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The vaping problem
The first time I was sure I was witnessing someone vaping occurred when I saw an alarming cloud of smoke billowing from driver’s side window of the car in front of me. My initial concern was that vehicle was on fire. But none of the other drivers around me seemed concerned and as I pulled up next to the car I could see the driver ostentatiously inhaling deeply in preparation for releasing another monstrous cloud of vapor.
However, you probably have learned, as have I, that most vaping is done furtively. In fact, the pocketability of vaping devices is part of their appeal to teenagers. Hiding a lit cigarette in one’s pocket is something even the most risk-loving adolescent usually won’t attempt. I suspect that regardless of what is in the vapor, the high one can get by putting one over on the school administration by vaping in the school restroom or in the middle of history class is a temptation that many teenagers can’t resist.
Listening to educators, substance abuse counselors, and police officers who have first hand knowledge,
Part of the problem seems to be that vaping was flying under the radar and expanding rapidly long before educators, parents, and I fear physicians woke up to the severity and magnitude of the problem. And now everybody is playing catchup.
Of course the initial, and as yet unconfirmed, notion that e-cigarettes might provide a viable strategy for tobacco withdrawal has added confusion to the mix. It turns out that vaping can provide many orders of magnitude more nicotine in a small volume than cigarettes, which creates an outsized addiction potential for those more vulnerable users – even with a very short history of use. My experts tell me that this level of addiction has forced them to consider strategies and dosages far beyond those they are accustomed to using with patients whose addiction stems from standard cigarette use.
The recent discovery of lung damage related to vaping provided a brief glimmer of hope that fear would turn the tide in the vaping epidemic. But unfortunately the Centers for Disease Control and Prevention did its job too well. Although maybe it was a bit late to uncover the condition, the agency acted quickly to chase down the epidemiology and eventually the chemical responsible for the pulmonary injury. My local experts tell me that, while the cause of the lung damage was still a mystery, they noticed a decline in vaping generated by the fear of this unknown killer. Young people were reporting that they were rethinking their vaping usage. However, once the chemical culprit was identified, their clients felt that they could safely vape again as long as they were more careful in choosing the source of liquid in their devices.
Not surprisingly, the current administration has been providing mixed messages about how it will address vaping. There always will be the argument that if you ban a substance, it will be driven underground and become more difficult to manage. However, in the case of vaping, its appeal and risk to young people and the apparent ineffectiveness of local efforts to control it demand a firm unwavering response at the federal level.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
The first time I was sure I was witnessing someone vaping occurred when I saw an alarming cloud of smoke billowing from driver’s side window of the car in front of me. My initial concern was that vehicle was on fire. But none of the other drivers around me seemed concerned and as I pulled up next to the car I could see the driver ostentatiously inhaling deeply in preparation for releasing another monstrous cloud of vapor.
However, you probably have learned, as have I, that most vaping is done furtively. In fact, the pocketability of vaping devices is part of their appeal to teenagers. Hiding a lit cigarette in one’s pocket is something even the most risk-loving adolescent usually won’t attempt. I suspect that regardless of what is in the vapor, the high one can get by putting one over on the school administration by vaping in the school restroom or in the middle of history class is a temptation that many teenagers can’t resist.
Listening to educators, substance abuse counselors, and police officers who have first hand knowledge,
Part of the problem seems to be that vaping was flying under the radar and expanding rapidly long before educators, parents, and I fear physicians woke up to the severity and magnitude of the problem. And now everybody is playing catchup.
Of course the initial, and as yet unconfirmed, notion that e-cigarettes might provide a viable strategy for tobacco withdrawal has added confusion to the mix. It turns out that vaping can provide many orders of magnitude more nicotine in a small volume than cigarettes, which creates an outsized addiction potential for those more vulnerable users – even with a very short history of use. My experts tell me that this level of addiction has forced them to consider strategies and dosages far beyond those they are accustomed to using with patients whose addiction stems from standard cigarette use.
The recent discovery of lung damage related to vaping provided a brief glimmer of hope that fear would turn the tide in the vaping epidemic. But unfortunately the Centers for Disease Control and Prevention did its job too well. Although maybe it was a bit late to uncover the condition, the agency acted quickly to chase down the epidemiology and eventually the chemical responsible for the pulmonary injury. My local experts tell me that, while the cause of the lung damage was still a mystery, they noticed a decline in vaping generated by the fear of this unknown killer. Young people were reporting that they were rethinking their vaping usage. However, once the chemical culprit was identified, their clients felt that they could safely vape again as long as they were more careful in choosing the source of liquid in their devices.
Not surprisingly, the current administration has been providing mixed messages about how it will address vaping. There always will be the argument that if you ban a substance, it will be driven underground and become more difficult to manage. However, in the case of vaping, its appeal and risk to young people and the apparent ineffectiveness of local efforts to control it demand a firm unwavering response at the federal level.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
The first time I was sure I was witnessing someone vaping occurred when I saw an alarming cloud of smoke billowing from driver’s side window of the car in front of me. My initial concern was that vehicle was on fire. But none of the other drivers around me seemed concerned and as I pulled up next to the car I could see the driver ostentatiously inhaling deeply in preparation for releasing another monstrous cloud of vapor.
However, you probably have learned, as have I, that most vaping is done furtively. In fact, the pocketability of vaping devices is part of their appeal to teenagers. Hiding a lit cigarette in one’s pocket is something even the most risk-loving adolescent usually won’t attempt. I suspect that regardless of what is in the vapor, the high one can get by putting one over on the school administration by vaping in the school restroom or in the middle of history class is a temptation that many teenagers can’t resist.
Listening to educators, substance abuse counselors, and police officers who have first hand knowledge,
Part of the problem seems to be that vaping was flying under the radar and expanding rapidly long before educators, parents, and I fear physicians woke up to the severity and magnitude of the problem. And now everybody is playing catchup.
Of course the initial, and as yet unconfirmed, notion that e-cigarettes might provide a viable strategy for tobacco withdrawal has added confusion to the mix. It turns out that vaping can provide many orders of magnitude more nicotine in a small volume than cigarettes, which creates an outsized addiction potential for those more vulnerable users – even with a very short history of use. My experts tell me that this level of addiction has forced them to consider strategies and dosages far beyond those they are accustomed to using with patients whose addiction stems from standard cigarette use.
The recent discovery of lung damage related to vaping provided a brief glimmer of hope that fear would turn the tide in the vaping epidemic. But unfortunately the Centers for Disease Control and Prevention did its job too well. Although maybe it was a bit late to uncover the condition, the agency acted quickly to chase down the epidemiology and eventually the chemical responsible for the pulmonary injury. My local experts tell me that, while the cause of the lung damage was still a mystery, they noticed a decline in vaping generated by the fear of this unknown killer. Young people were reporting that they were rethinking their vaping usage. However, once the chemical culprit was identified, their clients felt that they could safely vape again as long as they were more careful in choosing the source of liquid in their devices.
Not surprisingly, the current administration has been providing mixed messages about how it will address vaping. There always will be the argument that if you ban a substance, it will be driven underground and become more difficult to manage. However, in the case of vaping, its appeal and risk to young people and the apparent ineffectiveness of local efforts to control it demand a firm unwavering response at the federal level.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Envisioning the future of hospital medicine
I have written frequently over the last few years on topics related to the sustainability of the hospital medicine practice model. I continue to be concerned by what I see as a confluence of significant trends that are conspiring to challenge hospital medicine’s status quo.
On one hand, the financial pressures on U.S. hospitals are unrelenting, and their willingness or even ability to continue providing significant funding to support their hospital medicine groups is in question. Combine this with hospitalists’ rapidly evolving clinical scope and the ever-increasing demands of physicians in other specialties for hospitalist support, and the result is hospital medicine groups that will continue to grow in size, complexity, and the demand for ever more financial support.
On the other hand, the hospitalists I interact with in my work all over the country seem more stressed out than ever, and many are questioning whether this is a job that can be satisfying and sustainable for a career. Increasing patient complexity, productivity pressures, a lack of resources to address patients’ social issues, a systole-diastole schedule, the frustration of EHRs and other documentation responsibilities, and feeling “dumped on” by physicians in other specialties all contribute to hospitalist job stress.
A quick look at the literature confirms that in 2019 hospitalist burnout is definitely “a thing.” Interestingly, it’s been a thing for a while; the risk of hospitalist burnout was first identified by Hoff, et al., in 2002 (doi: 10.2307/30902462002). My colleague, John Nelson, MD, MHM, has written a number of times about strategies for preventing or mitigating hospitalist burnout.
As these trends converge, the hospital medicine practice model as we know it may be facing an existential crisis. If that sounds overly dramatic, let me say instead that the hospital medicine practice model will need to evolve significantly over the next decade in order to continue to meet patient and institutional needs while remaining both affordable and sustainable for the clinicians who work in it.
In September 2019, SHM’s Multi-Site Leaders Special Interest Group met in Chicago for their second annual Multi-Site Leaders Summit to explore the theme of sustainability in hospital medicine. The participants held robust discussions about coping with our changing practice environment, issues relating to hospitalist burnout and resiliency, innovative staffing models, the role of technology in HM sustainability, and financial sustainability
At the end of the meeting, the group engaged in a visioning exercise designed to move beyond what we are doing today by envisioning what the future of hospital medicine will look like and what interventions will be necessary for us to get from here to there. I’d like to share this visioning exercise with you and encourage you to “play along” by thinking seriously about the questions it poses.
Visioning exercise
Feel free to jot down some thoughts as we go through this exercise. But otherwise, just close your eyes and come along for the ride. Imagine yourself sitting at your desk looking at a desk calendar showing today’s date. Watch the pages flip from today, to tomorrow, to the next day, then to next month, and the next, and then to the next year and so on, until we arrive at December 2029.
