It wasn’t until I (Dr. Leistikow) finished my psychiatry residency that I realized the training I had received in women’s mental health was unusual. It was simply a required experience for PGY-3 residents at Johns Hopkins University, Baltimore.

Rawpixel/Getty Images

All of us, regardless of interest, spent 1 afternoon a week over 6 months caring for patients in a specialty psychiatric clinic for women (run by Dr. Payne and Dr. Osborne). We discussed cases and received didactics on such topics as risk factors for postpartum depression; the risks of untreated mental illness in pregnancy, compared with the risks of various psychiatric medications; how to choose and dose medications for bipolar disorder as blood levels change across pregnancy; which resources to consult to determine the amounts and risks of various medications passed on in breast milk; and how to diagnose and treat premenstrual dysphoric disorder, to name a few lecture subjects.

By the time we were done, all residents had received more than 20 hours of teaching about how to treat mental illness in women across the reproductive life cycle. This was 20 hours more than is currently required by the American College of Graduate Medical Education, the accrediting body for all residencies, including psychiatry.¹ It is time for that to change.

Women’s need for psychiatric treatment that addresses reproductive transitions is not new; it is as old as time. Not only do women who previously needed psychiatric treatment continue to need treatment when they get pregnant or are breastfeeding, but it is now well recognized that times of reproductive transition or flux – whether premenstrual, post partum, or perimenopausal – confer increased risk for both new-onset and exacerbations of prior mental illnesses.

What has changed is psychiatry’s ability to finally meet that need. Previously, despite the fact that women make up the majority of patients presenting for treatment, that nearly all women will menstruate and go through menopause, and that more than 80% of American women will have at least one pregnancy during their lifetime,psychiatrists practice as if these reproductive transitions were unfortunate blips getting in the doctor’s way.² We mostly threw up our hands when our patients became pregnant, reflexively stopped all medications, and expected women to suffer for the sake of their babies.

Over the last 20-30 years, however, a grassroots movement has established what is now an international reproductive psychiatry community with a large and growing research base, with both agreed-upon best practices and evolving standards of care informed by and responsive to the scientific literature. We now know that untreated maternal psychiatric illness carries its own risks for infants both before and after delivery; that many maternal pharmacologic treatments are lower risk for infants than previously thought; that protecting and treating women’s mental health in pregnancy has benefits for women, their babies, and the families that depend on them; and that there is now a growing evidence base informing both new and older treatments and enabling women and their doctors to make complex decisions balancing risk and benefit across the life cycle.

Many psychiatrists-in-training are hungry for this knowledge. At last count, in the United States alone, there were 16 women’s mental health fellowships available, up from just 3 in 2008.³ The problem is that none of them are accredited or funded by the ACGME, because reproductive psychiatry (here used interchangeably with the term women’s mental health) has not been officially recognized as a subspecialty. This means that current funding frequently rests on philanthropy, which often cannot be sustained, and clinical billing, which gives fellows in some programs such heavy clinical responsibilities that little time is left for scholarly work. Lack of subspecialty status also blocks numerous important downstream effects that would flow from this recognition.

Reproductive psychiatry clearly already meets criteria laid out by the American Board of Medical Specialties for defining a subspecialty field. As argued elsewhere, it has a distinct patient population with definable care needs and a standalone body of scientific medical knowledge as well as a national (and international) community of experts that has already done much to improve women’s access to care they desperately need.⁴ It also meets the ACGME’s criteria for a new subspecialty except for approval by the American Board of Psychiatry and Neurology.⁵ Finally, it also meets the requirements of the ABPN except for having 25 fellowship programs with 50 fellowship positions and 50 trainees per year completing fellowships, a challenging Catch-22 without the necessary funding that would accrue from accreditation.⁶

Despite growing awareness and demand, there remains a shortage of psychiatrists trained to treat women during times of reproductive transition and to pass their recommendations and knowledge on to their primary care and ob.gyn. colleagues. What official recognition would bring, in addition to funding for fellowships post residency, is a guaranteed seat at the table in psychiatry residencies, in terms of a required number of hours devoted to these topics for trainees, ensuring that all graduating psychiatrists have at least some exposure to the knowledge and practices so material to their patients.

It isn’t enough to wait for residencies to see the writing on the wall and voluntarily carve out a slice of pie devoted to women’s mental health from the limited time and resources available to train residents. A 2017 survey of psychiatry residency program training directors found that 23%, or almost a quarter of programs that responded, offered no reproductive psychiatry training at all, that 49% required 5 hours or less across all 4 years of training, and that 75% of programs had no required clinical exposure to reproductive psychiatry patients.⁷ Despite the fact that 87% of training directors surveyed agreed either that reproductive psychiatry was “an important area of education” or a subject general residents should be competent in, ACGME-recognized specialties take precedence.

A system so patchy and insufficient won’t do. It’s not good enough for the trainees who frequently have to look outside of their own institutions for the training they know they need. It’s not good enough for the pregnant or postpartum patient looking for evidence-based advice, who is currently left on her own to determine, prior to booking an appointment, whether a specific psychiatrist has received any training relevant to treating her. Adding reproductive psychiatry to the topics a graduating psychiatrist must have some proficiency in also signals to recent graduates and experienced attendings, as well as the relevant examining boards and producers of continuing medical education content, that women’s mental health is no longer a fringe topic but rather foundational to all practicing psychiatrists.

The oil needed to prime this pump is official recognition of the subspecialty that reproductive psychiatry already is. The women’s mental health community is ready. The research base is well established and growing exponentially. The number of women’s mental health fellowships is healthy and would increase significantly with ACGME funding. Psychiatry residency training programs can turn to recent graduates of these fellowships as well as their own faculty with reproductive psychiatry experience to teach trainees. In addition, the National Curriculum in Reproductive Psychiatry, over the last 4 years, has created a repository of free online modules dedicated to facilitating this type of training, with case discussions across numerous topics for use by both educators and trainees. The American Psychiatric Association recently formed the Committee on Women’s Mental Health in 2020 and will be publishing a textbook based on work done by the NCRP within the coming year.

Imagine the changed world that would open to all psychiatrists if reproductive psychiatry were given the credentials it deserves. When writing prescriptions, we would view pregnancy as the potential outcome it is in any woman of reproductive age, given that 50% of pregnancies are unplanned, and let women know ahead of time how to think about possible fetal effects rather than waiting for their panicked phone messages or hearing that they have stopped their medications abruptly. We would work to identify our patient’s individual risk factors for postpartum depression predelivery to reduce that risk and prevent or limit illness. We would plan ahead for close follow-up post partum during the window of greatest risk, rather than expecting women to drop out of care while taking care of their infants or languish on scheduling waiting lists. We would feel confident in giving evidence-based advice to our patients around times of reproductive transition across the life cycle, but especially in pregnancy and lactation, empowering women to make healthy decisions for themselves and their families, no longer abandoning them just when they need us most.

 

References

1. ACGME Program Requirements for Graduate Medical Education in Psychiatry. Accreditation Counsel for Graduate Medical Education. 2020 Jul 1.

2. Livingston G. “They’re waiting longer, but U.S. women today more likely to have children than a decade ago.” Pew Research Center’s Social & Demographic Trends Project. pewsocialtrends.org. 2018 Jan 18.

3. Nagle-Yang S et al. Acad Psychiatry. 2018 Apr;42(2):202-6.

4. Payne JL. Int Rev Psychiatry. 2019 May;31(3):207-9.

5. Accreditation Council for Graduate Medical Education Policies and Procedures. 2020 Sep 26.

6. American Board of Psychiatry and Neurology. Requirements for Subspecialty Recognition, Attachment A. 2008.

7. Osborne LM et al. Acad Psychiatry. 2018 Apr;42(2):197-201.
 

Dr. Leistikow is a reproductive psychiatrist and clinical assistant professor in the department of psychiatry at the University of Maryland, Baltimore, where she sees patients and helps train residents and fellows. She is on the education committee of the National Curriculum in Reproductive Psychiatry (NCRPtraining.org) and has written about women’s mental health for textbooks, scientific journals and on her private practice blog at www.womenspsychiatrybaltimore.com. Dr. Leistikow has no conflicts of interest.

Dr. Payne is associate professor of psychiatry and behavioral sciences and director of the Women’s Mood Disorders Center at Johns Hopkins University, Baltimore. In addition to providing outstanding clinical care for women with mood disorders, she conducts research into the genetic, biological, and environmental factors involved in postpartum depression. She and her colleagues have recently identified two epigenetic biomarkers of postpartum depression and are working hard to replicate this work with National Institutes of Health funding. Most recently, she was appointed to the American Psychiatric Association’s committee on women’s mental health and is serving as president-elect for both the Marcé of North America and the International Marcé Perinatal Mental Health Societies. She disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Sage Therapeutics and Janssen Pharmaceuticals.
 

Dr. Osborne is associate professor of psychiatry and behavioral sciences and of gynecology and obstetrics at Johns Hopkins University, where she directs a postdoctoral fellowship program in reproductive psychiatry. She is an expert on the diagnosis and treatment of mood and anxiety disorders during pregnancy, the post partum, the premenstrual period, and perimenopause. Her work is supported by the Brain and Behavior Foundation, the Doris Duke Foundation, the American Board of Psychiatry and Neurology, and the National Institute of Mental Health. She has no conflicts of interest.

It wasn’t until I (Dr. Leistikow) finished my psychiatry residency that I realized the training I had received in women’s mental health was unusual. It was simply a required experience for PGY-3 residents at Johns Hopkins University, Baltimore.

Rawpixel/Getty Images

All of us, regardless of interest, spent 1 afternoon a week over 6 months caring for patients in a specialty psychiatric clinic for women (run by Dr. Payne and Dr. Osborne). We discussed cases and received didactics on such topics as risk factors for postpartum depression; the risks of untreated mental illness in pregnancy, compared with the risks of various psychiatric medications; how to choose and dose medications for bipolar disorder as blood levels change across pregnancy; which resources to consult to determine the amounts and risks of various medications passed on in breast milk; and how to diagnose and treat premenstrual dysphoric disorder, to name a few lecture subjects.

By the time we were done, all residents had received more than 20 hours of teaching about how to treat mental illness in women across the reproductive life cycle. This was 20 hours more than is currently required by the American College of Graduate Medical Education, the accrediting body for all residencies, including psychiatry.¹ It is time for that to change.

Women’s need for psychiatric treatment that addresses reproductive transitions is not new; it is as old as time. Not only do women who previously needed psychiatric treatment continue to need treatment when they get pregnant or are breastfeeding, but it is now well recognized that times of reproductive transition or flux – whether premenstrual, post partum, or perimenopausal – confer increased risk for both new-onset and exacerbations of prior mental illnesses.

