MDedge Pediatrics

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

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

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

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

The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.

The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.

Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.

“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.

“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”

So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.

For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.

Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.

The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.

Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.

In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.

A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.

Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.

The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.

In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.

“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.

The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.

“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”

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

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

Postpartum depression isn’t just something new mothers can get. Turns out it can affect new fathers, too, according to a new study.

Michael W., a 38-year-old New Jersey–based attorney, and his wife had been excitedly planning for the birth of their baby and were overjoyed when she was born.

But after that, “I found that parenting a newborn was shockingly exhausting. I felt unprepared for the task, overwhelmed by the burden of the 24-hour-schedule and lack of sleep, and I struggled with feelings of inadequacy,” he said in an interview.

Michael never thought he had postpartum depression (PPD), perhaps because the condition is more commonly associated with women. But a study published in the American Journal of Men’s Health suggests that PPD also affects men.

A team of Danish investigators led by researcher Sarah Pedersen, of the department of public health, Aarhus University, extensively interviewed eight fathers with PPD and found their primary experiences involved feelings of being overwhelmed and powerless or inadequate, which sometimes turned into anger and frustration.

“I think one of the most important take-home messages is that practicing clinicians working with new parents should invite fathers to your consultations and engage the fathers as much as possible,” Ms. Pedersen said in an interview.

The findings also contained a message for parents, she says.

“I hope you will support each other and talk about your feelings and how you experience the transition to parenthood – know that it will take time to adjust to your new role,” she said.
 

Not enough attention

There’s been too little focus on fathers when it comes to PPD, according to Ms. Pedersen.

“During the last decade, several studies have examined the prevalence of PPD in men, and there is rising evidence that paternal PPD is associated with increased risk of long-term adverse behavioral and emotional outcomes in children,” she said.

Nevertheless, only three studies have been based on interviews with fathers who had personal experience with PPD.

“The purpose of our study was, first of all, to explore the lived experience of fathers who had PPD and, secondly, to gain deeper understanding of their help-seeking behavior – barriers to seeking help and facilitators of help-seeking,” Ms. Pedersen said.

The study was based on “semistructured” interviews with eight Danish fathers (ages 29-38 years) who had had PPD, none of whom had a previous history of depression.

All of them had received a formal diagnosis of PPD by a general practitioner or psychologist, and all had sought or received mental health care and considered themselves recovered from depression at the time of the interview.

The researchers used a technique called interpretative phenomenological analysis to analyze the interviews.

This method “aims to produce in-depth examinations of certain phenomena by examining how individuals make meaning of their own life experiences,” the authors wrote.
 

A ‘radical change’

Of the fathers, five described the period of pregnancy as a “time of happiness, full of positive expectations about fatherhood.”

But “the fathers’ great expectations were later replaced by a very different reality of fatherhood,” the authors wrote, noting that the transition to fatherhood was, in the words of one participant, a “radical change that you just can’t imagine.”

Most fathers expressed a feeling of being overwhelmed, and three felt unready for the task, which added to their depression.

“The participants wanted to be emotionally and physically present in their child’s life, but during the time of their depression, these kind-hearted intentions changed into feelings of guilt and inadequacy, as the participants did not feel they had enough energy and mental strength to become the kind of fathers they wanted to be,” the authors wrote.

The fathers mentioned stressors they believed contributed to their PPD, including complications during their partners’ pregnancies, unplanned cesarean birth (three fathers), the partners’ difficulties with breastfeeding (five fathers), and employment-related concerns. Five reported that their partners had postpartum emotional distress.
 

‘Masculine norms’

A second focus of the research was to examine fathers’ help-seeking behaviors, Ms. Pedersen said.

Ultimately, all the men sought formal help, either from their general practitioners or from a health visitor, with two seeking help right after birth.

Although the men were able to recognize changes in mood and behavior in retrospect, many did not regard them as signs of depression before their diagnosis.

Most had heard of PPD, but primarily as it affects women. Three sought information online about paternal PPD but couldn’t find any.

Four participants described experiencing PPD as “taboo,” based on a “combination of false beliefs, stigma, and masculine norms,” the authors stated, since men “are supposed to be big and strong and take care of everything, and suddenly you can’t.”

