications.

I was taught to think clinically first and legally second. There are moments when following every regulation is clearly detrimental to the well-being of both the patient and the medical community at large, and these challenges have been highlighted by issues with telemental health during the pandemic.

A friend emailed me with a problem: He has a son who is a traveling nurse and is currently in psychotherapy. The therapist has, in accordance with licensing requirements, told his son that she can not see him when assignments take him to any state where she is not licensed. The patient needs to physically be in the same state where the clinician holds a license, technically for every appointment. The nursing assignments last for 3 months and he will be going to a variety of states. Does he really need to get a new therapist every 90 days?

The logistics seem mind-boggling in a time when there is a shortage of mental health professionals, and there are often long wait lists to get care. And even if it was all easy, I’ll point out that working with a therapist is a bit different then going to an urgent care center to have sutures removed or to obtain antibiotics for strep throat: The relationship is not easily interchangeable, and I know of no one who would think it clinically optimal for anyone to change psychotherapists every 3 months. The traveling nurse does not just need to find a “provider” in each state, he needs to find one he is comfortable with and he will have to spend several sessions relaying his history and forming a new therapeutic alliance. And given the ambiguities of psychotherapy, he would optimally see therapists who do not make conflicting interpretations or recommendations. Mind-boggling. And while none of us are irreplaceable, it feels heartless to tell someone who is traveling to provide medical care to others during a pandemic that they can’t have mental health care when our technology would allow for it.

In the “old days” it was simpler: Patients came to the office and both the patient and the clinician were physically located in the same state, even if the patient resided in another state and commuted hours to the appointment. Telemental health was done in select rural areas or in military settings, and most physicians did not consider the option for video visits, much less full video treatment. For the average practitioner, issues of location were not relevant. The exception was for college students who might reside in one state and see a psychiatrist or therapist in another, but typically everyone was comfortable taking a break from therapy when the patient could not meet with the therapist in person. If psychiatrists were having phone or video sessions with out-of-state patients on an occasional basis, it may have been because there was less scrutiny and it was less obvious that this was not permitted.

When the pandemic forced treatment to go online, the issues changed. At the beginning, issues related to state licensing were waived. Now each state has a different requirement with regard to out-of-state physicians; some allow their residents to be seen, while others require the physician to get licensed in their state and the process may or may not be costly or arduous for the provider. The regulations change frequently, and can be quite confusing to follow. Since psychiatry is a shortage field, many psychiatrists are not looking to have more patients from other states and are not motivated to apply for extra licenses.

Life as a practicing psychiatrist has been a moving target: I reopened my practice for some in-person visits for vaccinated patients in June 2021, then closed it when the Omicron surge seemed too risky, and I’ll be reopening soon. Patients, too, have had unpredictable lives.

For the practitioner who is following the rules precisely, the issues can be sticky. It may be fine to have Zoom visits with a patient who lives across the street, but not with the elderly patient who has to drive 90 minutes across a state line, and it’s always fine to have a video session with a patient in Guam. If a patient signs on for a video visit with a doctor licensed in Maine and announces there will be a visit to a brother in Michigan, does the clinician abruptly end the session? Does he charge for the then missed appointment, and don’t we feel this is a waste of the psychiatrist’s time when appointments are limited?

If college students started with therapists in their home states when universities shut down in the spring of 2020, must they now try to get treatment in the states where their college campuses are located? What if the university has a long wait for services, there are no local psychiatrists taking on new patients, or the student feels he is making good progress with the doctor he is working with? And how do we even know for sure where our patients are located? Are we obligated to ask for a precise location at the beginning of each session? What if patients do not offer their locations, or lie about where they are?

Oddly, the issue is with the location of the patient; the doctor can be anywhere as long as the patient’s body is in a state where he or she is licensed. And it has never been a problem to send prescriptions to pharmacies in other states, though this seems to me the essence of practicing across state lines.

In the State of the Union Address on March 1, President Biden had a hefty agenda: The Russian invasion of Ukraine, a global pandemic, spiraling inflation, and for the first time in a SOTU address, our president discussed a strategy to address our National Mental Health Crisis. The fact sheet released by the White House details many long-awaited changes to increase the mental health workforce to address shortages, instituting a “988” crisis line to initiate “someone to call, someone to respond, and somewhere for every American in crisis to go.” The proposals call for a sweeping reform in providing access to services, strengthening parity, and improving community, veterans, and university services – and the Biden administration specifically addresses telemental health. “To maintain continuity of access, the Administration will work with Congress to ensure coverage of tele-behavioral health across health plans, and support appropriate delivery of telemedicine across state lines.”

This is good news, as it’s time we concentrated on allowing for access to care in a consumer-oriented way. It may let us focus on offering good clinical care and not focus on following outdated regulations. Hopefully, those who want help will be able to access it, and perhaps soon a traveling nurse will be permitted to get mental health care with continuity of treatment.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

I was taught to think clinically first and legally second. There are moments when following every regulation is clearly detrimental to the well-being of both the patient and the medical community at large, and these challenges have been highlighted by issues with telemental health during the pandemic.

