User login
News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
Meditations in an emergency: Talking through pandemic anxiety with a pioneer of mind-body medicine
Andrew N. Wilner, MD: Welcome to Medscape. I’m Dr Andrew Wilner. Today I have a special guest, Dr James Gordon, founder and executive director of the Center for Mind-Body Medicine. Welcome, Dr Gordon.
James S. Gordon, MD: Thank you very much. It’s good to be with you.
Dr. Wilner: Thanks for joining us. We are recording this in late May 2020, in the midst of the coronavirus pandemic. Millions of people have been infected. Hundreds of thousands have died. Millions have lost their jobs. I think it’s fair to say that people are under a greater degree of stress than they’re normally accustomed to. Would you agree with that?
Dr. Gordon: I think it’s more than fair to say that everybody in the United States, and actually pretty much everyone in the world, is under extreme stress. And that compounds any stresses that they’ve experienced before in their lives. Everyone is affected.
Dr. Wilner: The mind-body medicine concept is one that you’ve pursued for decades. Tell us a little bit about the Center for Mind-Body Medicine and how that’s led to the program that you have to help us deal with the coronavirus.
Dr. Gordon: I started the Center for Mind-Body Medicine about 30 years ago. I’d been a researcher at the National Institute of Mental Health for a number of years, in private practice, and a professor at Georgetown Medical School. But I wanted to really focus on how to change and enrich medicine by making self-care, self-awareness, and group support central to all healthcare.
Western medicine is enormously powerful in certain situations, such as physical trauma, high levels of infection, congenital anomalies. But we’re not so good at working with chronic physical or psychological problems. Those are much more complex.
We’ve been discovering that what is going to make the long-term difference in conditions like type 2 diabetes, pain syndromes, hypertension, depression, and anxiety are those approaches that we can learn to do for ourselves. These are changes we can make in how we deal with stress, eat, exercise, relate to other people, and whether we find meaning and purpose in our lives.
by wars, climate-related disasters, the opioid epidemic, chronic poverty, historical trauma. We do a lot of work with indigenous people here in North America. We’ve worked in a number of communities where school shootings have traumatized everyone.
What we’ve learned over these past 25 years, and what interested me professionally as well as personally over the past 50 years, is what we’re now bringing out on an even larger scale. The kind of approaches that we’ve developed, studied, and published research on are exactly what everyone needs to include and incorporate in their daily life, as well as in their medical and health care, from now on.
Dr. Wilner: Do you have a program that’s specifically for health care providers?
Dr. Gordon: Yes. The Center for Mind-Body Medicine is primarily an educational organization rather than a service organization. Since the beginning, I’ve been focused on training health professionals. My first passion was for training physicians – I’m a physician, so there’s a feeling of fellowship there – but also health care workers and mental health professionals of every kind.
We teach health professionals a whole system, a comprehensive program of techniques of self-awareness and self-care. We teach them so that they can practice on themselves and study the underlying science, so they can then teach what they’ve learned to the patients or clients they work with. They integrate it into what they’re already doing, regardless of their specialty. At times we also offer some of the same kinds of mind-body skills groups that are the fundamental part of our training as a stand-alone intervention. You can’t really teach other people how to take care of themselves unless you’re also doing it yourself. Otherwise, it’s just a theory.
Dr. Wilner: As a neurologist, I’m interested in the mind-body system. You are a psychiatrist and understand that it’s a lot more difficult to objectify certain things. What is stress? What is happiness? What is sadness? It’s very hard to measure. You can have scales, but it requires insight on the part of the individual. So I think it’s certainly an ambitious project.
Dr. Gordon: You’re absolutely right. It requires insight. And one of the shortcomings of our medical education is that it doesn’t encourage us to look inside ourselves enough. There’s so much focus on objectivity and on data, that we’ve lost some of the subjective art of medicine.
My experience with myself, as well as with the thousands of people we’ve trained here in the United States and around the world and the many hundreds of thousands with whom they’ve worked, is that all of us have a greater capacity to understand and help ourselves than we ordinarily think or than most of us learn about in our medical education.
This work is saying to people to take a little bit of time and relax a little in order to allow yourself to come into a meditative state. And I don’t mean anything fancy by that. Meditation is just being relaxed. Moment-to-moment awareness doesn’t have to do with any particular religion or spiritual practice. It’s part of all of them. If you can get into that state, then you can begin to say, “Oh, that’s what’s going on with me. That’s why my pain is worse.”
For example, you often wonder in people with peripheral neuropathy why it becomes worse or better at certain points. I would encourage neurologists and other physicians to ask your patients, “Why do you think it’s worse?” They may say, “I don’t know, doc; that’s why I’m here.” But I would ask them to take a couple of minutes to let me know. They could think it has something to do with the fact that they had a big fight with their wife that morning, they don’t want to go to work, or whatever it is. This is part of the lost art that we need to bring back into medicine for ourselves and especially for our patients.
Dr. Wilner: Can you give me an example of some of the exercises you’d do in a class?
Dr. Gordon: All of the exercises and our entire program that we teach at the Center for Mind-Body Medicine is in this new book of mine, “The Transformation: Discovering Wholeness and Healing After Trauma.” It’s really the distillation of not just the past 25 or 30 years, but really 50 years of work.
The techniques are all pretty simple and, as we say, evidence based. There is evidence that shows how they work on us physiologically, as well as psychologically. And they’re all pretty easy to teach to anyone.
Myself and about 60 or 70 of our faculty at the Center for Mind-Body Medicine are currently leading online groups. Then several hundred of the other people we’ve trained are also leading these groups. We’re still counting it up, but we probably have between 700 and 1,000 groups going around the world, led by our faculty and by people we’ve trained.
We teach a different technique every week in these online groups. Last week, after getting people energized and focused, we did a written dialogue with an emotion. You put down the initial of your name – in my case, “J” for Jim – and create a dialogue with an emotion, such as sadness. I would write it as fast as I can.
I would say, “OK, Sadness. Why are you here? What are you doing? I don’t enjoy having you around.” And Sadness writes back to me, “But you need me.” And J says, “What do you mean I need you?” And Sadness says, “Well, your brother died 7 weeks ago, didn’t he?” And I say, “Yes, he did.” And Sadness says, “Aren’t you sad?” I say, “Yes. I’m terribly sad and grieving all the time. But I wasn’t thinking about him at this moment.” And Sadness says, “But he’s there with you all the time and that sadness is in you.” And I say, “You mean it’s in me even here, now, as I’m talking with Andrew in this interview?” And Sadness says, “Yes. You can talk about your work. But in between the words, as you take a breath, don’t you feel it in your chest?” That’s the way the dialogue goes.
Dr. Wilner: What about specifically with the coronavirus? Fear is certainly an emotion. Nobody wants to get sick and die. Nobody wants to bring this disease home to their family. People are reluctant to even go outside and you can’t shake someone’s hand. Are there precedents for this?
Dr. Gordon: There are precedents, but only relatively small groups were affected before by, for example, severe acute respiratory syndrome or H1N1, at least in the United States. But we haven’t seen a global pandemic like this since 1918. None of us was around then – or I certainly wasn’t around. So for most everyone, not only has it not happened before, but we’ve never been so globally aware of everything that’s going on and how different groups are reacting.
I’ve been reading Daniel Defoe’s book, “A Journal of the Plague Year.” It’s really very interesting. It’s about the bubonic plague in 1665 London, although he wrote it in the 1720s. Some of the same things were going on then: the enormous fear, the isolation; rich people being able to escape, poor people having nowhere to go; conspiracy theories of one kind or another, about where the plague came from or blaming a group of people for it; magical thinking that it’s just going to go away. All of those things that happened several hundred years ago are going on now.
And we’re all simultaneously aware of all those things. There’s not only the fear, which should be universal because it’s a reasonable response to this situation, but also the terrible confusion about what to do. The President is saying one thing, governors something else; Anthony Fauci is saying something else, and Deborah Birx is saying something a little bit different. There’s this tremendous confusion that overlays the fear, and I think everybody is more or less feeling these things.
So yes, a dialogue with fear is a good thing to do because it can be clarifying. What we need here is a sense of, what is it that makes sense for me to do? What precautions should I take? What precautions shouldn’t I take?
I have a 17-year-old son who lives with his mom in California. He and I were on the phone the other day. He’s a basketball player and very serious about it. He said, “I don’t want to put my life on hold.” And my response was, “If you go outside too soon, your life may be on hold for a hell of a lot longer than if you stay inside because, if you get sick, it’s serious. But you also need to start looking at the evidence and asking yourself the right questions because I can’t be there all the time and neither can your mom.”
Everybody really needs to use these kinds of tools to help themselves. The tools we teach are extremely good at bringing us back into a state of psychological and physiological balance — slow, deep breathing being a very basic one. Because it’s only in that state that we’re going to be able to make the most intelligent decisions about what to do. It’s only in that state that we’re going to be able to really look our fear in the face and find out what we should be afraid of and what we shouldn’t be afraid of.