Imagine that you look up from your desk, and suddenly realize that you aren’t in your office at all, but instead in a huge auditorium where someone is speaking about an award that is going to be announced. It’s crowded and a little stuffy in the auditorium, but people around you are whispering to each other with an air of eager anticipation, their eyes glued to the stage. You realize that the person being introduced up on the podium is the President of the United States, and the award is the Presidential Medal of Freedom, which is only awarded to people or groups who have made “an especially meritorious contribution to the security or national interests of the United States, world peace, cultural, or other significant public or private endeavors.”
Today, the Medal is being awarded to the Society of Hospital Medicine on behalf of all hospital medicine leaders nationally, for their collective accomplishments in saving the specialty of hospital medicine and, by doing so, ensuring that sick people are able to continue receiving the care they need in our nation’s hospitals – and that the hospitals themselves have become reliably safe, efficient, and effective in achieving high quality outcomes.
The President says, “At no time in the history of this award until now have we given this, the highest civilian award in the land, to a whole group of physician leaders across an entire specialty. But the achievements of this group of people in preserving and even enhancing the presence of highly energized, dedicated, capable clinicians in our nation’s hospitals against the significant odds they have faced over the last 10 years is nothing short of extraordinary.” There is a standing ovation, as people jump up out of their chairs to cheer and applaud. When the applause finally dies down, the President goes on to list all the accomplishments that made this group of leaders deserving. Listen to what she is saying. Fill it in in your own mind. What is it that this group has accomplished?
[Brief silence]
Up on a huge screen beside the stage, a video starts. In it, there are several hospital and physician executives in a focus group, and one exec says, “The thing that is great about what these leaders have accomplished in the field of hospital medicine is…” Fill it in – what did that executive say? Another leader jumps in: “That’s all fine and wonderful, but the thing that really makes hospital medicine stand out today compared to where they were 10 years ago is…” Listen to what these executives are saying. What accomplishments are they praising?
The video then moves on to show a focus group of recent hospital patients. One patient says, “10 years ago when my mom was in the hospital, the poor hospitalists caring for her seemed completely overwhelmed and burnt out, and the whole care system seemed fragmented and inefficient; but my own recent hospital experience was so different because…” Additional patients chime in, talking about how confident they felt about the care they received in the hospital and the reasons for that. What is it these patients are describing?
SHM’s CEO gets up to accept the award and explains that 10 years ago, a group of multi-site hospital medicine leaders from across the country came together to begin addressing the issue of sustainability; this led to a formal process for developing a vision and a plan for the future of hospital medicine, and the execution of that plan eventually resulted in the outcomes recognized by this award. She acknowledges that over the years many people questioned whether the hospital medicine model should even continue to exist or whether some other model for inpatient care should be adopted. She talks about all the compelling reasons that supported the continued existence of the specialty of hospital medicine. What are some of the reasons she listed? The SHM CEO goes on to describe some of the key things that were done to address the issues associated with sustainability of the hospital medicine practice model. Listen to what she says; what was it that SHM and the hospital leaders it represents did?
As you are leaving the auditorium, you overhear a group of mid-career staff hospitalists talking. They are saying that they didn’t originally believe the specialty would actually change, and they weren’t sure if they could do this job for a career – but that it did change. They begin talking about what it feels like to work as a hospitalist now, and how these changes have improved their lives. Listen to what they are saying. How does it feel to work as a hospitalist?
As you leave the auditorium and go back to your desk, you sit down to record some of the things you heard. What was it the President of the US said as she presented the Presidential Medal of Freedom? Why did SHM and the hospital medicine leaders it represents deserve the award? What was it that the SHM CEO said was done to bring about the successful changes? What did the staff hospitalists say about working in the specialty?
Whenever you are ready, take a minute to jot down the specifics that came to mind as you read through this exercise. If you are willing to share your thoughts about sustainability in hospital medicine, I’d love to hear from you. Feel free to email me directly at [email protected].
Let’s build the foundation for a sustainable future for our specialty.
Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif. She serves on SHM’s Practice Analysis Committee, and helps to coordinate SHM’s bi-annual State of Hospital Medicine Survey. This article appeared originally in SHM’s official blog The Hospital Leader.
I have written frequently over the last few years on topics related to the sustainability of the hospital medicine practice model. I continue to be concerned by what I see as a confluence of significant trends that are conspiring to challenge hospital medicine’s status quo.
On one hand, the financial pressures on U.S. hospitals are unrelenting, and their willingness or even ability to continue providing significant funding to support their hospital medicine groups is in question. Combine this with hospitalists’ rapidly evolving clinical scope and the ever-increasing demands of physicians in other specialties for hospitalist support, and the result is hospital medicine groups that will continue to grow in size, complexity, and the demand for ever more financial support.
On the other hand, the hospitalists I interact with in my work all over the country seem more stressed out than ever, and many are questioning whether this is a job that can be satisfying and sustainable for a career. Increasing patient complexity, productivity pressures, a lack of resources to address patients’ social issues, a systole-diastole schedule, the frustration of EHRs and other documentation responsibilities, and feeling “dumped on” by physicians in other specialties all contribute to hospitalist job stress.
A quick look at the literature confirms that in 2019 hospitalist burnout is definitely “a thing.” Interestingly, it’s been a thing for a while; the risk of hospitalist burnout was first identified by Hoff, et al., in 2002 (doi: 10.2307/30902462002). My colleague, John Nelson, MD, MHM, has written a number of times about strategies for preventing or mitigating hospitalist burnout.
As these trends converge, the hospital medicine practice model as we know it may be facing an existential crisis. If that sounds overly dramatic, let me say instead that the hospital medicine practice model will need to evolve significantly over the next decade in order to continue to meet patient and institutional needs while remaining both affordable and sustainable for the clinicians who work in it.
In September 2019, SHM’s Multi-Site Leaders Special Interest Group met in Chicago for their second annual Multi-Site Leaders Summit to explore the theme of sustainability in hospital medicine. The participants held robust discussions about coping with our changing practice environment, issues relating to hospitalist burnout and resiliency, innovative staffing models, the role of technology in HM sustainability, and financial sustainability
At the end of the meeting, the group engaged in a visioning exercise designed to move beyond what we are doing today by envisioning what the future of hospital medicine will look like and what interventions will be necessary for us to get from here to there. I’d like to share this visioning exercise with you and encourage you to “play along” by thinking seriously about the questions it poses.
Visioning exercise
Feel free to jot down some thoughts as we go through this exercise. But otherwise, just close your eyes and come along for the ride. Imagine yourself sitting at your desk looking at a desk calendar showing today’s date. Watch the pages flip from today, to tomorrow, to the next day, then to next month, and the next, and then to the next year and so on, until we arrive at December 2029.
Imagine that you look up from your desk, and suddenly realize that you aren’t in your office at all, but instead in a huge auditorium where someone is speaking about an award that is going to be announced. It’s crowded and a little stuffy in the auditorium, but people around you are whispering to each other with an air of eager anticipation, their eyes glued to the stage. You realize that the person being introduced up on the podium is the President of the United States, and the award is the Presidential Medal of Freedom, which is only awarded to people or groups who have made “an especially meritorious contribution to the security or national interests of the United States, world peace, cultural, or other significant public or private endeavors.”
Today, the Medal is being awarded to the Society of Hospital Medicine on behalf of all hospital medicine leaders nationally, for their collective accomplishments in saving the specialty of hospital medicine and, by doing so, ensuring that sick people are able to continue receiving the care they need in our nation’s hospitals – and that the hospitals themselves have become reliably safe, efficient, and effective in achieving high quality outcomes.
The President says, “At no time in the history of this award until now have we given this, the highest civilian award in the land, to a whole group of physician leaders across an entire specialty. But the achievements of this group of people in preserving and even enhancing the presence of highly energized, dedicated, capable clinicians in our nation’s hospitals against the significant odds they have faced over the last 10 years is nothing short of extraordinary.” There is a standing ovation, as people jump up out of their chairs to cheer and applaud. When the applause finally dies down, the President goes on to list all the accomplishments that made this group of leaders deserving. Listen to what she is saying. Fill it in in your own mind. What is it that this group has accomplished?
[Brief silence]
Up on a huge screen beside the stage, a video starts. In it, there are several hospital and physician executives in a focus group, and one exec says, “The thing that is great about what these leaders have accomplished in the field of hospital medicine is…” Fill it in – what did that executive say? Another leader jumps in: “That’s all fine and wonderful, but the thing that really makes hospital medicine stand out today compared to where they were 10 years ago is…” Listen to what these executives are saying. What accomplishments are they praising?
The video then moves on to show a focus group of recent hospital patients. One patient says, “10 years ago when my mom was in the hospital, the poor hospitalists caring for her seemed completely overwhelmed and burnt out, and the whole care system seemed fragmented and inefficient; but my own recent hospital experience was so different because…” Additional patients chime in, talking about how confident they felt about the care they received in the hospital and the reasons for that. What is it these patients are describing?
SHM’s CEO gets up to accept the award and explains that 10 years ago, a group of multi-site hospital medicine leaders from across the country came together to begin addressing the issue of sustainability; this led to a formal process for developing a vision and a plan for the future of hospital medicine, and the execution of that plan eventually resulted in the outcomes recognized by this award. She acknowledges that over the years many people questioned whether the hospital medicine model should even continue to exist or whether some other model for inpatient care should be adopted. She talks about all the compelling reasons that supported the continued existence of the specialty of hospital medicine. What are some of the reasons she listed? The SHM CEO goes on to describe some of the key things that were done to address the issues associated with sustainability of the hospital medicine practice model. Listen to what she says; what was it that SHM and the hospital leaders it represents did?
