As psychiatrists, do we offer hope or do we offer death?

Article Type
Changed
Mon, 07/10/2023 - 13:44

I remember what it was like to be a medical student at a well-known cancer hospital where patients were dying of cancer. In life’s final stages, it was not uncommon for physicians to increase the dose of morphine; it alleviated pain, eased labored breathing, and yes, probably hastened the inevitable for patients who were in their final hours. In these scenarios, no one considered this euthanasia, and no one questioned whether it was the right thing to do.

Dr. Dinah Miller

Fast-forward to 2023 when the act of a physician hastening a patient’s death has become a controversial topic as criteria have expanded. Like all such topics in our polarized society, people aligned on sides, politics and religion rush to the head of the room, legislation is proposed, and words take on new meanings. If you’re in favor of legalization of clinician assistance in a patient’s death, the term is “medical assistance in dying”. If you’re opposed, the term is the more graphic physician-assisted suicide.

The scenario is entirely different from what I saw in my medical school rotations decades ago. It’s no longer an issue of easing the pain and discomfort of patients’ final hours; the question now is whether, faced with a potentially terminal or progressively debilitating physical illness, a patient has the right to determine when, and how, their life will end, and the medical profession is given a role in this.

In many places the bar has been further lowered to incorporate nonterminal conditions, and Belgium and the Netherlands now allow physician-facilitated suicide for psychiatric conditions, a practice that many find reprehensible. In these countries, patients may be provided with medications to ingest, but psychiatrists also administer lethal injections.

While Belgium and the Netherlands were the first countries to legalize physician-facilitated death, it could be argued that Canada has embraced it with the most gusto; physician-assisted suicide has been legal there since 2016.

Canada already has the largest number of physician-assisted deaths of any nation, with 10,064 in 2021 – an increase of 32% from 2020. The Canadian federal government is currently considering adding serious mental illness as an eligible category. If this law passes, the country will have the most liberal assisted-death policy in the world. The Canadian government planned to make serious mental illness an eligible category in March 2023, but in an eleventh-hour announcement, it deferred its decision until March 2024.

In a press release, the government said that the 1-year extension would “provide additional time to prepare for the safe and consistent assessment and provision of MAID in all cases, including where the person’s sole underlying medical condition is a mental illness. It will also allow time for the Government of Canada to fully consider the final report of the Special Joint Committee on MAID, tabled in Parliament on Feb. 15, 2023.”

As a psychiatrist who treats patients with treatment-refractory conditions, I have watched people undergo trial after trial of medications while having psychotherapy, and sometimes transcranial magnetic stimulation or electroconvulsive therapy (ECT). The thing that is sustaining for patients is the hope that they will get better and go on to find meaning and purpose in life, even if it is not in the form they once envisioned.

To offer the option of a death facilitated by the very person who is trying to get them better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide.

Where is the line, one wonders, when the patient has not responded to two medications or 12? Must they have ECT before we consider helping them end their lives? Do we try for 6 months or 6 years? What about new research pointing to better medications or psychedelics that are not yet available? According to Canada’s proposed legislation, the patient must be aware that treatment options exist, including facilitated suicide.

Physician-assisted suicide for psychiatric conditions creates a conundrum for psychiatrists. As mental health professionals, we work to prevent suicide and view it as an act that is frequently fueled by depression. Those who are determined to die by their own hand often do. Depression distorts cognition and leads many patients to believe that they would be better off dead and that their loved ones would be better off without them.

These cognitive distortions are part of their illness. So, how do we, as psychiatrists, move from a stance of preventing suicide – using measures such as involuntary treatment when necessary – to being the people who offer and facilitate death for our patients? I’ll leave this for my Canadian colleagues to contemplate, as I live in a state where assisted suicide for any condition remains illegal.

As Canada moves toward facilitating death for serious mental illness, we have to wonder whether racial or socioeconomic factors will play a role. Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death? And how do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?

As psychiatrists, we often struggle to help our patients overcome the stigma associated with treatments for mental illness. Still, patients often refuse potentially helpful treatments because they worry about the consequences of getting care. These include career repercussions and the disapproval of others. When this legislation is finally passed, will our Canadian colleagues offer it as an option when their patient refuses lithium or antipsychotics, inpatient care, or ECT?

Susan Kalish, MD, is a geriatric and palliative care physician in Boston who favors the availability of facilitated death. She practices in a state where this option is not available.

She told me that she is “in favor of expanding acceptance of, and access to, medical aid in dying for patients who choose to exercise autonomy over their dying process, for those who remain with irremediable suffering, despite provision of optimal palliative care.” However, she added, some countries have lowered the threshold “way too far.”

She noted, “It is complicated and harmful to the general issue of medical aid in dying.”

As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it? Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out? If we, as psychiatrists, aren’t the emissaries of hope, who exactly are we?

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

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

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I remember what it was like to be a medical student at a well-known cancer hospital where patients were dying of cancer. In life’s final stages, it was not uncommon for physicians to increase the dose of morphine; it alleviated pain, eased labored breathing, and yes, probably hastened the inevitable for patients who were in their final hours. In these scenarios, no one considered this euthanasia, and no one questioned whether it was the right thing to do.

Dr. Dinah Miller

Fast-forward to 2023 when the act of a physician hastening a patient’s death has become a controversial topic as criteria have expanded. Like all such topics in our polarized society, people aligned on sides, politics and religion rush to the head of the room, legislation is proposed, and words take on new meanings. If you’re in favor of legalization of clinician assistance in a patient’s death, the term is “medical assistance in dying”. If you’re opposed, the term is the more graphic physician-assisted suicide.

The scenario is entirely different from what I saw in my medical school rotations decades ago. It’s no longer an issue of easing the pain and discomfort of patients’ final hours; the question now is whether, faced with a potentially terminal or progressively debilitating physical illness, a patient has the right to determine when, and how, their life will end, and the medical profession is given a role in this.

In many places the bar has been further lowered to incorporate nonterminal conditions, and Belgium and the Netherlands now allow physician-facilitated suicide for psychiatric conditions, a practice that many find reprehensible. In these countries, patients may be provided with medications to ingest, but psychiatrists also administer lethal injections.

While Belgium and the Netherlands were the first countries to legalize physician-facilitated death, it could be argued that Canada has embraced it with the most gusto; physician-assisted suicide has been legal there since 2016.

Canada already has the largest number of physician-assisted deaths of any nation, with 10,064 in 2021 – an increase of 32% from 2020. The Canadian federal government is currently considering adding serious mental illness as an eligible category. If this law passes, the country will have the most liberal assisted-death policy in the world. The Canadian government planned to make serious mental illness an eligible category in March 2023, but in an eleventh-hour announcement, it deferred its decision until March 2024.

In a press release, the government said that the 1-year extension would “provide additional time to prepare for the safe and consistent assessment and provision of MAID in all cases, including where the person’s sole underlying medical condition is a mental illness. It will also allow time for the Government of Canada to fully consider the final report of the Special Joint Committee on MAID, tabled in Parliament on Feb. 15, 2023.”

As a psychiatrist who treats patients with treatment-refractory conditions, I have watched people undergo trial after trial of medications while having psychotherapy, and sometimes transcranial magnetic stimulation or electroconvulsive therapy (ECT). The thing that is sustaining for patients is the hope that they will get better and go on to find meaning and purpose in life, even if it is not in the form they once envisioned.

To offer the option of a death facilitated by the very person who is trying to get them better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide.

Where is the line, one wonders, when the patient has not responded to two medications or 12? Must they have ECT before we consider helping them end their lives? Do we try for 6 months or 6 years? What about new research pointing to better medications or psychedelics that are not yet available? According to Canada’s proposed legislation, the patient must be aware that treatment options exist, including facilitated suicide.

Physician-assisted suicide for psychiatric conditions creates a conundrum for psychiatrists. As mental health professionals, we work to prevent suicide and view it as an act that is frequently fueled by depression. Those who are determined to die by their own hand often do. Depression distorts cognition and leads many patients to believe that they would be better off dead and that their loved ones would be better off without them.

These cognitive distortions are part of their illness. So, how do we, as psychiatrists, move from a stance of preventing suicide – using measures such as involuntary treatment when necessary – to being the people who offer and facilitate death for our patients? I’ll leave this for my Canadian colleagues to contemplate, as I live in a state where assisted suicide for any condition remains illegal.

As Canada moves toward facilitating death for serious mental illness, we have to wonder whether racial or socioeconomic factors will play a role. Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death? And how do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?

As psychiatrists, we often struggle to help our patients overcome the stigma associated with treatments for mental illness. Still, patients often refuse potentially helpful treatments because they worry about the consequences of getting care. These include career repercussions and the disapproval of others. When this legislation is finally passed, will our Canadian colleagues offer it as an option when their patient refuses lithium or antipsychotics, inpatient care, or ECT?

Susan Kalish, MD, is a geriatric and palliative care physician in Boston who favors the availability of facilitated death. She practices in a state where this option is not available.

She told me that she is “in favor of expanding acceptance of, and access to, medical aid in dying for patients who choose to exercise autonomy over their dying process, for those who remain with irremediable suffering, despite provision of optimal palliative care.” However, she added, some countries have lowered the threshold “way too far.”

She noted, “It is complicated and harmful to the general issue of medical aid in dying.”

As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it? Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out? If we, as psychiatrists, aren’t the emissaries of hope, who exactly are we?

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

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

I remember what it was like to be a medical student at a well-known cancer hospital where patients were dying of cancer. In life’s final stages, it was not uncommon for physicians to increase the dose of morphine; it alleviated pain, eased labored breathing, and yes, probably hastened the inevitable for patients who were in their final hours. In these scenarios, no one considered this euthanasia, and no one questioned whether it was the right thing to do.

Dr. Dinah Miller

Fast-forward to 2023 when the act of a physician hastening a patient’s death has become a controversial topic as criteria have expanded. Like all such topics in our polarized society, people aligned on sides, politics and religion rush to the head of the room, legislation is proposed, and words take on new meanings. If you’re in favor of legalization of clinician assistance in a patient’s death, the term is “medical assistance in dying”. If you’re opposed, the term is the more graphic physician-assisted suicide.

The scenario is entirely different from what I saw in my medical school rotations decades ago. It’s no longer an issue of easing the pain and discomfort of patients’ final hours; the question now is whether, faced with a potentially terminal or progressively debilitating physical illness, a patient has the right to determine when, and how, their life will end, and the medical profession is given a role in this.

In many places the bar has been further lowered to incorporate nonterminal conditions, and Belgium and the Netherlands now allow physician-facilitated suicide for psychiatric conditions, a practice that many find reprehensible. In these countries, patients may be provided with medications to ingest, but psychiatrists also administer lethal injections.

While Belgium and the Netherlands were the first countries to legalize physician-facilitated death, it could be argued that Canada has embraced it with the most gusto; physician-assisted suicide has been legal there since 2016.

