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From past to future
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
This month, the current Editor-in-Chief and his Editorial Board will conclude our 5-year term. Megan Adams MD, JD, MSc, from the University of Michigan School of Medicine will assume my position. She has a stellar academic, research, and teaching record and is one of the best writers I know. She and her Board of Editors will carry on the tradition of GIHN.
The idea of an official newspaper of the AGA came from AGA staff in 2006. The goals of the newspaper were twofold: to communicate the latest news and information to practitioners to help them stay at the forefront of patient care and to develop another revenue stream for our society. The newspaper was launched in January 2007 with Charles Lightdale MD, AGAF, as the first editor and Colin W. Howden MD, AGAF, as the second (each with 5-year terms). While they wrote occasional editorials, I began writing 300-word essays for each issue. I have tried diligently to maintain a balanced viewpoint for all my editorials, although this has been difficult in the recent past and current national environment.
The paper evolved from a simple print publication to a multimedia communications vehicle that includes online-only content, videos, supplements, quizzes, and more. Last year, we published our first “Data Trends,” a supplement containing 10 or so brief articles written by content experts, covering current topics of high interest. As the paper evolved, we broadened our target audience to include research scientists, international practitioners and others interested in digestive diseases.
As I did last month, I would like to thank the AGA and Frontline Medical Communications staff for their dedication and constant work to bring you this newspaper.
Finally, I would like to pay tribute to Tadataka “Tachi” Yamada, who died this last month at the age of 76 years. He was one of the premier advocates for global health. His contributions to our field thru research, philanthropy, and leadership were enormous. We will miss him greatly.
John I Allen, MD, MBA, AGAF
Editor in Chief
The other epidemic: Violence against health care workers
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
After working two busy evening hospital shifts, I was eating breakfast with my children when I started reading about physicians confronted and verbally abused during school board meetings for advocating for face masks in school. The pandemic changed course with the Delta variant increasing hospitalizations, and it seems to me the public response to physicians and health care workers also changed.
During the first wave of the pandemic, public support accompanied health care workers’ sacrifices. Nightly applause rang through New York City, there were donations of food, and murals reflected public backing.
We as a nation rallied. We masked up and locked down. We produced vaccines. COVID cases decreased, and by spring, a hint of normalcy bloomed.
Then the virus changed, and the Delta variant spread. Pandemic fatigue set in. Health care workers asked for help with continued masking and increased vaccinations and instead were met with threats. The summer, already made difficult, makes the prospect of winter even more daunting.
This kind of abuse is persistent
Violence against health care workers is not a new dilemma. Stories abound of patients or family members physically attacking, verbally abusing, or harassing health care workers. A 2014 survey reported almost 80% of nurses attacked during their career. Data from the Bureau of Labor Statistics also reveals health care workers experience more nonfatal workplace violence, as compared with other professions.
Nurses, who often spend the most face-to-face time with patients, receive a litany of abuse. A 2019 nursing survey reported 59% of respondents experiencing verbal abuse from patients and more than 43% experiencing verbal abuse from patients’ families. Even more concerning is 23% of survey respondents reporting physical abuse, an increase from 20% in 2018.
Physicians, likewise, are not immune from the same maltreatment. A 2014 physician survey reported more than 71% of physicians in the United States have experienced at least one incident of workplace violence in their careers. Of the physician specialties, the highest rates of violence are in the emergency department and against less experienced physicians. This is likely caused by the higher rates of patient frustration in EDs as a result of long wait times, overcrowding, and boarding while awaiting an inpatient room.
These statistics are disheartening. However, what I find most discouraging is the almost submissive acceptance of this abuse in the health care field as almost 73% of health care workers feel that the abuse is part of the job.
COVID and the increase in violence against health care workers
As the Delta variant spreads, hospitals’ capacity to handle both COVID and non-COVID issues is further strained. Compounding this stress is the public’s pandemic fatigue and the ongoing battles with masking and vaccinations.
In San Antonio, health care workers faced verbal and physical abuse as they enforced masking and visitation restrictions for COVID patients. Online, health care workers, who advocate for masking or vaccination, are often subject to death threats, threats to family members, and verbal abuse on social media. Veiled threats of “we know who you are” and “we will find you” follow physicians who advocate for masking in schools.