What has changed is psychiatry’s ability to finally meet that need. Previously, despite the fact that women make up the majority of patients presenting for treatment, that nearly all women will menstruate and go through menopause, and that more than 80% of American women will have at least one pregnancy during their lifetime,psychiatrists practice as if these reproductive transitions were unfortunate blips getting in the doctor’s way.² We mostly threw up our hands when our patients became pregnant, reflexively stopped all medications, and expected women to suffer for the sake of their babies.

Over the last 20-30 years, however, a grassroots movement has established what is now an international reproductive psychiatry community with a large and growing research base, with both agreed-upon best practices and evolving standards of care informed by and responsive to the scientific literature. We now know that untreated maternal psychiatric illness carries its own risks for infants both before and after delivery; that many maternal pharmacologic treatments are lower risk for infants than previously thought; that protecting and treating women’s mental health in pregnancy has benefits for women, their babies, and the families that depend on them; and that there is now a growing evidence base informing both new and older treatments and enabling women and their doctors to make complex decisions balancing risk and benefit across the life cycle.

Many psychiatrists-in-training are hungry for this knowledge. At last count, in the United States alone, there were 16 women’s mental health fellowships available, up from just 3 in 2008.³ The problem is that none of them are accredited or funded by the ACGME, because reproductive psychiatry (here used interchangeably with the term women’s mental health) has not been officially recognized as a subspecialty. This means that current funding frequently rests on philanthropy, which often cannot be sustained, and clinical billing, which gives fellows in some programs such heavy clinical responsibilities that little time is left for scholarly work. Lack of subspecialty status also blocks numerous important downstream effects that would flow from this recognition.

Reproductive psychiatry clearly already meets criteria laid out by the American Board of Medical Specialties for defining a subspecialty field. As argued elsewhere, it has a distinct patient population with definable care needs and a standalone body of scientific medical knowledge as well as a national (and international) community of experts that has already done much to improve women’s access to care they desperately need.⁴ It also meets the ACGME’s criteria for a new subspecialty except for approval by the American Board of Psychiatry and Neurology.⁵ Finally, it also meets the requirements of the ABPN except for having 25 fellowship programs with 50 fellowship positions and 50 trainees per year completing fellowships, a challenging Catch-22 without the necessary funding that would accrue from accreditation.⁶

Despite growing awareness and demand, there remains a shortage of psychiatrists trained to treat women during times of reproductive transition and to pass their recommendations and knowledge on to their primary care and ob.gyn. colleagues. What official recognition would bring, in addition to funding for fellowships post residency, is a guaranteed seat at the table in psychiatry residencies, in terms of a required number of hours devoted to these topics for trainees, ensuring that all graduating psychiatrists have at least some exposure to the knowledge and practices so material to their patients.

It isn’t enough to wait for residencies to see the writing on the wall and voluntarily carve out a slice of pie devoted to women’s mental health from the limited time and resources available to train residents. A 2017 survey of psychiatry residency program training directors found that 23%, or almost a quarter of programs that responded, offered no reproductive psychiatry training at all, that 49% required 5 hours or less across all 4 years of training, and that 75% of programs had no required clinical exposure to reproductive psychiatry patients.⁷ Despite the fact that 87% of training directors surveyed agreed either that reproductive psychiatry was “an important area of education” or a subject general residents should be competent in, ACGME-recognized specialties take precedence.

A system so patchy and insufficient won’t do. It’s not good enough for the trainees who frequently have to look outside of their own institutions for the training they know they need. It’s not good enough for the pregnant or postpartum patient looking for evidence-based advice, who is currently left on her own to determine, prior to booking an appointment, whether a specific psychiatrist has received any training relevant to treating her. Adding reproductive psychiatry to the topics a graduating psychiatrist must have some proficiency in also signals to recent graduates and experienced attendings, as well as the relevant examining boards and producers of continuing medical education content, that women’s mental health is no longer a fringe topic but rather foundational to all practicing psychiatrists.

The oil needed to prime this pump is official recognition of the subspecialty that reproductive psychiatry already is. The women’s mental health community is ready. The research base is well established and growing exponentially. The number of women’s mental health fellowships is healthy and would increase significantly with ACGME funding. Psychiatry residency training programs can turn to recent graduates of these fellowships as well as their own faculty with reproductive psychiatry experience to teach trainees. In addition, the National Curriculum in Reproductive Psychiatry, over the last 4 years, has created a repository of free online modules dedicated to facilitating this type of training, with case discussions across numerous topics for use by both educators and trainees. The American Psychiatric Association recently formed the Committee on Women’s Mental Health in 2020 and will be publishing a textbook based on work done by the NCRP within the coming year.

Imagine the changed world that would open to all psychiatrists if reproductive psychiatry were given the credentials it deserves. When writing prescriptions, we would view pregnancy as the potential outcome it is in any woman of reproductive age, given that 50% of pregnancies are unplanned, and let women know ahead of time how to think about possible fetal effects rather than waiting for their panicked phone messages or hearing that they have stopped their medications abruptly. We would work to identify our patient’s individual risk factors for postpartum depression predelivery to reduce that risk and prevent or limit illness. We would plan ahead for close follow-up post partum during the window of greatest risk, rather than expecting women to drop out of care while taking care of their infants or languish on scheduling waiting lists. We would feel confident in giving evidence-based advice to our patients around times of reproductive transition across the life cycle, but especially in pregnancy and lactation, empowering women to make healthy decisions for themselves and their families, no longer abandoning them just when they need us most.

 

References

1. ACGME Program Requirements for Graduate Medical Education in Psychiatry. Accreditation Counsel for Graduate Medical Education. 2020 Jul 1.

2. Livingston G. “They’re waiting longer, but U.S. women today more likely to have children than a decade ago.” Pew Research Center’s Social & Demographic Trends Project. pewsocialtrends.org. 2018 Jan 18.

3. Nagle-Yang S et al. Acad Psychiatry. 2018 Apr;42(2):202-6.

4. Payne JL. Int Rev Psychiatry. 2019 May;31(3):207-9.

5. Accreditation Council for Graduate Medical Education Policies and Procedures. 2020 Sep 26.

6. American Board of Psychiatry and Neurology. Requirements for Subspecialty Recognition, Attachment A. 2008.

7. Osborne LM et al. Acad Psychiatry. 2018 Apr;42(2):197-201.
 

Dr. Leistikow is a reproductive psychiatrist and clinical assistant professor in the department of psychiatry at the University of Maryland, Baltimore, where she sees patients and helps train residents and fellows. She is on the education committee of the National Curriculum in Reproductive Psychiatry (NCRPtraining.org) and has written about women’s mental health for textbooks, scientific journals and on her private practice blog at www.womenspsychiatrybaltimore.com. Dr. Leistikow has no conflicts of interest.

Dr. Payne is associate professor of psychiatry and behavioral sciences and director of the Women’s Mood Disorders Center at Johns Hopkins University, Baltimore. In addition to providing outstanding clinical care for women with mood disorders, she conducts research into the genetic, biological, and environmental factors involved in postpartum depression. She and her colleagues have recently identified two epigenetic biomarkers of postpartum depression and are working hard to replicate this work with National Institutes of Health funding. Most recently, she was appointed to the American Psychiatric Association’s committee on women’s mental health and is serving as president-elect for both the Marcé of North America and the International Marcé Perinatal Mental Health Societies. She disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Sage Therapeutics and Janssen Pharmaceuticals.
 

Dr. Osborne is associate professor of psychiatry and behavioral sciences and of gynecology and obstetrics at Johns Hopkins University, where she directs a postdoctoral fellowship program in reproductive psychiatry. She is an expert on the diagnosis and treatment of mood and anxiety disorders during pregnancy, the post partum, the premenstrual period, and perimenopause. Her work is supported by the Brain and Behavior Foundation, the Doris Duke Foundation, the American Board of Psychiatry and Neurology, and the National Institute of Mental Health. She has no conflicts of interest.

It wasn’t until I (Dr. Leistikow) finished my psychiatry residency that I realized the training I had received in women’s mental health was unusual. It was simply a required experience for PGY-3 residents at Johns Hopkins University, Baltimore.

Rawpixel/Getty Images

All of us, regardless of interest, spent 1 afternoon a week over 6 months caring for patients in a specialty psychiatric clinic for women (run by Dr. Payne and Dr. Osborne). We discussed cases and received didactics on such topics as risk factors for postpartum depression; the risks of untreated mental illness in pregnancy, compared with the risks of various psychiatric medications; how to choose and dose medications for bipolar disorder as blood levels change across pregnancy; which resources to consult to determine the amounts and risks of various medications passed on in breast milk; and how to diagnose and treat premenstrual dysphoric disorder, to name a few lecture subjects.

By the time we were done, all residents had received more than 20 hours of teaching about how to treat mental illness in women across the reproductive life cycle. This was 20 hours more than is currently required by the American College of Graduate Medical Education, the accrediting body for all residencies, including psychiatry.¹ It is time for that to change.

Women’s need for psychiatric treatment that addresses reproductive transitions is not new; it is as old as time. Not only do women who previously needed psychiatric treatment continue to need treatment when they get pregnant or are breastfeeding, but it is now well recognized that times of reproductive transition or flux – whether premenstrual, post partum, or perimenopausal – confer increased risk for both new-onset and exacerbations of prior mental illnesses.

What has changed is psychiatry’s ability to finally meet that need. Previously, despite the fact that women make up the majority of patients presenting for treatment, that nearly all women will menstruate and go through menopause, and that more than 80% of American women will have at least one pregnancy during their lifetime,psychiatrists practice as if these reproductive transitions were unfortunate blips getting in the doctor’s way.² We mostly threw up our hands when our patients became pregnant, reflexively stopped all medications, and expected women to suffer for the sake of their babies.

Over the last 20-30 years, however, a grassroots movement has established what is now an international reproductive psychiatry community with a large and growing research base, with both agreed-upon best practices and evolving standards of care informed by and responsive to the scientific literature. We now know that untreated maternal psychiatric illness carries its own risks for infants both before and after delivery; that many maternal pharmacologic treatments are lower risk for infants than previously thought; that protecting and treating women’s mental health in pregnancy has benefits for women, their babies, and the families that depend on them; and that there is now a growing evidence base informing both new and older treatments and enabling women and their doctors to make complex decisions balancing risk and benefit across the life cycle.