Canada already has the largest number of physician-assisted deaths of any nation, with 10,064 in 2021 – an increase of 32% from 2020. The Canadian federal government is currently considering adding serious mental illness as an eligible category. If this law passes, the country will have the most liberal assisted-death policy in the world. The Canadian government planned to make serious mental illness an eligible category in March 2023, but in an eleventh-hour announcement, it deferred its decision until March 2024.

In a press release, the government said that the 1-year extension would “provide additional time to prepare for the safe and consistent assessment and provision of MAID in all cases, including where the person’s sole underlying medical condition is a mental illness. It will also allow time for the Government of Canada to fully consider the final report of the Special Joint Committee on MAID, tabled in Parliament on Feb. 15, 2023.”

As a psychiatrist who treats patients with treatment-refractory conditions, I have watched people undergo trial after trial of medications while having psychotherapy, and sometimes transcranial magnetic stimulation or electroconvulsive therapy (ECT). The thing that is sustaining for patients is the hope that they will get better and go on to find meaning and purpose in life, even if it is not in the form they once envisioned.

To offer the option of a death facilitated by the very person who is trying to get them better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide.

Where is the line, one wonders, when the patient has not responded to two medications or 12? Must they have ECT before we consider helping them end their lives? Do we try for 6 months or 6 years? What about new research pointing to better medications or psychedelics that are not yet available? According to Canada’s proposed legislation, the patient must be aware that treatment options exist, including facilitated suicide.

Physician-assisted suicide for psychiatric conditions creates a conundrum for psychiatrists. As mental health professionals, we work to prevent suicide and view it as an act that is frequently fueled by depression. Those who are determined to die by their own hand often do. Depression distorts cognition and leads many patients to believe that they would be better off dead and that their loved ones would be better off without them.

These cognitive distortions are part of their illness. So, how do we, as psychiatrists, move from a stance of preventing suicide – using measures such as involuntary treatment when necessary – to being the people who offer and facilitate death for our patients? I’ll leave this for my Canadian colleagues to contemplate, as I live in a state where assisted suicide for any condition remains illegal.

As Canada moves toward facilitating death for serious mental illness, we have to wonder whether racial or socioeconomic factors will play a role. Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death? And how do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?

As psychiatrists, we often struggle to help our patients overcome the stigma associated with treatments for mental illness. Still, patients often refuse potentially helpful treatments because they worry about the consequences of getting care. These include career repercussions and the disapproval of others. When this legislation is finally passed, will our Canadian colleagues offer it as an option when their patient refuses lithium or antipsychotics, inpatient care, or ECT?

Susan Kalish, MD, is a geriatric and palliative care physician in Boston who favors the availability of facilitated death. She practices in a state where this option is not available.

She told me that she is “in favor of expanding acceptance of, and access to, medical aid in dying for patients who choose to exercise autonomy over their dying process, for those who remain with irremediable suffering, despite provision of optimal palliative care.” However, she added, some countries have lowered the threshold “way too far.”

She noted, “It is complicated and harmful to the general issue of medical aid in dying.”

As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it? Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out? If we, as psychiatrists, aren’t the emissaries of hope, who exactly are we?

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

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

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Death anxiety in psychiatry and society: Facing our fears and embracing life

Article Type
Changed
Thu, 08/24/2023 - 17:10

Our fear of death is exposed often in medicine. It is not uncommon to hear the last moments of a patient’s life described as a series of futile, sterile medical interventions that attempt to prolong that life in quasi-sadistic fashion. So much effort is placed in making sure that “everything necessary” is tried that less emphasis is made on providing a comfortable death.

It seems obvious that a profession dedicated to prolonging health would have difficulty confronting death. But it should also be natural for psychiatry to be the specialty able to integrate this discomfort within the medical psyche.

Dr. Neha Akkoor
Dr. Neha Akkoor

Yet, in training, we have noted much more time spent on the assessment of capacity in patients in order to refuse medical intervention than on time spent educating about the importance to die at the right time, as suggested by Friedrich Nietzsche.1 A psychiatry resident may graduate knowing dozens of questions to assess the ability of a family member to consider the risk, benefits, and alternatives of continued intubation in a comatose patient, but may feel very ill-equipped in discussing the meaning of a rightful life and a rightful death.

Death anxiety can also come outside the context of not having endured enough traumas or successes in one’s life, or not having lived life right. As poignantly described by Dostoevsky in his 1864 novella, “Notes from the Underground,” death anxiety can manifest as a result of the deterministic nature of life.2 Doing everything which is expected of us can feel like a betrayal of our one chance to have lived life authentically. This concept is also particularly familiar to physicians, who may have – in part – chosen their career path in response to a recommendation from their parents, rather than a more authentic feeling. Dostoevsky goads us to transgress, to act in a rebellious way, to truly feel alive. This can serve as a solution for death anxiety – if you are scared to die then live, live your fullest. Even if that means doing the unexpected or changing your path.

The fear of being forgotten after death can also drive many to pursue a legacy. Even a parent choosing to have children and teaching them values and belief systems is a way of leaving behind a mark on the world. For some, finding ways for being remembered after death – whether through fame, fortune, or having children, is a way of dealing with death anxiety.

The Mexican holiday “Dia de los Muertos,” or Day of the Dead, and the Japanese holiday “Obon” are examples from cultures where deceased ancestors are celebrated through rituals and offerings. Such cultures may relieve the anxiety of death by suggesting that one’s descendants will still care for the departed, and their legacy may remain.
 

Coping with death anxiety

For others, the road to recovery from death anxiety may take a completely different approach. Some may find comfort in the position that, to extinguish death anxiety, one should not live to the fullest but accept the tragic and mostly inconsequential aspects of life. The philosophical movement of “absurdism” addresses this perspective.

Dr. Nicolas Badre

In our modern world, where we are so deeply attached to finding the cause and reason for things, absurdism reminds us that most of our lives and world do not have to make sense. While Albert Camus, arguably the most famous of the absurdist philosophers, encourages us to create meaning and transcend the tragedy and randomness of life,3 some patients can also find comfort in the idea that life is absurd, and thus one should not judge one’s own life and not fear own’s inevitable death.

Death anxiety can also be therapeutic. Especially in the existential tradition, one can enlist the fear of death for motivation. Many patients come to see us with a lack of motivation or drive. They feel paralyzed by their predicament and mental illness. As in the experiments of Martin Seligman, PhD, who shocked animals at random, a human exposed to repeated failure and abuse can get a sense of learned helplessness.4 Such patients can be very hard to reach, yet ultimately their despondence is no match for the reality that life will end. Reminding a patient that any day spent not feeling alive might as well be a metaphor for death is a challenging interpretation, but one that can lead to significant growth.

When considering the fear of death, psychiatry has generally taken the position that it is pathological, a form of anxiety. Psychiatry argues that one should strive to find fulfillment and joy in life. It thus may be a surprise to find that this is not a universally shared perspective.

In his 2010 book, author Thomas Ligotti argues on behalf of pessimistic and antinatalist views.5 Throughout the book he emphasizes the suffering that life can offer and argues against the endless pursuit of more life. To some psychiatrists, such arguments will be understood as insulting to our profession. Some may even interpret his texts as an argument in favor of ending one’s life.

However, psychiatrists must ask themselves “what are my answers to those arguments?” Mr. Ligotti’s book is a series of arguments against the idea that life will be pleasurable. Understanding those arguments and formulating a rebuttal would be an important process for any mental health provider. It is foolish to think that our patients do not have a rich and complicated relationship to death, and that none of our patients find death attractive in some ways. After all, accepting our fears as an important part of our body is a natural coping skill, which can also be taught.6

Part of the difficulty in discussing death and the fear of death may come from society’s resistance at having complicated conversations. It is not uncommon, currently, to include trigger warnings at the mention of discussions about death, even abstract ones. While we appreciate and encourage the articulation of feelings that a discussion about death may raise, we worry that such trigger warnings may be a form of censure that only makes society more resistant to talk about those important topics.

For another example of the avoidance of discussions about death, recall the “death panel” debates of 2009.7 When the U.S. government considered encouraging physicians to have discussions with their patients about end-of-life care, politicians and pundits decried that such discussions were “death panels,” and claimed they were an encouragement to patients to “cut [their] life short.” Such public projection of one’s anxiety about death has made it particularly difficult for psychiatry to make meaningful progress.
 

 

 

Acknowledging and addressing the fear

Death anxiety is such a common aspect of human life that most religions make some effort to address this fear. Many do so by offering a form of afterlife, often one described in idyllic fashion without anxiety.

Heaven, if one believes in it, is appealing for the person dreading death anxiety. Heaven is often described as being offered to those who have lived a rightful life, thus relieving the anxiety regarding the decisions one has made. Reincarnation can also be interpreted as another way of calming death anxiety, by promising a continual repetition of chances at getting life right. However, for many patients, religion doesn’t have the appeal that it once had.

Ultimately, the fear of death is a complex and multifaceted issue that can manifest in various ways. The medical profession, especially psychiatry, has a responsibility to address this fear in patients, but it also struggles with its own discomfort with the topic. The importance of providing a comfortable death is often overshadowed by the emphasis on prolonging life, which may manifest as a series of futile medical interventions.

The fear of death can be therapeutic and motivating, but it can also be pathological and lead to a lack of motivation or drive. The philosophical movements of absurdism and antinatalism offer alternative perspectives on death and life, and it is important for mental health providers to understand and engage with these views.

Society’s resistance to having a meaningful conversation about death only perpetuates the fear and makes progress difficult. Yet acknowledging and addressing the fear of death is an important aspect of mental health care and a crucial part of the human experience.

Dr. Akkoor is a psychiatry resident at the University of California, San Diego. She is interested in immigrant mental health, ethics, consultation-liaison psychiatry, and medical education. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Badre and Dr. Akkoor have no conflicts of interest.

References

1. Nietzsche F. Thus Spoke Zarathustra. 1883-1892.

2. Dostoevsky F. Notes from the Underground. 1864.

3. Camus A. The Plague. 1947.

4. Seligman M. Helplessness: On depression, development, and death. 1975.

5. Ligotti T. The Conspiracy Against the Human Race. 2010.

6. Hayes SC. Behav Ther. 2016 Nov;47(6):869-85. doi: 10.1016/j.beth.2016.11.006.

7. Nyhan B. The Forum. 2010 April 27;8(1). doi: 10.2202/1540-8884.1354.

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Our fear of death is exposed often in medicine. It is not uncommon to hear the last moments of a patient’s life described as a series of futile, sterile medical interventions that attempt to prolong that life in quasi-sadistic fashion. So much effort is placed in making sure that “everything necessary” is tried that less emphasis is made on providing a comfortable death.

It seems obvious that a profession dedicated to prolonging health would have difficulty confronting death. But it should also be natural for psychiatry to be the specialty able to integrate this discomfort within the medical psyche.

Dr. Neha Akkoor
Dr. Neha Akkoor

Yet, in training, we have noted much more time spent on the assessment of capacity in patients in order to refuse medical intervention than on time spent educating about the importance to die at the right time, as suggested by Friedrich Nietzsche.1 A psychiatry resident may graduate knowing dozens of questions to assess the ability of a family member to consider the risk, benefits, and alternatives of continued intubation in a comatose patient, but may feel very ill-equipped in discussing the meaning of a rightful life and a rightful death.