The authors reported that seven participants were screened for PPD or depression by a health care professional.

“The screening was an important part of the help-seeking process, as this was the first time two of the fathers were introduced to PPD,” the authors noted.

Although the screening “had the potential to spark conversation” about PPD, it was geared toward women, and some participants did not feel it was relevant to them.

“Future research should focus on identification of educational needs about paternal PPD among both parents, health care professionals, and other professionals taking care of new families,” Ms. Pedersen said.

Michael W. says it would have been helpful if someone had prepared him and his wife for what to expect, or if there had been some type of screening. Also, he advises expectant parents to “get some real-life experience by spending time around a newborn to see what’s involved.”
 

Different symptoms

“We often talk about mothers suffering from PPD, so it is more normalized for mothers to bring it up or for loved ones to ask mothers about how they are doing physically and psychologically after the birth,” Craig Garfield, MD, an attending physician and founder/director of Family and Child Health innovations at Ann and Robert H. Lurie Children’s Hospital, Chicago, said in an interview.

For fathers, “it is not discussed as commonly, so friends and families don’t often ask dads, and dads don’t know where to turn,” said Dr. Garfield, professor of pediatrics and medical social sciences at Northwestern University, Chicago. He was not involved with the study.

He noted that symptoms in fathers might differ from those of mothers.

“I have seen fathers who are anxious or more moody than they had been prior, or more angry, and I have seen fathers who throw themselves into work or begin drinking more – all related to changes in mood and depressive symptoms in the postnatal period,” he said.

Symptoms in men may last longer than in women. Dr. Garfield’s group published a study in which they surveyed 400 mothers and fathers of premature infants in the neonatal intensive care unit (NICU) about depressive symptoms around the time of NICU admission, at discharge home, and then after 30 days at home.

Roughly one-third of mothers screened positive for depressive symptoms around NICU admission, as did 17% of fathers. But the mothers’ depression scores improved by discharge and 30 days after being home, while the fathers’ remained “essentially unchanged,” he said.

“Further, we found that if doctors were to screen mothers and fathers during the NICU stay – at admission or even at discharge – that would greatly improve their ability to predict who would still have depressive symptoms 1 month after going home.”

Ms. Pedersen agrees that clinicians should incorporate screening for PPD into their practices and be proactive in encouraging fathers to get help.

“Keep pushing,” she advised, as “men rarely seek help, compared to women, in matters of mental health.”
 

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

Postpartum depression isn’t just something new mothers can get. Turns out it can affect new fathers, too, according to a new study.

Michael W., a 38-year-old New Jersey–based attorney, and his wife had been excitedly planning for the birth of their baby and were overjoyed when she was born.

But after that, “I found that parenting a newborn was shockingly exhausting. I felt unprepared for the task, overwhelmed by the burden of the 24-hour-schedule and lack of sleep, and I struggled with feelings of inadequacy,” he said in an interview.

Michael never thought he had postpartum depression (PPD), perhaps because the condition is more commonly associated with women. But a study published in the American Journal of Men’s Health suggests that PPD also affects men.

A team of Danish investigators led by researcher Sarah Pedersen, of the department of public health, Aarhus University, extensively interviewed eight fathers with PPD and found their primary experiences involved feelings of being overwhelmed and powerless or inadequate, which sometimes turned into anger and frustration.

“I think one of the most important take-home messages is that practicing clinicians working with new parents should invite fathers to your consultations and engage the fathers as much as possible,” Ms. Pedersen said in an interview.

The findings also contained a message for parents, she says.

“I hope you will support each other and talk about your feelings and how you experience the transition to parenthood – know that it will take time to adjust to your new role,” she said.
 

Not enough attention

There’s been too little focus on fathers when it comes to PPD, according to Ms. Pedersen.

“During the last decade, several studies have examined the prevalence of PPD in men, and there is rising evidence that paternal PPD is associated with increased risk of long-term adverse behavioral and emotional outcomes in children,” she said.

Nevertheless, only three studies have been based on interviews with fathers who had personal experience with PPD.