A friend emailed me with a problem: He has a son who is a traveling nurse and is currently in psychotherapy. The therapist has, in accordance with licensing requirements, told his son that she can not see him when assignments take him to any state where she is not licensed. The patient needs to physically be in the same state where the clinician holds a license, technically for every appointment. The nursing assignments last for 3 months and he will be going to a variety of states. Does he really need to get a new therapist every 90 days?

The logistics seem mind-boggling in a time when there is a shortage of mental health professionals, and there are often long wait lists to get care. And even if it was all easy, I’ll point out that working with a therapist is a bit different then going to an urgent care center to have sutures removed or to obtain antibiotics for strep throat: The relationship is not easily interchangeable, and I know of no one who would think it clinically optimal for anyone to change psychotherapists every 3 months. The traveling nurse does not just need to find a “provider” in each state, he needs to find one he is comfortable with and he will have to spend several sessions relaying his history and forming a new therapeutic alliance. And given the ambiguities of psychotherapy, he would optimally see therapists who do not make conflicting interpretations or recommendations. Mind-boggling. And while none of us are irreplaceable, it feels heartless to tell someone who is traveling to provide medical care to others during a pandemic that they can’t have mental health care when our technology would allow for it.

In the “old days” it was simpler: Patients came to the office and both the patient and the clinician were physically located in the same state, even if the patient resided in another state and commuted hours to the appointment. Telemental health was done in select rural areas or in military settings, and most physicians did not consider the option for video visits, much less full video treatment. For the average practitioner, issues of location were not relevant. The exception was for college students who might reside in one state and see a psychiatrist or therapist in another, but typically everyone was comfortable taking a break from therapy when the patient could not meet with the therapist in person. If psychiatrists were having phone or video sessions with out-of-state patients on an occasional basis, it may have been because there was less scrutiny and it was less obvious that this was not permitted.

When the pandemic forced treatment to go online, the issues changed. At the beginning, issues related to state licensing were waived. Now each state has a different requirement with regard to out-of-state physicians; some allow their residents to be seen, while others require the physician to get licensed in their state and the process may or may not be costly or arduous for the provider. The regulations change frequently, and can be quite confusing to follow. Since psychiatry is a shortage field, many psychiatrists are not looking to have more patients from other states and are not motivated to apply for extra licenses.

Life as a practicing psychiatrist has been a moving target: I reopened my practice for some in-person visits for vaccinated patients in June 2021, then closed it when the Omicron surge seemed too risky, and I’ll be reopening soon. Patients, too, have had unpredictable lives.

For the practitioner who is following the rules precisely, the issues can be sticky. It may be fine to have Zoom visits with a patient who lives across the street, but not with the elderly patient who has to drive 90 minutes across a state line, and it’s always fine to have a video session with a patient in Guam. If a patient signs on for a video visit with a doctor licensed in Maine and announces there will be a visit to a brother in Michigan, does the clinician abruptly end the session? Does he charge for the then missed appointment, and don’t we feel this is a waste of the psychiatrist’s time when appointments are limited?

If college students started with therapists in their home states when universities shut down in the spring of 2020, must they now try to get treatment in the states where their college campuses are located? What if the university has a long wait for services, there are no local psychiatrists taking on new patients, or the student feels he is making good progress with the doctor he is working with? And how do we even know for sure where our patients are located? Are we obligated to ask for a precise location at the beginning of each session? What if patients do not offer their locations, or lie about where they are?

Oddly, the issue is with the location of the patient; the doctor can be anywhere as long as the patient’s body is in a state where he or she is licensed. And it has never been a problem to send prescriptions to pharmacies in other states, though this seems to me the essence of practicing across state lines.

In the State of the Union Address on March 1, President Biden had a hefty agenda: The Russian invasion of Ukraine, a global pandemic, spiraling inflation, and for the first time in a SOTU address, our president discussed a strategy to address our National Mental Health Crisis. The fact sheet released by the White House details many long-awaited changes to increase the mental health workforce to address shortages, instituting a “988” crisis line to initiate “someone to call, someone to respond, and somewhere for every American in crisis to go.” The proposals call for a sweeping reform in providing access to services, strengthening parity, and improving community, veterans, and university services – and the Biden administration specifically addresses telemental health. “To maintain continuity of access, the Administration will work with Congress to ensure coverage of tele-behavioral health across health plans, and support appropriate delivery of telemedicine across state lines.”

This is good news, as it’s time we concentrated on allowing for access to care in a consumer-oriented way. It may let us focus on offering good clinical care and not focus on following outdated regulations. Hopefully, those who want help will be able to access it, and perhaps soon a traveling nurse will be permitted to get mental health care with continuity of treatment.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.