This problem is not isolated to the United States. In Italy, a COVID patient spat at health care workers who asked them to wait, resulting in closure of an entire hospital ward. In the United Kingdom, health care workers were subject to the same abuse as those in San Antonio when trying to enforce masking in the hospital. In India, Pakistan, and Spain, a stigma exists against health care workers for being sources of contagion.
The presence of a growing divide between health care workers and those we serve threatens to undermine not only delivery of care but also our response to the pandemic. This is in addition to the mental health burden and compassion fatigue suffered by many health care workers who find their efforts in doubt. An already strained medical system will find it difficult to withstand the loss of its essential workforce.
Standing united against health care worker abuse
Despite the level of discord surrounding COVID-19, it is important that health care workers remain united. An effective response to the increase in violence toward health care workers will greatly depend on how we address the following.
First, we must actively work to combat the spread of misinformation that erodes the public trust in science and medicine. Transparency is paramount. Policy changes and plans for implementation should be open and free of political influence. This remains a challenge due to the CDC’s standing as both a federal and scientific institution. A steadfast and explicit presentation of scientific evidence by the CDC is a vital first step in repairing this trust.
In addition, we must become our own advocates. The passage of HR 1195, the Workplace Violence Prevention for Health Care and Social Service Workers Act, in the House of Representatives with bipartisan support is an indication that the time is ripe for sweeping change. Its supporters include the American Nurses Association, American Psychiatric Nurses Association, National Nurses United, and the American College of Emergency Physicians. Active opposition includes the American Hospital Association, which cites prohibitive cost as a source of objection.
HR 1195 now waits in the U.S. Senate for approval. We should alert local, state, and health system leadership to the violence against health care workers. We should demand increased protection for our most vulnerable colleagues in EDs and hospitals. Our advocacy will produce a paradigm shift away from the acceptance of this abuse.
Lastly, we must be mindful of compassion fatigue and health care worker burnout. Cynicism threatens to take away our greatest strengths of empathy and humanity. In our work environment, we must lift each other up and increase our awareness of when our colleagues need help. Self-care and creative outlets are encouraged. Admittedly, I am blogging as a personal safeguard against compassion fatigue and burnout.
The pandemic will have enduring implications both positive and negative. It is my hope that support for health care workers not only endures but is also enhanced long after the pandemic ends.
Giancarlo Toledanes, DO, is an assistant professor of pediatrics and a pediatric hospitalist at Texas Children’s Hospital and Baylor College of Medicine, both in Houston. He has no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
The secret I’ll take to my grave: Doc reveals
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.
An internist will never forget the dark secret his patient revealed during a routine visit – or the grim aftermath.
The patient, who had a progressive, incurable neurological condition, confided that he planned to kill himself. The patient intended to conceal the true manner and make the death look natural.
“[He planned to do it] very carefully at home so no one would know,” said the internist, who remains anonymous. “[He shared] the methods he would use.”
Perhaps more shocking than the patient’s confession was the physician’s response.
“He did not require my help to do what he planned, and I did not try to stop him,” said the internist. “I reported his death as ‘natural causes’ and never told anyone.”
An ob.gyn., for instance, wrote about struggling with whether to tell a father that his newborn baby was not his genetic child. The newborn had a blood type that made it impossible for the father to be biologically related to the infant, the anonymous doctor wrote.
“I told the wife who then informed me she had a lover,” the ob.gyn. said. “I never told the husband.”
It’s uncertain whether carrying the burden of such hidden knowledge affected the physicians involved in these cases. However, in general, secrets can weigh heavily on the minds of those who keep them and can contribute to stress, said Malia Mason, PhD, a psychologist and dean of research at Columbia Business School in New York. Holding onto secrets can cause depression and anxiety, research shows. The more often people think about the secret, the greater the impact, according to a recent study coauthored by Dr. Mason.
“Keeping a secret diminishes well-being,” Dr. Mason said. “It makes people feel socially distant. It lowers relationship satisfaction, and it leads people to feel inauthentic. The reason that secrets do this is because people think about them all the time. The more you think about it, the more you see these consequences.”
Feelings that stem from a secret depend on the content. The more immoral a secret is thought to be, the more people feel ashamed, according to a 2021 analysis of thousands of secrets, reported by Michael L. Slepian, PhD, and Alex Koch, PhD. However, secrets more related to a person’s profession are often internalized differently, the study found. The more a secret fell higher on the profession/goal-oriented dimension, the more people felt they had insight into the secret, according to the analysis. For example, having clear thinking about the secret and/or knowing how to handle it.