“The purpose of our study was, first of all, to explore the lived experience of fathers who had PPD and, secondly, to gain deeper understanding of their help-seeking behavior – barriers to seeking help and facilitators of help-seeking,” Ms. Pedersen said.

The study was based on “semistructured” interviews with eight Danish fathers (ages 29-38 years) who had had PPD, none of whom had a previous history of depression.

All of them had received a formal diagnosis of PPD by a general practitioner or psychologist, and all had sought or received mental health care and considered themselves recovered from depression at the time of the interview.

The researchers used a technique called interpretative phenomenological analysis to analyze the interviews.

This method “aims to produce in-depth examinations of certain phenomena by examining how individuals make meaning of their own life experiences,” the authors wrote.
 

A ‘radical change’

Of the fathers, five described the period of pregnancy as a “time of happiness, full of positive expectations about fatherhood.”

But “the fathers’ great expectations were later replaced by a very different reality of fatherhood,” the authors wrote, noting that the transition to fatherhood was, in the words of one participant, a “radical change that you just can’t imagine.”

Most fathers expressed a feeling of being overwhelmed, and three felt unready for the task, which added to their depression.

“The participants wanted to be emotionally and physically present in their child’s life, but during the time of their depression, these kind-hearted intentions changed into feelings of guilt and inadequacy, as the participants did not feel they had enough energy and mental strength to become the kind of fathers they wanted to be,” the authors wrote.

The fathers mentioned stressors they believed contributed to their PPD, including complications during their partners’ pregnancies, unplanned cesarean birth (three fathers), the partners’ difficulties with breastfeeding (five fathers), and employment-related concerns. Five reported that their partners had postpartum emotional distress.
 

‘Masculine norms’

A second focus of the research was to examine fathers’ help-seeking behaviors, Ms. Pedersen said.

Ultimately, all the men sought formal help, either from their general practitioners or from a health visitor, with two seeking help right after birth.

Although the men were able to recognize changes in mood and behavior in retrospect, many did not regard them as signs of depression before their diagnosis.

Most had heard of PPD, but primarily as it affects women. Three sought information online about paternal PPD but couldn’t find any.

Four participants described experiencing PPD as “taboo,” based on a “combination of false beliefs, stigma, and masculine norms,” the authors stated, since men “are supposed to be big and strong and take care of everything, and suddenly you can’t.”

The authors reported that seven participants were screened for PPD or depression by a health care professional.

“The screening was an important part of the help-seeking process, as this was the first time two of the fathers were introduced to PPD,” the authors noted.

Although the screening “had the potential to spark conversation” about PPD, it was geared toward women, and some participants did not feel it was relevant to them.

“Future research should focus on identification of educational needs about paternal PPD among both parents, health care professionals, and other professionals taking care of new families,” Ms. Pedersen said.

Michael W. says it would have been helpful if someone had prepared him and his wife for what to expect, or if there had been some type of screening. Also, he advises expectant parents to “get some real-life experience by spending time around a newborn to see what’s involved.”
 

Different symptoms

“We often talk about mothers suffering from PPD, so it is more normalized for mothers to bring it up or for loved ones to ask mothers about how they are doing physically and psychologically after the birth,” Craig Garfield, MD, an attending physician and founder/director of Family and Child Health innovations at Ann and Robert H. Lurie Children’s Hospital, Chicago, said in an interview.

For fathers, “it is not discussed as commonly, so friends and families don’t often ask dads, and dads don’t know where to turn,” said Dr. Garfield, professor of pediatrics and medical social sciences at Northwestern University, Chicago. He was not involved with the study.

He noted that symptoms in fathers might differ from those of mothers.

“I have seen fathers who are anxious or more moody than they had been prior, or more angry, and I have seen fathers who throw themselves into work or begin drinking more – all related to changes in mood and depressive symptoms in the postnatal period,” he said.

Symptoms in men may last longer than in women. Dr. Garfield’s group published a study in which they surveyed 400 mothers and fathers of premature infants in the neonatal intensive care unit (NICU) about depressive symptoms around the time of NICU admission, at discharge home, and then after 30 days at home.