Death anxiety can also come outside the context of not having endured enough traumas or successes in one’s life, or not having lived life right. As poignantly described by Dostoevsky in his 1864 novella, “Notes from the Underground,” death anxiety can manifest as a result of the deterministic nature of life.2 Doing everything which is expected of us can feel like a betrayal of our one chance to have lived life authentically. This concept is also particularly familiar to physicians, who may have – in part – chosen their career path in response to a recommendation from their parents, rather than a more authentic feeling. Dostoevsky goads us to transgress, to act in a rebellious way, to truly feel alive. This can serve as a solution for death anxiety – if you are scared to die then live, live your fullest. Even if that means doing the unexpected or changing your path.

The fear of being forgotten after death can also drive many to pursue a legacy. Even a parent choosing to have children and teaching them values and belief systems is a way of leaving behind a mark on the world. For some, finding ways for being remembered after death – whether through fame, fortune, or having children, is a way of dealing with death anxiety.

The Mexican holiday “Dia de los Muertos,” or Day of the Dead, and the Japanese holiday “Obon” are examples from cultures where deceased ancestors are celebrated through rituals and offerings. Such cultures may relieve the anxiety of death by suggesting that one’s descendants will still care for the departed, and their legacy may remain.
 

Coping with death anxiety

For others, the road to recovery from death anxiety may take a completely different approach. Some may find comfort in the position that, to extinguish death anxiety, one should not live to the fullest but accept the tragic and mostly inconsequential aspects of life. The philosophical movement of “absurdism” addresses this perspective.

Dr. Nicolas Badre

In our modern world, where we are so deeply attached to finding the cause and reason for things, absurdism reminds us that most of our lives and world do not have to make sense. While Albert Camus, arguably the most famous of the absurdist philosophers, encourages us to create meaning and transcend the tragedy and randomness of life,3 some patients can also find comfort in the idea that life is absurd, and thus one should not judge one’s own life and not fear own’s inevitable death.

Death anxiety can also be therapeutic. Especially in the existential tradition, one can enlist the fear of death for motivation. Many patients come to see us with a lack of motivation or drive. They feel paralyzed by their predicament and mental illness. As in the experiments of Martin Seligman, PhD, who shocked animals at random, a human exposed to repeated failure and abuse can get a sense of learned helplessness.4 Such patients can be very hard to reach, yet ultimately their despondence is no match for the reality that life will end. Reminding a patient that any day spent not feeling alive might as well be a metaphor for death is a challenging interpretation, but one that can lead to significant growth.

When considering the fear of death, psychiatry has generally taken the position that it is pathological, a form of anxiety. Psychiatry argues that one should strive to find fulfillment and joy in life. It thus may be a surprise to find that this is not a universally shared perspective.

In his 2010 book, author Thomas Ligotti argues on behalf of pessimistic and antinatalist views.5 Throughout the book he emphasizes the suffering that life can offer and argues against the endless pursuit of more life. To some psychiatrists, such arguments will be understood as insulting to our profession. Some may even interpret his texts as an argument in favor of ending one’s life.

However, psychiatrists must ask themselves “what are my answers to those arguments?” Mr. Ligotti’s book is a series of arguments against the idea that life will be pleasurable. Understanding those arguments and formulating a rebuttal would be an important process for any mental health provider. It is foolish to think that our patients do not have a rich and complicated relationship to death, and that none of our patients find death attractive in some ways. After all, accepting our fears as an important part of our body is a natural coping skill, which can also be taught.6

Part of the difficulty in discussing death and the fear of death may come from society’s resistance at having complicated conversations. It is not uncommon, currently, to include trigger warnings at the mention of discussions about death, even abstract ones. While we appreciate and encourage the articulation of feelings that a discussion about death may raise, we worry that such trigger warnings may be a form of censure that only makes society more resistant to talk about those important topics.

For another example of the avoidance of discussions about death, recall the “death panel” debates of 2009.7 When the U.S. government considered encouraging physicians to have discussions with their patients about end-of-life care, politicians and pundits decried that such discussions were “death panels,” and claimed they were an encouragement to patients to “cut [their] life short.” Such public projection of one’s anxiety about death has made it particularly difficult for psychiatry to make meaningful progress.
 

 

 

Acknowledging and addressing the fear

Death anxiety is such a common aspect of human life that most religions make some effort to address this fear. Many do so by offering a form of afterlife, often one described in idyllic fashion without anxiety.

Heaven, if one believes in it, is appealing for the person dreading death anxiety. Heaven is often described as being offered to those who have lived a rightful life, thus relieving the anxiety regarding the decisions one has made. Reincarnation can also be interpreted as another way of calming death anxiety, by promising a continual repetition of chances at getting life right. However, for many patients, religion doesn’t have the appeal that it once had.

Ultimately, the fear of death is a complex and multifaceted issue that can manifest in various ways. The medical profession, especially psychiatry, has a responsibility to address this fear in patients, but it also struggles with its own discomfort with the topic. The importance of providing a comfortable death is often overshadowed by the emphasis on prolonging life, which may manifest as a series of futile medical interventions.

The fear of death can be therapeutic and motivating, but it can also be pathological and lead to a lack of motivation or drive. The philosophical movements of absurdism and antinatalism offer alternative perspectives on death and life, and it is important for mental health providers to understand and engage with these views.

Society’s resistance to having a meaningful conversation about death only perpetuates the fear and makes progress difficult. Yet acknowledging and addressing the fear of death is an important aspect of mental health care and a crucial part of the human experience.

Dr. Akkoor is a psychiatry resident at the University of California, San Diego. She is interested in immigrant mental health, ethics, consultation-liaison psychiatry, and medical education. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Badre and Dr. Akkoor have no conflicts of interest.

References

1. Nietzsche F. Thus Spoke Zarathustra. 1883-1892.

2. Dostoevsky F. Notes from the Underground. 1864.

3. Camus A. The Plague. 1947.

4. Seligman M. Helplessness: On depression, development, and death. 1975.

5. Ligotti T. The Conspiracy Against the Human Race. 2010.

6. Hayes SC. Behav Ther. 2016 Nov;47(6):869-85. doi: 10.1016/j.beth.2016.11.006.

7. Nyhan B. The Forum. 2010 April 27;8(1). doi: 10.2202/1540-8884.1354.

Our fear of death is exposed often in medicine. It is not uncommon to hear the last moments of a patient’s life described as a series of futile, sterile medical interventions that attempt to prolong that life in quasi-sadistic fashion. So much effort is placed in making sure that “everything necessary” is tried that less emphasis is made on providing a comfortable death.

It seems obvious that a profession dedicated to prolonging health would have difficulty confronting death. But it should also be natural for psychiatry to be the specialty able to integrate this discomfort within the medical psyche.

Dr. Neha Akkoor
Dr. Neha Akkoor

Yet, in training, we have noted much more time spent on the assessment of capacity in patients in order to refuse medical intervention than on time spent educating about the importance to die at the right time, as suggested by Friedrich Nietzsche.1 A psychiatry resident may graduate knowing dozens of questions to assess the ability of a family member to consider the risk, benefits, and alternatives of continued intubation in a comatose patient, but may feel very ill-equipped in discussing the meaning of a rightful life and a rightful death.

Death anxiety can also come outside the context of not having endured enough traumas or successes in one’s life, or not having lived life right. As poignantly described by Dostoevsky in his 1864 novella, “Notes from the Underground,” death anxiety can manifest as a result of the deterministic nature of life.2 Doing everything which is expected of us can feel like a betrayal of our one chance to have lived life authentically. This concept is also particularly familiar to physicians, who may have – in part – chosen their career path in response to a recommendation from their parents, rather than a more authentic feeling. Dostoevsky goads us to transgress, to act in a rebellious way, to truly feel alive. This can serve as a solution for death anxiety – if you are scared to die then live, live your fullest. Even if that means doing the unexpected or changing your path.

The fear of being forgotten after death can also drive many to pursue a legacy. Even a parent choosing to have children and teaching them values and belief systems is a way of leaving behind a mark on the world. For some, finding ways for being remembered after death – whether through fame, fortune, or having children, is a way of dealing with death anxiety.

The Mexican holiday “Dia de los Muertos,” or Day of the Dead, and the Japanese holiday “Obon” are examples from cultures where deceased ancestors are celebrated through rituals and offerings. Such cultures may relieve the anxiety of death by suggesting that one’s descendants will still care for the departed, and their legacy may remain.
 

Coping with death anxiety

For others, the road to recovery from death anxiety may take a completely different approach. Some may find comfort in the position that, to extinguish death anxiety, one should not live to the fullest but accept the tragic and mostly inconsequential aspects of life. The philosophical movement of “absurdism” addresses this perspective.

Dr. Nicolas Badre

In our modern world, where we are so deeply attached to finding the cause and reason for things, absurdism reminds us that most of our lives and world do not have to make sense. While Albert Camus, arguably the most famous of the absurdist philosophers, encourages us to create meaning and transcend the tragedy and randomness of life,3 some patients can also find comfort in the idea that life is absurd, and thus one should not judge one’s own life and not fear own’s inevitable death.

Death anxiety can also be therapeutic. Especially in the existential tradition, one can enlist the fear of death for motivation. Many patients come to see us with a lack of motivation or drive. They feel paralyzed by their predicament and mental illness. As in the experiments of Martin Seligman, PhD, who shocked animals at random, a human exposed to repeated failure and abuse can get a sense of learned helplessness.4 Such patients can be very hard to reach, yet ultimately their despondence is no match for the reality that life will end. Reminding a patient that any day spent not feeling alive might as well be a metaphor for death is a challenging interpretation, but one that can lead to significant growth.

When considering the fear of death, psychiatry has generally taken the position that it is pathological, a form of anxiety. Psychiatry argues that one should strive to find fulfillment and joy in life. It thus may be a surprise to find that this is not a universally shared perspective.

In his 2010 book, author Thomas Ligotti argues on behalf of pessimistic and antinatalist views.5 Throughout the book he emphasizes the suffering that life can offer and argues against the endless pursuit of more life. To some psychiatrists, such arguments will be understood as insulting to our profession. Some may even interpret his texts as an argument in favor of ending one’s life.

However, psychiatrists must ask themselves “what are my answers to those arguments?” Mr. Ligotti’s book is a series of arguments against the idea that life will be pleasurable. Understanding those arguments and formulating a rebuttal would be an important process for any mental health provider. It is foolish to think that our patients do not have a rich and complicated relationship to death, and that none of our patients find death attractive in some ways. After all, accepting our fears as an important part of our body is a natural coping skill, which can also be taught.6

Part of the difficulty in discussing death and the fear of death may come from society’s resistance at having complicated conversations. It is not uncommon, currently, to include trigger warnings at the mention of discussions about death, even abstract ones. While we appreciate and encourage the articulation of feelings that a discussion about death may raise, we worry that such trigger warnings may be a form of censure that only makes society more resistant to talk about those important topics.