As you are leaving the auditorium, you overhear a group of mid-career staff hospitalists talking. They are saying that they didn’t originally believe the specialty would actually change, and they weren’t sure if they could do this job for a career – but that it did change. They begin talking about what it feels like to work as a hospitalist now, and how these changes have improved their lives. Listen to what they are saying. How does it feel to work as a hospitalist?
As you leave the auditorium and go back to your desk, you sit down to record some of the things you heard. What was it the President of the US said as she presented the Presidential Medal of Freedom? Why did SHM and the hospital medicine leaders it represents deserve the award? What was it that the SHM CEO said was done to bring about the successful changes? What did the staff hospitalists say about working in the specialty?
Whenever you are ready, take a minute to jot down the specifics that came to mind as you read through this exercise. If you are willing to share your thoughts about sustainability in hospital medicine, I’d love to hear from you. Feel free to email me directly at [email protected].
Let’s build the foundation for a sustainable future for our specialty.
Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif. She serves on SHM’s Practice Analysis Committee, and helps to coordinate SHM’s bi-annual State of Hospital Medicine Survey. This article appeared originally in SHM’s official blog The Hospital Leader.
I have written frequently over the last few years on topics related to the sustainability of the hospital medicine practice model. I continue to be concerned by what I see as a confluence of significant trends that are conspiring to challenge hospital medicine’s status quo.
On one hand, the financial pressures on U.S. hospitals are unrelenting, and their willingness or even ability to continue providing significant funding to support their hospital medicine groups is in question. Combine this with hospitalists’ rapidly evolving clinical scope and the ever-increasing demands of physicians in other specialties for hospitalist support, and the result is hospital medicine groups that will continue to grow in size, complexity, and the demand for ever more financial support.
On the other hand, the hospitalists I interact with in my work all over the country seem more stressed out than ever, and many are questioning whether this is a job that can be satisfying and sustainable for a career. Increasing patient complexity, productivity pressures, a lack of resources to address patients’ social issues, a systole-diastole schedule, the frustration of EHRs and other documentation responsibilities, and feeling “dumped on” by physicians in other specialties all contribute to hospitalist job stress.
A quick look at the literature confirms that in 2019 hospitalist burnout is definitely “a thing.” Interestingly, it’s been a thing for a while; the risk of hospitalist burnout was first identified by Hoff, et al., in 2002 (doi: 10.2307/30902462002). My colleague, John Nelson, MD, MHM, has written a number of times about strategies for preventing or mitigating hospitalist burnout.
As these trends converge, the hospital medicine practice model as we know it may be facing an existential crisis. If that sounds overly dramatic, let me say instead that the hospital medicine practice model will need to evolve significantly over the next decade in order to continue to meet patient and institutional needs while remaining both affordable and sustainable for the clinicians who work in it.
In September 2019, SHM’s Multi-Site Leaders Special Interest Group met in Chicago for their second annual Multi-Site Leaders Summit to explore the theme of sustainability in hospital medicine. The participants held robust discussions about coping with our changing practice environment, issues relating to hospitalist burnout and resiliency, innovative staffing models, the role of technology in HM sustainability, and financial sustainability
At the end of the meeting, the group engaged in a visioning exercise designed to move beyond what we are doing today by envisioning what the future of hospital medicine will look like and what interventions will be necessary for us to get from here to there. I’d like to share this visioning exercise with you and encourage you to “play along” by thinking seriously about the questions it poses.
Visioning exercise
Feel free to jot down some thoughts as we go through this exercise. But otherwise, just close your eyes and come along for the ride. Imagine yourself sitting at your desk looking at a desk calendar showing today’s date. Watch the pages flip from today, to tomorrow, to the next day, then to next month, and the next, and then to the next year and so on, until we arrive at December 2029.
Imagine that you look up from your desk, and suddenly realize that you aren’t in your office at all, but instead in a huge auditorium where someone is speaking about an award that is going to be announced. It’s crowded and a little stuffy in the auditorium, but people around you are whispering to each other with an air of eager anticipation, their eyes glued to the stage. You realize that the person being introduced up on the podium is the President of the United States, and the award is the Presidential Medal of Freedom, which is only awarded to people or groups who have made “an especially meritorious contribution to the security or national interests of the United States, world peace, cultural, or other significant public or private endeavors.”
Today, the Medal is being awarded to the Society of Hospital Medicine on behalf of all hospital medicine leaders nationally, for their collective accomplishments in saving the specialty of hospital medicine and, by doing so, ensuring that sick people are able to continue receiving the care they need in our nation’s hospitals – and that the hospitals themselves have become reliably safe, efficient, and effective in achieving high quality outcomes.
The President says, “At no time in the history of this award until now have we given this, the highest civilian award in the land, to a whole group of physician leaders across an entire specialty. But the achievements of this group of people in preserving and even enhancing the presence of highly energized, dedicated, capable clinicians in our nation’s hospitals against the significant odds they have faced over the last 10 years is nothing short of extraordinary.” There is a standing ovation, as people jump up out of their chairs to cheer and applaud. When the applause finally dies down, the President goes on to list all the accomplishments that made this group of leaders deserving. Listen to what she is saying. Fill it in in your own mind. What is it that this group has accomplished?
[Brief silence]
Up on a huge screen beside the stage, a video starts. In it, there are several hospital and physician executives in a focus group, and one exec says, “The thing that is great about what these leaders have accomplished in the field of hospital medicine is…” Fill it in – what did that executive say? Another leader jumps in: “That’s all fine and wonderful, but the thing that really makes hospital medicine stand out today compared to where they were 10 years ago is…” Listen to what these executives are saying. What accomplishments are they praising?
The video then moves on to show a focus group of recent hospital patients. One patient says, “10 years ago when my mom was in the hospital, the poor hospitalists caring for her seemed completely overwhelmed and burnt out, and the whole care system seemed fragmented and inefficient; but my own recent hospital experience was so different because…” Additional patients chime in, talking about how confident they felt about the care they received in the hospital and the reasons for that. What is it these patients are describing?
SHM’s CEO gets up to accept the award and explains that 10 years ago, a group of multi-site hospital medicine leaders from across the country came together to begin addressing the issue of sustainability; this led to a formal process for developing a vision and a plan for the future of hospital medicine, and the execution of that plan eventually resulted in the outcomes recognized by this award. She acknowledges that over the years many people questioned whether the hospital medicine model should even continue to exist or whether some other model for inpatient care should be adopted. She talks about all the compelling reasons that supported the continued existence of the specialty of hospital medicine. What are some of the reasons she listed? The SHM CEO goes on to describe some of the key things that were done to address the issues associated with sustainability of the hospital medicine practice model. Listen to what she says; what was it that SHM and the hospital leaders it represents did?
As you are leaving the auditorium, you overhear a group of mid-career staff hospitalists talking. They are saying that they didn’t originally believe the specialty would actually change, and they weren’t sure if they could do this job for a career – but that it did change. They begin talking about what it feels like to work as a hospitalist now, and how these changes have improved their lives. Listen to what they are saying. How does it feel to work as a hospitalist?
As you leave the auditorium and go back to your desk, you sit down to record some of the things you heard. What was it the President of the US said as she presented the Presidential Medal of Freedom? Why did SHM and the hospital medicine leaders it represents deserve the award? What was it that the SHM CEO said was done to bring about the successful changes? What did the staff hospitalists say about working in the specialty?
Whenever you are ready, take a minute to jot down the specifics that came to mind as you read through this exercise. If you are willing to share your thoughts about sustainability in hospital medicine, I’d love to hear from you. Feel free to email me directly at [email protected].
Let’s build the foundation for a sustainable future for our specialty.
Ms. Flores is a partner at Nelson Flores Hospital Medicine Consultants, La Quinta, Calif. She serves on SHM’s Practice Analysis Committee, and helps to coordinate SHM’s bi-annual State of Hospital Medicine Survey. This article appeared originally in SHM’s official blog The Hospital Leader.
Breakfast or not?
In North America, breakfast is the most personal of all the traditional daily meals and usually the one at which people show the least amount of day-to-day variation.
For example, since retiring from active practice I eat three scrambled eggs and bowl of fresh fruit every morning (yes, I have my lipid screen done annually and it’s fine). When I was a child there were stretches measuring in years during which I would eat the same cold cereal and drink a glass of orange juice. As an adolescent trying to bulk up for football, there was a breakfast-in-a-glass that I drank along with the cereal every morning. There was the frozen waffle decade.
When I was a busy general pediatrician, the meals were short on preparation and equally short on variety. But I always had something to eat before heading out for the day. That’s what my folks did, and that’s the pattern my wife and I programmed into our children. I think my dietary history is not unique. Most people don’t have time for a complex breakfast, and in many cases, they aren’t feeling terribly adventuresome when it comes to food at 6 or 7 in the morning. Breakfast is more of a habit than an event to satisfy one’s hunger. Several generations ago, breakfast was a big deal. Men (and occasionally women) were headed out for a day of demanding physical labor and stoking the furnace at the beginning of the day made sense. In farm families, breakfast was a major meal after the morning chores were completed. Those Norman Rockwellesque days are behind us, and breakfast has receded into a minor nutritional role.
For many adults, it’s just something to chew on with a cup of a stimulant liquid. In some families, breakfast has disappeared completely. For as long as there have been dietitians and nutritionists, we have been told that breakfast can be the most important meal of the day. And for a child, the failure to eat breakfast could jeopardize his or her ability to perform in school. I guess at face value this dictum makes sense, but I’ve never been terribly impressed with the evidence supporting it. A recent study from England has gotten me thinking about the whole issue of breakfast and school performance again (“associations between habitual school-day breakfast consumption frequency and academic performance in British adolescents.” Front Public Health. 2019 Nov 20. doi. 10.3389/fpubh.2019.00283). A trio of researchers at the Human Appetite Research Unit of the School of Psychology, University of Leeds (England), found that in the study group of nearly 300 adolescents aged 16-18 years, the students who frequently skipped breakfast performed more poorly on a battery of standardized national tests. Well, I guess we have to chalk another one up for the dietitians and nutritionists. But let’s think this through again. The authors observe in the discussion of their results that “breakfast quality was not considered in the analysis and therefore conclusions regarding what aspects of breakfast are correlated with academic performance cannot be drawn.”