“The more shame participants felt from their secret, the more they indicated the secret hurt their well-being,” Dr. Slepian and Dr. Koch wrote in the study. “The more insight participants felt they had into their secret, the less they indicated the secret hurt their well-being.”
Suspicious deaths exposed after investigations
The internist’s account of keeping his patient’s suicide a secret raises many questions, such as how the patient masked his manner of death. The internist did not share any more details about the incident.
Suicides are among the most challenging manners of deaths to certify, according to James Gill, MD, a pathologist and president of the National Association of Medical Examiners. Death investigators must demonstrate intent, meaning the individuals caused the injury to intentionally harm themselves. Fewer than half of people who die by suicide leave a note, Dr. Gill said, so investigators can’t rely on the absence or the presence of a note in making their determination.
A decedent who had cancer or a severe neurological disorder presents further challenges, said Dr. Gill, who serves as chief medical examiner for the state of Connecticut.
“These [deaths] may not be unexpected and may not be reported to the medical examiner/coroner,” Dr. Gill said. “If there is no suspicion and the treating doctor is willing to sign the death certificate, the death will not come under the jurisdiction of the medical examiner.”
Dr. Gill recalled a death his colleague once investigated that appeared to be natural but emerged as something else after a deeper look.
A woman with metastatic breast cancer was about to be discharged from a hospital into hospice the next morning. The night before, she had a “going away” party with friends who came to visit her in the hospital. Shortly after the friends left, the woman was found dead. Because of her condition, she could have died at any time, Dr. Gill said, but she also had a history of depression and hospital staff were suspicious. The death was reported to the medical examiner’s office.
Toxicology testing found markedly elevated concentrations of phenytoin and pentobarbital, neither of which were prescribed during her hospital stay. Dr. Gill said it turned out that the woman and her friends worked at a veterinarian’s office, and the medication they used to euthanize dogs was a combination of phenytoin and pentobarbital.
“The death was certified as a homicide because of the direct actions of another, but a reasonable argument could be made for suicide,” Dr. Gill said.
In a similar case reported in the journal Science & Justice, a 64-year-old cardiologist was found lifeless by his wife after he collapsed near the stairs of his home. Next to his body was a bottle of whiskey and two cups, one that appeared to be used for the alcohol and one with a yellowish liquid smelling of honey. The wife reported that her husband always drank whiskey with honey before bed. The death was initially classified as natural, but after vehement protest by the family, a forensic autopsy was performed.
Prior to the autopsy, death investigators learned the decedent, who was a well-known and successful practitioner in his community, had Parkinson’s disease. At times, he could not sign his prescriptions because of the increasing tremor in his hands, according to the case study. Investigators learned the patient’s mother had also suffered from Parkinson’s, and that her son had witnessed her decline.
The autopsy revealed only nonspecific lesions such as acute stasis of the viscera, moderate pulmonary and cerebral edema, and moderate generalized atheromatosis. Histological examinations did not yield any unusual findings.
An analysis of the beverage containers detected pentobarbital in the yellowish syrup residue of the second cup. Testing of the doctor’s peripheral blood revealed the presence of a metabolite of pentobarbital, ethanol, and traces of phenobarbital. In addition, a urine analysis showed the presence of venlafaxine, an antidepressant, as well as the benzophenone of lorazepam, a sedating benzodiazepine, and metoclopramide, an antiemetic.
Lead author C. Brandt-Casadevall, MD, and colleagues wrote that the levels were clearly compatible with a scenario of a pentobarbital overdose with a lethal outcome.
“... It is obvious that the victim attempted to hide his suicide from his family circle,” Dr. Brandt-Casadevall and colleagues wrote. “Thus, we obtained no evidence indicating that he might have spoken at any point of putting an end to his life. There was no written note. The victim did not wait to be alone at home. Instead, he committed his act in a routine situation: his wife was watching television late at night and he was upstairs, presumably going to sleep. Thus, he had one to two hours at his disposal, and he ingested a very fast-acting drug which would make any attempt at reanimation impossible, even after a brief period of time. This may have induced the physician in charge to believe that the cause of death was cardiac origin, a likely hypothesis given the age of the victim.”