For another example of the avoidance of discussions about death, recall the “death panel” debates of 2009.7 When the U.S. government considered encouraging physicians to have discussions with their patients about end-of-life care, politicians and pundits decried that such discussions were “death panels,” and claimed they were an encouragement to patients to “cut [their] life short.” Such public projection of one’s anxiety about death has made it particularly difficult for psychiatry to make meaningful progress.
 

 

 

Acknowledging and addressing the fear

Death anxiety is such a common aspect of human life that most religions make some effort to address this fear. Many do so by offering a form of afterlife, often one described in idyllic fashion without anxiety.

Heaven, if one believes in it, is appealing for the person dreading death anxiety. Heaven is often described as being offered to those who have lived a rightful life, thus relieving the anxiety regarding the decisions one has made. Reincarnation can also be interpreted as another way of calming death anxiety, by promising a continual repetition of chances at getting life right. However, for many patients, religion doesn’t have the appeal that it once had.

Ultimately, the fear of death is a complex and multifaceted issue that can manifest in various ways. The medical profession, especially psychiatry, has a responsibility to address this fear in patients, but it also struggles with its own discomfort with the topic. The importance of providing a comfortable death is often overshadowed by the emphasis on prolonging life, which may manifest as a series of futile medical interventions.

The fear of death can be therapeutic and motivating, but it can also be pathological and lead to a lack of motivation or drive. The philosophical movements of absurdism and antinatalism offer alternative perspectives on death and life, and it is important for mental health providers to understand and engage with these views.

Society’s resistance to having a meaningful conversation about death only perpetuates the fear and makes progress difficult. Yet acknowledging and addressing the fear of death is an important aspect of mental health care and a crucial part of the human experience.

Dr. Akkoor is a psychiatry resident at the University of California, San Diego. She is interested in immigrant mental health, ethics, consultation-liaison psychiatry, and medical education. Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Badre and Dr. Akkoor have no conflicts of interest.

References

1. Nietzsche F. Thus Spoke Zarathustra. 1883-1892.

2. Dostoevsky F. Notes from the Underground. 1864.

3. Camus A. The Plague. 1947.

4. Seligman M. Helplessness: On depression, development, and death. 1975.

5. Ligotti T. The Conspiracy Against the Human Race. 2010.

6. Hayes SC. Behav Ther. 2016 Nov;47(6):869-85. doi: 10.1016/j.beth.2016.11.006.

7. Nyhan B. The Forum. 2010 April 27;8(1). doi: 10.2202/1540-8884.1354.

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Parsing the split-decision victory for biologics in COPD

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Fri, 07/07/2023 - 12:01

It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

 

 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

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It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

 

 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

It’s tough to keep up with the proliferation of monoclonal antibodies. Seems every day I’m confronted by a patient who’s using a new drug with a name ending in “mab.” That drug blocks a cellular receptor I haven’t heard of that’s involved in a cascade of interactions I haven’t thought about since medical school. The resulting disruption reduces disease burden, typically at great expense to the medical system, the patient, or both. We’ve truly entered the era of precision medicine. It’s not enough to understand disease; you also must know its heterogeneous expression so that you can prescribe the ‘mab that targets the biology responsible for variants in behavior. All diseases are, in fact, syndromes. This isn’t a bad thing, but it’s a challenge.

A series of ‘mabs have been approved for treating type 2 high (TH2) or eosinophilic asthma. We refer to this group of ‘mabs generically as biologics. The group includes omalizumab, mepolizumab, dupilumab, benralizumab, reslizumab, and tezepelumab. While mechanism of action varies slightly across drugs, the biologics all target a specific arm of the immune system. Efficacy is linearly related to serum eosinophil count and there’s little clinically or pharmacologically to distinguish one from another. Of course, no head-to-head comparisons of efficacy are available and there’s no financial incentive for them to be performed.
 

Latest research

A new randomized controlled trial (RCT) of dupilumab for chronic obstructive pulmonary disease (COPD) adds to the aforementioned biologic knowledge base. Turns out it works as long as the patients are carefully selected. Researchers enrolled GOLD D (or E depending on which iteration of the GOLD Statement you use) patients on triple inhaler therapy (inhaled corticosteroids [ICS]/long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) with two moderate exacerbations or one exacerbation requiring hospitalization in the past year. Blood eosinophil counts were > 300 cells/mcL and chronic bronchitis was present clinically. The primary and multiple secondary outcomes were improved with dupilumab.

This is welcome news. I’ve treated countless patients with severe COPD who have repeated exacerbations despite my efforts to prevent them. These patients are on ICS/LABA/LAMA and azithromycin or roflumilast, and occasionally both. While every COPD guideline known to man forbids using chronic oral corticosteroids (OCS), I’ve prescribed them repeatedly because the benefits to keeping a recalcitrant, exacerbating patient out of the hospital seem to outweigh OCS risks. It would be nice to have a better option. Although we were taught that they were immutably distinct in medical school, every first-year pulmonary fellow knows that asthma and COPD share more similarities than differences, so it makes sense that proven asthma therapies would work for some patients with COPD.

However, the dupilumab study must be placed in context. Past studies haven’t been as positive. In 2017, two separate RCTs found that mepolizumab reduced the annual rate of moderate to severe exacerbations (primary outcome) in one trial but not the other. Interpretation gets more complicated when broken down by intention to treat (ITT) vs. modified ITT and when secondary outcomes are considered. Sparing you those details, this trial does not instill confidence, leading the Food and Drug Administration to refuse approval for mepolizumab for COPD. A second RCT of benralizumab for COPD was published in 2019. Much less cognitive load was required to interpret this one; it was negative. FDA approval was not requested.

Looking through the trial designs for the three RCTs of biologics for COPD, I couldn’t find major differences that could explain the discordant results. Sample size and enrollment criteria were similar. As stated, I don’t believe that the biologic data in asthma allow for predicting efficacy in one eosinophilic patient vs. another and I assume the same would be true for COPD. All three trials found that eosinophils were eliminated, so responses were biologically equivalent.
 

 

 

Key takeaways

If trial design and pharmacology don’t account for the disparate outcomes, how do we explain them? More important, how do we translate these trials into clinical practice? I looked for a review or editorial by a scientist-clinician smarter than I so I could steal their ideas and express them as pedantic euphemisms here. I found it curious that I was unable to find one. A recent publication in the American Journal of Respiratory and Critical Care Medicine suggests that the answer lies within the complex lattice of eosinophil subtypes, but I’m unqualified to judge the veracity of this “phenotype within a phenotype” theory.

For now, there will be no biologics prescribed for COPD – at least not by me. More trials in COPD are being done. We should have results on tezepelumab, that great savior that may cover noneosinophilic asthma phenotypes, within the next few years. Until then, we’re stuck defying guidelines with the anachronistic use of OCS for the COPD patient who exacerbates through ICS/LABA/LAMA, roflumilast, and azithromycin.

Dr. Holley is professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported receiving income from CHEST College, Metapharm, and WebMD.

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

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Flying cars and subdermal labs

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Changed
Fri, 07/07/2023 - 11:15

A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A headline recently caught my eye about flying cars close to being a reality. Since this is pretty much the dream of everyone who grew up watching “The Jetsons,” I paused to read it.

Of course, it wasn’t quite what I hoped. Battery-powered short-range helicopter services to fly people to airports – to alleviate traffic congestion – have received Food and Drug Administration approval for testing.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

In other words, they are still years away, I’m not going to be at the controls, and I won’t be taking them to my office anytime soon. (Granted, it’s only 5 minutes from my house, but wouldn’t you rather fly?)

Maybe it’s hyperbole, maybe clickbait, maybe just an enthusiastic writer, or a little of each.

On a similar note, a recent article titled, “A tiny patch may someday do your patients’ lab work,” about patches with microneedles to measure interstitial fluid, got my attention.

It certainly sounds promising, and more reasonable than the Theranos scam. This has interesting potential as a way to track lab values without repeated needle sticks.

But “someday” is the key word here. The technology is promising. For some conditions it certainly has the potential to improve patient care without frequent lab trips and blood draws.

But the point is ... it ain’t here yet. At the end of the article it says it may be available for some things within 2 years, with more indications over the next decade.

I’m not knocking the technology. That’s great news. But I’m seeing patients today. If I can’t offer it to them now, it doesn’t matter to me.

Maybe I’m a skeptic, but I’ve seen too many initially promising treatments or tests go nowhere when they move into large-scale trials. A lot of things seem like great ideas that don’t work out.

I think the microneedle patch probably has a future for certain conditions, and when it gets here it will be great for those who need it. But that won’t be tomorrow, or even 2024.

But, as with someday flying to work, I’m not holding my breath for it, either.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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Oral GLP-1 agonists could be game changers for obesity

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Fri, 07/07/2023 - 07:37

The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

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The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

The advent of subcutaneously injectable glucagonlike peptide–1 (GLP-1) receptor agonists for the management of type 2 diabetes during 2005 was arguably one of the greatest therapeutic advances for the condition since metformin.

I was an early advocate of the class, given its potent glucose-lowering efficacy, secondary benefits of significant weight reduction, and a low risk for hypoglycemia (if not used alongside sulfonylureas or insulin).

During 2016, the first cardiovascular outcomes trial for a GLP-1 agonist, in the form of the LEADER study, was reported. These trials were mandated by the Food and Drug Administration in the aftermath of the rosiglitazone debacle in which the type 2 diabetes drug had its use restricted because of cardiovascular events attributed to it in a meta-analysis. These events weren’t seen in a subsequent trial, and the FDA’s restrictions were later lifted.

LEADER examined the once-daily GLP-1 agonist liraglutide and showed that, in addition to its glucose-lowering effects, liraglutide brought cardiovascular benefits to the table. Moreover, during 2019, the REWIND trial, the cardiovascular outcome trial for once-weekly subcutaneous dulaglutide, revealed the same cardiovascular benefits but also demonstrated a lower incidence of macroalbuminuria, albeit with no significant improvements in hard renal endpoints such as estimated glomerular filtration decline or rates of dialysis.

Despite these compelling benefits, the uptake of GLP-1 agonists has always been slower than that of other compelling agents such as the sodium-glucose cotransporter 2 inhibitors, mainly because the latter are oral drugs, while GLP-1 agonists were initially injectable medications. This difference has proven to be a barrier for patients and clinicians alike.

However, in 2019, oral semaglutide, in doses of 7 mg and 14 mg, was approved by the FDA as the first (and still only) commercially available oral GLP-1 agonist to improve glycemic control in adults with type 2 diabetes. This approval was hailed as a “game changer” at the time. The treatment had no proven cardiovascular benefits, only lack of cardiovascular harm in PIONEER 6. The SOUL cardiovascular outcome trial for oral semaglutide in doses of 7 mg and 14 mg is due to be completed during 2024. But semaglutide certainly had compelling glucose-lowering efficacy and secondary benefits of significant weight loss similar to those of its injectable counterparts.