Could it be that families who don’t give breakfast a priority also don’t prioritize school work? Maybe teenagers with poor sleep hygiene who are habitually difficult to awaken in the morning don’t have time to eat breakfast. It is likely their sleep deprivation is more of a factor in their school performance than the small nutritional deficit that they have incurred by not eating breakfast. The study that might answer these questions hasn’t been done yet. And maybe it doesn’t need to be done. We don’t need to be asking children what they have for breakfast. But we should be entering into a dialogue that begins with “Why don’t you have breakfast?” The answers may lead into a productive discussion with the family about more important contributors to poor school performance.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In North America, breakfast is the most personal of all the traditional daily meals and usually the one at which people show the least amount of day-to-day variation.
For example, since retiring from active practice I eat three scrambled eggs and bowl of fresh fruit every morning (yes, I have my lipid screen done annually and it’s fine). When I was a child there were stretches measuring in years during which I would eat the same cold cereal and drink a glass of orange juice. As an adolescent trying to bulk up for football, there was a breakfast-in-a-glass that I drank along with the cereal every morning. There was the frozen waffle decade.
When I was a busy general pediatrician, the meals were short on preparation and equally short on variety. But I always had something to eat before heading out for the day. That’s what my folks did, and that’s the pattern my wife and I programmed into our children. I think my dietary history is not unique. Most people don’t have time for a complex breakfast, and in many cases, they aren’t feeling terribly adventuresome when it comes to food at 6 or 7 in the morning. Breakfast is more of a habit than an event to satisfy one’s hunger. Several generations ago, breakfast was a big deal. Men (and occasionally women) were headed out for a day of demanding physical labor and stoking the furnace at the beginning of the day made sense. In farm families, breakfast was a major meal after the morning chores were completed. Those Norman Rockwellesque days are behind us, and breakfast has receded into a minor nutritional role.
For many adults, it’s just something to chew on with a cup of a stimulant liquid. In some families, breakfast has disappeared completely. For as long as there have been dietitians and nutritionists, we have been told that breakfast can be the most important meal of the day. And for a child, the failure to eat breakfast could jeopardize his or her ability to perform in school. I guess at face value this dictum makes sense, but I’ve never been terribly impressed with the evidence supporting it. A recent study from England has gotten me thinking about the whole issue of breakfast and school performance again (“associations between habitual school-day breakfast consumption frequency and academic performance in British adolescents.” Front Public Health. 2019 Nov 20. doi. 10.3389/fpubh.2019.00283). A trio of researchers at the Human Appetite Research Unit of the School of Psychology, University of Leeds (England), found that in the study group of nearly 300 adolescents aged 16-18 years, the students who frequently skipped breakfast performed more poorly on a battery of standardized national tests. Well, I guess we have to chalk another one up for the dietitians and nutritionists. But let’s think this through again. The authors observe in the discussion of their results that “breakfast quality was not considered in the analysis and therefore conclusions regarding what aspects of breakfast are correlated with academic performance cannot be drawn.”
Could it be that families who don’t give breakfast a priority also don’t prioritize school work? Maybe teenagers with poor sleep hygiene who are habitually difficult to awaken in the morning don’t have time to eat breakfast. It is likely their sleep deprivation is more of a factor in their school performance than the small nutritional deficit that they have incurred by not eating breakfast. The study that might answer these questions hasn’t been done yet. And maybe it doesn’t need to be done. We don’t need to be asking children what they have for breakfast. But we should be entering into a dialogue that begins with “Why don’t you have breakfast?” The answers may lead into a productive discussion with the family about more important contributors to poor school performance.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
In North America, breakfast is the most personal of all the traditional daily meals and usually the one at which people show the least amount of day-to-day variation.
For example, since retiring from active practice I eat three scrambled eggs and bowl of fresh fruit every morning (yes, I have my lipid screen done annually and it’s fine). When I was a child there were stretches measuring in years during which I would eat the same cold cereal and drink a glass of orange juice. As an adolescent trying to bulk up for football, there was a breakfast-in-a-glass that I drank along with the cereal every morning. There was the frozen waffle decade.
When I was a busy general pediatrician, the meals were short on preparation and equally short on variety. But I always had something to eat before heading out for the day. That’s what my folks did, and that’s the pattern my wife and I programmed into our children. I think my dietary history is not unique. Most people don’t have time for a complex breakfast, and in many cases, they aren’t feeling terribly adventuresome when it comes to food at 6 or 7 in the morning. Breakfast is more of a habit than an event to satisfy one’s hunger. Several generations ago, breakfast was a big deal. Men (and occasionally women) were headed out for a day of demanding physical labor and stoking the furnace at the beginning of the day made sense. In farm families, breakfast was a major meal after the morning chores were completed. Those Norman Rockwellesque days are behind us, and breakfast has receded into a minor nutritional role.
For many adults, it’s just something to chew on with a cup of a stimulant liquid. In some families, breakfast has disappeared completely. For as long as there have been dietitians and nutritionists, we have been told that breakfast can be the most important meal of the day. And for a child, the failure to eat breakfast could jeopardize his or her ability to perform in school. I guess at face value this dictum makes sense, but I’ve never been terribly impressed with the evidence supporting it. A recent study from England has gotten me thinking about the whole issue of breakfast and school performance again (“associations between habitual school-day breakfast consumption frequency and academic performance in British adolescents.” Front Public Health. 2019 Nov 20. doi. 10.3389/fpubh.2019.00283). A trio of researchers at the Human Appetite Research Unit of the School of Psychology, University of Leeds (England), found that in the study group of nearly 300 adolescents aged 16-18 years, the students who frequently skipped breakfast performed more poorly on a battery of standardized national tests. Well, I guess we have to chalk another one up for the dietitians and nutritionists. But let’s think this through again. The authors observe in the discussion of their results that “breakfast quality was not considered in the analysis and therefore conclusions regarding what aspects of breakfast are correlated with academic performance cannot be drawn.”
Could it be that families who don’t give breakfast a priority also don’t prioritize school work? Maybe teenagers with poor sleep hygiene who are habitually difficult to awaken in the morning don’t have time to eat breakfast. It is likely their sleep deprivation is more of a factor in their school performance than the small nutritional deficit that they have incurred by not eating breakfast. The study that might answer these questions hasn’t been done yet. And maybe it doesn’t need to be done. We don’t need to be asking children what they have for breakfast. But we should be entering into a dialogue that begins with “Why don’t you have breakfast?” The answers may lead into a productive discussion with the family about more important contributors to poor school performance.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Wellness vacations
It’s best practice to not set an alarm when on vacation. The point of vacation, after all, is to escape the rock-hard constraints of the daily grind. But the melody pulling me from slumber wasn’t coming from my phone. It was the ethereal chant of Fajr, morning prayer rising from surrounding mosques. I was in the medina of Marrakesh sleeping in a hotel that was once a home, called a riad. Some parts of the building date from the medieval period. Fajr occurs at dawn, before morning light. Getting from the bed to the toilet was treacherous – you must traverse cold, uneven steps to get there. Yet I had to get dressed: Morning yoga on our riad rooftop would start with sunrise. I guess even my vacations have agendas: I was in Morocco not only to holiday, but also to improve mind, body, and spirit.
For those who can afford them, your travel is fully arranged and activities such as yoga, cooking classes, hikes, and meditation are scheduled. This was my first wellness trip and it was transformative. Many times have I tried to disconnect from the distractions of life, but there is nothing so purifying as having no phone or Internet access. When I made peace with the reality that I couldn’t access EPIC or email, it was like a ringing in the ears had lifted: I could hear silence again.
This trip took us to three locations: Marrakesh, the Atlas Mountains, and the edge of the Sahara Desert. Yoga was prescribed twice a day. Morning practice was 90 minutes of shedding layers as the sun rose and our bodies warmed to increasingly difficult sequences. This was followed by Moroccan breakfast with fellow travelers from around the world. All were professionals and I wasn’t surprised to learn that burnout is common to many. I was surprised to realize that sharing stories with strangers about the vicissitudes of life was deeply bonding. (Or perhaps it was doing yoga inversions together.)
Also surprising was how easy it is to get lost in the maze that is Marrakesh. And yet, it was rewarding. Finding our way back through the mass of people, donkeys, and motorbikes along dark, unmarked alleys – without Waze – was intensely clarifying. Few things help you be present “in the moment” as being adrift and disoriented in a foreign city.
There was relaxation too. We made Khobz, traditional Moroccan bread by mixing just the right amounts of flour, yeast, sugar, oil, water, and salt. Knead, add, knead, add, and stop when done. We then walked a half mile to give our doughy creations to a baker who, with blackened calloused hands, worked an ancient communal oven. Then we waited patiently for the sardines ahead of us to finish baking first. I’ve no idea how long it all took – I had nowhere else to be.
The next day we hiked to a village in the Ourika Valley. There we had lunch at the home of a local Berber family. They served us their best tea, vegetable couscous, and lamb tagine while their chickens and donkeys watched us curiously. It was Thanksgiving (not on the Berber calendar of course) and sharing a meal prepared by a faraway stranger who doesn’t speak English makes you feel thankful in a refreshing way. Way more alike than different we are, I learned.