It’s a process that’s very much integrated. We’re talking now about how to deal with the emotions. But the first part of what we do in our groups and our online trainings and webinars is teach people to just take a few deep breaths. Just take a few deep breaths in through the nose, out through the mouth, with your belly soft and relaxed. You can keep breathing this way while talking. That’s the antidote to the fight-or-flight response. We all learn about fight-or-flight in first-year physiology. We need to deal with it. We need to bring ourselves into balance. That’s the way we’re going to make the wisest decisions for ourselves and be best able to help our patients.
Dr. Wilner: As you mentioned, part of modern culture is that we now have access to all of this information worldwide. There’s a continual stream of newsfeeds, people flipping on their phones, receiving constant updates, 24/7. That’s a new phenomenon. Does that steal from us the time we had before for just breathing and synthesizing data as opposed to just acquiring it all the time?
Dr. Gordon: You’re absolutely right. It does and it’s a challenge. It can’t steal from us unless we’re letting our emotional, psychological, and physiological pockets be picked!
What we need to do is to make it our priority to come into balance. I don’t watch news all day long – a little tiny bit in the morning and in the evening, just to get a sense of what’s happening. That’s enough. And I think everybody needs to take a step back, ask if this is really what they want to be doing, and to come into balance.
The other thing that’s really important is physical activity, especially during this time. In addition to using slow, deep breathing to come into balance, physical exercise and movement of any kind is extremely good as an antidote to fight-or-flight and that shut-down, freeze-up response that we get into when we feel completely overwhelmed.
We’ve got to take it into our own hands. The media just want to sell us things. Let’s face it: They’re not here for our good. Our job as physicians and health care professionals is to really reinforce for people not only what we can do for them but what they can do for themselves.
Dr. Wilner: I’m certainly interested in learning more about mind-body medicine. For those who feel the same, where do you recommend they go to learn more?
Dr. Gordon: We have a website, cmbm.org, which features a number of webinars. I do a free webinar there every week. We have mind-body skills groups that meet once a week for 8 weeks. There are six physicians in my group and all kinds of health professionals in other groups. We have a training program that we’re bringing online. We’ve trained well over 6,000 people around the world and would love to train more. You can read about that on the website.
We’re starting to do more and more consulting with health care organizations. We’re working with the largest division of Veterans Affairs, which is in Florida, as well as in south Georgia and the Caribbean. We’re working with a large health system in Indiana and others elsewhere. In addition, we’re working with groups of physicians and mental health professionals, helping them to integrate what we have to offer into what they’re already doing.
That’s our job – to help you do your job.
Dr. Wilner: Dr Gordon, I feel more relaxed just speaking with you. Thank you for talking with me and sharing your experiences with Medscape. I look forward to learning more.
Dr. Gordon: Thank you. My pleasure.
A version of this article originally appeared on Medscape.com.
Andrew N. Wilner, MD: Welcome to Medscape. I’m Dr Andrew Wilner. Today I have a special guest, Dr James Gordon, founder and executive director of the Center for Mind-Body Medicine. Welcome, Dr Gordon.
James S. Gordon, MD: Thank you very much. It’s good to be with you.
Dr. Wilner: Thanks for joining us. We are recording this in late May 2020, in the midst of the coronavirus pandemic. Millions of people have been infected. Hundreds of thousands have died. Millions have lost their jobs. I think it’s fair to say that people are under a greater degree of stress than they’re normally accustomed to. Would you agree with that?
Dr. Gordon: I think it’s more than fair to say that everybody in the United States, and actually pretty much everyone in the world, is under extreme stress. And that compounds any stresses that they’ve experienced before in their lives. Everyone is affected.
Dr. Wilner: The mind-body medicine concept is one that you’ve pursued for decades. Tell us a little bit about the Center for Mind-Body Medicine and how that’s led to the program that you have to help us deal with the coronavirus.
Dr. Gordon: I started the Center for Mind-Body Medicine about 30 years ago. I’d been a researcher at the National Institute of Mental Health for a number of years, in private practice, and a professor at Georgetown Medical School. But I wanted to really focus on how to change and enrich medicine by making self-care, self-awareness, and group support central to all healthcare.
Western medicine is enormously powerful in certain situations, such as physical trauma, high levels of infection, congenital anomalies. But we’re not so good at working with chronic physical or psychological problems. Those are much more complex.
We’ve been discovering that what is going to make the long-term difference in conditions like type 2 diabetes, pain syndromes, hypertension, depression, and anxiety are those approaches that we can learn to do for ourselves. These are changes we can make in how we deal with stress, eat, exercise, relate to other people, and whether we find meaning and purpose in our lives.
by wars, climate-related disasters, the opioid epidemic, chronic poverty, historical trauma. We do a lot of work with indigenous people here in North America. We’ve worked in a number of communities where school shootings have traumatized everyone.
What we’ve learned over these past 25 years, and what interested me professionally as well as personally over the past 50 years, is what we’re now bringing out on an even larger scale. The kind of approaches that we’ve developed, studied, and published research on are exactly what everyone needs to include and incorporate in their daily life, as well as in their medical and health care, from now on.
Dr. Wilner: Do you have a program that’s specifically for health care providers?
Dr. Gordon: Yes. The Center for Mind-Body Medicine is primarily an educational organization rather than a service organization. Since the beginning, I’ve been focused on training health professionals. My first passion was for training physicians – I’m a physician, so there’s a feeling of fellowship there – but also health care workers and mental health professionals of every kind.
We teach health professionals a whole system, a comprehensive program of techniques of self-awareness and self-care. We teach them so that they can practice on themselves and study the underlying science, so they can then teach what they’ve learned to the patients or clients they work with. They integrate it into what they’re already doing, regardless of their specialty. At times we also offer some of the same kinds of mind-body skills groups that are the fundamental part of our training as a stand-alone intervention. You can’t really teach other people how to take care of themselves unless you’re also doing it yourself. Otherwise, it’s just a theory.
Dr. Wilner: As a neurologist, I’m interested in the mind-body system. You are a psychiatrist and understand that it’s a lot more difficult to objectify certain things. What is stress? What is happiness? What is sadness? It’s very hard to measure. You can have scales, but it requires insight on the part of the individual. So I think it’s certainly an ambitious project.
Dr. Gordon: You’re absolutely right. It requires insight. And one of the shortcomings of our medical education is that it doesn’t encourage us to look inside ourselves enough. There’s so much focus on objectivity and on data, that we’ve lost some of the subjective art of medicine.
My experience with myself, as well as with the thousands of people we’ve trained here in the United States and around the world and the many hundreds of thousands with whom they’ve worked, is that all of us have a greater capacity to understand and help ourselves than we ordinarily think or than most of us learn about in our medical education.
This work is saying to people to take a little bit of time and relax a little in order to allow yourself to come into a meditative state. And I don’t mean anything fancy by that. Meditation is just being relaxed. Moment-to-moment awareness doesn’t have to do with any particular religion or spiritual practice. It’s part of all of them. If you can get into that state, then you can begin to say, “Oh, that’s what’s going on with me. That’s why my pain is worse.”
For example, you often wonder in people with peripheral neuropathy why it becomes worse or better at certain points. I would encourage neurologists and other physicians to ask your patients, “Why do you think it’s worse?” They may say, “I don’t know, doc; that’s why I’m here.” But I would ask them to take a couple of minutes to let me know. They could think it has something to do with the fact that they had a big fight with their wife that morning, they don’t want to go to work, or whatever it is. This is part of the lost art that we need to bring back into medicine for ourselves and especially for our patients.
Dr. Wilner: Can you give me an example of some of the exercises you’d do in a class?
Dr. Gordon: All of the exercises and our entire program that we teach at the Center for Mind-Body Medicine is in this new book of mine, “The Transformation: Discovering Wholeness and Healing After Trauma.” It’s really the distillation of not just the past 25 or 30 years, but really 50 years of work.
The techniques are all pretty simple and, as we say, evidence based. There is evidence that shows how they work on us physiologically, as well as psychologically. And they’re all pretty easy to teach to anyone.
Myself and about 60 or 70 of our faculty at the Center for Mind-Body Medicine are currently leading online groups. Then several hundred of the other people we’ve trained are also leading these groups. We’re still counting it up, but we probably have between 700 and 1,000 groups going around the world, led by our faculty and by people we’ve trained.
We teach a different technique every week in these online groups. Last week, after getting people energized and focused, we did a written dialogue with an emotion. You put down the initial of your name – in my case, “J” for Jim – and create a dialogue with an emotion, such as sadness. I would write it as fast as I can.
I would say, “OK, Sadness. Why are you here? What are you doing? I don’t enjoy having you around.” And Sadness writes back to me, “But you need me.” And J says, “What do you mean I need you?” And Sadness says, “Well, your brother died 7 weeks ago, didn’t he?” And I say, “Yes, he did.” And Sadness says, “Aren’t you sad?” I say, “Yes. I’m terribly sad and grieving all the time. But I wasn’t thinking about him at this moment.” And Sadness says, “But he’s there with you all the time and that sadness is in you.” And I say, “You mean it’s in me even here, now, as I’m talking with Andrew in this interview?” And Sadness says, “Yes. You can talk about your work. But in between the words, as you take a breath, don’t you feel it in your chest?” That’s the way the dialogue goes.