Cardiovascular benefits of injectable semaglutide for type 2 diabetes were demonstrated in the SUSTAIN-6 trial in 2016, and the U.S. label for Ozempic was amended accordingly in 2020.

Again, I was an early adopter of oral semaglutide, and it has been great for my patients with type 2 diabetes to have the option of a noninjectable GLP-1 agonist. However, it is not without its drawbacks: Oral semaglutide must be taken on an empty stomach, at least 30 minutes before any other food, drink, or medication, and with no more than 120 mL water to maximize absorption and bioavailability.

I am of South Asian origin and have a strong family history of type 2 diabetes. If I develop type 2 diabetes in the future and require treatment escalation to a GLP-1 agonist, I will most likely opt for a weekly injectable, as it would best fit my lifestyle. But having choices of preparation has been a huge advantage in helping my patients best individualize their therapies.

I attended the recent American Diabetes Association congress in San Diego, which had two interesting oral GLP-1 agonist sessions on the program.

The first discussed the efficacy and safety of a new daily oral nonpeptide GLP-1 agonist, orforglipron, for weight reduction in adults with obesity. The phase 2 results were impressive, with clinically significant reductions in weight and cardiometabolic parameters, and a reassuring safety profile similar to that of the injectable GLP-1 agonists.

Notably, because orforglipron is a nonpeptide, it can be taken without any food, water, or medication restrictions. This indeed could turn out to be a real game changer by simplifying the complex administration of oral semaglutide, which no doubt has hampered compliance.

In fact, an Association of British Clinical Diabetologists real-world audit (also presented at the ADA Congress as a poster) of oral semaglutide use for type 2 diabetes found clinically significant hemoglobin A1c and weight reductions, but perhaps less than expected when compared with the clinical trial program, which could be a sign of poor adherence.

A phase 3 trial of orforglipron is underway (ATTAIN-2), exploring its efficacy and safety in adults with obesity or overweight and type 2 diabetes, but it is not due to be completed until 2027.

I also attended the session presenting the results of the OASIS 1 and PIONEER-PLUS trials of higher-dose oral semaglutide.

OASIS 1 explored the efficacy and safety of high-dose oral semaglutide, 50 mg once daily, for the treatment of adults with overweight or obesity without type 2 diabetes. The investigators found clinically significant reductions in body weight of around 15%-17% from baseline, compared with placebo. This result was similar to the weight loss observed in the STEP 1 trial of 2.4 mg weekly subcutaneous injectable semaglutide in adults with obesity (a much lower dose is needed when GLP-1 agonists are given as injectables because the oral forms are not very bioavailable). The side-effect profile was also similar.

PIONEER PLUS explored the efficacy and safety of high-dose oral semaglutide 25 mg and 50 mg in adults with inadequately controlled type 2 diabetes. Patients treated with 50 mg oral semaglutide had around a 2% reduction in A1c and an 8-kg (18-lb) reduction in weight from baseline. It is well known that people with obesity and type 2 diabetes lose less weight than those with obesity alone, so this result was impressive. Again, the safety profile was similar to that of the wider class, with predictably high levels of gastrointestinal side effects.

So, the future appears very bright for oral GLP-1 agonists. I hope that future developments bring the class to an even wider demographic and perhaps reduce some of the global inequities in managing type 2 diabetes and obesity. It should be easier (and cheaper) to mass-produce and distribute an oral medication, compared with an injectable one.

However, it should be noted that, in the United Kingdom, the National Health Service tariff cost of oral semaglutide (at usual doses for type 2 diabetes) remains similar to that of injectable semaglutide (at doses for type 2 diabetes rather than obesity). And notably, the U.K. National Institute for Health and Care Excellence, which decides whether new drugs will be funded on the NHS, has recently delayed its decision on approving tirzepatide, a dual GLP-1 and GIP agonist, for type 2 diabetes, citing the requirement for further evidence for its clinical and cost-effectiveness. This is not uncommon for NICE, and I fully expect tirzepatide to gain NICE approval on resubmission later in 2023.

One solution to contain costs might be a phased approach to the management of obesity, with initial stages using highly efficacious obesity drugs such as tirzepatide, injectable semaglutide, or high-dose oral semaglutide, and then transitioning to lower-efficacy and cheaper obesity drugs for weight maintenance.

On this note, a generic version of liraglutide (a once-daily injectable GLP-1 agonist) will be available during 2024. Moreover, it will be interesting to see the cost of orforglipron, assuming that it is approved, when it becomes commercially available in a few years, given that a nonpeptide agent should be cheaper to produce than a peptide-like semaglutide.

This phased approach is analogous to the treatment of rheumatoid arthritis, where potent targeted biologic therapy is often used early on to achieve remission of rheumatoid arthritis, followed by a switch to a conventional disease-modifying antirheumatic drug for maintenance therapy, for reasons of long-term safety and health economics.

Using this approach for obesity management might help the sustainability of health care systems.

Dr. Fernando is a general practitioner near Edinburgh. He reported receiving speaker fees from Eli Lilly and Novo Nordisk.

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

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Developing training pathways in advanced endoscopic resection and third-space endoscopy in the U.S.

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Thu, 07/06/2023 - 12:05

As a gastroenterology and hepatology fellow, choosing a career path was a daunting prospect. Despite the additional specialization, there seemed to be endless career options to consider. Did I want to join an academic, private, or hybrid practice? Should I subspecialize within the field? Was it important to incorporate research or teaching into my practice? What about opportunities to take on administrative or leadership roles?

Fellowship training at a large academic research institution provided me the opportunity to work with expert faculty in inflammatory bowel disease, esophageal disease, motility and functional gastrointestinal disease, pancreaticobiliary disease, and hepatology. I enjoyed seeing patients in each of these subspecialty clinics. But, by the end of my second year of GI fellowship, I still wasn’t sure what I wanted to do professionally.

Dr. Daniel A. Kroch

A career in academic general gastroenterology seemed to be a good fit for my personality and goals. Rather than focusing on research, I chose to position myself as a clinician educator. I knew that having a subspecialty area of expertise would help improve my clinical practice and make me a more attractive candidate to academic centers. To help narrow my choice, I looked at the clinical enterprise at our institution and assessed where the unmet clinical needs were most acute. Simultaneously, I identified potential mentors to support and guide me through the transition from fellow to independent practitioner. I decided to focus on acquiring the skills to care for patients with anorectal diseases and lower-GI motility disorders, as this area met both of my criteria – excellent mentorship and an unmet clinical need. Under the guidance of Dr. Yolanda Scarlett, I spent my 3rd year in clinic learning to interpret anorectal manometry tests, defecograms, and sitz marker studies and treating patients with refractory constipation, fecal incontinence, and anal fissures.

With a plan to develop an expertise in anorectal diseases and low-GI motility disorders, I also wanted to focus on improving my endoscopic skills to graduate as well rounded a clinician as possible. To achieve this goal, I sought out a separate endoscopy mentor, Dr. Ian Grimm, the director of endoscopy at the University of North Carolina at Chapel Hill. Dr. Grimm, a classically trained advanced endoscopist performing endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), had a burgeoning interest in endoscopic mucosal resection (EMR) and had just returned from a few months in Japan learning to perform endoscopic submucosal dissection (ESD) and peroral endoscopic myotomy (POEM).

When I began working with Dr. Grimm, I had not even heard the term third-space endoscopy and knew nothing about ESD or POEM. I spent as much time as possible watching and assisting Dr. Grimm with complex endoscopic mucosal resection (EMR) during the first few months of my 3rd year. Soon after my exposure to advanced endoscopic resection, it was clear that I wanted to learn and incorporate this into my clinical practice. I watched Dr. Grimm perform the first POEM at UNC in the fall of 2016 and by that time I was hooked on learning third-space endoscopy. I observed and assisted with as many EMR, ESD, and POEM cases as I could that year. In addition to the hands-on and cognitive training with Dr. Grimm, I attended national meetings and workshops focused on learning third-space endoscopy. In the spring of my 3rd year I was honored to be the first fellow to complete the Olympus master class in ESD – a 2-day hands-on training course sponsored by Olympus. By the end of that year, I was performing complex EMR with minimal assistance and had completed multiple ESDs and POEMs with cognitive supervision only.

 

 

After fellowship, I joined the UNC faculty as a general gastroenterologist with expertise in anorectal disease and lower-GI motility disorders. While I was comfortable performing complex EMR, I still needed additional training and supervision before I felt ready to independently perform ESD or POEM. With the gracious support and encouragement of our division chief, I continued third-space endoscopy training with Dr. Grimm during dedicated protected time 2 days each month. Over the ensuing 4 years, I transitioned to fully independent practice performing all types of advanced EMR and third-space endoscopy including complex EMR, ESD, endoscopic full-thickness resection (EFTR), submucosal tunnel endoscopic resection (STER), esophageal POEM, gastric POEM, and Zenker’s POEM.

As one of the first gastroenterologists in the United States to perform third-space endoscopy without any formal training in advanced pancreaticobiliary endoscopy, I believe learning advanced endoscopic resection and third-space endoscopy is best achieved through a training pathway separate from the conventional advanced endoscopy fellowship focused on teaching EUS and ERCP. Although there are transferable skills learned from EUS and ERCP to the techniques used in third-space endoscopy, there is nothing inherent to performing EUS or ERCP that enables one to learn how to perform an ESD or a POEM.

There is a robust training pathway to teach advanced pancreaticobiliary endoscopy, but no formal training pathway exists to teach third-space endoscopy in the United States. Historically, a small number of interested and motivated advanced pancreaticobiliary endoscopists sought out opportunities to learn third-space endoscopy after completion of their advanced endoscopy fellowship, in some cases many years after graduation. For these early adopters in the United States, the only training opportunities required travel to Japan or another Eastern country with arrangements made to observe and participate in third-space endoscopy cases with experts there. With increased recognition of the benefits of ESD and POEM over the past 5-10 years in the United States, there has been greater adoption of third-space endoscopy and with it, more training opportunities. Still, there are very few institutions with formalized training programs in advanced endoscopic resection and third-space endoscopy in the United States to date.
 

Proof that this model works

In Eastern countries such as Japan, training endoscopists to perform ESD and POEM has been successfully achieved through an apprenticeship model whereby an expert in third-space endoscopy closely supervises a trainee who gains greater autonomy with increasing experience and skill over time. My personal experience is proof that this model works. But, adopting such a model more widely in the United States may prove difficult. We lack a sufficient number of experienced third-space endoscopy operators and, given the challenges to appropriate reimbursement for third-space endoscopy in the United States, there is understandable resistance to accepting the prolonged training period necessary for technical mastery of this skill.