I was taught to think clinically first and legally second. There are moments when following every regulation is clearly detrimental to the well-being of both the patient and the medical community at large, and these challenges have been highlighted by issues with telemental health during the pandemic.

A friend emailed me with a problem: He has a son who is a traveling nurse and is currently in psychotherapy. The therapist has, in accordance with licensing requirements, told his son that she can not see him when assignments take him to any state where she is not licensed. The patient needs to physically be in the same state where the clinician holds a license, technically for every appointment. The nursing assignments last for 3 months and he will be going to a variety of states. Does he really need to get a new therapist every 90 days?

The logistics seem mind-boggling in a time when there is a shortage of mental health professionals, and there are often long wait lists to get care. And even if it was all easy, I’ll point out that working with a therapist is a bit different then going to an urgent care center to have sutures removed or to obtain antibiotics for strep throat: The relationship is not easily interchangeable, and I know of no one who would think it clinically optimal for anyone to change psychotherapists every 3 months. The traveling nurse does not just need to find a “provider” in each state, he needs to find one he is comfortable with and he will have to spend several sessions relaying his history and forming a new therapeutic alliance. And given the ambiguities of psychotherapy, he would optimally see therapists who do not make conflicting interpretations or recommendations. Mind-boggling. And while none of us are irreplaceable, it feels heartless to tell someone who is traveling to provide medical care to others during a pandemic that they can’t have mental health care when our technology would allow for it.

In the “old days” it was simpler: Patients came to the office and both the patient and the clinician were physically located in the same state, even if the patient resided in another state and commuted hours to the appointment. Telemental health was done in select rural areas or in military settings, and most physicians did not consider the option for video visits, much less full video treatment. For the average practitioner, issues of location were not relevant. The exception was for college students who might reside in one state and see a psychiatrist or therapist in another, but typically everyone was comfortable taking a break from therapy when the patient could not meet with the therapist in person. If psychiatrists were having phone or video sessions with out-of-state patients on an occasional basis, it may have been because there was less scrutiny and it was less obvious that this was not permitted.

When the pandemic forced treatment to go online, the issues changed. At the beginning, issues related to state licensing were waived. Now each state has a different requirement with regard to out-of-state physicians; some allow their residents to be seen, while others require the physician to get licensed in their state and the process may or may not be costly or arduous for the provider. The regulations change frequently, and can be quite confusing to follow. Since psychiatry is a shortage field, many psychiatrists are not looking to have more patients from other states and are not motivated to apply for extra licenses.

Life as a practicing psychiatrist has been a moving target: I reopened my practice for some in-person visits for vaccinated patients in June 2021, then closed it when the Omicron surge seemed too risky, and I’ll be reopening soon. Patients, too, have had unpredictable lives.

For the practitioner who is following the rules precisely, the issues can be sticky. It may be fine to have Zoom visits with a patient who lives across the street, but not with the elderly patient who has to drive 90 minutes across a state line, and it’s always fine to have a video session with a patient in Guam. If a patient signs on for a video visit with a doctor licensed in Maine and announces there will be a visit to a brother in Michigan, does the clinician abruptly end the session? Does he charge for the then missed appointment, and don’t we feel this is a waste of the psychiatrist’s time when appointments are limited?

If college students started with therapists in their home states when universities shut down in the spring of 2020, must they now try to get treatment in the states where their college campuses are located? What if the university has a long wait for services, there are no local psychiatrists taking on new patients, or the student feels he is making good progress with the doctor he is working with? And how do we even know for sure where our patients are located? Are we obligated to ask for a precise location at the beginning of each session? What if patients do not offer their locations, or lie about where they are?

Oddly, the issue is with the location of the patient; the doctor can be anywhere as long as the patient’s body is in a state where he or she is licensed. And it has never been a problem to send prescriptions to pharmacies in other states, though this seems to me the essence of practicing across state lines.

In the State of the Union Address on March 1, President Biden had a hefty agenda: The Russian invasion of Ukraine, a global pandemic, spiraling inflation, and for the first time in a SOTU address, our president discussed a strategy to address our National Mental Health Crisis. The fact sheet released by the White House details many long-awaited changes to increase the mental health workforce to address shortages, instituting a “988” crisis line to initiate “someone to call, someone to respond, and somewhere for every American in crisis to go.” The proposals call for a sweeping reform in providing access to services, strengthening parity, and improving community, veterans, and university services – and the Biden administration specifically addresses telemental health. “To maintain continuity of access, the Administration will work with Congress to ensure coverage of tele-behavioral health across health plans, and support appropriate delivery of telemedicine across state lines.”

This is good news, as it’s time we concentrated on allowing for access to care in a consumer-oriented way. It may let us focus on offering good clinical care and not focus on following outdated regulations. Hopefully, those who want help will be able to access it, and perhaps soon a traveling nurse will be permitted to get mental health care with continuity of treatment.

Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. Dr. Miller has no conflicts of interest.