We finished our trip with a little desert “glamping.” The vast expanse of desert, interrupted by swirling winds and camel bellows quiets your mind, opens you to the immensity of life. That night we sat close to a bonfire and watched the Milky Way drift across the true black sky. I woke the next morning to the best night’s sleep I’ve had all year. My last wellness activity was unplanned, but meaningful nonetheless. As it happens, there’s no hot water in the desert and a bracingly cold shower marked the end of my treatment/vacation.
If the opposite of burned out is repleted, then I am. Also grateful to have such a transformative experience, for friends new and old who love me, and for hot water. Prescribe yourself one if you can.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
It’s best practice to not set an alarm when on vacation. The point of vacation, after all, is to escape the rock-hard constraints of the daily grind. But the melody pulling me from slumber wasn’t coming from my phone. It was the ethereal chant of Fajr, morning prayer rising from surrounding mosques. I was in the medina of Marrakesh sleeping in a hotel that was once a home, called a riad. Some parts of the building date from the medieval period. Fajr occurs at dawn, before morning light. Getting from the bed to the toilet was treacherous – you must traverse cold, uneven steps to get there. Yet I had to get dressed: Morning yoga on our riad rooftop would start with sunrise. I guess even my vacations have agendas: I was in Morocco not only to holiday, but also to improve mind, body, and spirit.
For those who can afford them, your travel is fully arranged and activities such as yoga, cooking classes, hikes, and meditation are scheduled. This was my first wellness trip and it was transformative. Many times have I tried to disconnect from the distractions of life, but there is nothing so purifying as having no phone or Internet access. When I made peace with the reality that I couldn’t access EPIC or email, it was like a ringing in the ears had lifted: I could hear silence again.
This trip took us to three locations: Marrakesh, the Atlas Mountains, and the edge of the Sahara Desert. Yoga was prescribed twice a day. Morning practice was 90 minutes of shedding layers as the sun rose and our bodies warmed to increasingly difficult sequences. This was followed by Moroccan breakfast with fellow travelers from around the world. All were professionals and I wasn’t surprised to learn that burnout is common to many. I was surprised to realize that sharing stories with strangers about the vicissitudes of life was deeply bonding. (Or perhaps it was doing yoga inversions together.)
Also surprising was how easy it is to get lost in the maze that is Marrakesh. And yet, it was rewarding. Finding our way back through the mass of people, donkeys, and motorbikes along dark, unmarked alleys – without Waze – was intensely clarifying. Few things help you be present “in the moment” as being adrift and disoriented in a foreign city.
There was relaxation too. We made Khobz, traditional Moroccan bread by mixing just the right amounts of flour, yeast, sugar, oil, water, and salt. Knead, add, knead, add, and stop when done. We then walked a half mile to give our doughy creations to a baker who, with blackened calloused hands, worked an ancient communal oven. Then we waited patiently for the sardines ahead of us to finish baking first. I’ve no idea how long it all took – I had nowhere else to be.
The next day we hiked to a village in the Ourika Valley. There we had lunch at the home of a local Berber family. They served us their best tea, vegetable couscous, and lamb tagine while their chickens and donkeys watched us curiously. It was Thanksgiving (not on the Berber calendar of course) and sharing a meal prepared by a faraway stranger who doesn’t speak English makes you feel thankful in a refreshing way. Way more alike than different we are, I learned.
We finished our trip with a little desert “glamping.” The vast expanse of desert, interrupted by swirling winds and camel bellows quiets your mind, opens you to the immensity of life. That night we sat close to a bonfire and watched the Milky Way drift across the true black sky. I woke the next morning to the best night’s sleep I’ve had all year. My last wellness activity was unplanned, but meaningful nonetheless. As it happens, there’s no hot water in the desert and a bracingly cold shower marked the end of my treatment/vacation.
If the opposite of burned out is repleted, then I am. Also grateful to have such a transformative experience, for friends new and old who love me, and for hot water. Prescribe yourself one if you can.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
It’s best practice to not set an alarm when on vacation. The point of vacation, after all, is to escape the rock-hard constraints of the daily grind. But the melody pulling me from slumber wasn’t coming from my phone. It was the ethereal chant of Fajr, morning prayer rising from surrounding mosques. I was in the medina of Marrakesh sleeping in a hotel that was once a home, called a riad. Some parts of the building date from the medieval period. Fajr occurs at dawn, before morning light. Getting from the bed to the toilet was treacherous – you must traverse cold, uneven steps to get there. Yet I had to get dressed: Morning yoga on our riad rooftop would start with sunrise. I guess even my vacations have agendas: I was in Morocco not only to holiday, but also to improve mind, body, and spirit.
For those who can afford them, your travel is fully arranged and activities such as yoga, cooking classes, hikes, and meditation are scheduled. This was my first wellness trip and it was transformative. Many times have I tried to disconnect from the distractions of life, but there is nothing so purifying as having no phone or Internet access. When I made peace with the reality that I couldn’t access EPIC or email, it was like a ringing in the ears had lifted: I could hear silence again.
This trip took us to three locations: Marrakesh, the Atlas Mountains, and the edge of the Sahara Desert. Yoga was prescribed twice a day. Morning practice was 90 minutes of shedding layers as the sun rose and our bodies warmed to increasingly difficult sequences. This was followed by Moroccan breakfast with fellow travelers from around the world. All were professionals and I wasn’t surprised to learn that burnout is common to many. I was surprised to realize that sharing stories with strangers about the vicissitudes of life was deeply bonding. (Or perhaps it was doing yoga inversions together.)
Also surprising was how easy it is to get lost in the maze that is Marrakesh. And yet, it was rewarding. Finding our way back through the mass of people, donkeys, and motorbikes along dark, unmarked alleys – without Waze – was intensely clarifying. Few things help you be present “in the moment” as being adrift and disoriented in a foreign city.
There was relaxation too. We made Khobz, traditional Moroccan bread by mixing just the right amounts of flour, yeast, sugar, oil, water, and salt. Knead, add, knead, add, and stop when done. We then walked a half mile to give our doughy creations to a baker who, with blackened calloused hands, worked an ancient communal oven. Then we waited patiently for the sardines ahead of us to finish baking first. I’ve no idea how long it all took – I had nowhere else to be.
The next day we hiked to a village in the Ourika Valley. There we had lunch at the home of a local Berber family. They served us their best tea, vegetable couscous, and lamb tagine while their chickens and donkeys watched us curiously. It was Thanksgiving (not on the Berber calendar of course) and sharing a meal prepared by a faraway stranger who doesn’t speak English makes you feel thankful in a refreshing way. Way more alike than different we are, I learned.
We finished our trip with a little desert “glamping.” The vast expanse of desert, interrupted by swirling winds and camel bellows quiets your mind, opens you to the immensity of life. That night we sat close to a bonfire and watched the Milky Way drift across the true black sky. I woke the next morning to the best night’s sleep I’ve had all year. My last wellness activity was unplanned, but meaningful nonetheless. As it happens, there’s no hot water in the desert and a bracingly cold shower marked the end of my treatment/vacation.
If the opposite of burned out is repleted, then I am. Also grateful to have such a transformative experience, for friends new and old who love me, and for hot water. Prescribe yourself one if you can.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Being whole
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Paid (and unpaid) time off
Many medical offices are following a popular trend in the business world: They are replacing employee sick leave, vacation, and any other miscellaneous time benefits with a combination of all of them, collectively referred to as “, and you should carefully consider all the pros and cons before adopting it.
Employees generally like the concept because most never use all their sick leave. Allowing them to take the difference as extra vacation time makes them happy, and makes your office more attractive to excellent prospects. They also appreciate being treated more like adults who can make time off decisions for themselves.
Employers like it because there is less paperwork and less abuse of sick leave. They don’t have to make any decisions about whether an employee is really sick or not; reasons for absence are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics say employees are absent more frequently under a PTO system, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Besides, you should be suspicious of any employee who won’t take vacations. They are often embezzlers who fear that their illicit modus operandi will be discovered during their absence. (More on that next month.)
Most extra absences can be controlled by requiring prior approval for any time off, except emergencies. Critics point out that you are then replacing decisions about what constitutes an illness with decisions about what constitutes an emergency; but many criteria for emergencies can be settled upon in advance.
Some experts suggest dealing with increased absenteeism by allowing employees to take salary in exchange for unused PTO. I disagree because again, time off should be taken. If you want to allow PTO to be paid as salary, set a limit – say, 10%. Use the rest, or lose it.
A major issue with PTO is the possibility that employees will resist staying home when they are actually sick. Some businesses have found that employees tend to view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees must stay home, and if they come to work sick, they will be sent home. You have an obligation to protect the rest of your employees, not to mention your patients (especially those who are elderly or immunocompromised) from a staff member with a potentially communicable illness.
Other clear guidelines should be established as well. Make sure everyone knows they will have to request PTO in advance, except for emergencies. First define “in advance” (72 hours? A week?), and then “emergency,” and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what about a malfunctioning car? Some circumstances will necessarily be decided on a case-by-case basis; but the more situations you can anticipate and settle in advance, the fewer hassles you will have.
What about unpaid time off? There are two basic options: Don’t allow it at all, or require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it far less likely that anyone will abuse the privilege. And it allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Many medical offices are following a popular trend in the business world: They are replacing employee sick leave, vacation, and any other miscellaneous time benefits with a combination of all of them, collectively referred to as “, and you should carefully consider all the pros and cons before adopting it.
Employees generally like the concept because most never use all their sick leave. Allowing them to take the difference as extra vacation time makes them happy, and makes your office more attractive to excellent prospects. They also appreciate being treated more like adults who can make time off decisions for themselves.