Many psychiatrists-in-training are hungry for this knowledge. At last count, in the United States alone, there were 16 women’s mental health fellowships available, up from just 3 in 2008.³ The problem is that none of them are accredited or funded by the ACGME, because reproductive psychiatry (here used interchangeably with the term women’s mental health) has not been officially recognized as a subspecialty. This means that current funding frequently rests on philanthropy, which often cannot be sustained, and clinical billing, which gives fellows in some programs such heavy clinical responsibilities that little time is left for scholarly work. Lack of subspecialty status also blocks numerous important downstream effects that would flow from this recognition.

Reproductive psychiatry clearly already meets criteria laid out by the American Board of Medical Specialties for defining a subspecialty field. As argued elsewhere, it has a distinct patient population with definable care needs and a standalone body of scientific medical knowledge as well as a national (and international) community of experts that has already done much to improve women’s access to care they desperately need.⁴ It also meets the ACGME’s criteria for a new subspecialty except for approval by the American Board of Psychiatry and Neurology.⁵ Finally, it also meets the requirements of the ABPN except for having 25 fellowship programs with 50 fellowship positions and 50 trainees per year completing fellowships, a challenging Catch-22 without the necessary funding that would accrue from accreditation.⁶

Despite growing awareness and demand, there remains a shortage of psychiatrists trained to treat women during times of reproductive transition and to pass their recommendations and knowledge on to their primary care and ob.gyn. colleagues. What official recognition would bring, in addition to funding for fellowships post residency, is a guaranteed seat at the table in psychiatry residencies, in terms of a required number of hours devoted to these topics for trainees, ensuring that all graduating psychiatrists have at least some exposure to the knowledge and practices so material to their patients.

It isn’t enough to wait for residencies to see the writing on the wall and voluntarily carve out a slice of pie devoted to women’s mental health from the limited time and resources available to train residents. A 2017 survey of psychiatry residency program training directors found that 23%, or almost a quarter of programs that responded, offered no reproductive psychiatry training at all, that 49% required 5 hours or less across all 4 years of training, and that 75% of programs had no required clinical exposure to reproductive psychiatry patients.⁷ Despite the fact that 87% of training directors surveyed agreed either that reproductive psychiatry was “an important area of education” or a subject general residents should be competent in, ACGME-recognized specialties take precedence.

A system so patchy and insufficient won’t do. It’s not good enough for the trainees who frequently have to look outside of their own institutions for the training they know they need. It’s not good enough for the pregnant or postpartum patient looking for evidence-based advice, who is currently left on her own to determine, prior to booking an appointment, whether a specific psychiatrist has received any training relevant to treating her. Adding reproductive psychiatry to the topics a graduating psychiatrist must have some proficiency in also signals to recent graduates and experienced attendings, as well as the relevant examining boards and producers of continuing medical education content, that women’s mental health is no longer a fringe topic but rather foundational to all practicing psychiatrists.

The oil needed to prime this pump is official recognition of the subspecialty that reproductive psychiatry already is. The women’s mental health community is ready. The research base is well established and growing exponentially. The number of women’s mental health fellowships is healthy and would increase significantly with ACGME funding. Psychiatry residency training programs can turn to recent graduates of these fellowships as well as their own faculty with reproductive psychiatry experience to teach trainees. In addition, the National Curriculum in Reproductive Psychiatry, over the last 4 years, has created a repository of free online modules dedicated to facilitating this type of training, with case discussions across numerous topics for use by both educators and trainees. The American Psychiatric Association recently formed the Committee on Women’s Mental Health in 2020 and will be publishing a textbook based on work done by the NCRP within the coming year.

Imagine the changed world that would open to all psychiatrists if reproductive psychiatry were given the credentials it deserves. When writing prescriptions, we would view pregnancy as the potential outcome it is in any woman of reproductive age, given that 50% of pregnancies are unplanned, and let women know ahead of time how to think about possible fetal effects rather than waiting for their panicked phone messages or hearing that they have stopped their medications abruptly. We would work to identify our patient’s individual risk factors for postpartum depression predelivery to reduce that risk and prevent or limit illness. We would plan ahead for close follow-up post partum during the window of greatest risk, rather than expecting women to drop out of care while taking care of their infants or languish on scheduling waiting lists. We would feel confident in giving evidence-based advice to our patients around times of reproductive transition across the life cycle, but especially in pregnancy and lactation, empowering women to make healthy decisions for themselves and their families, no longer abandoning them just when they need us most.

 

References

1. ACGME Program Requirements for Graduate Medical Education in Psychiatry. Accreditation Counsel for Graduate Medical Education. 2020 Jul 1.

2. Livingston G. “They’re waiting longer, but U.S. women today more likely to have children than a decade ago.” Pew Research Center’s Social & Demographic Trends Project. pewsocialtrends.org. 2018 Jan 18.

3. Nagle-Yang S et al. Acad Psychiatry. 2018 Apr;42(2):202-6.

4. Payne JL. Int Rev Psychiatry. 2019 May;31(3):207-9.

5. Accreditation Council for Graduate Medical Education Policies and Procedures. 2020 Sep 26.

6. American Board of Psychiatry and Neurology. Requirements for Subspecialty Recognition, Attachment A. 2008.

7. Osborne LM et al. Acad Psychiatry. 2018 Apr;42(2):197-201.
 

Dr. Leistikow is a reproductive psychiatrist and clinical assistant professor in the department of psychiatry at the University of Maryland, Baltimore, where she sees patients and helps train residents and fellows. She is on the education committee of the National Curriculum in Reproductive Psychiatry (NCRPtraining.org) and has written about women’s mental health for textbooks, scientific journals and on her private practice blog at www.womenspsychiatrybaltimore.com. Dr. Leistikow has no conflicts of interest.

Dr. Payne is associate professor of psychiatry and behavioral sciences and director of the Women’s Mood Disorders Center at Johns Hopkins University, Baltimore. In addition to providing outstanding clinical care for women with mood disorders, she conducts research into the genetic, biological, and environmental factors involved in postpartum depression. She and her colleagues have recently identified two epigenetic biomarkers of postpartum depression and are working hard to replicate this work with National Institutes of Health funding. Most recently, she was appointed to the American Psychiatric Association’s committee on women’s mental health and is serving as president-elect for both the Marcé of North America and the International Marcé Perinatal Mental Health Societies. She disclosed the following relevant financial relationships: serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Sage Therapeutics and Janssen Pharmaceuticals.
 

Dr. Osborne is associate professor of psychiatry and behavioral sciences and of gynecology and obstetrics at Johns Hopkins University, where she directs a postdoctoral fellowship program in reproductive psychiatry. She is an expert on the diagnosis and treatment of mood and anxiety disorders during pregnancy, the post partum, the premenstrual period, and perimenopause. Her work is supported by the Brain and Behavior Foundation, the Doris Duke Foundation, the American Board of Psychiatry and Neurology, and the National Institute of Mental Health. She has no conflicts of interest.

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

[email protected]

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

[email protected]

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

[email protected]

Until now, the neurological manifestations of COVID-19 have been believed to be a result of direct damage to nerve cells. However, a new study suggests that the virus might actually damage the brain’s small blood vessels rather than nerve cells themselves.

A postmortem analysis found abnormalities in the brains of a small sample of patients with COVID-19, suggesting inflammation and vascular damage to the brain stem and olfactory bulb. The findings add further weight to previous research into neurological complications from COVID-19, according to Anna Cervantes, MD. Dr. Cervantes is assistant professor of neurology at the Boston University and has been studying the neurological effects of COVID-19, though she was not involved in this study. “I can tell from my personal experience, and things we’ve published on and the literature that’s out there – there are patients that are having complications like stroke that aren’t even critically ill from COVID. We’re seeing that not in just the acute setting, but also in a delayed fashion. Even though most of the coagulopathy is largely venous and probably microvascular, this does affect the brain through a myriad of ways,” Dr. Cervantes said.

The research was published online Jan. 12 in the New England Journal of Medicine. Myoung‑Hwa Lee, PhD, was the lead author.

The study included high resolution magnetic resonance imaging and histopathological examination of 13 individuals with a median age of 50 years. Among 10 patients with brain alterations, the researchers conducted further studies in 5 individuals using multiplex fluorescence imaging and chromogenic immunostaining in all 10.

The team conducted conventional histopathology on the brains of 18 individuals. Fourteen had a history of chronic illness, including diabetes, and hypertension, and 11 had died unexpectedly or been found dead. Magnetic resonance microscopy revealed punctuate hypo-intensities in nine subjects, indicating microvascular injury and fibrinogen leakage. Histopathology using fluorescence imaging showed the same features. Collagen IV immunostaining showed thinning of the basal lamina of the endothelial cells in five patients. Ten patients had congested blood vessels and surrounding fibrinogen leakage, but comparatively intact vasculature. The researchers interpreted linear hypo-intensities as micro-hemorrhages.

The researchers found little perivascular inflammation, and no vascular occlusion. Thirteen subjects had perivascular-activated microglia, macrophage infiltrates, and hypertrophic astrocytes. Eight had CD3+ and CD8+ T cells in the perivascular spaces and in lumens next to endothelial cells, which could help explain vascular injury.

The researchers found no evidence of the SARS-CoV-2 virus itself, despite efforts using polymerase chain reaction with multiple primer sets, RNA sequencing within the brain, or RNA in situ hybridization and immunostaining. Subjects may have cleared the virus by the time they died, or viral copy numbers could have been below the detection limit of the assays.

The researchers also obtained a convenience sample of subjects who had died from COVID-19. Magnetic resonance microscopy, histopathology, and immunohistochemical analysis of sections revealed microvascular injury in the brain and olfactory bulb, despite no evidence of viral infection. The authors stressed that they could not draw conclusions about the neurological features of COVID-19 because of a lack of clinical information.

Dr. Cervantes noted that limitation: “We’re seeing a lot of patients with encephalopathy or alterations in their mental status. A lot of things can cause that, and some are common in patients who are critically ill, like medications and metabolic derangement.”

Still, the findings could help to inform future medical management. “There’s going to be a large number of patients who don’t have really bad pulmonary disease but still may have encephalopathy. So if there is small vessel involvement because of inflammation that we might not necessarily catch in a lumbar puncture or routine imaging, there’s still somebody we can make better (using) steroids. Having more information on what’s happening on a pathophysiologic level and on pathology is really helpful.”

The study was supported by internal funds from the National Institute of Neurological Disorders and Stroke. Dr. Cervantes has no relevant financial disclosures.

Until now, the neurological manifestations of COVID-19 have been believed to be a result of direct damage to nerve cells. However, a new study suggests that the virus might actually damage the brain’s small blood vessels rather than nerve cells themselves.