Dr. Wilner: What about specifically with the coronavirus? Fear is certainly an emotion. Nobody wants to get sick and die. Nobody wants to bring this disease home to their family. People are reluctant to even go outside and you can’t shake someone’s hand. Are there precedents for this?
Dr. Gordon: There are precedents, but only relatively small groups were affected before by, for example, severe acute respiratory syndrome or H1N1, at least in the United States. But we haven’t seen a global pandemic like this since 1918. None of us was around then – or I certainly wasn’t around. So for most everyone, not only has it not happened before, but we’ve never been so globally aware of everything that’s going on and how different groups are reacting.
I’ve been reading Daniel Defoe’s book, “A Journal of the Plague Year.” It’s really very interesting. It’s about the bubonic plague in 1665 London, although he wrote it in the 1720s. Some of the same things were going on then: the enormous fear, the isolation; rich people being able to escape, poor people having nowhere to go; conspiracy theories of one kind or another, about where the plague came from or blaming a group of people for it; magical thinking that it’s just going to go away. All of those things that happened several hundred years ago are going on now.
And we’re all simultaneously aware of all those things. There’s not only the fear, which should be universal because it’s a reasonable response to this situation, but also the terrible confusion about what to do. The President is saying one thing, governors something else; Anthony Fauci is saying something else, and Deborah Birx is saying something a little bit different. There’s this tremendous confusion that overlays the fear, and I think everybody is more or less feeling these things.
So yes, a dialogue with fear is a good thing to do because it can be clarifying. What we need here is a sense of, what is it that makes sense for me to do? What precautions should I take? What precautions shouldn’t I take?
I have a 17-year-old son who lives with his mom in California. He and I were on the phone the other day. He’s a basketball player and very serious about it. He said, “I don’t want to put my life on hold.” And my response was, “If you go outside too soon, your life may be on hold for a hell of a lot longer than if you stay inside because, if you get sick, it’s serious. But you also need to start looking at the evidence and asking yourself the right questions because I can’t be there all the time and neither can your mom.”
Everybody really needs to use these kinds of tools to help themselves. The tools we teach are extremely good at bringing us back into a state of psychological and physiological balance — slow, deep breathing being a very basic one. Because it’s only in that state that we’re going to be able to make the most intelligent decisions about what to do. It’s only in that state that we’re going to be able to really look our fear in the face and find out what we should be afraid of and what we shouldn’t be afraid of.
It’s a process that’s very much integrated. We’re talking now about how to deal with the emotions. But the first part of what we do in our groups and our online trainings and webinars is teach people to just take a few deep breaths. Just take a few deep breaths in through the nose, out through the mouth, with your belly soft and relaxed. You can keep breathing this way while talking. That’s the antidote to the fight-or-flight response. We all learn about fight-or-flight in first-year physiology. We need to deal with it. We need to bring ourselves into balance. That’s the way we’re going to make the wisest decisions for ourselves and be best able to help our patients.
Dr. Wilner: As you mentioned, part of modern culture is that we now have access to all of this information worldwide. There’s a continual stream of newsfeeds, people flipping on their phones, receiving constant updates, 24/7. That’s a new phenomenon. Does that steal from us the time we had before for just breathing and synthesizing data as opposed to just acquiring it all the time?
Dr. Gordon: You’re absolutely right. It does and it’s a challenge. It can’t steal from us unless we’re letting our emotional, psychological, and physiological pockets be picked!
What we need to do is to make it our priority to come into balance. I don’t watch news all day long – a little tiny bit in the morning and in the evening, just to get a sense of what’s happening. That’s enough. And I think everybody needs to take a step back, ask if this is really what they want to be doing, and to come into balance.
The other thing that’s really important is physical activity, especially during this time. In addition to using slow, deep breathing to come into balance, physical exercise and movement of any kind is extremely good as an antidote to fight-or-flight and that shut-down, freeze-up response that we get into when we feel completely overwhelmed.
We’ve got to take it into our own hands. The media just want to sell us things. Let’s face it: They’re not here for our good. Our job as physicians and health care professionals is to really reinforce for people not only what we can do for them but what they can do for themselves.
Dr. Wilner: I’m certainly interested in learning more about mind-body medicine. For those who feel the same, where do you recommend they go to learn more?
Dr. Gordon: We have a website, cmbm.org, which features a number of webinars. I do a free webinar there every week. We have mind-body skills groups that meet once a week for 8 weeks. There are six physicians in my group and all kinds of health professionals in other groups. We have a training program that we’re bringing online. We’ve trained well over 6,000 people around the world and would love to train more. You can read about that on the website.
We’re starting to do more and more consulting with health care organizations. We’re working with the largest division of Veterans Affairs, which is in Florida, as well as in south Georgia and the Caribbean. We’re working with a large health system in Indiana and others elsewhere. In addition, we’re working with groups of physicians and mental health professionals, helping them to integrate what we have to offer into what they’re already doing.
That’s our job – to help you do your job.
Dr. Wilner: Dr Gordon, I feel more relaxed just speaking with you. Thank you for talking with me and sharing your experiences with Medscape. I look forward to learning more.
Dr. Gordon: Thank you. My pleasure.
A version of this article originally appeared on Medscape.com.
Andrew N. Wilner, MD: Welcome to Medscape. I’m Dr Andrew Wilner. Today I have a special guest, Dr James Gordon, founder and executive director of the Center for Mind-Body Medicine. Welcome, Dr Gordon.
James S. Gordon, MD: Thank you very much. It’s good to be with you.
Dr. Wilner: Thanks for joining us. We are recording this in late May 2020, in the midst of the coronavirus pandemic. Millions of people have been infected. Hundreds of thousands have died. Millions have lost their jobs. I think it’s fair to say that people are under a greater degree of stress than they’re normally accustomed to. Would you agree with that?
Dr. Gordon: I think it’s more than fair to say that everybody in the United States, and actually pretty much everyone in the world, is under extreme stress. And that compounds any stresses that they’ve experienced before in their lives. Everyone is affected.
Dr. Wilner: The mind-body medicine concept is one that you’ve pursued for decades. Tell us a little bit about the Center for Mind-Body Medicine and how that’s led to the program that you have to help us deal with the coronavirus.
Dr. Gordon: I started the Center for Mind-Body Medicine about 30 years ago. I’d been a researcher at the National Institute of Mental Health for a number of years, in private practice, and a professor at Georgetown Medical School. But I wanted to really focus on how to change and enrich medicine by making self-care, self-awareness, and group support central to all healthcare.
Western medicine is enormously powerful in certain situations, such as physical trauma, high levels of infection, congenital anomalies. But we’re not so good at working with chronic physical or psychological problems. Those are much more complex.
We’ve been discovering that what is going to make the long-term difference in conditions like type 2 diabetes, pain syndromes, hypertension, depression, and anxiety are those approaches that we can learn to do for ourselves. These are changes we can make in how we deal with stress, eat, exercise, relate to other people, and whether we find meaning and purpose in our lives.
by wars, climate-related disasters, the opioid epidemic, chronic poverty, historical trauma. We do a lot of work with indigenous people here in North America. We’ve worked in a number of communities where school shootings have traumatized everyone.
What we’ve learned over these past 25 years, and what interested me professionally as well as personally over the past 50 years, is what we’re now bringing out on an even larger scale. The kind of approaches that we’ve developed, studied, and published research on are exactly what everyone needs to include and incorporate in their daily life, as well as in their medical and health care, from now on.
Dr. Wilner: Do you have a program that’s specifically for health care providers?
Dr. Gordon: Yes. The Center for Mind-Body Medicine is primarily an educational organization rather than a service organization. Since the beginning, I’ve been focused on training health professionals. My first passion was for training physicians – I’m a physician, so there’s a feeling of fellowship there – but also health care workers and mental health professionals of every kind.
We teach health professionals a whole system, a comprehensive program of techniques of self-awareness and self-care. We teach them so that they can practice on themselves and study the underlying science, so they can then teach what they’ve learned to the patients or clients they work with. They integrate it into what they’re already doing, regardless of their specialty. At times we also offer some of the same kinds of mind-body skills groups that are the fundamental part of our training as a stand-alone intervention. You can’t really teach other people how to take care of themselves unless you’re also doing it yourself. Otherwise, it’s just a theory.
Dr. Wilner: As a neurologist, I’m interested in the mind-body system. You are a psychiatrist and understand that it’s a lot more difficult to objectify certain things. What is stress? What is happiness? What is sadness? It’s very hard to measure. You can have scales, but it requires insight on the part of the individual. So I think it’s certainly an ambitious project.
Dr. Gordon: You’re absolutely right. It requires insight. And one of the shortcomings of our medical education is that it doesn’t encourage us to look inside ourselves enough. There’s so much focus on objectivity and on data, that we’ve lost some of the subjective art of medicine.
My experience with myself, as well as with the thousands of people we’ve trained here in the United States and around the world and the many hundreds of thousands with whom they’ve worked, is that all of us have a greater capacity to understand and help ourselves than we ordinarily think or than most of us learn about in our medical education.