In part, a long training period is needed because of a relative paucity of appropriate target lesions for ESD and the rarity of achalasia in the United States. While there is consensus among experts regarding the benefits of ESD for resection of early gastric cancer (EGC), relatively few EGCs are found in the United States and indications for ESD outside resection of EGC are less well defined with less clear benefits over more widely performed piecemeal EMR. Despite these challenges, it is critical that we continue to develop dedicated training pathways to teach advanced endoscopic resection and third-space endoscopy in the United States. My practice has evolved considerably since completion of fellowship nearly 6 years ago, and I now focus almost exclusively on advanced endoscopic resection and third-space endoscopy. Recently, Dr. Grimm and I began an advanced endoscopic resection elective for the general GI fellows at UNC and we are excited to welcome our first advanced endoscopic resection and third-space endoscopy fellow to UNC this July.

While there are many possible avenues to expertise in advanced endoscopic resection, few will likely follow the same path that I have taken. Trainees who are interested in pursuing this subspecialty should seek out supportive mentors in a setting where there is already a robust case volume of esophageal motility disorders and endoscopic resections. Success requires the persistent motivation to seek out diverse opportunities for self-study, exposure to experts, data on developments in the field, and hands-on exposure to as many ex-vivo and in-vivo cases as possible.

Dr. Kroch is assistant professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. He disclosed having no conflicts of interest.

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As a gastroenterology and hepatology fellow, choosing a career path was a daunting prospect. Despite the additional specialization, there seemed to be endless career options to consider. Did I want to join an academic, private, or hybrid practice? Should I subspecialize within the field? Was it important to incorporate research or teaching into my practice? What about opportunities to take on administrative or leadership roles?

Fellowship training at a large academic research institution provided me the opportunity to work with expert faculty in inflammatory bowel disease, esophageal disease, motility and functional gastrointestinal disease, pancreaticobiliary disease, and hepatology. I enjoyed seeing patients in each of these subspecialty clinics. But, by the end of my second year of GI fellowship, I still wasn’t sure what I wanted to do professionally.

Dr. Daniel A. Kroch

A career in academic general gastroenterology seemed to be a good fit for my personality and goals. Rather than focusing on research, I chose to position myself as a clinician educator. I knew that having a subspecialty area of expertise would help improve my clinical practice and make me a more attractive candidate to academic centers. To help narrow my choice, I looked at the clinical enterprise at our institution and assessed where the unmet clinical needs were most acute. Simultaneously, I identified potential mentors to support and guide me through the transition from fellow to independent practitioner. I decided to focus on acquiring the skills to care for patients with anorectal diseases and lower-GI motility disorders, as this area met both of my criteria – excellent mentorship and an unmet clinical need. Under the guidance of Dr. Yolanda Scarlett, I spent my 3rd year in clinic learning to interpret anorectal manometry tests, defecograms, and sitz marker studies and treating patients with refractory constipation, fecal incontinence, and anal fissures.

With a plan to develop an expertise in anorectal diseases and low-GI motility disorders, I also wanted to focus on improving my endoscopic skills to graduate as well rounded a clinician as possible. To achieve this goal, I sought out a separate endoscopy mentor, Dr. Ian Grimm, the director of endoscopy at the University of North Carolina at Chapel Hill. Dr. Grimm, a classically trained advanced endoscopist performing endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), had a burgeoning interest in endoscopic mucosal resection (EMR) and had just returned from a few months in Japan learning to perform endoscopic submucosal dissection (ESD) and peroral endoscopic myotomy (POEM).

When I began working with Dr. Grimm, I had not even heard the term third-space endoscopy and knew nothing about ESD or POEM. I spent as much time as possible watching and assisting Dr. Grimm with complex endoscopic mucosal resection (EMR) during the first few months of my 3rd year. Soon after my exposure to advanced endoscopic resection, it was clear that I wanted to learn and incorporate this into my clinical practice. I watched Dr. Grimm perform the first POEM at UNC in the fall of 2016 and by that time I was hooked on learning third-space endoscopy. I observed and assisted with as many EMR, ESD, and POEM cases as I could that year. In addition to the hands-on and cognitive training with Dr. Grimm, I attended national meetings and workshops focused on learning third-space endoscopy. In the spring of my 3rd year I was honored to be the first fellow to complete the Olympus master class in ESD – a 2-day hands-on training course sponsored by Olympus. By the end of that year, I was performing complex EMR with minimal assistance and had completed multiple ESDs and POEMs with cognitive supervision only.

 

 

After fellowship, I joined the UNC faculty as a general gastroenterologist with expertise in anorectal disease and lower-GI motility disorders. While I was comfortable performing complex EMR, I still needed additional training and supervision before I felt ready to independently perform ESD or POEM. With the gracious support and encouragement of our division chief, I continued third-space endoscopy training with Dr. Grimm during dedicated protected time 2 days each month. Over the ensuing 4 years, I transitioned to fully independent practice performing all types of advanced EMR and third-space endoscopy including complex EMR, ESD, endoscopic full-thickness resection (EFTR), submucosal tunnel endoscopic resection (STER), esophageal POEM, gastric POEM, and Zenker’s POEM.

As one of the first gastroenterologists in the United States to perform third-space endoscopy without any formal training in advanced pancreaticobiliary endoscopy, I believe learning advanced endoscopic resection and third-space endoscopy is best achieved through a training pathway separate from the conventional advanced endoscopy fellowship focused on teaching EUS and ERCP. Although there are transferable skills learned from EUS and ERCP to the techniques used in third-space endoscopy, there is nothing inherent to performing EUS or ERCP that enables one to learn how to perform an ESD or a POEM.

There is a robust training pathway to teach advanced pancreaticobiliary endoscopy, but no formal training pathway exists to teach third-space endoscopy in the United States. Historically, a small number of interested and motivated advanced pancreaticobiliary endoscopists sought out opportunities to learn third-space endoscopy after completion of their advanced endoscopy fellowship, in some cases many years after graduation. For these early adopters in the United States, the only training opportunities required travel to Japan or another Eastern country with arrangements made to observe and participate in third-space endoscopy cases with experts there. With increased recognition of the benefits of ESD and POEM over the past 5-10 years in the United States, there has been greater adoption of third-space endoscopy and with it, more training opportunities. Still, there are very few institutions with formalized training programs in advanced endoscopic resection and third-space endoscopy in the United States to date.
 

Proof that this model works

In Eastern countries such as Japan, training endoscopists to perform ESD and POEM has been successfully achieved through an apprenticeship model whereby an expert in third-space endoscopy closely supervises a trainee who gains greater autonomy with increasing experience and skill over time. My personal experience is proof that this model works. But, adopting such a model more widely in the United States may prove difficult. We lack a sufficient number of experienced third-space endoscopy operators and, given the challenges to appropriate reimbursement for third-space endoscopy in the United States, there is understandable resistance to accepting the prolonged training period necessary for technical mastery of this skill.

In part, a long training period is needed because of a relative paucity of appropriate target lesions for ESD and the rarity of achalasia in the United States. While there is consensus among experts regarding the benefits of ESD for resection of early gastric cancer (EGC), relatively few EGCs are found in the United States and indications for ESD outside resection of EGC are less well defined with less clear benefits over more widely performed piecemeal EMR. Despite these challenges, it is critical that we continue to develop dedicated training pathways to teach advanced endoscopic resection and third-space endoscopy in the United States. My practice has evolved considerably since completion of fellowship nearly 6 years ago, and I now focus almost exclusively on advanced endoscopic resection and third-space endoscopy. Recently, Dr. Grimm and I began an advanced endoscopic resection elective for the general GI fellows at UNC and we are excited to welcome our first advanced endoscopic resection and third-space endoscopy fellow to UNC this July.

While there are many possible avenues to expertise in advanced endoscopic resection, few will likely follow the same path that I have taken. Trainees who are interested in pursuing this subspecialty should seek out supportive mentors in a setting where there is already a robust case volume of esophageal motility disorders and endoscopic resections. Success requires the persistent motivation to seek out diverse opportunities for self-study, exposure to experts, data on developments in the field, and hands-on exposure to as many ex-vivo and in-vivo cases as possible.

Dr. Kroch is assistant professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. He disclosed having no conflicts of interest.

As a gastroenterology and hepatology fellow, choosing a career path was a daunting prospect. Despite the additional specialization, there seemed to be endless career options to consider. Did I want to join an academic, private, or hybrid practice? Should I subspecialize within the field? Was it important to incorporate research or teaching into my practice? What about opportunities to take on administrative or leadership roles?

Fellowship training at a large academic research institution provided me the opportunity to work with expert faculty in inflammatory bowel disease, esophageal disease, motility and functional gastrointestinal disease, pancreaticobiliary disease, and hepatology. I enjoyed seeing patients in each of these subspecialty clinics. But, by the end of my second year of GI fellowship, I still wasn’t sure what I wanted to do professionally.

Dr. Daniel A. Kroch

A career in academic general gastroenterology seemed to be a good fit for my personality and goals. Rather than focusing on research, I chose to position myself as a clinician educator. I knew that having a subspecialty area of expertise would help improve my clinical practice and make me a more attractive candidate to academic centers. To help narrow my choice, I looked at the clinical enterprise at our institution and assessed where the unmet clinical needs were most acute. Simultaneously, I identified potential mentors to support and guide me through the transition from fellow to independent practitioner. I decided to focus on acquiring the skills to care for patients with anorectal diseases and lower-GI motility disorders, as this area met both of my criteria – excellent mentorship and an unmet clinical need. Under the guidance of Dr. Yolanda Scarlett, I spent my 3rd year in clinic learning to interpret anorectal manometry tests, defecograms, and sitz marker studies and treating patients with refractory constipation, fecal incontinence, and anal fissures.

With a plan to develop an expertise in anorectal diseases and low-GI motility disorders, I also wanted to focus on improving my endoscopic skills to graduate as well rounded a clinician as possible. To achieve this goal, I sought out a separate endoscopy mentor, Dr. Ian Grimm, the director of endoscopy at the University of North Carolina at Chapel Hill. Dr. Grimm, a classically trained advanced endoscopist performing endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), had a burgeoning interest in endoscopic mucosal resection (EMR) and had just returned from a few months in Japan learning to perform endoscopic submucosal dissection (ESD) and peroral endoscopic myotomy (POEM).

When I began working with Dr. Grimm, I had not even heard the term third-space endoscopy and knew nothing about ESD or POEM. I spent as much time as possible watching and assisting Dr. Grimm with complex endoscopic mucosal resection (EMR) during the first few months of my 3rd year. Soon after my exposure to advanced endoscopic resection, it was clear that I wanted to learn and incorporate this into my clinical practice. I watched Dr. Grimm perform the first POEM at UNC in the fall of 2016 and by that time I was hooked on learning third-space endoscopy. I observed and assisted with as many EMR, ESD, and POEM cases as I could that year. In addition to the hands-on and cognitive training with Dr. Grimm, I attended national meetings and workshops focused on learning third-space endoscopy. In the spring of my 3rd year I was honored to be the first fellow to complete the Olympus master class in ESD – a 2-day hands-on training course sponsored by Olympus. By the end of that year, I was performing complex EMR with minimal assistance and had completed multiple ESDs and POEMs with cognitive supervision only.