A postmortem analysis found abnormalities in the brains of a small sample of patients with COVID-19, suggesting inflammation and vascular damage to the brain stem and olfactory bulb. The findings add further weight to previous research into neurological complications from COVID-19, according to Anna Cervantes, MD. Dr. Cervantes is assistant professor of neurology at the Boston University and has been studying the neurological effects of COVID-19, though she was not involved in this study. “I can tell from my personal experience, and things we’ve published on and the literature that’s out there – there are patients that are having complications like stroke that aren’t even critically ill from COVID. We’re seeing that not in just the acute setting, but also in a delayed fashion. Even though most of the coagulopathy is largely venous and probably microvascular, this does affect the brain through a myriad of ways,” Dr. Cervantes said.

The research was published online Jan. 12 in the New England Journal of Medicine. Myoung‑Hwa Lee, PhD, was the lead author.

The study included high resolution magnetic resonance imaging and histopathological examination of 13 individuals with a median age of 50 years. Among 10 patients with brain alterations, the researchers conducted further studies in 5 individuals using multiplex fluorescence imaging and chromogenic immunostaining in all 10.

The team conducted conventional histopathology on the brains of 18 individuals. Fourteen had a history of chronic illness, including diabetes, and hypertension, and 11 had died unexpectedly or been found dead. Magnetic resonance microscopy revealed punctuate hypo-intensities in nine subjects, indicating microvascular injury and fibrinogen leakage. Histopathology using fluorescence imaging showed the same features. Collagen IV immunostaining showed thinning of the basal lamina of the endothelial cells in five patients. Ten patients had congested blood vessels and surrounding fibrinogen leakage, but comparatively intact vasculature. The researchers interpreted linear hypo-intensities as micro-hemorrhages.

The researchers found little perivascular inflammation, and no vascular occlusion. Thirteen subjects had perivascular-activated microglia, macrophage infiltrates, and hypertrophic astrocytes. Eight had CD3+ and CD8+ T cells in the perivascular spaces and in lumens next to endothelial cells, which could help explain vascular injury.

The researchers found no evidence of the SARS-CoV-2 virus itself, despite efforts using polymerase chain reaction with multiple primer sets, RNA sequencing within the brain, or RNA in situ hybridization and immunostaining. Subjects may have cleared the virus by the time they died, or viral copy numbers could have been below the detection limit of the assays.

The researchers also obtained a convenience sample of subjects who had died from COVID-19. Magnetic resonance microscopy, histopathology, and immunohistochemical analysis of sections revealed microvascular injury in the brain and olfactory bulb, despite no evidence of viral infection. The authors stressed that they could not draw conclusions about the neurological features of COVID-19 because of a lack of clinical information.

Dr. Cervantes noted that limitation: “We’re seeing a lot of patients with encephalopathy or alterations in their mental status. A lot of things can cause that, and some are common in patients who are critically ill, like medications and metabolic derangement.”

Still, the findings could help to inform future medical management. “There’s going to be a large number of patients who don’t have really bad pulmonary disease but still may have encephalopathy. So if there is small vessel involvement because of inflammation that we might not necessarily catch in a lumbar puncture or routine imaging, there’s still somebody we can make better (using) steroids. Having more information on what’s happening on a pathophysiologic level and on pathology is really helpful.”

The study was supported by internal funds from the National Institute of Neurological Disorders and Stroke. Dr. Cervantes has no relevant financial disclosures.

Until now, the neurological manifestations of COVID-19 have been believed to be a result of direct damage to nerve cells. However, a new study suggests that the virus might actually damage the brain’s small blood vessels rather than nerve cells themselves.

A postmortem analysis found abnormalities in the brains of a small sample of patients with COVID-19, suggesting inflammation and vascular damage to the brain stem and olfactory bulb. The findings add further weight to previous research into neurological complications from COVID-19, according to Anna Cervantes, MD. Dr. Cervantes is assistant professor of neurology at the Boston University and has been studying the neurological effects of COVID-19, though she was not involved in this study. “I can tell from my personal experience, and things we’ve published on and the literature that’s out there – there are patients that are having complications like stroke that aren’t even critically ill from COVID. We’re seeing that not in just the acute setting, but also in a delayed fashion. Even though most of the coagulopathy is largely venous and probably microvascular, this does affect the brain through a myriad of ways,” Dr. Cervantes said.

The research was published online Jan. 12 in the New England Journal of Medicine. Myoung‑Hwa Lee, PhD, was the lead author.

The study included high resolution magnetic resonance imaging and histopathological examination of 13 individuals with a median age of 50 years. Among 10 patients with brain alterations, the researchers conducted further studies in 5 individuals using multiplex fluorescence imaging and chromogenic immunostaining in all 10.

The team conducted conventional histopathology on the brains of 18 individuals. Fourteen had a history of chronic illness, including diabetes, and hypertension, and 11 had died unexpectedly or been found dead. Magnetic resonance microscopy revealed punctuate hypo-intensities in nine subjects, indicating microvascular injury and fibrinogen leakage. Histopathology using fluorescence imaging showed the same features. Collagen IV immunostaining showed thinning of the basal lamina of the endothelial cells in five patients. Ten patients had congested blood vessels and surrounding fibrinogen leakage, but comparatively intact vasculature. The researchers interpreted linear hypo-intensities as micro-hemorrhages.

The researchers found little perivascular inflammation, and no vascular occlusion. Thirteen subjects had perivascular-activated microglia, macrophage infiltrates, and hypertrophic astrocytes. Eight had CD3+ and CD8+ T cells in the perivascular spaces and in lumens next to endothelial cells, which could help explain vascular injury.

The researchers found no evidence of the SARS-CoV-2 virus itself, despite efforts using polymerase chain reaction with multiple primer sets, RNA sequencing within the brain, or RNA in situ hybridization and immunostaining. Subjects may have cleared the virus by the time they died, or viral copy numbers could have been below the detection limit of the assays.

The researchers also obtained a convenience sample of subjects who had died from COVID-19. Magnetic resonance microscopy, histopathology, and immunohistochemical analysis of sections revealed microvascular injury in the brain and olfactory bulb, despite no evidence of viral infection. The authors stressed that they could not draw conclusions about the neurological features of COVID-19 because of a lack of clinical information.

Dr. Cervantes noted that limitation: “We’re seeing a lot of patients with encephalopathy or alterations in their mental status. A lot of things can cause that, and some are common in patients who are critically ill, like medications and metabolic derangement.”

Still, the findings could help to inform future medical management. “There’s going to be a large number of patients who don’t have really bad pulmonary disease but still may have encephalopathy. So if there is small vessel involvement because of inflammation that we might not necessarily catch in a lumbar puncture or routine imaging, there’s still somebody we can make better (using) steroids. Having more information on what’s happening on a pathophysiologic level and on pathology is really helpful.”

The study was supported by internal funds from the National Institute of Neurological Disorders and Stroke. Dr. Cervantes has no relevant financial disclosures.

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Allogeneic hematopoietic stem-cell transplantation (AHSCT) improved disease-free survival (DFS), compared with pediatric-inspired Berlin-Frankfurt-Münster (BFM-95) chemotherapy in adults with acute lymphoblastic leukemia (ALL), according to the results of retrospective study published in Clinical Lymphoma, Myeloma & Leukemia. However, overall survival (OS) was not significantly different between the two groups, as reported by Elifcan Aladag, MD, of the Hacettepe University Faculty of Medicine, Ankara, Turkey, and colleagues.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Despite this, “AHSCT is recommended for all patients with suitable donors, but the risk of transplant-related mortality should be kept in mind,” according to the researchers.

The multicenter study compared two different treatment approaches (BFM-95 chemotherapy regimen and AHSCT). The BFM-95 chemotherapy group comprised 47 newly diagnosed ALL patients. The transplant cohort comprised 83 patients with ALL in first complete remission who received AHSCT from fully matched human leukocyte antigen (HLA)-identical siblings. Thirty-five of the AHSCT patients (42.1%) received chemotherapy at least until the M stage of the BFM-95 protocol.

The primary endpoints of the study were OS and duration of DFS. OS was defined from the day of starting BFM-95 chemotherapy until death from any cause, and DFS was calculated from the date of complete remission until the date of first relapse or death from any cause, whichever occurred first, according to the authors.
 

Study results

The median OS was 68 months in patients who underwent AHSCT and 46 months in patients treated only with BFM-95 (P = .3). Two- and 5-year OS rates were 78% and 60% , respectively, in the AHSCT group, and 69% and 64% in the BFM-95 group (P = .06 and .13, respectively).

The median DFS was 36.6 months in patients who underwent AHSCT and 28 months in patients treated with BFM-95 (P = .033). Two- and 5-year DFS rates were 68.5% and 57%, respectively, in the AHSCT group, and 63% and 38% respectively, in the BFM-95 group (P = .12 and .029, respectively).

Mortality in the BFM-95 group was the result of sepsis due to infections (fungal infection in two patients, resistant bacterial infections in four patients). In the AHSCT group, respectively, three and seven patients died of graft-versus-host disease and bacterial infections (with fungal infections in four patients and resistant bacterial infections in three patients), according to the researchers.

“In our study, no 2-year OS and DFS difference was observed in any treatment group; however, a significant difference occurred in 5-year DFS in favor of AHSCT. This may be due to transplant-related mortality in the first 2 years, which led to no statistically significant difference,” the authors stated.

“In order to further elucidate the role of AHSCT when pediatric-derived regimens are used for the treatment of adult lymphoblastic leukemia, higher-powered randomized prospective studies are needed,” they concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Allogeneic hematopoietic stem-cell transplantation (AHSCT) improved disease-free survival (DFS), compared with pediatric-inspired Berlin-Frankfurt-Münster (BFM-95) chemotherapy in adults with acute lymphoblastic leukemia (ALL), according to the results of retrospective study published in Clinical Lymphoma, Myeloma & Leukemia. However, overall survival (OS) was not significantly different between the two groups, as reported by Elifcan Aladag, MD, of the Hacettepe University Faculty of Medicine, Ankara, Turkey, and colleagues.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Despite this, “AHSCT is recommended for all patients with suitable donors, but the risk of transplant-related mortality should be kept in mind,” according to the researchers.

The multicenter study compared two different treatment approaches (BFM-95 chemotherapy regimen and AHSCT). The BFM-95 chemotherapy group comprised 47 newly diagnosed ALL patients. The transplant cohort comprised 83 patients with ALL in first complete remission who received AHSCT from fully matched human leukocyte antigen (HLA)-identical siblings. Thirty-five of the AHSCT patients (42.1%) received chemotherapy at least until the M stage of the BFM-95 protocol.

The primary endpoints of the study were OS and duration of DFS. OS was defined from the day of starting BFM-95 chemotherapy until death from any cause, and DFS was calculated from the date of complete remission until the date of first relapse or death from any cause, whichever occurred first, according to the authors.
 