What to do when a terminally ill patient talks suicide
When a terminally ill patient expresses the desire to end his or her life, it’s important to understand that desire is often a result of existential suffering, a sense of hopelessness, and lack of social support, said Lynn A. Jansen, PhD, a bioethicist at the University of Arizona in Tucson.
“The duty of beneficence requires that physicians attempt to provide the support and care that is needed,” said Dr. Jansen. “Here, interdisciplinary teamwork is important and should be utilized. Physicians should refer patients to professionals, such as social workers, pastoral care, psychologists, etc., who are better able to address these issues.”
The rate of desire for a hastened death among terminally ill patients ranges from 17% to 45%, depending on the population studied and how the desire is evaluated, according to an analysis in the Primary Care Companion to the Journal of Clinical Psychiatry. In one study, 14% of about 130 palliative care patients with cancer had a strong desire to quicken the dying process.
In addition, patients with neurologic disorders have a significantly higher suicide rate than that of those without neurologic disorders, a recent JAMA study found. About 1 in 150 patients diagnosed with a neurological disorder dies by suicide, the analysis determined.
A tricky point to remember is that a desire by a terminally ill patient to hasten his or her death by suicide should not be taken by itself to indicate depression, Dr. Jansen noted.
“In principle, such patients can make an autonomous decision to end their lives,” she said. “However, the expression of such a desire is very often associated with depression and forms of suffering that can be effectively addressed by the health care team.”
Physicians can also explore other avenues with the patient such as palliative care or making sure adequate pain relief is available, added Robert Klitzman, MD, professor of psychiatry and academic director of the master of science in bioethics program at Columbia University, New York.
“If they are saying it’s because they are distressed, ethically, a doctor can and should find ways to decrease their distress,” he said.
Of course, those who practice in the U.S. jurisdictions that have physician-assisted-dying laws have different legal and ethical elements to consider. Physicians in these areas have no ethical duty to participate in the process, Dr. Jansen said, but they have a duty to refer patients who express a desire to pursue physician aid-in-dying to another provider who can assist them.
Physician aid-in-dying laws vary somewhat so it’s important that physicians in these areas be aware of their specific statute, Dr. Klitzman said. California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, Washington, and the District of Columbia have these laws.
“In these states, if a terminally ill patient says they don’t want to live anymore, a physician would first decide if this is a result of depression or if it’s a request for physician aid-in-dying,” he said. “Even then, in most cases, the patient would be evaluated by not one, but two different health professionals at two different points. We want to see if it is a consistent decision that the person has made that they want physician aid-in-dying, and not just that they’ve had a bad day or a setback in their treatment.”
In the case of the internist who told no one of his patient’s suicide plan, Dr. Klitzman said he would have dug deeper into the patient’s mindset.
“Not knowing anything about the patient or the doctor, I would have responded differently,” he said. “I think a physician should address why a patient feels that way. They may feel their pain is unbearable, and we potentially offer more pain relief. Maybe the patient shows evidence of having depression, which may be treatable [with medication]. The patient would then feel better and be able to spend quality time with family and loved ones, make sure their affairs are in order, and have a chance to say goodbye.”
A version of this article first appeared on Medscape.com.
EAACI review urges reduction in antibiotic overuse with allergy
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease.
Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis.
The review, by lead author Gerdien Tramper-Stranders, MD, PhD, department of pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online Aug. 13 in the journal Allergy.
Several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases, the authors noted.
In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit.
“In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking,” the authors wrote.
Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Dr. Tramper-Stranders said in an interview. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones.
Dr. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.
Recommendations have global relevance
She said although the recommendations are coming from the EAACI group, they apply worldwide.
“Especially in countries outside Northern Europe, antibiotic use is tremendous, leading to high rates of antibiotic resistance; but also increasing the risk for developing allergic diseases when prescribed in infancy,” she said.
She pointed out that in the United States, as many as one in six children receive unnecessary antibiotics for an asthma exacerbation. Overtreatment in adults with flare-ups is also prevalent, at rates from 40%-50%.
Millie Kwan, MD, PhD, an allergy specialist at University of North Carolina in Chapel Hill, said in an interview that in the U.S. there’s been a culture change in the direction of antibiotic restraint – but there are still problems.