This work is saying to people to take a little bit of time and relax a little in order to allow yourself to come into a meditative state. And I don’t mean anything fancy by that. Meditation is just being relaxed. Moment-to-moment awareness doesn’t have to do with any particular religion or spiritual practice. It’s part of all of them. If you can get into that state, then you can begin to say, “Oh, that’s what’s going on with me. That’s why my pain is worse.”
For example, you often wonder in people with peripheral neuropathy why it becomes worse or better at certain points. I would encourage neurologists and other physicians to ask your patients, “Why do you think it’s worse?” They may say, “I don’t know, doc; that’s why I’m here.” But I would ask them to take a couple of minutes to let me know. They could think it has something to do with the fact that they had a big fight with their wife that morning, they don’t want to go to work, or whatever it is. This is part of the lost art that we need to bring back into medicine for ourselves and especially for our patients.
Dr. Wilner: Can you give me an example of some of the exercises you’d do in a class?
Dr. Gordon: All of the exercises and our entire program that we teach at the Center for Mind-Body Medicine is in this new book of mine, “The Transformation: Discovering Wholeness and Healing After Trauma.” It’s really the distillation of not just the past 25 or 30 years, but really 50 years of work.
The techniques are all pretty simple and, as we say, evidence based. There is evidence that shows how they work on us physiologically, as well as psychologically. And they’re all pretty easy to teach to anyone.
Myself and about 60 or 70 of our faculty at the Center for Mind-Body Medicine are currently leading online groups. Then several hundred of the other people we’ve trained are also leading these groups. We’re still counting it up, but we probably have between 700 and 1,000 groups going around the world, led by our faculty and by people we’ve trained.
We teach a different technique every week in these online groups. Last week, after getting people energized and focused, we did a written dialogue with an emotion. You put down the initial of your name – in my case, “J” for Jim – and create a dialogue with an emotion, such as sadness. I would write it as fast as I can.
I would say, “OK, Sadness. Why are you here? What are you doing? I don’t enjoy having you around.” And Sadness writes back to me, “But you need me.” And J says, “What do you mean I need you?” And Sadness says, “Well, your brother died 7 weeks ago, didn’t he?” And I say, “Yes, he did.” And Sadness says, “Aren’t you sad?” I say, “Yes. I’m terribly sad and grieving all the time. But I wasn’t thinking about him at this moment.” And Sadness says, “But he’s there with you all the time and that sadness is in you.” And I say, “You mean it’s in me even here, now, as I’m talking with Andrew in this interview?” And Sadness says, “Yes. You can talk about your work. But in between the words, as you take a breath, don’t you feel it in your chest?” That’s the way the dialogue goes.
Dr. Wilner: What about specifically with the coronavirus? Fear is certainly an emotion. Nobody wants to get sick and die. Nobody wants to bring this disease home to their family. People are reluctant to even go outside and you can’t shake someone’s hand. Are there precedents for this?
Dr. Gordon: There are precedents, but only relatively small groups were affected before by, for example, severe acute respiratory syndrome or H1N1, at least in the United States. But we haven’t seen a global pandemic like this since 1918. None of us was around then – or I certainly wasn’t around. So for most everyone, not only has it not happened before, but we’ve never been so globally aware of everything that’s going on and how different groups are reacting.
I’ve been reading Daniel Defoe’s book, “A Journal of the Plague Year.” It’s really very interesting. It’s about the bubonic plague in 1665 London, although he wrote it in the 1720s. Some of the same things were going on then: the enormous fear, the isolation; rich people being able to escape, poor people having nowhere to go; conspiracy theories of one kind or another, about where the plague came from or blaming a group of people for it; magical thinking that it’s just going to go away. All of those things that happened several hundred years ago are going on now.
And we’re all simultaneously aware of all those things. There’s not only the fear, which should be universal because it’s a reasonable response to this situation, but also the terrible confusion about what to do. The President is saying one thing, governors something else; Anthony Fauci is saying something else, and Deborah Birx is saying something a little bit different. There’s this tremendous confusion that overlays the fear, and I think everybody is more or less feeling these things.
So yes, a dialogue with fear is a good thing to do because it can be clarifying. What we need here is a sense of, what is it that makes sense for me to do? What precautions should I take? What precautions shouldn’t I take?
I have a 17-year-old son who lives with his mom in California. He and I were on the phone the other day. He’s a basketball player and very serious about it. He said, “I don’t want to put my life on hold.” And my response was, “If you go outside too soon, your life may be on hold for a hell of a lot longer than if you stay inside because, if you get sick, it’s serious. But you also need to start looking at the evidence and asking yourself the right questions because I can’t be there all the time and neither can your mom.”
Everybody really needs to use these kinds of tools to help themselves. The tools we teach are extremely good at bringing us back into a state of psychological and physiological balance — slow, deep breathing being a very basic one. Because it’s only in that state that we’re going to be able to make the most intelligent decisions about what to do. It’s only in that state that we’re going to be able to really look our fear in the face and find out what we should be afraid of and what we shouldn’t be afraid of.
It’s a process that’s very much integrated. We’re talking now about how to deal with the emotions. But the first part of what we do in our groups and our online trainings and webinars is teach people to just take a few deep breaths. Just take a few deep breaths in through the nose, out through the mouth, with your belly soft and relaxed. You can keep breathing this way while talking. That’s the antidote to the fight-or-flight response. We all learn about fight-or-flight in first-year physiology. We need to deal with it. We need to bring ourselves into balance. That’s the way we’re going to make the wisest decisions for ourselves and be best able to help our patients.
Dr. Wilner: As you mentioned, part of modern culture is that we now have access to all of this information worldwide. There’s a continual stream of newsfeeds, people flipping on their phones, receiving constant updates, 24/7. That’s a new phenomenon. Does that steal from us the time we had before for just breathing and synthesizing data as opposed to just acquiring it all the time?
Dr. Gordon: You’re absolutely right. It does and it’s a challenge. It can’t steal from us unless we’re letting our emotional, psychological, and physiological pockets be picked!
What we need to do is to make it our priority to come into balance. I don’t watch news all day long – a little tiny bit in the morning and in the evening, just to get a sense of what’s happening. That’s enough. And I think everybody needs to take a step back, ask if this is really what they want to be doing, and to come into balance.
The other thing that’s really important is physical activity, especially during this time. In addition to using slow, deep breathing to come into balance, physical exercise and movement of any kind is extremely good as an antidote to fight-or-flight and that shut-down, freeze-up response that we get into when we feel completely overwhelmed.
We’ve got to take it into our own hands. The media just want to sell us things. Let’s face it: They’re not here for our good. Our job as physicians and health care professionals is to really reinforce for people not only what we can do for them but what they can do for themselves.
Dr. Wilner: I’m certainly interested in learning more about mind-body medicine. For those who feel the same, where do you recommend they go to learn more?
Dr. Gordon: We have a website, cmbm.org, which features a number of webinars. I do a free webinar there every week. We have mind-body skills groups that meet once a week for 8 weeks. There are six physicians in my group and all kinds of health professionals in other groups. We have a training program that we’re bringing online. We’ve trained well over 6,000 people around the world and would love to train more. You can read about that on the website.
We’re starting to do more and more consulting with health care organizations. We’re working with the largest division of Veterans Affairs, which is in Florida, as well as in south Georgia and the Caribbean. We’re working with a large health system in Indiana and others elsewhere. In addition, we’re working with groups of physicians and mental health professionals, helping them to integrate what we have to offer into what they’re already doing.
That’s our job – to help you do your job.
Dr. Wilner: Dr Gordon, I feel more relaxed just speaking with you. Thank you for talking with me and sharing your experiences with Medscape. I look forward to learning more.
Dr. Gordon: Thank you. My pleasure.
A version of this article originally appeared on Medscape.com.
Expert shares his approach to treating warts in children
In the clinical experience of Anthony J. Mancini, MD, one option for children and adolescents who present with common warts is to do nothing, since they may resolve on their own.
“Many effective treatments that we have are painful and poorly tolerated, especially in younger children,” Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “However, while they’re harmless and often self-limited, warts often form a social stigma, and parents often desire therapy.”
Even though warts may spontaneously resolve in up to 65% of patients at 2 years and 80% at 4 years, the goals of treatment are to eradicate them, minimize pain, avoid scarring, and help prevent recurrence.
One effective topical therapy he highlighted is WartPEEL cream, which is a proprietary, compounded formulation of 17% salicylic acid and 2% 5-fluorouracil. “It’s in a sustained release vehicle called Remedium, and is available from a compounding pharmacy, but not FDA approved,” said Dr. Mancini, who is also head of pediatric dermatology at Lurie Children’s Hospital of Chicago. “It’s applied nightly with plastic tape occlusion and rinsed off each morning.”
WartPEEL is available through NuCara Pharmacy at 877-268-2272. It is not covered by most insurance plans and it costs around $80. “It is very effective, tends to be totally painless, and has a much quicker response than over-the-counter salicylic acid-based treatments for warts,” he said.