Employers like it because there is less paperwork and less abuse of sick leave. They don’t have to make any decisions about whether an employee is really sick or not; reasons for absence are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics say employees are absent more frequently under a PTO system, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Besides, you should be suspicious of any employee who won’t take vacations. They are often embezzlers who fear that their illicit modus operandi will be discovered during their absence. (More on that next month.)
Most extra absences can be controlled by requiring prior approval for any time off, except emergencies. Critics point out that you are then replacing decisions about what constitutes an illness with decisions about what constitutes an emergency; but many criteria for emergencies can be settled upon in advance.
Some experts suggest dealing with increased absenteeism by allowing employees to take salary in exchange for unused PTO. I disagree because again, time off should be taken. If you want to allow PTO to be paid as salary, set a limit – say, 10%. Use the rest, or lose it.
A major issue with PTO is the possibility that employees will resist staying home when they are actually sick. Some businesses have found that employees tend to view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees must stay home, and if they come to work sick, they will be sent home. You have an obligation to protect the rest of your employees, not to mention your patients (especially those who are elderly or immunocompromised) from a staff member with a potentially communicable illness.
Other clear guidelines should be established as well. Make sure everyone knows they will have to request PTO in advance, except for emergencies. First define “in advance” (72 hours? A week?), and then “emergency,” and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what about a malfunctioning car? Some circumstances will necessarily be decided on a case-by-case basis; but the more situations you can anticipate and settle in advance, the fewer hassles you will have.
What about unpaid time off? There are two basic options: Don’t allow it at all, or require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it far less likely that anyone will abuse the privilege. And it allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Many medical offices are following a popular trend in the business world: They are replacing employee sick leave, vacation, and any other miscellaneous time benefits with a combination of all of them, collectively referred to as “, and you should carefully consider all the pros and cons before adopting it.
Employees generally like the concept because most never use all their sick leave. Allowing them to take the difference as extra vacation time makes them happy, and makes your office more attractive to excellent prospects. They also appreciate being treated more like adults who can make time off decisions for themselves.
Employers like it because there is less paperwork and less abuse of sick leave. They don’t have to make any decisions about whether an employee is really sick or not; reasons for absence are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics say employees are absent more frequently under a PTO system, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Besides, you should be suspicious of any employee who won’t take vacations. They are often embezzlers who fear that their illicit modus operandi will be discovered during their absence. (More on that next month.)
Most extra absences can be controlled by requiring prior approval for any time off, except emergencies. Critics point out that you are then replacing decisions about what constitutes an illness with decisions about what constitutes an emergency; but many criteria for emergencies can be settled upon in advance.
Some experts suggest dealing with increased absenteeism by allowing employees to take salary in exchange for unused PTO. I disagree because again, time off should be taken. If you want to allow PTO to be paid as salary, set a limit – say, 10%. Use the rest, or lose it.
A major issue with PTO is the possibility that employees will resist staying home when they are actually sick. Some businesses have found that employees tend to view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees must stay home, and if they come to work sick, they will be sent home. You have an obligation to protect the rest of your employees, not to mention your patients (especially those who are elderly or immunocompromised) from a staff member with a potentially communicable illness.
Other clear guidelines should be established as well. Make sure everyone knows they will have to request PTO in advance, except for emergencies. First define “in advance” (72 hours? A week?), and then “emergency,” and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what about a malfunctioning car? Some circumstances will necessarily be decided on a case-by-case basis; but the more situations you can anticipate and settle in advance, the fewer hassles you will have.
What about unpaid time off? There are two basic options: Don’t allow it at all, or require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it far less likely that anyone will abuse the privilege. And it allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Negligent use of steroids
Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?
A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.
B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.
C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.
D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.
E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.
Answer: E. The above hypothetical was modified from an old Montana case1 in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
Steroid-related litigation
Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.2 Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).
Learned intermediary
“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.
The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
Complications
Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.
Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,3 aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.
Aseptic necrosis is a feared complication of steroid therapy.
A recent report4 featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.
In a case5 of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
Contributory role
The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court6 upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.
The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.
In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected] .
References
1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).
2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.
3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.
4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.
5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.
6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).
Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?
A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.
B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.
C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.
D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.
E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.
Answer: E. The above hypothetical was modified from an old Montana case1 in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
Steroid-related litigation
Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.2 Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).
Learned intermediary
“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.
The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
Complications
Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.
Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,3 aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.
Aseptic necrosis is a feared complication of steroid therapy.
A recent report4 featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.
In a case5 of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
Contributory role
The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court6 upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.
The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.
In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected] .
References
1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).
2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.
3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.
4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.
5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.
6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).
Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?
A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.
B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.
C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.
D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.
E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.
Answer: E. The above hypothetical was modified from an old Montana case1 in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
Steroid-related litigation
Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.2 Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).
Learned intermediary
“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.
The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
Complications
Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.
Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,3 aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.
Aseptic necrosis is a feared complication of steroid therapy.
A recent report4 featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.
In a case5 of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
Contributory role
The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court6 upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.
The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.
In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected] .
References
1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).
2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.
3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.
4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.
5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.
6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).
The clinical impact of new approvals in sickle cell, MCL
In this edition of “How I Will Treat My Next Patient,” I highlight two recent drug approvals by the Food and Drug Administration – crizanlizumab for sickle cell patients with painful crises and zanubrutinib for mantle cell lymphoma (MCL) patients in relapse.
Crizanlizumab
P-selectin is an adhesion molecule expressed on activated vascular endothelial cells and platelets. It is a key molecule in the initiation of leukocyte rolling on vessel walls and promotes firm attachment and extravasation to underlying tissues during inflammation. Up-regulation of P-selectin on endothelial cells and platelets contributes to the cell-cell interactions involved in the pathogenesis of sickle cell pain crises.
The SUSTAIN study was a multisite, placebo-controlled, randomized phase 2 trial of two different dosage levels of intravenous crizanlizumab (2.5 mg/kg or 5 mg/kg for 52 weeks), a humanized anti–P-selectin antibody, examining its effect on pain crises in patients with sickle cell disease. The primary endpoint was the annual rate of sickle cell pain crises, with a variety of clinically relevant secondary endpoints. The target population had 2-10 pain crises in the 12 months before enrollment. Patients on a stable dose of hydroxyurea for at least the most recent 3 months were allowed to enter, but if patients were not receiving hydroxyurea, it could not be initiated during the trial. Patients who were undergoing chronic red-cell transfusion therapy were excluded.
Among 198 enrolled patients, 35% did not complete the 52 weeks of treatment. Discontinuations were equally balanced among patients assigned to the high-dose, low-dose, and placebo cohorts. Adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. Serious adverse events occurred in 55 patients, with 5 deaths, all of which were unrelated to treatment. Crizanlizumab did not augment hemolysis or bacterial infections.
In the efficacy analysis, patients receiving high-dose crizanlizumab had a median annual rate of 1.63 health care visits for sickle cell pain crises, compared with 2.98 visits for placebo patients (P = .01). In comparison with placebo, high-dose crizanlizumab also delayed the first pain crisis after starting treatment (4.1 months vs. 1.4 months), delayed the median time to a second pain crisis, and decreased the median number of pain crises annually.
More than twice as many high-dose crizanlizumab patients had no pain crisis episodes, compared with placebo patients. In general, differences were more striking in patients who were not taking hydroxyurea and who had non–hemoglobin SS disease. Differences in the primary endpoint between low-dose crizanlizumab and placebo were numerically, but not statistically, different.
How these results influence practice
It has been over 20 years since a new agent (hydroxyurea) was approved for sickle cell patients and, despite its use, sickle cell pain crises remain a frequent problem. Pain crises are associated with worse quality of life and increased risk of death. A promising advance is badly needed, especially in an era in which sensitivity to providers’ role in the opioid addiction crisis is highly scrutinized and may contribute to future undertreatment of pain episodes. This is especially true for patients from areas with high levels of opioid misuse.
The SUSTAIN trial was international, multi-institutional, placebo-controlled, and inclusive. These attributes enhance the likelihood that crizanlizumab will enhance patient care in routine practice. As an intravenous agent, monitoring adherence and toxicity are less challenging than with hydroxyurea. Despite these factors, however, there are some concerns. Crizanlizumab was not free of toxicity, quality of life via the Brief Pain Inventory used in the trial was not improved, and changes in the pain-severity and pain-interference domains were small. Treatment in SUSTAIN ensued for 52 weeks, so the emergence of late neutralizing antibodies and late toxicities with longer-term therapy will require careful postmarketing assessment.
These concerns notwithstanding, anyone who has cared for sickle cell patients would be excited about the potential benefits crizanlizumab could bring to patient care.
Zanubrutinib
The FDA has approved zanubrutinib for the treatment of MCL in adult patients who have received at least one prior therapy. The approval is based on the results of two studies in which overall response rate was the primary endpoint.
BGB-3111-206 (NCT03206970) was a phase 2, open-label, multicenter, single-arm trial of 86 patients with MCL who received at least one prior therapy. Zanubrutinib was given orally at 160 mg twice daily until disease progression or unacceptable toxicity. BGB-3111-AU-003 (NCT 02343120) was a phase 1/2, open-label, dose-escalation trial of B-cell malignancies, including 32 previously treated MCL patients treated with zanubrutinib at 160 mg twice daily or 320 mg once daily.
In the phase 2 trial, 18fluorodeoxyglucose (FDG)–PET scans were required and the ORR was 84% (95% confidence interval, 74%-91%), with a complete response rate of 59% (95% CI, 48%-70%) and a median response duration of 19.5 months (95% CI, 16.6% to not estimable). In the phase 1/2 dose-escalation trial, FDG-PET scans were not required and the ORR was 84% (95% CI, 67%-95%), with a complete response rate of 22% (95% CI, 9%-40%) and a median response duration of 18.5 months (95% CI, 12.6% to not estimable). In both trials, median follow-up on study was about 18 months.