 

 

After fellowship, I joined the UNC faculty as a general gastroenterologist with expertise in anorectal disease and lower-GI motility disorders. While I was comfortable performing complex EMR, I still needed additional training and supervision before I felt ready to independently perform ESD or POEM. With the gracious support and encouragement of our division chief, I continued third-space endoscopy training with Dr. Grimm during dedicated protected time 2 days each month. Over the ensuing 4 years, I transitioned to fully independent practice performing all types of advanced EMR and third-space endoscopy including complex EMR, ESD, endoscopic full-thickness resection (EFTR), submucosal tunnel endoscopic resection (STER), esophageal POEM, gastric POEM, and Zenker’s POEM.

As one of the first gastroenterologists in the United States to perform third-space endoscopy without any formal training in advanced pancreaticobiliary endoscopy, I believe learning advanced endoscopic resection and third-space endoscopy is best achieved through a training pathway separate from the conventional advanced endoscopy fellowship focused on teaching EUS and ERCP. Although there are transferable skills learned from EUS and ERCP to the techniques used in third-space endoscopy, there is nothing inherent to performing EUS or ERCP that enables one to learn how to perform an ESD or a POEM.

There is a robust training pathway to teach advanced pancreaticobiliary endoscopy, but no formal training pathway exists to teach third-space endoscopy in the United States. Historically, a small number of interested and motivated advanced pancreaticobiliary endoscopists sought out opportunities to learn third-space endoscopy after completion of their advanced endoscopy fellowship, in some cases many years after graduation. For these early adopters in the United States, the only training opportunities required travel to Japan or another Eastern country with arrangements made to observe and participate in third-space endoscopy cases with experts there. With increased recognition of the benefits of ESD and POEM over the past 5-10 years in the United States, there has been greater adoption of third-space endoscopy and with it, more training opportunities. Still, there are very few institutions with formalized training programs in advanced endoscopic resection and third-space endoscopy in the United States to date.
 

Proof that this model works

In Eastern countries such as Japan, training endoscopists to perform ESD and POEM has been successfully achieved through an apprenticeship model whereby an expert in third-space endoscopy closely supervises a trainee who gains greater autonomy with increasing experience and skill over time. My personal experience is proof that this model works. But, adopting such a model more widely in the United States may prove difficult. We lack a sufficient number of experienced third-space endoscopy operators and, given the challenges to appropriate reimbursement for third-space endoscopy in the United States, there is understandable resistance to accepting the prolonged training period necessary for technical mastery of this skill.

In part, a long training period is needed because of a relative paucity of appropriate target lesions for ESD and the rarity of achalasia in the United States. While there is consensus among experts regarding the benefits of ESD for resection of early gastric cancer (EGC), relatively few EGCs are found in the United States and indications for ESD outside resection of EGC are less well defined with less clear benefits over more widely performed piecemeal EMR. Despite these challenges, it is critical that we continue to develop dedicated training pathways to teach advanced endoscopic resection and third-space endoscopy in the United States. My practice has evolved considerably since completion of fellowship nearly 6 years ago, and I now focus almost exclusively on advanced endoscopic resection and third-space endoscopy. Recently, Dr. Grimm and I began an advanced endoscopic resection elective for the general GI fellows at UNC and we are excited to welcome our first advanced endoscopic resection and third-space endoscopy fellow to UNC this July.

While there are many possible avenues to expertise in advanced endoscopic resection, few will likely follow the same path that I have taken. Trainees who are interested in pursuing this subspecialty should seek out supportive mentors in a setting where there is already a robust case volume of esophageal motility disorders and endoscopic resections. Success requires the persistent motivation to seek out diverse opportunities for self-study, exposure to experts, data on developments in the field, and hands-on exposure to as many ex-vivo and in-vivo cases as possible.

Dr. Kroch is assistant professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill. He disclosed having no conflicts of interest.

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Thoughts on primary care in 2023

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As we all face remarkable challenges in giving great care to our patients and maintaining great care for ourselves, I wanted to share a few thoughts I have had regarding difficult things I have seen in the past few months.

  • Call centers: Yikes! I think this is an overlooked stress on the primary care system. In a cost-cutting effort, organizations have gone to call centers to handle incoming calls, and hold times can be enormous. My own organization often has wait times longer than 30 minutes. I recently called another organization and had a wait time more than 30 minutes. Patients become frustrated and will message their primary care team to intervene for scheduling issues then will arrive at their appointments frustrated by all the hassles.
  • Difficult encounters: We all have visits that we know will be challenging. I think it is even more difficult when we enter the visit stressed and tired. I have always found that, when I am in a calm place, even the most difficult visits go much better. Our patients arrive at clinic visits more stressed and tired too, as they face the challenge of a stretched and overwhelmed primary care system.
  • Limited availability of specialists: My organization has had a sharp increase in wait times for specialty care over the past few years. Waits for some specialties can be almost a year. A study by Reddy and colleagues found a wait time of 3 months for patients referred to gastroenterologists.1 The lack of timely access to specialists adds to the stress and burden of primary care professionals. Managing problems deemed in need of subspecialty care as patients wait for appointments is difficult.
  • Patient portals: Some practices are starting to figure this out this problem, others aren’t. Budd reviewed all the factors with the EHR that contribute to physician burnout.2 Portals have added another source of patient care outside face-to-face visits that adds to physician work load; for many practices is not appropriately accounted for in effort or productivity measures. Some practices are now starting to charge for patient messaging, but this may require even more physician time in documentation and billing. Unless this directly helps the physician reduce work hours or improve compensation, then it may make the problem worse.

There is little mystery why it seems so hard ... it is! Many things have been added to the plate of primary care professionals (increased messaging, calming patients frustrated with the medical system, and increased need for bridging care while patients wait for specialty appointments). Our patients need us now more than ever to give excellent, compassionate care in a poorly functioning system. We need to be emotionally and physically healthy enough to be there for our patients. Prioritize your own needs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Reddy K et al. Health Equity. 2018 Jun 1;2(1):103-8.

2. Budd J. J Prim Care Community Health. 2023 Apr 19.

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As we all face remarkable challenges in giving great care to our patients and maintaining great care for ourselves, I wanted to share a few thoughts I have had regarding difficult things I have seen in the past few months.

  • Call centers: Yikes! I think this is an overlooked stress on the primary care system. In a cost-cutting effort, organizations have gone to call centers to handle incoming calls, and hold times can be enormous. My own organization often has wait times longer than 30 minutes. I recently called another organization and had a wait time more than 30 minutes. Patients become frustrated and will message their primary care team to intervene for scheduling issues then will arrive at their appointments frustrated by all the hassles.
  • Difficult encounters: We all have visits that we know will be challenging. I think it is even more difficult when we enter the visit stressed and tired. I have always found that, when I am in a calm place, even the most difficult visits go much better. Our patients arrive at clinic visits more stressed and tired too, as they face the challenge of a stretched and overwhelmed primary care system.
  • Limited availability of specialists: My organization has had a sharp increase in wait times for specialty care over the past few years. Waits for some specialties can be almost a year. A study by Reddy and colleagues found a wait time of 3 months for patients referred to gastroenterologists.1 The lack of timely access to specialists adds to the stress and burden of primary care professionals. Managing problems deemed in need of subspecialty care as patients wait for appointments is difficult.
  • Patient portals: Some practices are starting to figure this out this problem, others aren’t. Budd reviewed all the factors with the EHR that contribute to physician burnout.2 Portals have added another source of patient care outside face-to-face visits that adds to physician work load; for many practices is not appropriately accounted for in effort or productivity measures. Some practices are now starting to charge for patient messaging, but this may require even more physician time in documentation and billing. Unless this directly helps the physician reduce work hours or improve compensation, then it may make the problem worse.

There is little mystery why it seems so hard ... it is! Many things have been added to the plate of primary care professionals (increased messaging, calming patients frustrated with the medical system, and increased need for bridging care while patients wait for specialty appointments). Our patients need us now more than ever to give excellent, compassionate care in a poorly functioning system. We need to be emotionally and physically healthy enough to be there for our patients. Prioritize your own needs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Reddy K et al. Health Equity. 2018 Jun 1;2(1):103-8.

2. Budd J. J Prim Care Community Health. 2023 Apr 19.

As we all face remarkable challenges in giving great care to our patients and maintaining great care for ourselves, I wanted to share a few thoughts I have had regarding difficult things I have seen in the past few months.

  • Call centers: Yikes! I think this is an overlooked stress on the primary care system. In a cost-cutting effort, organizations have gone to call centers to handle incoming calls, and hold times can be enormous. My own organization often has wait times longer than 30 minutes. I recently called another organization and had a wait time more than 30 minutes. Patients become frustrated and will message their primary care team to intervene for scheduling issues then will arrive at their appointments frustrated by all the hassles.
  • Difficult encounters: We all have visits that we know will be challenging. I think it is even more difficult when we enter the visit stressed and tired. I have always found that, when I am in a calm place, even the most difficult visits go much better. Our patients arrive at clinic visits more stressed and tired too, as they face the challenge of a stretched and overwhelmed primary care system.
  • Limited availability of specialists: My organization has had a sharp increase in wait times for specialty care over the past few years. Waits for some specialties can be almost a year. A study by Reddy and colleagues found a wait time of 3 months for patients referred to gastroenterologists.1 The lack of timely access to specialists adds to the stress and burden of primary care professionals. Managing problems deemed in need of subspecialty care as patients wait for appointments is difficult.
  • Patient portals: Some practices are starting to figure this out this problem, others aren’t. Budd reviewed all the factors with the EHR that contribute to physician burnout.2 Portals have added another source of patient care outside face-to-face visits that adds to physician work load; for many practices is not appropriately accounted for in effort or productivity measures. Some practices are now starting to charge for patient messaging, but this may require even more physician time in documentation and billing. Unless this directly helps the physician reduce work hours or improve compensation, then it may make the problem worse.

There is little mystery why it seems so hard ... it is! Many things have been added to the plate of primary care professionals (increased messaging, calming patients frustrated with the medical system, and increased need for bridging care while patients wait for specialty appointments). Our patients need us now more than ever to give excellent, compassionate care in a poorly functioning system. We need to be emotionally and physically healthy enough to be there for our patients. Prioritize your own needs.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Reddy K et al. Health Equity. 2018 Jun 1;2(1):103-8.

2. Budd J. J Prim Care Community Health. 2023 Apr 19.

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Disconnecting to reconnect

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Sat, 07/01/2023 - 00:15

I recently returned from a bucket list trip rafting the full length of the Grand Canyon via the Colorado River. It was a spectacular trip, filled with thrilling rapids, awe-inspiring hikes through slot canyons, and swimming in the turquoise waters of Havasu Falls.