Another treatment option is oral cimetidine, especially in patients who have multiple or recalcitrant warts. The recommended dosing is 30-40 mg/kg per day, divided into twice-daily dosing. “You have to give it for at least 8-12 weeks to determine whether it’s working or not,” Dr. Mancini said. “In the initial report, [investigators] described an 81% complete response rate, but subsequent randomized, controlled trials were not able to confirm that data against placebo or topical treatments. I will say, though, that cimetidine is well tolerated. It’s always worth a try but, if you do use it, always consider other medications the patient may be taking and potential drug-drug interactions.”
For flat warts, verrucous papules that commonly occur on the face, Dr. Mancini recommends off-label treatment with 5% 5-fluorouracil cream (Efudex), which is normally indicated for actinic keratoses in adults. “I have patients apply this for 3 nights per week and work their way up gradually to nightly application,” he said. “It’s really important that parents and patients understand the importance of sun protection when they’re using Efudex, and they need to know that some irritation is possible. Overall, this treatment seems to be very well tolerated.”
Other treatment options for common warts, in addition to over-the-counter products that contain salicylic acid, are home cryotherapy kits that contain a mixture of diethyl ether and propane. “These can be effective for small warts,” Dr. Mancini said. “But for larger, thicker lesions, they’re not going to quite as effective.”
Treatment options best reserved for dermatologists, he continued, include in-office liquid nitrogen cryotherapy, “if it’s tolerated,” he said. “I have a no-hold policy, so if we have to hold a child down who’s flailing and crying and screaming during treatment, we’re probably not going to use liquid nitrogen.” He also mentioned topical immunotherapy with agents like squaric acid dibutylester. “This is almost like putting poison ivy on your warts to get the immune system revved up,” he said. “It can be very effective.” Other treatment options include intralesional immune therapy, topical cidofovir, and even pulsed-dye laser.
Dr. Mancini disclosed that he is a consultant to and a member of the scientific advisory board for Verrica Pharmaceuticals.
In the clinical experience of Anthony J. Mancini, MD, one option for children and adolescents who present with common warts is to do nothing, since they may resolve on their own.
“Many effective treatments that we have are painful and poorly tolerated, especially in younger children,” Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “However, while they’re harmless and often self-limited, warts often form a social stigma, and parents often desire therapy.”
Even though warts may spontaneously resolve in up to 65% of patients at 2 years and 80% at 4 years, the goals of treatment are to eradicate them, minimize pain, avoid scarring, and help prevent recurrence.
One effective topical therapy he highlighted is WartPEEL cream, which is a proprietary, compounded formulation of 17% salicylic acid and 2% 5-fluorouracil. “It’s in a sustained release vehicle called Remedium, and is available from a compounding pharmacy, but not FDA approved,” said Dr. Mancini, who is also head of pediatric dermatology at Lurie Children’s Hospital of Chicago. “It’s applied nightly with plastic tape occlusion and rinsed off each morning.”
WartPEEL is available through NuCara Pharmacy at 877-268-2272. It is not covered by most insurance plans and it costs around $80. “It is very effective, tends to be totally painless, and has a much quicker response than over-the-counter salicylic acid-based treatments for warts,” he said.
Another treatment option is oral cimetidine, especially in patients who have multiple or recalcitrant warts. The recommended dosing is 30-40 mg/kg per day, divided into twice-daily dosing. “You have to give it for at least 8-12 weeks to determine whether it’s working or not,” Dr. Mancini said. “In the initial report, [investigators] described an 81% complete response rate, but subsequent randomized, controlled trials were not able to confirm that data against placebo or topical treatments. I will say, though, that cimetidine is well tolerated. It’s always worth a try but, if you do use it, always consider other medications the patient may be taking and potential drug-drug interactions.”
For flat warts, verrucous papules that commonly occur on the face, Dr. Mancini recommends off-label treatment with 5% 5-fluorouracil cream (Efudex), which is normally indicated for actinic keratoses in adults. “I have patients apply this for 3 nights per week and work their way up gradually to nightly application,” he said. “It’s really important that parents and patients understand the importance of sun protection when they’re using Efudex, and they need to know that some irritation is possible. Overall, this treatment seems to be very well tolerated.”
Other treatment options for common warts, in addition to over-the-counter products that contain salicylic acid, are home cryotherapy kits that contain a mixture of diethyl ether and propane. “These can be effective for small warts,” Dr. Mancini said. “But for larger, thicker lesions, they’re not going to quite as effective.”
Treatment options best reserved for dermatologists, he continued, include in-office liquid nitrogen cryotherapy, “if it’s tolerated,” he said. “I have a no-hold policy, so if we have to hold a child down who’s flailing and crying and screaming during treatment, we’re probably not going to use liquid nitrogen.” He also mentioned topical immunotherapy with agents like squaric acid dibutylester. “This is almost like putting poison ivy on your warts to get the immune system revved up,” he said. “It can be very effective.” Other treatment options include intralesional immune therapy, topical cidofovir, and even pulsed-dye laser.
Dr. Mancini disclosed that he is a consultant to and a member of the scientific advisory board for Verrica Pharmaceuticals.
In the clinical experience of Anthony J. Mancini, MD, one option for children and adolescents who present with common warts is to do nothing, since they may resolve on their own.
“Many effective treatments that we have are painful and poorly tolerated, especially in younger children,” Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “However, while they’re harmless and often self-limited, warts often form a social stigma, and parents often desire therapy.”
Even though warts may spontaneously resolve in up to 65% of patients at 2 years and 80% at 4 years, the goals of treatment are to eradicate them, minimize pain, avoid scarring, and help prevent recurrence.
One effective topical therapy he highlighted is WartPEEL cream, which is a proprietary, compounded formulation of 17% salicylic acid and 2% 5-fluorouracil. “It’s in a sustained release vehicle called Remedium, and is available from a compounding pharmacy, but not FDA approved,” said Dr. Mancini, who is also head of pediatric dermatology at Lurie Children’s Hospital of Chicago. “It’s applied nightly with plastic tape occlusion and rinsed off each morning.”
WartPEEL is available through NuCara Pharmacy at 877-268-2272. It is not covered by most insurance plans and it costs around $80. “It is very effective, tends to be totally painless, and has a much quicker response than over-the-counter salicylic acid-based treatments for warts,” he said.
Another treatment option is oral cimetidine, especially in patients who have multiple or recalcitrant warts. The recommended dosing is 30-40 mg/kg per day, divided into twice-daily dosing. “You have to give it for at least 8-12 weeks to determine whether it’s working or not,” Dr. Mancini said. “In the initial report, [investigators] described an 81% complete response rate, but subsequent randomized, controlled trials were not able to confirm that data against placebo or topical treatments. I will say, though, that cimetidine is well tolerated. It’s always worth a try but, if you do use it, always consider other medications the patient may be taking and potential drug-drug interactions.”
For flat warts, verrucous papules that commonly occur on the face, Dr. Mancini recommends off-label treatment with 5% 5-fluorouracil cream (Efudex), which is normally indicated for actinic keratoses in adults. “I have patients apply this for 3 nights per week and work their way up gradually to nightly application,” he said. “It’s really important that parents and patients understand the importance of sun protection when they’re using Efudex, and they need to know that some irritation is possible. Overall, this treatment seems to be very well tolerated.”
Other treatment options for common warts, in addition to over-the-counter products that contain salicylic acid, are home cryotherapy kits that contain a mixture of diethyl ether and propane. “These can be effective for small warts,” Dr. Mancini said. “But for larger, thicker lesions, they’re not going to quite as effective.”
Treatment options best reserved for dermatologists, he continued, include in-office liquid nitrogen cryotherapy, “if it’s tolerated,” he said. “I have a no-hold policy, so if we have to hold a child down who’s flailing and crying and screaming during treatment, we’re probably not going to use liquid nitrogen.” He also mentioned topical immunotherapy with agents like squaric acid dibutylester. “This is almost like putting poison ivy on your warts to get the immune system revved up,” he said. “It can be very effective.” Other treatment options include intralesional immune therapy, topical cidofovir, and even pulsed-dye laser.
Dr. Mancini disclosed that he is a consultant to and a member of the scientific advisory board for Verrica Pharmaceuticals.
FROM PEDIATRIC DERMATOLOGY 2020
HIV does not appear to worsen COVID-19 outcomes
People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.
“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.
“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”
The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”
The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.
One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.
Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.
The New York City cohort
For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.
They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.
The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.
Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.
The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.
Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.
“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”
In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).
The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.
A surprise association
What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.
This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.
“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”
“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.
A “modest” increase
Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.
But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”
“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.
Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).
Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.
What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.
“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”
“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.
Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.
“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.
This article first appeared on Medscape.com.
People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.
“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.
“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”
The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”
The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.
One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.
Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.
The New York City cohort
For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.
They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.
The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.
Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.
The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.
Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.
“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”
In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).
The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.
A surprise association
What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.
This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.
“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”
“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.
A “modest” increase
Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.
But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”
“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.
Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).
Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.
What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.
“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”
“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.
Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.
“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.
This article first appeared on Medscape.com.
People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.
“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.
“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”
The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”
The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.
One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.
Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.
The New York City cohort
For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.
They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.
The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.
Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.
The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.
Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.
“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”
In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).
The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.
A surprise association
What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.
This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.
“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”
“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.
A “modest” increase
Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.
But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”
“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.
Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).
Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.
What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.
“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”
“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.
Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.
“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.
This article first appeared on Medscape.com.