Study results

The median OS was 68 months in patients who underwent AHSCT and 46 months in patients treated only with BFM-95 (P = .3). Two- and 5-year OS rates were 78% and 60% , respectively, in the AHSCT group, and 69% and 64% in the BFM-95 group (P = .06 and .13, respectively).

The median DFS was 36.6 months in patients who underwent AHSCT and 28 months in patients treated with BFM-95 (P = .033). Two- and 5-year DFS rates were 68.5% and 57%, respectively, in the AHSCT group, and 63% and 38% respectively, in the BFM-95 group (P = .12 and .029, respectively).

Mortality in the BFM-95 group was the result of sepsis due to infections (fungal infection in two patients, resistant bacterial infections in four patients). In the AHSCT group, respectively, three and seven patients died of graft-versus-host disease and bacterial infections (with fungal infections in four patients and resistant bacterial infections in three patients), according to the researchers.

“In our study, no 2-year OS and DFS difference was observed in any treatment group; however, a significant difference occurred in 5-year DFS in favor of AHSCT. This may be due to transplant-related mortality in the first 2 years, which led to no statistically significant difference,” the authors stated.

“In order to further elucidate the role of AHSCT when pediatric-derived regimens are used for the treatment of adult lymphoblastic leukemia, higher-powered randomized prospective studies are needed,” they concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Allogeneic hematopoietic stem-cell transplantation (AHSCT) improved disease-free survival (DFS), compared with pediatric-inspired Berlin-Frankfurt-Münster (BFM-95) chemotherapy in adults with acute lymphoblastic leukemia (ALL), according to the results of retrospective study published in Clinical Lymphoma, Myeloma & Leukemia. However, overall survival (OS) was not significantly different between the two groups, as reported by Elifcan Aladag, MD, of the Hacettepe University Faculty of Medicine, Ankara, Turkey, and colleagues.

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

Despite this, “AHSCT is recommended for all patients with suitable donors, but the risk of transplant-related mortality should be kept in mind,” according to the researchers.

The multicenter study compared two different treatment approaches (BFM-95 chemotherapy regimen and AHSCT). The BFM-95 chemotherapy group comprised 47 newly diagnosed ALL patients. The transplant cohort comprised 83 patients with ALL in first complete remission who received AHSCT from fully matched human leukocyte antigen (HLA)-identical siblings. Thirty-five of the AHSCT patients (42.1%) received chemotherapy at least until the M stage of the BFM-95 protocol.

The primary endpoints of the study were OS and duration of DFS. OS was defined from the day of starting BFM-95 chemotherapy until death from any cause, and DFS was calculated from the date of complete remission until the date of first relapse or death from any cause, whichever occurred first, according to the authors.
 

Study results

The median OS was 68 months in patients who underwent AHSCT and 46 months in patients treated only with BFM-95 (P = .3). Two- and 5-year OS rates were 78% and 60% , respectively, in the AHSCT group, and 69% and 64% in the BFM-95 group (P = .06 and .13, respectively).

The median DFS was 36.6 months in patients who underwent AHSCT and 28 months in patients treated with BFM-95 (P = .033). Two- and 5-year DFS rates were 68.5% and 57%, respectively, in the AHSCT group, and 63% and 38% respectively, in the BFM-95 group (P = .12 and .029, respectively).

Mortality in the BFM-95 group was the result of sepsis due to infections (fungal infection in two patients, resistant bacterial infections in four patients). In the AHSCT group, respectively, three and seven patients died of graft-versus-host disease and bacterial infections (with fungal infections in four patients and resistant bacterial infections in three patients), according to the researchers.

“In our study, no 2-year OS and DFS difference was observed in any treatment group; however, a significant difference occurred in 5-year DFS in favor of AHSCT. This may be due to transplant-related mortality in the first 2 years, which led to no statistically significant difference,” the authors stated.

“In order to further elucidate the role of AHSCT when pediatric-derived regimens are used for the treatment of adult lymphoblastic leukemia, higher-powered randomized prospective studies are needed,” they concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Combining standard neoadjuvant chemotherapy for locally advanced esophageal cancer with either radiation or docetaxel did not increase the risk of surgical complications, investigators in the JCOG1109 trial reported.

The trial included patients with clinical stage IB, II, or III (non-T4) thoracic esophageal cancer randomly assigned to cisplatin plus 5-fluorouracil (CF), CF plus radiotherapy (CF-RT), or docetaxel plus CF (DCF) prior to surgery.

Results showed the type of therapy did not significantly affect risk for either perioperative complications or deaths. There was also evidence to suggest that a lower risk of postoperative complications with DCF compared with CF might translate into improved prognosis with the addition of docetaxel, said Kazuo Koyanagi, MD, PhD, of National Cancer Center Hospital in Tokyo.

Dr. Koyanagi presented these results at the 2021 Gastrointestinal Cancers Symposium.

“Based on these results, we could say that preoperative chemotherapy with DCF and CF-RT didn’t increase the risk of postoperative complications when compared with standard CF, and whether the decrease in the risk in the DCF would be reflected in the improvement of prognosis should be examined in the future,” Dr. Koyanagi said.
 

Trial details

The JCOG1109 trial is a three-arm, phase 3 trial designed to see whether adding docetaxel or radiation to CF could improve outcomes. In the analysis presented here, the investigators examined whether the choice of regimen could affect the safety of esophagectomy, and they looked for risk factors for postoperative complications.

Patients with histologically proven squamous cell, adenosquamous, or basaloid carcinoma with locally advanced lesions in the thoracic esophagus were eligible.

The patients had to have good performance status (Eastern Cooperative Oncology Group 0 or 1) and could not have had chemotherapy, radiotherapy, or hormonal therapy for any cancer, or prior therapy for esophageal cancer except for complete endoscopic mucosal or submucosal dissection.

A total of 601 patients were enrolled and randomized to receive one of the following treatments:

• CF, with cisplatin at a dose of 80 mg/m² on day 1 and 5-fluorouracil at 800 mg/m² on days 1-5 every 3 weeks for two cycles (199 assigned; 185 had surgery)
• DCF, with cisplatin at 70 mg/m² on day 1, 5-fluorouracil at 750 mg/m² on days 1-5, and docetaxel at 70 mg/m² on day 1 every 3 weeks for three cycles (202 assigned; 183 had surgery)
• CF-RT, with cisplatin at 75 mg/m² on day 1, 5-fluorouracil at 1,000 mg/m² on days 1-4 every 4 weeks for two cycles, plus 1.8 Gy radiation divided into 23 fractions for a total of 41.4 Gy (200 assigned; 178 had surgery).

Patient age, body mass index, tumor location, clinical stage and node status were comparable among the treatment groups.

Operative characteristics (duration, blood loss, approach, extent of lymph node dissection) were generally similar between the arms as well, except that significantly fewer lymph nodes were harvested with CF-RT compared with either CF or DCF (median of 49, 58, and 59, respectively).
 

Results

Incidence rates of major postoperative complications – pneumonia, leakage, and recurrent laryngeal nerve paralysis – were generally similar among the groups.

The cumulative rate of grade 2 or greater postoperative complications was significantly lower for DCF than for CF (P = .02), but not for DCF compared with CF-RT (P = .11). The rates were 43.7% with DCF, 47.8% with CF-RT, and 56.2% with CF.

The rate of grade 2 or greater chylothorax (leakage of lymphatics into the pleural space) was significantly higher with CF-RT than CF (5.1% vs. 1.1%, P = .03) but not with DCF vs. CF (3.8% vs. 1.1%, P = .10)

In multivariable analysis controlling for demographic, clinical, and operative characteristics, factors associated with lower risk for complications included:

• Middle esophageal tumor location vs. upper esophageal tumors (relative risk [RR], 0.79; P = .03)
• DCF (RR, 0.79; P = .02)
• A thoracoscopic vs. open approach (RR, 0.77; P = .002).

The only factor associated with higher risk was operative time longer than 492 minutes (RR, 1.26; P = .008).

Dr. Koyanagi said the reasons for the lower lymph node yield and more frequent chylothorax with CF-RT are unclear but may be related to tissue fibrosis from radiation exposure.
 

CROSS talk

“As a North American surgeon, I generally look to CROSS induction chemotherapy for the majority of my patients for both adenocarcinoma and squamous cell carcinoma of the esophagus,” said invited discussant Jonathan Yeung, MD, PhD, of the Princess Margaret Cancer Centre in Toronto.

The CROSS regimen consists of carboplatin titrated to an area under the curve of 2 mg/mL per minute and paclitaxel at 50 mg/m² for 5 weeks with concurrent radiotherapy to a total dose of 41.4 Gy delivered in 23 fractions, 5 days per week.

Dr. Yeung noted that, of the eligible patients in JCOG1109, 92% of those assigned to DCF actually underwent surgery, and 90% of those assigned to CF-RT went on to surgery, compared with 98% of patients who had surgery in the CROSS trial, suggesting that the DCF and CF-RT regimens may be more toxic.

He also noted that the lower lymph node harvest seen with CF-RT was seen in other studies.

“I must say I’m always impressed by the lymph node yields that our Japanese colleagues can obtain at surgery, but this lower lymph node yield is also borne out in the CROSS data, where there are less lymph nodes harvested following chemoradiotherapy,” he said.

A higher rate of chylothorax with CF-RT was also seen in patients in the CROSS trial who were randomized to receive radiation compared with those who received chemotherapy alone.

“I await the final results to see if there is ultimately better survival,” Dr. Yeung said.

JCOG1109 was supported by grants from the National Cancer Center Research and Development Funds and Agency for Medical Research and Development of Japan. Dr. Koyanagi and Dr. Yeung reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Combining standard neoadjuvant chemotherapy for locally advanced esophageal cancer with either radiation or docetaxel did not increase the risk of surgical complications, investigators in the JCOG1109 trial reported.

The trial included patients with clinical stage IB, II, or III (non-T4) thoracic esophageal cancer randomly assigned to cisplatin plus 5-fluorouracil (CF), CF plus radiotherapy (CF-RT), or docetaxel plus CF (DCF) prior to surgery.

Results showed the type of therapy did not significantly affect risk for either perioperative complications or deaths. There was also evidence to suggest that a lower risk of postoperative complications with DCF compared with CF might translate into improved prognosis with the addition of docetaxel, said Kazuo Koyanagi, MD, PhD, of National Cancer Center Hospital in Tokyo.

Dr. Koyanagi presented these results at the 2021 Gastrointestinal Cancers Symposium.