Roughly one-third of mothers screened positive for depressive symptoms around NICU admission, as did 17% of fathers. But the mothers’ depression scores improved by discharge and 30 days after being home, while the fathers’ remained “essentially unchanged,” he said.

“Further, we found that if doctors were to screen mothers and fathers during the NICU stay – at admission or even at discharge – that would greatly improve their ability to predict who would still have depressive symptoms 1 month after going home.”

Ms. Pedersen agrees that clinicians should incorporate screening for PPD into their practices and be proactive in encouraging fathers to get help.

“Keep pushing,” she advised, as “men rarely seek help, compared to women, in matters of mental health.”
 

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

Postpartum depression isn’t just something new mothers can get. Turns out it can affect new fathers, too, according to a new study.

Michael W., a 38-year-old New Jersey–based attorney, and his wife had been excitedly planning for the birth of their baby and were overjoyed when she was born.

But after that, “I found that parenting a newborn was shockingly exhausting. I felt unprepared for the task, overwhelmed by the burden of the 24-hour-schedule and lack of sleep, and I struggled with feelings of inadequacy,” he said in an interview.

Michael never thought he had postpartum depression (PPD), perhaps because the condition is more commonly associated with women. But a study published in the American Journal of Men’s Health suggests that PPD also affects men.

A team of Danish investigators led by researcher Sarah Pedersen, of the department of public health, Aarhus University, extensively interviewed eight fathers with PPD and found their primary experiences involved feelings of being overwhelmed and powerless or inadequate, which sometimes turned into anger and frustration.

“I think one of the most important take-home messages is that practicing clinicians working with new parents should invite fathers to your consultations and engage the fathers as much as possible,” Ms. Pedersen said in an interview.

The findings also contained a message for parents, she says.

“I hope you will support each other and talk about your feelings and how you experience the transition to parenthood – know that it will take time to adjust to your new role,” she said.
 

Not enough attention

There’s been too little focus on fathers when it comes to PPD, according to Ms. Pedersen.

“During the last decade, several studies have examined the prevalence of PPD in men, and there is rising evidence that paternal PPD is associated with increased risk of long-term adverse behavioral and emotional outcomes in children,” she said.

Nevertheless, only three studies have been based on interviews with fathers who had personal experience with PPD.

“The purpose of our study was, first of all, to explore the lived experience of fathers who had PPD and, secondly, to gain deeper understanding of their help-seeking behavior – barriers to seeking help and facilitators of help-seeking,” Ms. Pedersen said.

The study was based on “semistructured” interviews with eight Danish fathers (ages 29-38 years) who had had PPD, none of whom had a previous history of depression.

All of them had received a formal diagnosis of PPD by a general practitioner or psychologist, and all had sought or received mental health care and considered themselves recovered from depression at the time of the interview.

The researchers used a technique called interpretative phenomenological analysis to analyze the interviews.

This method “aims to produce in-depth examinations of certain phenomena by examining how individuals make meaning of their own life experiences,” the authors wrote.
 

A ‘radical change’

Of the fathers, five described the period of pregnancy as a “time of happiness, full of positive expectations about fatherhood.”

But “the fathers’ great expectations were later replaced by a very different reality of fatherhood,” the authors wrote, noting that the transition to fatherhood was, in the words of one participant, a “radical change that you just can’t imagine.”

Most fathers expressed a feeling of being overwhelmed, and three felt unready for the task, which added to their depression.

“The participants wanted to be emotionally and physically present in their child’s life, but during the time of their depression, these kind-hearted intentions changed into feelings of guilt and inadequacy, as the participants did not feel they had enough energy and mental strength to become the kind of fathers they wanted to be,” the authors wrote.

The fathers mentioned stressors they believed contributed to their PPD, including complications during their partners’ pregnancies, unplanned cesarean birth (three fathers), the partners’ difficulties with breastfeeding (five fathers), and employment-related concerns. Five reported that their partners had postpartum emotional distress.
 

‘Masculine norms’

A second focus of the research was to examine fathers’ help-seeking behaviors, Ms. Pedersen said.

Ultimately, all the men sought formal help, either from their general practitioners or from a health visitor, with two seeking help right after birth.