FROM AIDS 2020
Treat acne aggressively upfront, expert advises
First, determine the types of lesions they have. “Do they have comedones, papules/pustules, and nodules present?” she asked during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. Second, quantify the number of lesions that they have. Is it few? Several? Many? Third, determine the extent of their acne. “Is it limited to half the face, or is it generalized to the face, back, chest, and shoulders?” added Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey.
Fourth, identify postinflammatory changes such as erythema, hyperpigmentation, and scarring “because that’s going to influence your management,” she said. “Finally, you want to give a quick investigative global assessment of the acne severity where you quantify them as being clear, almost clear, mild, moderate, or severe. You want to do this with each patient at every visit so you can determine what their initial treatment’s going to be and what their management going forward is going to be.”
According to Dr. Zaenglein, the best acne treatments are based on the pathogenesis of the skin condition and trying to target as many pathogenic factors as possible. The four main pathogenic factors in acne include hyperkeratinization, increased sebum production, cutibacterium, and inflammation. “This is not a stepwise process; there’s an interplay between all of those factors,” she said. “All acne is inflammatory, but each of the treatments we have target specific factors. Retinoids target hyperkeratinization and inflammation, whereas the hormonal therapies will address decreased sebum production. Antimicrobial agents like benzoyl peroxide and antibiotics will work to decrease cutibacterium acnes. All of these are influenced by the exposome. This includes your genetics, external factors like pollution or changes in seasons that can affect your skin and the severity of your acne.” A state of hyperandrogenism, she added, “can definitely increase acne” and is seen in patients with polycystic ovary syndrome (PCOS).
For patients with mild acne, initial treatment should consist of a topical retinoid and, almost always, benzoyl peroxide, “unless it’s a pure comedonal form of acne,” Dr. Zaenglein said. She recommended using the combination of a topical retinoid and benzoyl peroxide, noting that while it used to be difficult to find benzoyl peroxide, “nowadays there are numerous manufacturers and different formulations of benzoyl peroxide. We also have over-the-counter adapalene now, which is great. So now we have a complete routine for patients with adapalene and benzoyl peroxide that you can combine together in a cost-effective way.”
If the initial regimen fails to improve the patient’s mild acne, a second-line treatment would be to change the retinoid and continue on the existing benzoyl peroxide formulation or to add dapsone gel if the patient is experiencing skin irritation. The four retinoids currently available include adapalene, tretinoin, tazarotene, and trifarotene. “These normalize keratinocyte differentiation, reduce keratinocyte proliferation, and decrease expression of inflammatory markers,” Dr. Zaenglein noted. “They also prevent scarring. Adapalene is considered to be the most tolerable, whereas tazarotene may have an edge on efficacy. There’s a lot of overlap; head-to-head studies may not always match them up exactly, but generally this is how it’s considered. Picking the right retinoid for your patient based on efficacy and tolerability is most important.”
The newest topical retinoid, trifarotene 50 mcg/g cream, is a fourth-generation retinoid which is retinoic acid receptor gamma selective. Pivotal trials were conducted in patients aged 9 years and older with moderate facial and truncal acne. With monotherapy there was a success rate of 36% at 12 weeks and 60% at 52 weeks based on the Investigator’s Global Assessment. Another newcomer, tazarotene 0.045% lotion, is a third-generation retinoid which is retinoic acid receptor alpha beta gamma selective. It’s approved for moderate to severe facial acne in patients 9 years and older.
To optimize tolerance to retinoids, Dr. Zaenglein asks patients about their typical skin care regimen. “I ask them what they’re washing their face with,” she said. “Are they using apricot scrubs or harsh cleansers? Make sure they’re applying it to the entire face and not spot-treating. You get less irritation when it’s applied to dry skin, so you can recommend that. Make sure that they use a bland unscented moisturizer in the morning and apply it over top of their retinoid. I always warn them that irritation usually peaks at about 2 weeks. If they can power through, the irritation will improve with continued use.”
To optimize adherence to retinoids, she asks patients how many nights per week that they apply it. If they are using it all seven nights, “they’re good at using it,” she said. “If they say three nights, then they need to work on getting it on more frequently.”
Topical dapsone gel (5% and 7.5%) is mainly used for patients with papular-pustular acne. “Its mechanism of action for acne is not known, but presumptively it’s anti-inflammatory,” Dr. Zaenglein said. “It doesn’t require G6PD [glucose-6-phosphate dehydrogenase] testing. It can cause some orange discoloration of your skin or fabrics if you use it with benzoyl peroxide, so you want to apply them at different times of the day. It’s well tolerated. I tend to use it in patients who have problems tolerating any topical retinoid or any benzoyl peroxide but have mild to moderate acne.”
For patients with moderate acne, consider combination therapy to target as many pathogenic factors as possible. “Use a topical retinoid plus benzoyl peroxide with or without a systemic antibiotic,” Dr. Zaenglein advised. “I may give them an oral antibiotic if their acne is not responsive to the routine. But you wouldn’t want to combine the systemic antibiotic with a topical antibiotic, like clindamycin with doxycycline, because you don’t need two antibiotics. Make sure that you treat aggressively up front. It can take up to 3 months to see improvement. I counsel my patients that we’ll rescue with the antibiotic and then we maintain, but we’re going to stop that antibiotic after 3 months.”
Systemic antibiotic options for acne include tetracyclines, doxycycline, minocycline, and sarecycline. “Tetracycline itself we don’t use too much because you have to take it on an empty stomach, and availability is sometimes an issue,” she said. “Primarily, we use doxycycline. You can take it with food, so that helps. The main side effects are gastrointestinal upset and photosensitivity. Alternately, you can use minocycline, which is also okay to take with food. It does have more potentially worrisome side effects, including pseudotumor cerebri, blue pigmentation, autoimmune hepatitis, and DRESS [drug reaction with eosinophilia and systemic symptoms].”
Sarecycline is the first narrow spectrum tetracycline for acne, with fewer vestibular and phototoxic side effects, compared with other tetracyclines. “It also has less effect on the GI flora,” Dr. Zaenglein said. “It’s a good alternative but it can be costly, so make sure to check the pricing for your patients.” She does not use other antibiotics such as TMP/SMX, penicillins, or cephalosporins for acne patients. “The reason is, the tetracyclines are not only antibacterial, but they’re anti-inflammatory,” she explained. “They also are lipophilic, so they will penetrate into the sebaceous unit where the heart of the acne is.”
For patients who don’t want to take an oral antibiotic, consider minocycline 4% foam, which was studied in moderate to severe acne in patients aged 9 years and older. The pooled results from the three studies showed a 47% mean improvement in inflammatory acne, compared with 37% among those in the vehicle arm. “You wouldn’t use this as monotherapy; you’d use this in combination with the topical retinoid and the benzoyl peroxide,” Dr. Zaenglein said.
Most primary care providers do not prescribe isotretinoin for patients with severe acne, but they can start patients on triple therapy with a topical retinoid, benzoyl peroxide, and a systemic antibiotic at its full dose. “The efficacy of triple therapy in patients you would typically deem as isotretinoin worthy is actually pretty good,” she said. “There have been several studies looking at this, and about 70%-80% of patients will respond to triple therapy, where they are no longer deemed isotretinoin candidates. They still may need to move on to isotretinoin, but they will be improved.”
Dr. Zaenglein disclosed that she is a consultant for Cassiopea, Novartis, and Pfizer. She has also received grants or research support from AbbVie, Incyte, and Pfizer.
First, determine the types of lesions they have. “Do they have comedones, papules/pustules, and nodules present?” she asked during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. Second, quantify the number of lesions that they have. Is it few? Several? Many? Third, determine the extent of their acne. “Is it limited to half the face, or is it generalized to the face, back, chest, and shoulders?” added Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey.
Fourth, identify postinflammatory changes such as erythema, hyperpigmentation, and scarring “because that’s going to influence your management,” she said. “Finally, you want to give a quick investigative global assessment of the acne severity where you quantify them as being clear, almost clear, mild, moderate, or severe. You want to do this with each patient at every visit so you can determine what their initial treatment’s going to be and what their management going forward is going to be.”
According to Dr. Zaenglein, the best acne treatments are based on the pathogenesis of the skin condition and trying to target as many pathogenic factors as possible. The four main pathogenic factors in acne include hyperkeratinization, increased sebum production, cutibacterium, and inflammation. “This is not a stepwise process; there’s an interplay between all of those factors,” she said. “All acne is inflammatory, but each of the treatments we have target specific factors. Retinoids target hyperkeratinization and inflammation, whereas the hormonal therapies will address decreased sebum production. Antimicrobial agents like benzoyl peroxide and antibiotics will work to decrease cutibacterium acnes. All of these are influenced by the exposome. This includes your genetics, external factors like pollution or changes in seasons that can affect your skin and the severity of your acne.” A state of hyperandrogenism, she added, “can definitely increase acne” and is seen in patients with polycystic ovary syndrome (PCOS).