The most common adverse reactions were cytopenias, upper respiratory tract infection, rash, bruising, diarrhea, and cough. The most common serious adverse reactions were pneumonia in 11% and hemorrhage in 5% of patients. Of 118 MCL patients, 8 stopped therapy because of an adverse event, most frequently pneumonia (3.4%).
How these results influence practice
Unfortunately, the therapy of recurrent MCL is noncurative, because of the rapid development of treatment resistance. There are multiple single-and multiagent chemotherapy regimens that may be tried, many incorporating immunotherapy options such as anti-CD20- or Bruton tyrosine kinase (BTK)–targeted agents. Given the limited efficacy of these agents, temporary nature of remissions, and paucity of data comparing these various treatment options, participation in clinical trials is encouraged whenever possible.
Outside of a clinical trial, zanubrutinib joins ibrutinib and acalabrutinib as approved single-agent BTK inhibitors for adult MCL patients in relapse. The impressive ORR and response duration reported for zanubrutinib are similar to the results achieved with the other agents, but the toxicity pattern may be slightly different.
As in the treatment of hormonally sensitive breast cancer, clinicians and patients benefit when they have multiple similar, equally efficacious oral agents with slightly different toxicity patterns so that quality of life can be improved and treatment duration maximized before treatment resistance develops and a more toxic and/or inconvenient therapy needs to be employed.
Whether zanubrutinib has benefits beyond those for MCL patients in relapse will depend on the results of confirmatory trials and patient-reported outcome data.
Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.
In this edition of “How I Will Treat My Next Patient,” I highlight two recent drug approvals by the Food and Drug Administration – crizanlizumab for sickle cell patients with painful crises and zanubrutinib for mantle cell lymphoma (MCL) patients in relapse.
Crizanlizumab
P-selectin is an adhesion molecule expressed on activated vascular endothelial cells and platelets. It is a key molecule in the initiation of leukocyte rolling on vessel walls and promotes firm attachment and extravasation to underlying tissues during inflammation. Up-regulation of P-selectin on endothelial cells and platelets contributes to the cell-cell interactions involved in the pathogenesis of sickle cell pain crises.
The SUSTAIN study was a multisite, placebo-controlled, randomized phase 2 trial of two different dosage levels of intravenous crizanlizumab (2.5 mg/kg or 5 mg/kg for 52 weeks), a humanized anti–P-selectin antibody, examining its effect on pain crises in patients with sickle cell disease. The primary endpoint was the annual rate of sickle cell pain crises, with a variety of clinically relevant secondary endpoints. The target population had 2-10 pain crises in the 12 months before enrollment. Patients on a stable dose of hydroxyurea for at least the most recent 3 months were allowed to enter, but if patients were not receiving hydroxyurea, it could not be initiated during the trial. Patients who were undergoing chronic red-cell transfusion therapy were excluded.
Among 198 enrolled patients, 35% did not complete the 52 weeks of treatment. Discontinuations were equally balanced among patients assigned to the high-dose, low-dose, and placebo cohorts. Adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. Serious adverse events occurred in 55 patients, with 5 deaths, all of which were unrelated to treatment. Crizanlizumab did not augment hemolysis or bacterial infections.
In the efficacy analysis, patients receiving high-dose crizanlizumab had a median annual rate of 1.63 health care visits for sickle cell pain crises, compared with 2.98 visits for placebo patients (P = .01). In comparison with placebo, high-dose crizanlizumab also delayed the first pain crisis after starting treatment (4.1 months vs. 1.4 months), delayed the median time to a second pain crisis, and decreased the median number of pain crises annually.
More than twice as many high-dose crizanlizumab patients had no pain crisis episodes, compared with placebo patients. In general, differences were more striking in patients who were not taking hydroxyurea and who had non–hemoglobin SS disease. Differences in the primary endpoint between low-dose crizanlizumab and placebo were numerically, but not statistically, different.
How these results influence practice
It has been over 20 years since a new agent (hydroxyurea) was approved for sickle cell patients and, despite its use, sickle cell pain crises remain a frequent problem. Pain crises are associated with worse quality of life and increased risk of death. A promising advance is badly needed, especially in an era in which sensitivity to providers’ role in the opioid addiction crisis is highly scrutinized and may contribute to future undertreatment of pain episodes. This is especially true for patients from areas with high levels of opioid misuse.
The SUSTAIN trial was international, multi-institutional, placebo-controlled, and inclusive. These attributes enhance the likelihood that crizanlizumab will enhance patient care in routine practice. As an intravenous agent, monitoring adherence and toxicity are less challenging than with hydroxyurea. Despite these factors, however, there are some concerns. Crizanlizumab was not free of toxicity, quality of life via the Brief Pain Inventory used in the trial was not improved, and changes in the pain-severity and pain-interference domains were small. Treatment in SUSTAIN ensued for 52 weeks, so the emergence of late neutralizing antibodies and late toxicities with longer-term therapy will require careful postmarketing assessment.
These concerns notwithstanding, anyone who has cared for sickle cell patients would be excited about the potential benefits crizanlizumab could bring to patient care.
Zanubrutinib
The FDA has approved zanubrutinib for the treatment of MCL in adult patients who have received at least one prior therapy. The approval is based on the results of two studies in which overall response rate was the primary endpoint.
BGB-3111-206 (NCT03206970) was a phase 2, open-label, multicenter, single-arm trial of 86 patients with MCL who received at least one prior therapy. Zanubrutinib was given orally at 160 mg twice daily until disease progression or unacceptable toxicity. BGB-3111-AU-003 (NCT 02343120) was a phase 1/2, open-label, dose-escalation trial of B-cell malignancies, including 32 previously treated MCL patients treated with zanubrutinib at 160 mg twice daily or 320 mg once daily.
In the phase 2 trial, 18fluorodeoxyglucose (FDG)–PET scans were required and the ORR was 84% (95% confidence interval, 74%-91%), with a complete response rate of 59% (95% CI, 48%-70%) and a median response duration of 19.5 months (95% CI, 16.6% to not estimable). In the phase 1/2 dose-escalation trial, FDG-PET scans were not required and the ORR was 84% (95% CI, 67%-95%), with a complete response rate of 22% (95% CI, 9%-40%) and a median response duration of 18.5 months (95% CI, 12.6% to not estimable). In both trials, median follow-up on study was about 18 months.
The most common adverse reactions were cytopenias, upper respiratory tract infection, rash, bruising, diarrhea, and cough. The most common serious adverse reactions were pneumonia in 11% and hemorrhage in 5% of patients. Of 118 MCL patients, 8 stopped therapy because of an adverse event, most frequently pneumonia (3.4%).
How these results influence practice
Unfortunately, the therapy of recurrent MCL is noncurative, because of the rapid development of treatment resistance. There are multiple single-and multiagent chemotherapy regimens that may be tried, many incorporating immunotherapy options such as anti-CD20- or Bruton tyrosine kinase (BTK)–targeted agents. Given the limited efficacy of these agents, temporary nature of remissions, and paucity of data comparing these various treatment options, participation in clinical trials is encouraged whenever possible.
Outside of a clinical trial, zanubrutinib joins ibrutinib and acalabrutinib as approved single-agent BTK inhibitors for adult MCL patients in relapse. The impressive ORR and response duration reported for zanubrutinib are similar to the results achieved with the other agents, but the toxicity pattern may be slightly different.
As in the treatment of hormonally sensitive breast cancer, clinicians and patients benefit when they have multiple similar, equally efficacious oral agents with slightly different toxicity patterns so that quality of life can be improved and treatment duration maximized before treatment resistance develops and a more toxic and/or inconvenient therapy needs to be employed.
Whether zanubrutinib has benefits beyond those for MCL patients in relapse will depend on the results of confirmatory trials and patient-reported outcome data.
Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.
In this edition of “How I Will Treat My Next Patient,” I highlight two recent drug approvals by the Food and Drug Administration – crizanlizumab for sickle cell patients with painful crises and zanubrutinib for mantle cell lymphoma (MCL) patients in relapse.
Crizanlizumab
P-selectin is an adhesion molecule expressed on activated vascular endothelial cells and platelets. It is a key molecule in the initiation of leukocyte rolling on vessel walls and promotes firm attachment and extravasation to underlying tissues during inflammation. Up-regulation of P-selectin on endothelial cells and platelets contributes to the cell-cell interactions involved in the pathogenesis of sickle cell pain crises.
The SUSTAIN study was a multisite, placebo-controlled, randomized phase 2 trial of two different dosage levels of intravenous crizanlizumab (2.5 mg/kg or 5 mg/kg for 52 weeks), a humanized anti–P-selectin antibody, examining its effect on pain crises in patients with sickle cell disease. The primary endpoint was the annual rate of sickle cell pain crises, with a variety of clinically relevant secondary endpoints. The target population had 2-10 pain crises in the 12 months before enrollment. Patients on a stable dose of hydroxyurea for at least the most recent 3 months were allowed to enter, but if patients were not receiving hydroxyurea, it could not be initiated during the trial. Patients who were undergoing chronic red-cell transfusion therapy were excluded.
Among 198 enrolled patients, 35% did not complete the 52 weeks of treatment. Discontinuations were equally balanced among patients assigned to the high-dose, low-dose, and placebo cohorts. Adverse events associated with crizanlizumab included back pain, nausea, pyrexia, and arthralgia. Serious adverse events occurred in 55 patients, with 5 deaths, all of which were unrelated to treatment. Crizanlizumab did not augment hemolysis or bacterial infections.