Although the men were able to recognize changes in mood and behavior in retrospect, many did not regard them as signs of depression before their diagnosis.

Most had heard of PPD, but primarily as it affects women. Three sought information online about paternal PPD but couldn’t find any.

Four participants described experiencing PPD as “taboo,” based on a “combination of false beliefs, stigma, and masculine norms,” the authors stated, since men “are supposed to be big and strong and take care of everything, and suddenly you can’t.”

The authors reported that seven participants were screened for PPD or depression by a health care professional.

“The screening was an important part of the help-seeking process, as this was the first time two of the fathers were introduced to PPD,” the authors noted.

Although the screening “had the potential to spark conversation” about PPD, it was geared toward women, and some participants did not feel it was relevant to them.

“Future research should focus on identification of educational needs about paternal PPD among both parents, health care professionals, and other professionals taking care of new families,” Ms. Pedersen said.

Michael W. says it would have been helpful if someone had prepared him and his wife for what to expect, or if there had been some type of screening. Also, he advises expectant parents to “get some real-life experience by spending time around a newborn to see what’s involved.”
 

Different symptoms

“We often talk about mothers suffering from PPD, so it is more normalized for mothers to bring it up or for loved ones to ask mothers about how they are doing physically and psychologically after the birth,” Craig Garfield, MD, an attending physician and founder/director of Family and Child Health innovations at Ann and Robert H. Lurie Children’s Hospital, Chicago, said in an interview.

For fathers, “it is not discussed as commonly, so friends and families don’t often ask dads, and dads don’t know where to turn,” said Dr. Garfield, professor of pediatrics and medical social sciences at Northwestern University, Chicago. He was not involved with the study.

He noted that symptoms in fathers might differ from those of mothers.

“I have seen fathers who are anxious or more moody than they had been prior, or more angry, and I have seen fathers who throw themselves into work or begin drinking more – all related to changes in mood and depressive symptoms in the postnatal period,” he said.

Symptoms in men may last longer than in women. Dr. Garfield’s group published a study in which they surveyed 400 mothers and fathers of premature infants in the neonatal intensive care unit (NICU) about depressive symptoms around the time of NICU admission, at discharge home, and then after 30 days at home.

Roughly one-third of mothers screened positive for depressive symptoms around NICU admission, as did 17% of fathers. But the mothers’ depression scores improved by discharge and 30 days after being home, while the fathers’ remained “essentially unchanged,” he said.

“Further, we found that if doctors were to screen mothers and fathers during the NICU stay – at admission or even at discharge – that would greatly improve their ability to predict who would still have depressive symptoms 1 month after going home.”

Ms. Pedersen agrees that clinicians should incorporate screening for PPD into their practices and be proactive in encouraging fathers to get help.

“Keep pushing,” she advised, as “men rarely seek help, compared to women, in matters of mental health.”
 

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

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

“What’s my number?” When I hear this from my financial planning clients, I know they mean: “What investment net worth do I need to be financially independent and make practicing medicine optional?” In my 20-year career, this “magic number” is by far the most common thing physicians want to know.

Wiroj Sidhisoradej/EyeEm/Getty Images

If you look online, articles may recommend having a portfolio valued at $2 million, $5 million, and not uncommonly $10 million or more to retire. Really? $10 million? You might be thinking that surely not everyone needs that amount. Luckily, that’s true.

There’s no magic number your portfolio should be – just your number.

It’s human nature to want a simple, clear target to shoot for. But unfortunately, there’s no generic answer when it comes to saving for retirement. Even after a comprehensive hour-long review of a client’s financial plan – including insurance, investments, estate planning, and other items – the most honest answer I can give is: “It depends.” Not satisfying, I know. But there are still too many holes to fill.

By far the most important factor in getting beyond “it depends” is having an accurate estimate of annual retirement expenses. I have clients who live comfortably on $50,000 a year in retirement and others who need $250,000 or more. Knowing how much you need – your personal number – depends on the individual’s unique dream for retirement and calculating what that dream will cost.