“Based on these results, we could say that preoperative chemotherapy with DCF and CF-RT didn’t increase the risk of postoperative complications when compared with standard CF, and whether the decrease in the risk in the DCF would be reflected in the improvement of prognosis should be examined in the future,” Dr. Koyanagi said.
 

Trial details

The JCOG1109 trial is a three-arm, phase 3 trial designed to see whether adding docetaxel or radiation to CF could improve outcomes. In the analysis presented here, the investigators examined whether the choice of regimen could affect the safety of esophagectomy, and they looked for risk factors for postoperative complications.

Patients with histologically proven squamous cell, adenosquamous, or basaloid carcinoma with locally advanced lesions in the thoracic esophagus were eligible.

The patients had to have good performance status (Eastern Cooperative Oncology Group 0 or 1) and could not have had chemotherapy, radiotherapy, or hormonal therapy for any cancer, or prior therapy for esophageal cancer except for complete endoscopic mucosal or submucosal dissection.

A total of 601 patients were enrolled and randomized to receive one of the following treatments:

• CF, with cisplatin at a dose of 80 mg/m² on day 1 and 5-fluorouracil at 800 mg/m² on days 1-5 every 3 weeks for two cycles (199 assigned; 185 had surgery)
• DCF, with cisplatin at 70 mg/m² on day 1, 5-fluorouracil at 750 mg/m² on days 1-5, and docetaxel at 70 mg/m² on day 1 every 3 weeks for three cycles (202 assigned; 183 had surgery)
• CF-RT, with cisplatin at 75 mg/m² on day 1, 5-fluorouracil at 1,000 mg/m² on days 1-4 every 4 weeks for two cycles, plus 1.8 Gy radiation divided into 23 fractions for a total of 41.4 Gy (200 assigned; 178 had surgery).

Patient age, body mass index, tumor location, clinical stage and node status were comparable among the treatment groups.

Operative characteristics (duration, blood loss, approach, extent of lymph node dissection) were generally similar between the arms as well, except that significantly fewer lymph nodes were harvested with CF-RT compared with either CF or DCF (median of 49, 58, and 59, respectively).
 

Results

Incidence rates of major postoperative complications – pneumonia, leakage, and recurrent laryngeal nerve paralysis – were generally similar among the groups.

The cumulative rate of grade 2 or greater postoperative complications was significantly lower for DCF than for CF (P = .02), but not for DCF compared with CF-RT (P = .11). The rates were 43.7% with DCF, 47.8% with CF-RT, and 56.2% with CF.

The rate of grade 2 or greater chylothorax (leakage of lymphatics into the pleural space) was significantly higher with CF-RT than CF (5.1% vs. 1.1%, P = .03) but not with DCF vs. CF (3.8% vs. 1.1%, P = .10)

In multivariable analysis controlling for demographic, clinical, and operative characteristics, factors associated with lower risk for complications included:

• Middle esophageal tumor location vs. upper esophageal tumors (relative risk [RR], 0.79; P = .03)
• DCF (RR, 0.79; P = .02)
• A thoracoscopic vs. open approach (RR, 0.77; P = .002).

The only factor associated with higher risk was operative time longer than 492 minutes (RR, 1.26; P = .008).

Dr. Koyanagi said the reasons for the lower lymph node yield and more frequent chylothorax with CF-RT are unclear but may be related to tissue fibrosis from radiation exposure.
 

CROSS talk

“As a North American surgeon, I generally look to CROSS induction chemotherapy for the majority of my patients for both adenocarcinoma and squamous cell carcinoma of the esophagus,” said invited discussant Jonathan Yeung, MD, PhD, of the Princess Margaret Cancer Centre in Toronto.

The CROSS regimen consists of carboplatin titrated to an area under the curve of 2 mg/mL per minute and paclitaxel at 50 mg/m² for 5 weeks with concurrent radiotherapy to a total dose of 41.4 Gy delivered in 23 fractions, 5 days per week.

Dr. Yeung noted that, of the eligible patients in JCOG1109, 92% of those assigned to DCF actually underwent surgery, and 90% of those assigned to CF-RT went on to surgery, compared with 98% of patients who had surgery in the CROSS trial, suggesting that the DCF and CF-RT regimens may be more toxic.

He also noted that the lower lymph node harvest seen with CF-RT was seen in other studies.

“I must say I’m always impressed by the lymph node yields that our Japanese colleagues can obtain at surgery, but this lower lymph node yield is also borne out in the CROSS data, where there are less lymph nodes harvested following chemoradiotherapy,” he said.

A higher rate of chylothorax with CF-RT was also seen in patients in the CROSS trial who were randomized to receive radiation compared with those who received chemotherapy alone.

“I await the final results to see if there is ultimately better survival,” Dr. Yeung said.

JCOG1109 was supported by grants from the National Cancer Center Research and Development Funds and Agency for Medical Research and Development of Japan. Dr. Koyanagi and Dr. Yeung reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Combining standard neoadjuvant chemotherapy for locally advanced esophageal cancer with either radiation or docetaxel did not increase the risk of surgical complications, investigators in the JCOG1109 trial reported.

The trial included patients with clinical stage IB, II, or III (non-T4) thoracic esophageal cancer randomly assigned to cisplatin plus 5-fluorouracil (CF), CF plus radiotherapy (CF-RT), or docetaxel plus CF (DCF) prior to surgery.

Results showed the type of therapy did not significantly affect risk for either perioperative complications or deaths. There was also evidence to suggest that a lower risk of postoperative complications with DCF compared with CF might translate into improved prognosis with the addition of docetaxel, said Kazuo Koyanagi, MD, PhD, of National Cancer Center Hospital in Tokyo.

Dr. Koyanagi presented these results at the 2021 Gastrointestinal Cancers Symposium.

“Based on these results, we could say that preoperative chemotherapy with DCF and CF-RT didn’t increase the risk of postoperative complications when compared with standard CF, and whether the decrease in the risk in the DCF would be reflected in the improvement of prognosis should be examined in the future,” Dr. Koyanagi said.
 

Trial details

The JCOG1109 trial is a three-arm, phase 3 trial designed to see whether adding docetaxel or radiation to CF could improve outcomes. In the analysis presented here, the investigators examined whether the choice of regimen could affect the safety of esophagectomy, and they looked for risk factors for postoperative complications.

Patients with histologically proven squamous cell, adenosquamous, or basaloid carcinoma with locally advanced lesions in the thoracic esophagus were eligible.

The patients had to have good performance status (Eastern Cooperative Oncology Group 0 or 1) and could not have had chemotherapy, radiotherapy, or hormonal therapy for any cancer, or prior therapy for esophageal cancer except for complete endoscopic mucosal or submucosal dissection.

A total of 601 patients were enrolled and randomized to receive one of the following treatments:

• CF, with cisplatin at a dose of 80 mg/m² on day 1 and 5-fluorouracil at 800 mg/m² on days 1-5 every 3 weeks for two cycles (199 assigned; 185 had surgery)
• DCF, with cisplatin at 70 mg/m² on day 1, 5-fluorouracil at 750 mg/m² on days 1-5, and docetaxel at 70 mg/m² on day 1 every 3 weeks for three cycles (202 assigned; 183 had surgery)
• CF-RT, with cisplatin at 75 mg/m² on day 1, 5-fluorouracil at 1,000 mg/m² on days 1-4 every 4 weeks for two cycles, plus 1.8 Gy radiation divided into 23 fractions for a total of 41.4 Gy (200 assigned; 178 had surgery).

Patient age, body mass index, tumor location, clinical stage and node status were comparable among the treatment groups.

Operative characteristics (duration, blood loss, approach, extent of lymph node dissection) were generally similar between the arms as well, except that significantly fewer lymph nodes were harvested with CF-RT compared with either CF or DCF (median of 49, 58, and 59, respectively).
 

Results

Incidence rates of major postoperative complications – pneumonia, leakage, and recurrent laryngeal nerve paralysis – were generally similar among the groups.

The cumulative rate of grade 2 or greater postoperative complications was significantly lower for DCF than for CF (P = .02), but not for DCF compared with CF-RT (P = .11). The rates were 43.7% with DCF, 47.8% with CF-RT, and 56.2% with CF.

The rate of grade 2 or greater chylothorax (leakage of lymphatics into the pleural space) was significantly higher with CF-RT than CF (5.1% vs. 1.1%, P = .03) but not with DCF vs. CF (3.8% vs. 1.1%, P = .10)

In multivariable analysis controlling for demographic, clinical, and operative characteristics, factors associated with lower risk for complications included:

• Middle esophageal tumor location vs. upper esophageal tumors (relative risk [RR], 0.79; P = .03)
• DCF (RR, 0.79; P = .02)
• A thoracoscopic vs. open approach (RR, 0.77; P = .002).

The only factor associated with higher risk was operative time longer than 492 minutes (RR, 1.26; P = .008).

Dr. Koyanagi said the reasons for the lower lymph node yield and more frequent chylothorax with CF-RT are unclear but may be related to tissue fibrosis from radiation exposure.
 

CROSS talk

“As a North American surgeon, I generally look to CROSS induction chemotherapy for the majority of my patients for both adenocarcinoma and squamous cell carcinoma of the esophagus,” said invited discussant Jonathan Yeung, MD, PhD, of the Princess Margaret Cancer Centre in Toronto.

The CROSS regimen consists of carboplatin titrated to an area under the curve of 2 mg/mL per minute and paclitaxel at 50 mg/m² for 5 weeks with concurrent radiotherapy to a total dose of 41.4 Gy delivered in 23 fractions, 5 days per week.

Dr. Yeung noted that, of the eligible patients in JCOG1109, 92% of those assigned to DCF actually underwent surgery, and 90% of those assigned to CF-RT went on to surgery, compared with 98% of patients who had surgery in the CROSS trial, suggesting that the DCF and CF-RT regimens may be more toxic.

He also noted that the lower lymph node harvest seen with CF-RT was seen in other studies.

“I must say I’m always impressed by the lymph node yields that our Japanese colleagues can obtain at surgery, but this lower lymph node yield is also borne out in the CROSS data, where there are less lymph nodes harvested following chemoradiotherapy,” he said.

A higher rate of chylothorax with CF-RT was also seen in patients in the CROSS trial who were randomized to receive radiation compared with those who received chemotherapy alone.

“I await the final results to see if there is ultimately better survival,” Dr. Yeung said.

JCOG1109 was supported by grants from the National Cancer Center Research and Development Funds and Agency for Medical Research and Development of Japan. Dr. Koyanagi and Dr. Yeung reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) are often treated with chemotherapy, radiotherapy, or both before undergoing surgery, but the optimal regimen in this setting is controversial.