In the efficacy analysis, patients receiving high-dose crizanlizumab had a median annual rate of 1.63 health care visits for sickle cell pain crises, compared with 2.98 visits for placebo patients (P = .01). In comparison with placebo, high-dose crizanlizumab also delayed the first pain crisis after starting treatment (4.1 months vs. 1.4 months), delayed the median time to a second pain crisis, and decreased the median number of pain crises annually.
More than twice as many high-dose crizanlizumab patients had no pain crisis episodes, compared with placebo patients. In general, differences were more striking in patients who were not taking hydroxyurea and who had non–hemoglobin SS disease. Differences in the primary endpoint between low-dose crizanlizumab and placebo were numerically, but not statistically, different.
How these results influence practice
It has been over 20 years since a new agent (hydroxyurea) was approved for sickle cell patients and, despite its use, sickle cell pain crises remain a frequent problem. Pain crises are associated with worse quality of life and increased risk of death. A promising advance is badly needed, especially in an era in which sensitivity to providers’ role in the opioid addiction crisis is highly scrutinized and may contribute to future undertreatment of pain episodes. This is especially true for patients from areas with high levels of opioid misuse.
The SUSTAIN trial was international, multi-institutional, placebo-controlled, and inclusive. These attributes enhance the likelihood that crizanlizumab will enhance patient care in routine practice. As an intravenous agent, monitoring adherence and toxicity are less challenging than with hydroxyurea. Despite these factors, however, there are some concerns. Crizanlizumab was not free of toxicity, quality of life via the Brief Pain Inventory used in the trial was not improved, and changes in the pain-severity and pain-interference domains were small. Treatment in SUSTAIN ensued for 52 weeks, so the emergence of late neutralizing antibodies and late toxicities with longer-term therapy will require careful postmarketing assessment.
These concerns notwithstanding, anyone who has cared for sickle cell patients would be excited about the potential benefits crizanlizumab could bring to patient care.
Zanubrutinib
The FDA has approved zanubrutinib for the treatment of MCL in adult patients who have received at least one prior therapy. The approval is based on the results of two studies in which overall response rate was the primary endpoint.
BGB-3111-206 (NCT03206970) was a phase 2, open-label, multicenter, single-arm trial of 86 patients with MCL who received at least one prior therapy. Zanubrutinib was given orally at 160 mg twice daily until disease progression or unacceptable toxicity. BGB-3111-AU-003 (NCT 02343120) was a phase 1/2, open-label, dose-escalation trial of B-cell malignancies, including 32 previously treated MCL patients treated with zanubrutinib at 160 mg twice daily or 320 mg once daily.
In the phase 2 trial, 18fluorodeoxyglucose (FDG)–PET scans were required and the ORR was 84% (95% confidence interval, 74%-91%), with a complete response rate of 59% (95% CI, 48%-70%) and a median response duration of 19.5 months (95% CI, 16.6% to not estimable). In the phase 1/2 dose-escalation trial, FDG-PET scans were not required and the ORR was 84% (95% CI, 67%-95%), with a complete response rate of 22% (95% CI, 9%-40%) and a median response duration of 18.5 months (95% CI, 12.6% to not estimable). In both trials, median follow-up on study was about 18 months.
The most common adverse reactions were cytopenias, upper respiratory tract infection, rash, bruising, diarrhea, and cough. The most common serious adverse reactions were pneumonia in 11% and hemorrhage in 5% of patients. Of 118 MCL patients, 8 stopped therapy because of an adverse event, most frequently pneumonia (3.4%).
How these results influence practice
Unfortunately, the therapy of recurrent MCL is noncurative, because of the rapid development of treatment resistance. There are multiple single-and multiagent chemotherapy regimens that may be tried, many incorporating immunotherapy options such as anti-CD20- or Bruton tyrosine kinase (BTK)–targeted agents. Given the limited efficacy of these agents, temporary nature of remissions, and paucity of data comparing these various treatment options, participation in clinical trials is encouraged whenever possible.
Outside of a clinical trial, zanubrutinib joins ibrutinib and acalabrutinib as approved single-agent BTK inhibitors for adult MCL patients in relapse. The impressive ORR and response duration reported for zanubrutinib are similar to the results achieved with the other agents, but the toxicity pattern may be slightly different.
As in the treatment of hormonally sensitive breast cancer, clinicians and patients benefit when they have multiple similar, equally efficacious oral agents with slightly different toxicity patterns so that quality of life can be improved and treatment duration maximized before treatment resistance develops and a more toxic and/or inconvenient therapy needs to be employed.
Whether zanubrutinib has benefits beyond those for MCL patients in relapse will depend on the results of confirmatory trials and patient-reported outcome data.
Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.
Bariatric surgery should be considered in individuals with class 1 obesity
Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.
Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.
This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.
There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.
Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.
The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.
While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.
Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.
He made these comments in response to questions from MDedge and had no relevant disclosures.
Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.
Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.
This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.
There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.
Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.
The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.
While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.
Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.
He made these comments in response to questions from MDedge and had no relevant disclosures.
Mitchel L. Zoler’s article on Abstract A105, presented at Obesity Week 2019, addresses an important health concern and is timely.
Over the past 4 decades we have seen a rise in the prevalence of obesity and associated health complications, not just in the United States but across the world. The incidence of obesity (having a BMI greater than 30) was 35% for women and 31% for men in the United States, and associated deaths and disability were primarily attributed to diabetes and cardiovascular disease resulting from obesity.
This article references the benefits of bariatric/metabolic surgery in individuals with class 1 obesity. In the United States, more than half of those who meet the criteria for obesity come under the class 1 category (BMI, 30-34.9). Those in this class of obesity are at increased risk of developing diabetes, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, obstructive sleep apnea, polycystic ovarian syndrome, and bone and joint disorders.
There are several studies that document the significant reduction in incidence of the above cardiometabolic risks with sustained weight loss. Nonsurgical interventions in individuals with class 1 obesity through lifestyle modifications and pharmacotherapy have not demonstrated success in providing persistent weight loss or metabolic benefits. The data presented in this article are of great significance to patients and physicians alike as they highlight the long-term benefits and reversal of metabolic disorders.
Current guidelines for bariatric surgery for individuals with a BMI greater than 35 were published in 1991. Since then several safe surgical options including laparoscopic procedures, sleeve gastrectomy, and adjustable gastric banding have been developed with decreased surgical risks, morbidity, and mortality.
The International Federation for the Surgery of Obesity and Metabolic Disorders, the International Diabetes Federation, and the National Institute for Health and Care Excellence of the United Kingdom, have supported the option of bariatric surgery in class 1 obese individuals with metabolic disorders.
While lifestyle modifications with medications should be the first-line treatment for class 1 obesity, as a primary care physician I believe that, given the major changes in the surgical options, the proven long-term benefits, and the rising incidences of obesity and metabolic syndrome, it is time for the health care community, insurers, patients, and all other stakeholders to consider bariatric surgery in class 1 obese individuals as a potential and viable option.
Noel N. Deep, MD, is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, Wausau, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News.
He made these comments in response to questions from MDedge and had no relevant disclosures.
Is it time for neurologists to manage high blood pressure?
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Nov. 1, 2019, issue of JAMA Neurology, an editorial argues that it’s time for neurologists to start managing high blood pressure.
It makes some very valid points: that targeting a systolic blood pressure of less than 120 mm Hg results in lower rates of cardiovascular events and all causes of mortality, that poorly controlled hypertension leads to debilitating neurologic conditions, and that high blood pressure is the most common modifiable risk factor for stroke.
All are strong points. I agree with them and definitely believe that more can and should be done to control hypertension.
The editorial then goes on to say that “first and foremost we are charging neurologists with actively diagnosing hypertension and prescribing medications when appropriate.”
Uh, no. I’m not going to be the one managing hypertension, nor should any outpatient neurologist.
Outpatient hypertension treatment has historically been, and should remain, the province of general practitioners, cardiologists, and nephrologists. Too many cooks, as they say, spoils the broth. I don’t want to be in a situation where two (or more) doctors are simultaneously trying to treat the same condition. On that path lies danger.
This doesn’t mean I ignore blood pressure. On the contrary, I take it (myself) at every patient visit, and put it in my note. In most cases I do nothing further, as nothing further needs to be done. On occasion, though, if it’s concerningly high, I’ll write it down for the patient and direct them to call the physician handling it. I also fax a note about it to that office, and if it’s dangerously high will call the doctor myself.
But try to manage it? No. Elevated readings definitely overlap with my world, but treating them shouldn’t.
The article says that, for some chronic patients, neurologists are their de facto internist. Perhaps for a few, but when a patient calls with concerns about a respiratory ailment, gastrointestinal problem, or other nonneurologic issue, I tell them to call their general practitioner. If they don’t have one I’m happy to give them the names and phone numbers of colleagues who practice that field, or even urgent care and emergency department information if needed. Just because I see them for their neurologic problems doesn’t qualify me to practice another branch of medicine.
Beyond the dangers of having more than one doctor involved, as a specialist it’s not practical for me to know the antihypertensive medications – possibly the largest group of agents on the market, – in detail, with their mechanisms of action, side effects, and contraindications. Yes, I do keep a handful in mind, since they’re needed off label for migraines and tremors, but not in the kind of detail a cardiologist would. I have to keep track of enough medications in my specialty as it is.
I wouldn’t try to handle blood pressure any more than I’d expect a nephrologist to treat epilepsy. It’s just looking for trouble.
Even when covering the hospital, I’ll stay out of that arena. This doesn’t mean I ignore blood pressure in such serious conditions as stroke or posterior reversible encephalopathy syndrome. I’m more than happy to provide guidelines and parameters. But as far as choosing the medications and doses? No.
Like driving, we all have to share the road. We may even be focused on the same journey (or patient). But part of practicing medicine and handling traffic is knowing when to stay in your lane.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.