Form a guesstimate based on savings and anticipated expenses

The total portfolio value needed to sustain an annual expense of $50,000 a year in retirement spending versus the portfolio size needed for $250,000 or more, blows apart the fiction of a universal “magic number.” It’s just not that simple. While it’s hard to gauge exactly what you will need, the right information can lead to a logical guesstimate about what size portfolio will provide you with financial independence.

In the end, it’s up to you to determine your desired retirement lifestyle. Then, the only way to get there is to calculate how much it will cost and save up for it by following a well-informed financial plan. This plan will be based on strategy that shifts from the middle to the later stages of your medical career and into retirement.

Let’s see how it works.
 

Early to mid-career: Focus on building up retirement savings

We ultimately want to save enough to meet our retirement expenses. But figuring out how much to save when you’re in your 40s and 50s is difficult. A mid-career physician likely has significant family- and child-related expenses. When we become empty-nesters, those expenses will decline. In retirement they may disappear entirely, but new expenses may arise.

With large variations in expenses at different life stages, it’s hard to calculate exactly how much you will need to save. Early on, the most sensible thing is putting aside a “reasonable” percentage of gross income for retirement savings.

What is a ‘reasonable’ savings goal for retirement?

As is often the case with high-income earners, many of our clients don’t have a budget or a clear picture of their current expenses and spending habits. That’s alright as long as they are building up a reasonable nest egg for the future – which begs the question of what is reasonable.

For mid-career docs, a reasonable goal to aim for is putting aside 20% of gross income for retirement. What you spend the rest of your money on is less important than how much you’re saving.

This is quite different from how you’ll handle expenses during retirement, when you no longer have a steady stream of income; rather, you have a pot of money that needs to last you another 20, 30, or even 40 years. At that point, thinking about specific expenses becomes more important (more on this topic later). That said, if you’re a mid-career doctor who is not meeting this 20% savings goal, it’s time to make a plan that will free up cash for retirement savings and investments.
 

Later-career docs: Calculate your spending level in retirement

Financial success means having a portfolio that can support your retirement dreams – with the confidence that your money will last and you won’t need to watch every dollar you spend. As you near retirement, your focus will shift away from accumulating savings to calculating the annual expenses you will have to meet in retirement.

A good place to start is figuring out which expenses will be necessary and which will be more flexible. To do this, separate your anticipated spending into these two categories:

• Fixed expenses: You can confidently forecast your “must-have” fixed expenses – such as property taxes, property/casualty insurance, health care costs, utilities, and groceries – because they remain steady from month to month.
• Discretionary expenses: These “like-to-have” expenses vary from month to month. This makes them harder to predict but easier to control. They might include dining out, travel, and charitable contributions.

As a retiree, understanding your fixed and discretionary expenses can help you prepare for a bear market, when the stock market can decline by 20% or more. Your portfolio won’t consist entirely of stocks, so it shouldn’t drop to that degree. Still, it will decline significantly. You may need to cut back on spending for a year or 2 to allow your portfolio to recover, particularly if the portfolio declines early in retirement.

Are you ready for retirement?

During the long bull market preceding the great recession of 2007 and 2009, many physicians retired –only to return to their practices when their portfolio values plummeted. In the exuberance of the moment, many failed to heed the warnings of many economists and got caught flat-footed.

Right now it’s a bull market, but we’re seeing concerning signs, such as an out-of-control housing market and rumblings about inflation and rising consumer costs. Sound familiar? If you hope to retire soon, take the time to objectively look around the corner so you can plan appropriately – whether your goal is to retire completely, stay in practice part-time, or even take on a new opportunity.

In an “it-depends” world, don’t be lured by a fictitious magic number, no matter what comes up when you Google: “When can I retire?” Instead, save early, imagine your dream retirement, and calculate expenses later to see what’s possible.

Dr. Greenwald is a graduate of the Albert Einstein College of Medicine, New York. Dr. Greenwald completed his internal medicine residency at the University of Minnesota, Minneapolis. He practiced internal medicine in the Twin Cities for 11 years before making the transition to financial planning for physicians, beginning in 1998.