Results from the Alliance A021501 study suggest the reference regimen should be neoadjuvant therapy with modified FOLFIRINOX (oxaliplatin 85 mg/m², irinotecan 180 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours), according to Matthew Katz, MD, FACS, chief of the pancreatic surgery service at the University of Texas MD Anderson Cancer Center, Houston.

This regimen improved survival for patients with PDAC, relative to historical data. For patients who received mFOLFIRINOX, the overall 18-month survival rate was 66.4%. However, when this regimen was combined with hypofractionated radiotherapy, the survival benefit was significantly lower, at 47.3%.

These findings were presented at the 2021 Gastrointestinal Cancers Symposium (GICS), which was held online this year.

“ASCO guidelines recommend that preoperative therapy be administered to patients with localized pancreatic adenocarcinoma who have tumors that have a significant radiographic interface with the major mesenteric blood vessels, as these patients are at high risk for a margin-positive operation and short survival when pancreatectomy is performed de novo,” Dr. Katz explained.

Although both chemotherapy and radiotherapy are used in these patients, there is no consensus as to the best approach, he commented.

The goal of Alliance A021501 “was to define a reference preoperative regimen for future trials of preoperative therapy,” he said.

The cohort included 126 patients who were randomly assigned to receive either mFOLFIRINOX (arm A) or mFOLFIRINOX plus radiotherapy (arm B).

Patients in arm A received eight cycles of neoadjuvant mFOLFIRINOX. Patients in arm B received seven cycles of mFOLFIRINOX followed by 5 days of hypofractionated radiotherapy with either stereotactic body radiotherapy or hypofractionated image-guided radiotherapy.

In either arm, patients who did not experience disease progression underwent pancreatectomy followed by four cycles of adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours).

The study’s primary endpoint was 18-month overall survival in comparison to a historical control of 50%. “An interim futility analysis was scheduled to be conducted following treatment of 30 patients on each arm,” Dr. Katz said. “Either arm in which 11 or fewer patients underwent [curative] R0 resection on protocol was to be declared futile and closed to further enrollment.

“With 62 evaluable patients in each arm, the final efficacy analysis was powered to detect an improvement in 18-month overall survival of 13% over the historical rate of 50%,” said Dr. Katz. “The two arms would be compared only if both were declared efficacious.”

At the interim analysis, 57% of the first 30 patients in arm A had undergone a resection, vs. 33% in arm B. Therefore, arm B was considered futile and was closed to accrual.

The median overall survival in arm A was 29.8 months. The median event-free survival was 15 months. Nearly half (49%) of patients proceeded to pancreatectomy following neoadjuvant therapy. The R0 resection rate was 88%, the pathologic complete response rate was 0%, and the 18-month overall survival rate was 93.1%.

For the patients in arm B, which had been closed to accrual, the median overall survival was 17.1 months, and the median event-free survival was 10.2 months. About one-third (35%) of patients were able to proceed to pancreatectomy. The R0 resection rate was 74%, the pathologic complete response rate was 11%, and the 18-month overall survival rate was 78.9%.

“Preoperative mFOLFIRINOX was associated with favorable overall survival relative to historical criteria in patients with borderline resectable PDAC, and mFOLFIRINOX with radiation therapy met the predefined futility boundary for R0 resection at interim analysis,” Dr. Katz concluded. “Therefore, mFOLFIRINOX represents a reference perioperative regimen for patients with borderline resectable PDAC.”
 

Further investigation needed

The paper’s discussant, Rebecca A. Snyder, MD, MPH, of the Brody School of Medicine, East Carolina University, Greenville, N.C., emphasized that this study was not designed or powered to directly compare chemotherapy alone with chemotherapy plus radiotherapy in the neoadjuvant setting.

She noted that it is surprising that the radiotherapy arm was closed early. She said the reasons for this remain unclear, although a few possible reasons can be speculated.

“Based on multiple studies in both the adjuvant and neoadjuvant setting, including the Alliance [A021501] trial presented today, there is no convincing randomized data that radiation therapy prolongs survival in any population of unselected patients with pancreatic cancer,” said Dr. Snyder.

“Certainly, follow-up questions still remain, specifically regarding the role for non-SBRT radiation in the preoperative setting, which may be answered by the ongoing PREOPANC-2 and PRODIGE 44 trials,” she said.

She added that the “addition of SBRT in the preoperative setting does not appear to be justified.”

The role of radiotherapy for subsets of patients remains unknown, and future investigation should focus on patient-centered endpoints, such as symptomatic local control rates, Dr. Snyder concluded.

The study was funded by the National Institutes of Health. Dr. Katz has had a consulting or advisory role for AbbVie and Alcresta Therapeutics. Dr. Snyder has disclosed no relevant financial relationships.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

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

Patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) are often treated with chemotherapy, radiotherapy, or both before undergoing surgery, but the optimal regimen in this setting is controversial.

Results from the Alliance A021501 study suggest the reference regimen should be neoadjuvant therapy with modified FOLFIRINOX (oxaliplatin 85 mg/m², irinotecan 180 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours), according to Matthew Katz, MD, FACS, chief of the pancreatic surgery service at the University of Texas MD Anderson Cancer Center, Houston.

This regimen improved survival for patients with PDAC, relative to historical data. For patients who received mFOLFIRINOX, the overall 18-month survival rate was 66.4%. However, when this regimen was combined with hypofractionated radiotherapy, the survival benefit was significantly lower, at 47.3%.

These findings were presented at the 2021 Gastrointestinal Cancers Symposium (GICS), which was held online this year.

“ASCO guidelines recommend that preoperative therapy be administered to patients with localized pancreatic adenocarcinoma who have tumors that have a significant radiographic interface with the major mesenteric blood vessels, as these patients are at high risk for a margin-positive operation and short survival when pancreatectomy is performed de novo,” Dr. Katz explained.

Although both chemotherapy and radiotherapy are used in these patients, there is no consensus as to the best approach, he commented.

The goal of Alliance A021501 “was to define a reference preoperative regimen for future trials of preoperative therapy,” he said.

The cohort included 126 patients who were randomly assigned to receive either mFOLFIRINOX (arm A) or mFOLFIRINOX plus radiotherapy (arm B).

Patients in arm A received eight cycles of neoadjuvant mFOLFIRINOX. Patients in arm B received seven cycles of mFOLFIRINOX followed by 5 days of hypofractionated radiotherapy with either stereotactic body radiotherapy or hypofractionated image-guided radiotherapy.

In either arm, patients who did not experience disease progression underwent pancreatectomy followed by four cycles of adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours).

The study’s primary endpoint was 18-month overall survival in comparison to a historical control of 50%. “An interim futility analysis was scheduled to be conducted following treatment of 30 patients on each arm,” Dr. Katz said. “Either arm in which 11 or fewer patients underwent [curative] R0 resection on protocol was to be declared futile and closed to further enrollment.

“With 62 evaluable patients in each arm, the final efficacy analysis was powered to detect an improvement in 18-month overall survival of 13% over the historical rate of 50%,” said Dr. Katz. “The two arms would be compared only if both were declared efficacious.”

At the interim analysis, 57% of the first 30 patients in arm A had undergone a resection, vs. 33% in arm B. Therefore, arm B was considered futile and was closed to accrual.

The median overall survival in arm A was 29.8 months. The median event-free survival was 15 months. Nearly half (49%) of patients proceeded to pancreatectomy following neoadjuvant therapy. The R0 resection rate was 88%, the pathologic complete response rate was 0%, and the 18-month overall survival rate was 93.1%.

For the patients in arm B, which had been closed to accrual, the median overall survival was 17.1 months, and the median event-free survival was 10.2 months. About one-third (35%) of patients were able to proceed to pancreatectomy. The R0 resection rate was 74%, the pathologic complete response rate was 11%, and the 18-month overall survival rate was 78.9%.

“Preoperative mFOLFIRINOX was associated with favorable overall survival relative to historical criteria in patients with borderline resectable PDAC, and mFOLFIRINOX with radiation therapy met the predefined futility boundary for R0 resection at interim analysis,” Dr. Katz concluded. “Therefore, mFOLFIRINOX represents a reference perioperative regimen for patients with borderline resectable PDAC.”
 

Further investigation needed

The paper’s discussant, Rebecca A. Snyder, MD, MPH, of the Brody School of Medicine, East Carolina University, Greenville, N.C., emphasized that this study was not designed or powered to directly compare chemotherapy alone with chemotherapy plus radiotherapy in the neoadjuvant setting.

She noted that it is surprising that the radiotherapy arm was closed early. She said the reasons for this remain unclear, although a few possible reasons can be speculated.

“Based on multiple studies in both the adjuvant and neoadjuvant setting, including the Alliance [A021501] trial presented today, there is no convincing randomized data that radiation therapy prolongs survival in any population of unselected patients with pancreatic cancer,” said Dr. Snyder.

“Certainly, follow-up questions still remain, specifically regarding the role for non-SBRT radiation in the preoperative setting, which may be answered by the ongoing PREOPANC-2 and PRODIGE 44 trials,” she said.

She added that the “addition of SBRT in the preoperative setting does not appear to be justified.”

The role of radiotherapy for subsets of patients remains unknown, and future investigation should focus on patient-centered endpoints, such as symptomatic local control rates, Dr. Snyder concluded.

The study was funded by the National Institutes of Health. Dr. Katz has had a consulting or advisory role for AbbVie and Alcresta Therapeutics. Dr. Snyder has disclosed no relevant financial relationships.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

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

Patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) are often treated with chemotherapy, radiotherapy, or both before undergoing surgery, but the optimal regimen in this setting is controversial.

Results from the Alliance A021501 study suggest the reference regimen should be neoadjuvant therapy with modified FOLFIRINOX (oxaliplatin 85 mg/m², irinotecan 180 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours), according to Matthew Katz, MD, FACS, chief of the pancreatic surgery service at the University of Texas MD Anderson Cancer Center, Houston.

This regimen improved survival for patients with PDAC, relative to historical data. For patients who received mFOLFIRINOX, the overall 18-month survival rate was 66.4%. However, when this regimen was combined with hypofractionated radiotherapy, the survival benefit was significantly lower, at 47.3%.

These findings were presented at the 2021 Gastrointestinal Cancers Symposium (GICS), which was held online this year.

“ASCO guidelines recommend that preoperative therapy be administered to patients with localized pancreatic adenocarcinoma who have tumors that have a significant radiographic interface with the major mesenteric blood vessels, as these patients are at high risk for a margin-positive operation and short survival when pancreatectomy is performed de novo,” Dr. Katz explained.

Although both chemotherapy and radiotherapy are used in these patients, there is no consensus as to the best approach, he commented.

The goal of Alliance A021501 “was to define a reference preoperative regimen for future trials of preoperative therapy,” he said.