For those of you who are fortunate to have experienced a similar adventure, I think you’ll agree one of the best things about the trip (aside from the breathtaking scenery) was the ability to completely unplug. Not only did I travel without my trusty laptop, but cell service was nonexistent. The effect of this forced digital detox was magical. By mentally disconnecting from work without the constant ping of my email and EHR inbox, our group had deeper conversations and formed genuine connections without the distractions of technology. In the frenetically paced world of modern health care where clinicians are reachable wherever they are in the world (even on vacation) as the boundaries between work and life blur, there are increasingly fewer times like this when we can fully disconnect. Yet, periodically disconnecting from work is critical, particularly for the clinician community, which is grappling with increasing levels of burnout and its consequences. As you embark on your well-deserved summer vacations, I hope you have an opportunity to set aside your devices to reconnect more fully with your family and friends, but also yourself.

Dr. Megan A. Adams

In this month’s issue of GI&Hepatology News, we update you on AGA’s ongoing advocacy efforts to challenge UnitedHealthcare’s plans to impose increased administrative burdens on GI practices relating to routine GI procedures. We also highlight a landmark clinical trial in pediatric Crohn’s disease recently published in Gastroenterology. In our quarterly Perspectives column, Dr. Mariam Naveed and Dr. Petr Protiva outline important considerations regarding when to stop surveillance for colorectal neoplasia in elderly patients. Finally, our July Member Spotlight features gastroenterologist Dr. Russ Arjal, who shares his experiences launching Telebelly Health, an entirely virtual GI practice.
 

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

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I recently returned from a bucket list trip rafting the full length of the Grand Canyon via the Colorado River. It was a spectacular trip, filled with thrilling rapids, awe-inspiring hikes through slot canyons, and swimming in the turquoise waters of Havasu Falls.

For those of you who are fortunate to have experienced a similar adventure, I think you’ll agree one of the best things about the trip (aside from the breathtaking scenery) was the ability to completely unplug. Not only did I travel without my trusty laptop, but cell service was nonexistent. The effect of this forced digital detox was magical. By mentally disconnecting from work without the constant ping of my email and EHR inbox, our group had deeper conversations and formed genuine connections without the distractions of technology. In the frenetically paced world of modern health care where clinicians are reachable wherever they are in the world (even on vacation) as the boundaries between work and life blur, there are increasingly fewer times like this when we can fully disconnect. Yet, periodically disconnecting from work is critical, particularly for the clinician community, which is grappling with increasing levels of burnout and its consequences. As you embark on your well-deserved summer vacations, I hope you have an opportunity to set aside your devices to reconnect more fully with your family and friends, but also yourself.

Dr. Megan A. Adams

In this month’s issue of GI&Hepatology News, we update you on AGA’s ongoing advocacy efforts to challenge UnitedHealthcare’s plans to impose increased administrative burdens on GI practices relating to routine GI procedures. We also highlight a landmark clinical trial in pediatric Crohn’s disease recently published in Gastroenterology. In our quarterly Perspectives column, Dr. Mariam Naveed and Dr. Petr Protiva outline important considerations regarding when to stop surveillance for colorectal neoplasia in elderly patients. Finally, our July Member Spotlight features gastroenterologist Dr. Russ Arjal, who shares his experiences launching Telebelly Health, an entirely virtual GI practice.
 

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

I recently returned from a bucket list trip rafting the full length of the Grand Canyon via the Colorado River. It was a spectacular trip, filled with thrilling rapids, awe-inspiring hikes through slot canyons, and swimming in the turquoise waters of Havasu Falls.

For those of you who are fortunate to have experienced a similar adventure, I think you’ll agree one of the best things about the trip (aside from the breathtaking scenery) was the ability to completely unplug. Not only did I travel without my trusty laptop, but cell service was nonexistent. The effect of this forced digital detox was magical. By mentally disconnecting from work without the constant ping of my email and EHR inbox, our group had deeper conversations and formed genuine connections without the distractions of technology. In the frenetically paced world of modern health care where clinicians are reachable wherever they are in the world (even on vacation) as the boundaries between work and life blur, there are increasingly fewer times like this when we can fully disconnect. Yet, periodically disconnecting from work is critical, particularly for the clinician community, which is grappling with increasing levels of burnout and its consequences. As you embark on your well-deserved summer vacations, I hope you have an opportunity to set aside your devices to reconnect more fully with your family and friends, but also yourself.

Dr. Megan A. Adams

In this month’s issue of GI&Hepatology News, we update you on AGA’s ongoing advocacy efforts to challenge UnitedHealthcare’s plans to impose increased administrative burdens on GI practices relating to routine GI procedures. We also highlight a landmark clinical trial in pediatric Crohn’s disease recently published in Gastroenterology. In our quarterly Perspectives column, Dr. Mariam Naveed and Dr. Petr Protiva outline important considerations regarding when to stop surveillance for colorectal neoplasia in elderly patients. Finally, our July Member Spotlight features gastroenterologist Dr. Russ Arjal, who shares his experiences launching Telebelly Health, an entirely virtual GI practice.
 

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

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MD rushes in after lightning strikes four people at White House

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Fri, 06/30/2023 - 12:05

It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

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It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

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What’s new in the new jaundice guidelines?

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Fri, 06/30/2023 - 11:45

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 384/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

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More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 384/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

More than 15 years in the making, the revised AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation was released in 2022. A key driving force for this revision was the expanded evidence base regarding monitoring and treatment of newborns 35 or more weeks’ gestation to prevent bilirubin encephalopathy and kernicterus.

Here, we summarize the highlights of the new guidelines and point out practical ways to incorporate these guidelines into daily practice.
 

What has changed?

If you are familiar with the previous guidelines (2004 or the 2009 update) for the management of newborn jaundice, you’ll note that the treatment graphs for phototherapy and exchange transfusion have been updated with new, slightly higher thresholds.

Bilirubin thresholds for starting phototherapy are about 2 mg/dL higher overall than indicated in previous iterations of the guidelines.

This change reflects new evidence that infants don’t typically develop bilirubin neurotoxicity until the total serum bilirubin (TSB) reaches levels well above the previous exchange transfusion threshold, justifying a narrow increase in the bilirubin level for starting phototherapy. Also, phototherapy treatment thresholds are now risk-adjusted, with separate curves for each gestational age from 35 weeks to > 38 weeks.

To find the applicable phototherapy threshold, use the infant’s gestational age (rounding down) and determine whether the infant has even a single neurotoxicity risk factor other than prematurity. Neurotoxicity risk factors include a low albumin level, isoimmune hemolytic disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or other hemolytic conditions; sepsis; or any significant clinical instability in the previous 24 hours.

For example, a 384/7 weeks’ gestation newborn has a TSB of 12 mg/dL at 48 hours of age but no neurotoxicity risk factors. Using the graph Phototherapy Thresholds: No Hyperbilirubinemia Neurotoxicity Risk Factors, should the infant be placed under phototherapy at this time? (Answer: No. The threshold for starting phototherapy on this infant is approximately 16 mg/dL.)

When hyperbilirubinemia becomes a medical emergency

A new term, “escalation of care,” has been adopted to describe actions to take when the newborn’s TSB climbs to within 2 mg/dL of the exchange transfusion threshold – a medical emergency. Instructions on how to ensure intensive phototherapy, and when to initiate an urgent exchange transfusion, are given, including the critical need to maintain intensive phototherapy continuously during infant transport and admission to another facility.

Transcutaneous vs. serum bilirubin

Either a serum TSB or a transcutaneous bilirubin (TcB) should be measured in all infants between 24 and 48 hours after birth or before discharge if that occurs earlier. TcB measurements are valid and reliable when used as a screening test to identify infants who require a TSB measurement. Although the two tests are generally correlated, they are not identical, and treatment decisions should be based on TSB levels. A TSB should be obtained if the TcB exceeds or is within 3 mg/dL of the phototherapy treatment threshold, or if the TcB is ≥ 15 mg/dL.

Following up: When to check another bilirubin level

Prior to these new guidelines, the question of when to get the next bilirubin level was based on Vinod Bhutani, MD’s risk nomogram, which classified newborn bilirubin levels within high-, intermediate-, or low-risk zones for needing phototherapy. A bilirubin level in the high-risk zone indicated the need for earlier follow-up. These risk zones have been replaced with a more specific table that provides recommended postdischarge follow-up based on how close the newborn’s bilirubin level is to the hour-specific threshold for treatment. The closer the latest TSB or TcB level is to the newborn’s risk-based phototherapy threshold, the sooner the follow-up to check another bilirubin level will need to be.

Most infants discharged before 72 hours of age will need follow-up within 2 days. Newborns with TSB levels nearing the level for phototherapy (within 2 mg/dL or less) should remain in the hospital.
 

Five tips for using the new guidelines

Bilitool.org, a popular and useful app, has already been updated to reflect the changes in the new guidelines, making it easy to apply the new thresholds and create a follow-up plan for each patient.

The guidelines provide recommendations for when to check rebound bilirubin levels after stopping phototherapy (hint: babies with neurotoxic risk factors). A TcB device should not be used while the infant is being treated with phototherapy. However, a TcB can be measured once the baby has been off phototherapy for at least 24 hours.

If you have at least two bilirubin measurements, you can calculate the “rate of rise” in bilirubin level. A rapid rate of rise, which serves as a clinical indicator of hemolysis, is defined as ≥ 0.3 mg/dL per hour in the first 24 hours or ≥ 0.2 mg/dL per hour after the first 24 hours of life. This is especially helpful when hemolysis is suspected even if the newborn’s direct antibody test (DAT) is negative. In this scenario, the infant is considered to have a neurotoxic risk factor.

When you initiate phototherapy, be aware of the infant’s bilirubin level threshold for stopping phototherapy (2 mg/dL below the starting phototherapy threshold), as well as the threshold for escalation of care (2 mg/dL below the exchange transfusion threshold).

Because the thresholds for starting phototherapy and initiating exchange transfusion are slightly higher and specific to gestational age, clinicians can more confidently use less phototherapy.
 

Other guideline highlights

The neurotoxic risk factors and corresponding thresholds are important. If the newborn has one or more neurotoxic risk factors other than prematurity, the neurotoxic risk threshold graph should be used when assessing the need for treatment. Neurotoxic risk thresholds should also be used for newborns whose bilirubin levels continue rising on phototherapy.

The guidelines emphasize that G6PD is one of the most important causes of hazardous hyperbilirubinemia leading to kernicterus in the United States and worldwide. Overall, 13% of African American males and about 4% of African American females have G6PD deficiency.

Finally, the guidelines remind clinicians that an important way to reduce the chances that phototherapy will be needed is to encourage early and frequent feeding (8-12 times in 24 hours).

The AAP Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation contains a great deal more information, but these basic principles should allow practitioners to begin to incorporate these guidelines into daily practice.

Dr. Amaya is associate professor, department of pediatrics, Medical University of South Carolina, Charleston, and medical director, level 1 nursery, department of pediatrics, MUSC general academic pediatrics. She disclosed ties with Medical University of South Carolina. Dr. Balog is clinical associate professor of pediatrics, Medical University of South Carolina, Charleston. She has no relevant financial relationships. Dr. Basco is professor, department of pediatrics, Medical University of South Carolina, Charleston; director, division of general pediatrics, department of pediatrics, MUSC Children’s Hospital. He has disclosed no relevant financial relationships.

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

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