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

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

Adults with sickle cell disease who experienced a vaso-occlusive crisis had substantially better outcomes when they were treated at specialty infusion centers than those treated in emergency departments (EDs), a prospective observational study shows.

At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.

“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”

To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.

The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.

The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs. 

Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.

The investigators used propensity score methodology to balance patient characteristics in the study groups.
 

Quick, effective pain reduction is beneficial

The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write. 

Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.

The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note. 

“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write. 

“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.

Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote. 

The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study. 

“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
 

Infusion centers are scarce

“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.

“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.” 

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.

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

Adults with sickle cell disease who experienced a vaso-occlusive crisis had substantially better outcomes when they were treated at specialty infusion centers than those treated in emergency departments (EDs), a prospective observational study shows.

At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.

“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”

To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.

The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.

The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs. 

Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.

The investigators used propensity score methodology to balance patient characteristics in the study groups.
 

Quick, effective pain reduction is beneficial

The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write. 

Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.

The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note. 

“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write. 

“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.

Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote. 

The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study. 

“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
 

Infusion centers are scarce

“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.

“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.” 

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.

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

Adults with sickle cell disease who experienced a vaso-occlusive crisis had substantially better outcomes when they were treated at specialty infusion centers than those treated in emergency departments (EDs), a prospective observational study shows.

At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.

“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”

To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.

The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.

The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs. 

Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.

The investigators used propensity score methodology to balance patient characteristics in the study groups.
 

Quick, effective pain reduction is beneficial

The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write. 

Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.

The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note. 

“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write. 

“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.

Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote. 

The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study. 

“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
 

Infusion centers are scarce

“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.

“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.” 

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.

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

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .

The hashtag #BigHoopEnergy has sparked an online conversation about how women of color in the medical field are pressured to conform to traditional standards of professional appearance.

It started when a Latina doctor tweeted that she lost points on a practical exam in medical school because of her hoop earrings, with the evaluator writing “earrings, unprofessional.”

That led other female doctors to cite their own experiences, reported The Lily, a Washington Post publication aimed at millennial women. Many women posted photos of themselves wearing hoops, which have long been associated with Latina and African American women, the outlet said.

“There’s a big movement to police women of color and how they present themselves in medical spaces,” said Briana Christophers, an MD-PhD student at the Tri-Institutional MD-PhD Program in New York. “I think in part it’s a way of trying to make people who don’t usually fit the mold, fit the mold.”

Ms. Christophers, who identifies as Latina, said she was urged to wear a black or navy suit when interviewing for doctorate programs. She wore a black suit with a lavender blouse and received comments about that – some positive, some not, she said.

“Sometimes you don’t know how to interpret those sorts of comments,” Ms. Christophers said. “Do you remember because you like the shirt, or because you don’t think I should have done that?”

Doctors of color still stand out in American medicine. The Lily cited the Association of American Medical Colleges as saying that in 2018, Hispanics made up 5.8% of active American doctors and African Americans made up 5%.

Studies show that medical professionals of color often don’t receive the same respect as their White counterparts, with some people questioning whether they’re actually doctors.

“At work, wearing my white coat that has my name pretty big on it with a badge that says doctor on it, I still get asked if I’m the environmental services staff,” Alexandra Sims, MD, a pediatrician in Cincinnati, told The Lily. “I think it just demonstrates how deeply ingrained bias, racism, and sexism are in society and that we have a lot of work to do to disrupt that.”

Dr. Sims said the tweet about hoop earrings led her to wonder about daily decisions she makes about dress.

“Am I too much? Is this too much? Is this earring too big? Is this nail polish color too loud? And how will that be received at work?” she said, noting that she may opt not to wear hoops in certain situations, such as when she’s dealing with a grabby baby.

Monica Verduzco-Gutierrez, MD, professor and chair of the department of rehabilitation medicine at University of Texas Health, San Antonio, said doctors should be judged on the care they provide, not their appearance.

“Judging someone based on their earrings or their jumpsuit or whatever else that they’re noticing about the student is not an appropriate way to judge the student’s ability to take care of a patient,” Dr. Verduzco-Gutierrez said, noting that she was not speaking on behalf of the school.
 

A version of this article was first published on WebMD.com .