For patients with mild acne, initial treatment should consist of a topical retinoid and, almost always, benzoyl peroxide, “unless it’s a pure comedonal form of acne,” Dr. Zaenglein said. She recommended using the combination of a topical retinoid and benzoyl peroxide, noting that while it used to be difficult to find benzoyl peroxide, “nowadays there are numerous manufacturers and different formulations of benzoyl peroxide. We also have over-the-counter adapalene now, which is great. So now we have a complete routine for patients with adapalene and benzoyl peroxide that you can combine together in a cost-effective way.”
If the initial regimen fails to improve the patient’s mild acne, a second-line treatment would be to change the retinoid and continue on the existing benzoyl peroxide formulation or to add dapsone gel if the patient is experiencing skin irritation. The four retinoids currently available include adapalene, tretinoin, tazarotene, and trifarotene. “These normalize keratinocyte differentiation, reduce keratinocyte proliferation, and decrease expression of inflammatory markers,” Dr. Zaenglein noted. “They also prevent scarring. Adapalene is considered to be the most tolerable, whereas tazarotene may have an edge on efficacy. There’s a lot of overlap; head-to-head studies may not always match them up exactly, but generally this is how it’s considered. Picking the right retinoid for your patient based on efficacy and tolerability is most important.”
The newest topical retinoid, trifarotene 50 mcg/g cream, is a fourth-generation retinoid which is retinoic acid receptor gamma selective. Pivotal trials were conducted in patients aged 9 years and older with moderate facial and truncal acne. With monotherapy there was a success rate of 36% at 12 weeks and 60% at 52 weeks based on the Investigator’s Global Assessment. Another newcomer, tazarotene 0.045% lotion, is a third-generation retinoid which is retinoic acid receptor alpha beta gamma selective. It’s approved for moderate to severe facial acne in patients 9 years and older.
To optimize tolerance to retinoids, Dr. Zaenglein asks patients about their typical skin care regimen. “I ask them what they’re washing their face with,” she said. “Are they using apricot scrubs or harsh cleansers? Make sure they’re applying it to the entire face and not spot-treating. You get less irritation when it’s applied to dry skin, so you can recommend that. Make sure that they use a bland unscented moisturizer in the morning and apply it over top of their retinoid. I always warn them that irritation usually peaks at about 2 weeks. If they can power through, the irritation will improve with continued use.”
To optimize adherence to retinoids, she asks patients how many nights per week that they apply it. If they are using it all seven nights, “they’re good at using it,” she said. “If they say three nights, then they need to work on getting it on more frequently.”
Topical dapsone gel (5% and 7.5%) is mainly used for patients with papular-pustular acne. “Its mechanism of action for acne is not known, but presumptively it’s anti-inflammatory,” Dr. Zaenglein said. “It doesn’t require G6PD [glucose-6-phosphate dehydrogenase] testing. It can cause some orange discoloration of your skin or fabrics if you use it with benzoyl peroxide, so you want to apply them at different times of the day. It’s well tolerated. I tend to use it in patients who have problems tolerating any topical retinoid or any benzoyl peroxide but have mild to moderate acne.”
For patients with moderate acne, consider combination therapy to target as many pathogenic factors as possible. “Use a topical retinoid plus benzoyl peroxide with or without a systemic antibiotic,” Dr. Zaenglein advised. “I may give them an oral antibiotic if their acne is not responsive to the routine. But you wouldn’t want to combine the systemic antibiotic with a topical antibiotic, like clindamycin with doxycycline, because you don’t need two antibiotics. Make sure that you treat aggressively up front. It can take up to 3 months to see improvement. I counsel my patients that we’ll rescue with the antibiotic and then we maintain, but we’re going to stop that antibiotic after 3 months.”
Systemic antibiotic options for acne include tetracyclines, doxycycline, minocycline, and sarecycline. “Tetracycline itself we don’t use too much because you have to take it on an empty stomach, and availability is sometimes an issue,” she said. “Primarily, we use doxycycline. You can take it with food, so that helps. The main side effects are gastrointestinal upset and photosensitivity. Alternately, you can use minocycline, which is also okay to take with food. It does have more potentially worrisome side effects, including pseudotumor cerebri, blue pigmentation, autoimmune hepatitis, and DRESS [drug reaction with eosinophilia and systemic symptoms].”
Sarecycline is the first narrow spectrum tetracycline for acne, with fewer vestibular and phototoxic side effects, compared with other tetracyclines. “It also has less effect on the GI flora,” Dr. Zaenglein said. “It’s a good alternative but it can be costly, so make sure to check the pricing for your patients.” She does not use other antibiotics such as TMP/SMX, penicillins, or cephalosporins for acne patients. “The reason is, the tetracyclines are not only antibacterial, but they’re anti-inflammatory,” she explained. “They also are lipophilic, so they will penetrate into the sebaceous unit where the heart of the acne is.”
For patients who don’t want to take an oral antibiotic, consider minocycline 4% foam, which was studied in moderate to severe acne in patients aged 9 years and older. The pooled results from the three studies showed a 47% mean improvement in inflammatory acne, compared with 37% among those in the vehicle arm. “You wouldn’t use this as monotherapy; you’d use this in combination with the topical retinoid and the benzoyl peroxide,” Dr. Zaenglein said.
Most primary care providers do not prescribe isotretinoin for patients with severe acne, but they can start patients on triple therapy with a topical retinoid, benzoyl peroxide, and a systemic antibiotic at its full dose. “The efficacy of triple therapy in patients you would typically deem as isotretinoin worthy is actually pretty good,” she said. “There have been several studies looking at this, and about 70%-80% of patients will respond to triple therapy, where they are no longer deemed isotretinoin candidates. They still may need to move on to isotretinoin, but they will be improved.”
Dr. Zaenglein disclosed that she is a consultant for Cassiopea, Novartis, and Pfizer. She has also received grants or research support from AbbVie, Incyte, and Pfizer.
First, determine the types of lesions they have. “Do they have comedones, papules/pustules, and nodules present?” she asked during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. Second, quantify the number of lesions that they have. Is it few? Several? Many? Third, determine the extent of their acne. “Is it limited to half the face, or is it generalized to the face, back, chest, and shoulders?” added Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey.
Fourth, identify postinflammatory changes such as erythema, hyperpigmentation, and scarring “because that’s going to influence your management,” she said. “Finally, you want to give a quick investigative global assessment of the acne severity where you quantify them as being clear, almost clear, mild, moderate, or severe. You want to do this with each patient at every visit so you can determine what their initial treatment’s going to be and what their management going forward is going to be.”
According to Dr. Zaenglein, the best acne treatments are based on the pathogenesis of the skin condition and trying to target as many pathogenic factors as possible. The four main pathogenic factors in acne include hyperkeratinization, increased sebum production, cutibacterium, and inflammation. “This is not a stepwise process; there’s an interplay between all of those factors,” she said. “All acne is inflammatory, but each of the treatments we have target specific factors. Retinoids target hyperkeratinization and inflammation, whereas the hormonal therapies will address decreased sebum production. Antimicrobial agents like benzoyl peroxide and antibiotics will work to decrease cutibacterium acnes. All of these are influenced by the exposome. This includes your genetics, external factors like pollution or changes in seasons that can affect your skin and the severity of your acne.” A state of hyperandrogenism, she added, “can definitely increase acne” and is seen in patients with polycystic ovary syndrome (PCOS).
For patients with mild acne, initial treatment should consist of a topical retinoid and, almost always, benzoyl peroxide, “unless it’s a pure comedonal form of acne,” Dr. Zaenglein said. She recommended using the combination of a topical retinoid and benzoyl peroxide, noting that while it used to be difficult to find benzoyl peroxide, “nowadays there are numerous manufacturers and different formulations of benzoyl peroxide. We also have over-the-counter adapalene now, which is great. So now we have a complete routine for patients with adapalene and benzoyl peroxide that you can combine together in a cost-effective way.”
If the initial regimen fails to improve the patient’s mild acne, a second-line treatment would be to change the retinoid and continue on the existing benzoyl peroxide formulation or to add dapsone gel if the patient is experiencing skin irritation. The four retinoids currently available include adapalene, tretinoin, tazarotene, and trifarotene. “These normalize keratinocyte differentiation, reduce keratinocyte proliferation, and decrease expression of inflammatory markers,” Dr. Zaenglein noted. “They also prevent scarring. Adapalene is considered to be the most tolerable, whereas tazarotene may have an edge on efficacy. There’s a lot of overlap; head-to-head studies may not always match them up exactly, but generally this is how it’s considered. Picking the right retinoid for your patient based on efficacy and tolerability is most important.”
The newest topical retinoid, trifarotene 50 mcg/g cream, is a fourth-generation retinoid which is retinoic acid receptor gamma selective. Pivotal trials were conducted in patients aged 9 years and older with moderate facial and truncal acne. With monotherapy there was a success rate of 36% at 12 weeks and 60% at 52 weeks based on the Investigator’s Global Assessment. Another newcomer, tazarotene 0.045% lotion, is a third-generation retinoid which is retinoic acid receptor alpha beta gamma selective. It’s approved for moderate to severe facial acne in patients 9 years and older.