The cohort included 126 patients who were randomly assigned to receive either mFOLFIRINOX (arm A) or mFOLFIRINOX plus radiotherapy (arm B).

Patients in arm A received eight cycles of neoadjuvant mFOLFIRINOX. Patients in arm B received seven cycles of mFOLFIRINOX followed by 5 days of hypofractionated radiotherapy with either stereotactic body radiotherapy or hypofractionated image-guided radiotherapy.

In either arm, patients who did not experience disease progression underwent pancreatectomy followed by four cycles of adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and infusional 5-fluorouracil 2,400 mg/m² over 46 hours).

The study’s primary endpoint was 18-month overall survival in comparison to a historical control of 50%. “An interim futility analysis was scheduled to be conducted following treatment of 30 patients on each arm,” Dr. Katz said. “Either arm in which 11 or fewer patients underwent [curative] R0 resection on protocol was to be declared futile and closed to further enrollment.

“With 62 evaluable patients in each arm, the final efficacy analysis was powered to detect an improvement in 18-month overall survival of 13% over the historical rate of 50%,” said Dr. Katz. “The two arms would be compared only if both were declared efficacious.”

At the interim analysis, 57% of the first 30 patients in arm A had undergone a resection, vs. 33% in arm B. Therefore, arm B was considered futile and was closed to accrual.

The median overall survival in arm A was 29.8 months. The median event-free survival was 15 months. Nearly half (49%) of patients proceeded to pancreatectomy following neoadjuvant therapy. The R0 resection rate was 88%, the pathologic complete response rate was 0%, and the 18-month overall survival rate was 93.1%.

For the patients in arm B, which had been closed to accrual, the median overall survival was 17.1 months, and the median event-free survival was 10.2 months. About one-third (35%) of patients were able to proceed to pancreatectomy. The R0 resection rate was 74%, the pathologic complete response rate was 11%, and the 18-month overall survival rate was 78.9%.

“Preoperative mFOLFIRINOX was associated with favorable overall survival relative to historical criteria in patients with borderline resectable PDAC, and mFOLFIRINOX with radiation therapy met the predefined futility boundary for R0 resection at interim analysis,” Dr. Katz concluded. “Therefore, mFOLFIRINOX represents a reference perioperative regimen for patients with borderline resectable PDAC.”
 

Further investigation needed

The paper’s discussant, Rebecca A. Snyder, MD, MPH, of the Brody School of Medicine, East Carolina University, Greenville, N.C., emphasized that this study was not designed or powered to directly compare chemotherapy alone with chemotherapy plus radiotherapy in the neoadjuvant setting.

She noted that it is surprising that the radiotherapy arm was closed early. She said the reasons for this remain unclear, although a few possible reasons can be speculated.

“Based on multiple studies in both the adjuvant and neoadjuvant setting, including the Alliance [A021501] trial presented today, there is no convincing randomized data that radiation therapy prolongs survival in any population of unselected patients with pancreatic cancer,” said Dr. Snyder.

“Certainly, follow-up questions still remain, specifically regarding the role for non-SBRT radiation in the preoperative setting, which may be answered by the ongoing PREOPANC-2 and PRODIGE 44 trials,” she said.

She added that the “addition of SBRT in the preoperative setting does not appear to be justified.”

The role of radiotherapy for subsets of patients remains unknown, and future investigation should focus on patient-centered endpoints, such as symptomatic local control rates, Dr. Snyder concluded.

The study was funded by the National Institutes of Health. Dr. Katz has had a consulting or advisory role for AbbVie and Alcresta Therapeutics. Dr. Snyder has disclosed no relevant financial relationships.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

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

Background: It is common practice for providers to intensify antihypertensive regimen during admission for noncardiac conditions even if a patient has a history of well-controlled blood pressure as an outpatient. Many providers have assumed that these changes will benefit patients; however, this outcome had never been studied.

Patients discharged with regimen intensification were more likely to be readmitted (hazard ratio, 1.23; 95% confidence interval, 1.07-1.42; number needed to harm = 27), experience a medication-related serious adverse event (HR, 1.42; 95% CI, 1.06-1.88; NNH = 63), and have a cardiovascular event (HR, 1.65; 95% CI, 1.13-2.4) within 30 days of discharge. At 1 year, no significant difference in mortality, cardiovascular events, or systolic BP were noted between the two groups.

A subgroup analysis of patients with poorly controlled blood pressure as outpatients (defined as systolic blood pressure greater than 140 mm Hg) who had their anti-hypertensive medications intensified did not show significant difference in 30-day readmission, severe adverse events, or cardiovascular events.

Limitations of the study include observational design and majority male sex (97.5%) of the study population.

Bottom line: Intensification of antihypertensive regimen among older adults hospitalized for noncardiac conditions with well-controlled blood pressure as an outpatient can potentially cause harm.

Citation: Anderson TS et al. Clinical outcomes after intensifying antihypertensive medication regimens among older adults at hospital discharge. JAMA Intern Med. 2019 Aug 19. doi: 10.1001/jamainternmed.2019.3007.

Dr. Zarookian is a hospitalist at Maine Medical Center in Portland and Stephens Memorial Hospital in Norway, Maine.

Background: It is common practice for providers to intensify antihypertensive regimen during admission for noncardiac conditions even if a patient has a history of well-controlled blood pressure as an outpatient. Many providers have assumed that these changes will benefit patients; however, this outcome had never been studied.

Patients discharged with regimen intensification were more likely to be readmitted (hazard ratio, 1.23; 95% confidence interval, 1.07-1.42; number needed to harm = 27), experience a medication-related serious adverse event (HR, 1.42; 95% CI, 1.06-1.88; NNH = 63), and have a cardiovascular event (HR, 1.65; 95% CI, 1.13-2.4) within 30 days of discharge. At 1 year, no significant difference in mortality, cardiovascular events, or systolic BP were noted between the two groups.

A subgroup analysis of patients with poorly controlled blood pressure as outpatients (defined as systolic blood pressure greater than 140 mm Hg) who had their anti-hypertensive medications intensified did not show significant difference in 30-day readmission, severe adverse events, or cardiovascular events.

Limitations of the study include observational design and majority male sex (97.5%) of the study population.

Bottom line: Intensification of antihypertensive regimen among older adults hospitalized for noncardiac conditions with well-controlled blood pressure as an outpatient can potentially cause harm.

Citation: Anderson TS et al. Clinical outcomes after intensifying antihypertensive medication regimens among older adults at hospital discharge. JAMA Intern Med. 2019 Aug 19. doi: 10.1001/jamainternmed.2019.3007.

Dr. Zarookian is a hospitalist at Maine Medical Center in Portland and Stephens Memorial Hospital in Norway, Maine.

Background: It is common practice for providers to intensify antihypertensive regimen during admission for noncardiac conditions even if a patient has a history of well-controlled blood pressure as an outpatient. Many providers have assumed that these changes will benefit patients; however, this outcome had never been studied.

Patients discharged with regimen intensification were more likely to be readmitted (hazard ratio, 1.23; 95% confidence interval, 1.07-1.42; number needed to harm = 27), experience a medication-related serious adverse event (HR, 1.42; 95% CI, 1.06-1.88; NNH = 63), and have a cardiovascular event (HR, 1.65; 95% CI, 1.13-2.4) within 30 days of discharge. At 1 year, no significant difference in mortality, cardiovascular events, or systolic BP were noted between the two groups.

A subgroup analysis of patients with poorly controlled blood pressure as outpatients (defined as systolic blood pressure greater than 140 mm Hg) who had their anti-hypertensive medications intensified did not show significant difference in 30-day readmission, severe adverse events, or cardiovascular events.

Limitations of the study include observational design and majority male sex (97.5%) of the study population.

Bottom line: Intensification of antihypertensive regimen among older adults hospitalized for noncardiac conditions with well-controlled blood pressure as an outpatient can potentially cause harm.

Citation: Anderson TS et al. Clinical outcomes after intensifying antihypertensive medication regimens among older adults at hospital discharge. JAMA Intern Med. 2019 Aug 19. doi: 10.1001/jamainternmed.2019.3007.

Dr. Zarookian is a hospitalist at Maine Medical Center in Portland and Stephens Memorial Hospital in Norway, Maine.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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

Many emergency medicine (EM) physicians who responded to a Medscape survey said they have treated COVID-19 patients without appropriate personal protective equipment (PPE).

In the Medscape Emergency Medicine Physicians’ COVID-19 Experience Report, 21% of respondents said that that was sometimes the case; 7% said that it was often the case; and 1% said they always treat patients without appropriate PPE.

EM physicians were the physicians most likely to treat COVID-19 patients in person.

Steep income drops

Survey authors wrote that two-thirds of EM physicians have experienced income loss during the pandemic. Most (71%) saw their income drop by between 11% and 50%; 11% saw a decrease of more than 50%. Among other specialties, the percentages of those who have experienced a drop of more than 50% are far higher. Among ophthalmologists, 51% said they had experienced such a drop; among allergists, 46%; plastic surgeons, 46%; and otolaryngologists, 45%.

Asked whether their burnout levels have increased in the wake of COVID-19, 74% of EM physicians said burnout had intensified; 23% reported no change; and 3% said burnout had lessened.

Reports of loneliness have been widespread during the pandemic, owing to stay-at-home orders and social distancing. More EM physicians than physicians in general said feelings of loneliness had increased for them in the past year.

More than half of EM doctors (55%) said they are experiencing more loneliness in the pandemic, compared with 46% of all physicians who felt that way; 42% said those feelings have not changed; and 3% said they have been less lonely.
 

Grief and stress relief

Fewer than half (42%) of the respondents reported that their workplace offers clinician activities to help with grief and stress; 39% said their workplace didn’t offer such help; and 19% said they were unsure.

The percentages were nearly identical to the percentages of physicians overall who answered whether their workplace offered help for grief and stress.

Along with insecurity regarding physical and mental health, COVID-19 has introduced more questions about financial health. Here’s a look at how emergency physicians said they would change the way they save and spend.

Challenges to daily practice

By the time this survey was taken, a large percentage of patients had delayed or avoided urgent or routine medical care for reasons related to COVID-19, so survey authors asked whether EM physicians’ patient population had changed.

Survey authors wrote that “most EM physicians (82%) are seeing patients with non-COVID diseases, such as cardiovascular problems or diabetes, who otherwise probably would have sought treatment earlier.”

COVID-19 has also thrown a major obstacle into most EM physicians’ careers by preventing them from doing the job to the best of their ability. That loss is one of the three primary components of burnout.

More than two-thirds (67%) said COVID-19 has hampered their ability to be as good a doctor as they would like.

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