To optimize tolerance to retinoids, Dr. Zaenglein asks patients about their typical skin care regimen. “I ask them what they’re washing their face with,” she said. “Are they using apricot scrubs or harsh cleansers? Make sure they’re applying it to the entire face and not spot-treating. You get less irritation when it’s applied to dry skin, so you can recommend that. Make sure that they use a bland unscented moisturizer in the morning and apply it over top of their retinoid. I always warn them that irritation usually peaks at about 2 weeks. If they can power through, the irritation will improve with continued use.”
To optimize adherence to retinoids, she asks patients how many nights per week that they apply it. If they are using it all seven nights, “they’re good at using it,” she said. “If they say three nights, then they need to work on getting it on more frequently.”
Topical dapsone gel (5% and 7.5%) is mainly used for patients with papular-pustular acne. “Its mechanism of action for acne is not known, but presumptively it’s anti-inflammatory,” Dr. Zaenglein said. “It doesn’t require G6PD [glucose-6-phosphate dehydrogenase] testing. It can cause some orange discoloration of your skin or fabrics if you use it with benzoyl peroxide, so you want to apply them at different times of the day. It’s well tolerated. I tend to use it in patients who have problems tolerating any topical retinoid or any benzoyl peroxide but have mild to moderate acne.”
For patients with moderate acne, consider combination therapy to target as many pathogenic factors as possible. “Use a topical retinoid plus benzoyl peroxide with or without a systemic antibiotic,” Dr. Zaenglein advised. “I may give them an oral antibiotic if their acne is not responsive to the routine. But you wouldn’t want to combine the systemic antibiotic with a topical antibiotic, like clindamycin with doxycycline, because you don’t need two antibiotics. Make sure that you treat aggressively up front. It can take up to 3 months to see improvement. I counsel my patients that we’ll rescue with the antibiotic and then we maintain, but we’re going to stop that antibiotic after 3 months.”
Systemic antibiotic options for acne include tetracyclines, doxycycline, minocycline, and sarecycline. “Tetracycline itself we don’t use too much because you have to take it on an empty stomach, and availability is sometimes an issue,” she said. “Primarily, we use doxycycline. You can take it with food, so that helps. The main side effects are gastrointestinal upset and photosensitivity. Alternately, you can use minocycline, which is also okay to take with food. It does have more potentially worrisome side effects, including pseudotumor cerebri, blue pigmentation, autoimmune hepatitis, and DRESS [drug reaction with eosinophilia and systemic symptoms].”
Sarecycline is the first narrow spectrum tetracycline for acne, with fewer vestibular and phototoxic side effects, compared with other tetracyclines. “It also has less effect on the GI flora,” Dr. Zaenglein said. “It’s a good alternative but it can be costly, so make sure to check the pricing for your patients.” She does not use other antibiotics such as TMP/SMX, penicillins, or cephalosporins for acne patients. “The reason is, the tetracyclines are not only antibacterial, but they’re anti-inflammatory,” she explained. “They also are lipophilic, so they will penetrate into the sebaceous unit where the heart of the acne is.”
For patients who don’t want to take an oral antibiotic, consider minocycline 4% foam, which was studied in moderate to severe acne in patients aged 9 years and older. The pooled results from the three studies showed a 47% mean improvement in inflammatory acne, compared with 37% among those in the vehicle arm. “You wouldn’t use this as monotherapy; you’d use this in combination with the topical retinoid and the benzoyl peroxide,” Dr. Zaenglein said.
Most primary care providers do not prescribe isotretinoin for patients with severe acne, but they can start patients on triple therapy with a topical retinoid, benzoyl peroxide, and a systemic antibiotic at its full dose. “The efficacy of triple therapy in patients you would typically deem as isotretinoin worthy is actually pretty good,” she said. “There have been several studies looking at this, and about 70%-80% of patients will respond to triple therapy, where they are no longer deemed isotretinoin candidates. They still may need to move on to isotretinoin, but they will be improved.”
Dr. Zaenglein disclosed that she is a consultant for Cassiopea, Novartis, and Pfizer. She has also received grants or research support from AbbVie, Incyte, and Pfizer.
FROM PEDIATRIC DERMATOLOGY 2020
Despite guidelines, children receive opioids and steroids for pneumonia and sinusitis
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
FROM PEDIATRICS
Big pharma sues to block Minnesota insulin affordability law
PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.
Advocates said they were appalled by the PhRMA action.
PhRMA says law is unconstitutional
In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”
“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.
The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”
The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.
“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.
The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
Advocates decry suit
Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.
It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.
Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”
Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.
“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”
Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.
“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”
T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.
“We will not stop showing them the real price we pay for their greed,” said the organization.
Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.
“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”
A version of this article originally appeared on Medscape.com.
PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.
Advocates said they were appalled by the PhRMA action.
PhRMA says law is unconstitutional
In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”
“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.
The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”
The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.
“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.
The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
Advocates decry suit
Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.
It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.
Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”
Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.
“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”
Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.
“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”
T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.
“We will not stop showing them the real price we pay for their greed,” said the organization.
Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.
“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”
A version of this article originally appeared on Medscape.com.
PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.
Advocates said they were appalled by the PhRMA action.
PhRMA says law is unconstitutional
In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”
“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.
The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”
The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.
“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.
The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
Advocates decry suit
Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.
It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.
Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”
Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.
“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”
Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.
“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”
T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.
“We will not stop showing them the real price we pay for their greed,” said the organization.
Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.
“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”
A version of this article originally appeared on Medscape.com.
Primary care practices may lose about $68k per physician this year
Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.
For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.
That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.
When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.
Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.
“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.
When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
Much depends on the future of telehealth
Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.
COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.
Several things need to happen to change the outlook for outpatient care, he said.
A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.
If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.
“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.
In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.
However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.
Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.
“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
Visit trends still down
Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.
Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”
They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.
Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.
“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.
It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
Telemedicine rates dropping
Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.
He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”
Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.
He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”
Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.
Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”
For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”
Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.
A version of this article originally on Medscape.com.
Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.
For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.
That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.
When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.
Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.
“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.
When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
Much depends on the future of telehealth
Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.
COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.
Several things need to happen to change the outlook for outpatient care, he said.
A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.
If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.
“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.
In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.
However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.
Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.
“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
Visit trends still down
Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.
Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”
They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.
Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.
“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.
It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
Telemedicine rates dropping
Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.
He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”
Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.
He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”
Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.
Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”
For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”
Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.
A version of this article originally on Medscape.com.
Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.
For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.
That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.
When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.
Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.
“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.
When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
Much depends on the future of telehealth
Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.
COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.
Several things need to happen to change the outlook for outpatient care, he said.
A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.
If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.
“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.
In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.
However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.
Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.
“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
Visit trends still down
Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.
Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”
They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.
Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.
“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.
It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
Telemedicine rates dropping
Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.
He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”
Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.
He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”
Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.
Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”
For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”
Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.
A version of this article originally on Medscape.com.
Physician shortage grows in latest projections
Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.
Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.
The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.
This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.
In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.
“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.
The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”
Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.
Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.
The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.
Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.
The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.
According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).
“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.
However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.
The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
Stemming the shortages
The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.
“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.
He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.
However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.
Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.
Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”
The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.
Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.
She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.
Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.
Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.
Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.
The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.
This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.
In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.
“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.
The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”
Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.
Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.
The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.
Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.
The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.
According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).
“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.
However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.
The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
Stemming the shortages
The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.
“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.
He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.
However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.
Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.
Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”
The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.
Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.
She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.
Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.
Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.
Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.
The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.
This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.
In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.
“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.
The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”
Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.
Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.
The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.
Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.
The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.
According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).
“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.
However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.
The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
Stemming the shortages
The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.
“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.
He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.
However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.
Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.
Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”
The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.
Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.
She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.
Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.
Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Diagnostic criteria may miss some MIS-C cases, experts say
New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.
In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.
For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.
The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.
“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.
All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.
Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.
The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.
“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.
The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”
Important Differences From Kawasaki Disease
In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).
Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.
The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.
In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.
Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.
Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”
As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.
Questions Remain
With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.
“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.
“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”
Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.
“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”
Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:
- Why do some children get MIS-C and not others?
- What is the long-term outcome of children with MIS-C?
- How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
- Does MIS-C occur in young adults?
Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.
On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”
Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.
This article first appeared on Medscape.com.
New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.
In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.
For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.
The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.
“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.
All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.
Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.
The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.
“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.
The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”
Important Differences From Kawasaki Disease
In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).
Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.
The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.
In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.
Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.
Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”
As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.
Questions Remain
With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.
“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.
“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”
Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.
“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”
Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:
- Why do some children get MIS-C and not others?
- What is the long-term outcome of children with MIS-C?
- How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
- Does MIS-C occur in young adults?
Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.
On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”
Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.
This article first appeared on Medscape.com.
New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.
In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.
For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.
The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.
“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.
All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.
Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.
The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.
“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.
The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”
Important Differences From Kawasaki Disease
In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).
Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.
The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.
In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.
Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.
Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”
As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.
Questions Remain
With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.
“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.
“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”
Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.
“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”
Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:
- Why do some children get MIS-C and not others?
- What is the long-term outcome of children with MIS-C?
- How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
- Does MIS-C occur in young adults?
Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.
On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”
Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.
This article first appeared on Medscape.com.
Lawmakers question mental health disclosure rules
State medical licensing queries criticized
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
State medical licensing queries criticized
State medical licensing queries criticized
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
FROM A HOUSE ENERGY AND COMMERCE’S HEALTH SUBCOMMITTEE HEARING