“It’s a lot easier for us to whip out our prescription pads and prescribe antibiotics for an asthma patient who’s having a flare-up or a patient who has atopic dermatitis before addressing the underlying mechanism directly,” Dr. Kwan said. She agreed that antibiotic overuse is prevalent in pregnancies in the U.S., and she said that starts with the high prevalence of cesarean births. Nearly one-third of all births in the U.S. are by C-section, twice the rate recommended by the World Health Organization.
“Just bypassing the birth canal actually changes what kind of microflora the infant is being exposed to,” Dr. Kwan said. “That’s the first huge problem.”
The second problem, she said, is the potential for overuse of antibiotics with the surgical procedure.
The researchers wrote that pre-, pro- or postbiotics might alter the course of allergic disease, but clear evidence is lacking.
Until now, Dr. Tramper-Stranders said, pre- or probiotic treatment in infancy, irrespective of previous antibiotic use, has not proved effective in preventing allergies.
Data describing the effect of pre- or probiotics after an antibiotic course are scarce, are limited to older children and adults, and are focused on short-term effects, such as diarrhea prevention, she explained.
Dr. Kwan says she agrees that current data are not strong enough to recommend one over another.
“We don’t even know what the normal amount of bacteria should be to constitute an environment where the immune system develops ‘normally,’ “ she said.
Antibiotics should be prescribed cautiously and by following current recommendations to use the narrowest spectrum available, the authors wrote. Future research in antibiotic stewardship should incorporate biomarker-guided therapy to determine which patients might benefit most from antibiotic therapy.
“Practicing antibiotic stewardship needs recurrent attention and we hope that with this initiative, we specifically reach allergy doctors who will rethink their next [antibiotic] prescription. Within our EAACI task force, we will next work on a guideline for rational antibiotic use in asthma,” Dr. Tramper-Stranders said.
The review’s authors and Dr. Kwan have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA warns clinicians to stop using Eco-Med products because of contamination concerns
Earlier this month, the Centers for Disease Control and Prevention and the FDA announced an outbreak of at least 15 Bcc infections associated with contaminated ultrasound gel, and, according to the FDA, Eco-Med ultrasound gels have now been linked to at least 59 infections, 48 of which were blood infections.
On Aug. 4, the Canadian pharmaceutical company, based in Etobicoke, Ont., initiated a voluntary recall of certain lots of EcoGel 200 Ultrasound gel because of contamination with Bcc, but now the FDA warns that all Eco-Med’s ultrasound gels and lotions are at risk.
“The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls),” the FDA said in a letter to health care providers published Aug. 18.
The letter lists 25 products manufactured by Eco-Med that are sold by distributors in 10 different countries, including the United States and Canada. The list may not be completely comprehensive, the organization notes.
Eco-Med has ceased all operations and is no longer manufacturing or distributing products, according to the FDA statement. Both phone numbers listed for the company were not in operation at the time of reporting.
Beyond stopping use of and discarding Eco-Med products, the FDA recommends that health care providers and facilities stop purchases of Eco-Med products, contact distributors with product disposal questions, and follow professional society guidelines and CDC guidelines for ultrasound use and cleaning products. Providers are encouraged to report adverse events related to Eco-Med ultrasound gels or lotions through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
Though Eco-Med is listed as one of the “prominent players in the ultrasound gel market,” according to a June 2020 report by Grand View Research, the announcement will likely not cause many issues, Lauren Golding, MD, chair of the American College of Radiology Commission on Ultrasound, said in an interview.
“Fortunately, several companies produce ultrasound gel. Barring unforeseen circumstances, we do not expect this FDA action to have a widespread impact on patients’ access to ultrasound exams in the United States,” she said.
A version of this article first appeared on Medscape.com.
Earlier this month, the Centers for Disease Control and Prevention and the FDA announced an outbreak of at least 15 Bcc infections associated with contaminated ultrasound gel, and, according to the FDA, Eco-Med ultrasound gels have now been linked to at least 59 infections, 48 of which were blood infections.
On Aug. 4, the Canadian pharmaceutical company, based in Etobicoke, Ont., initiated a voluntary recall of certain lots of EcoGel 200 Ultrasound gel because of contamination with Bcc, but now the FDA warns that all Eco-Med’s ultrasound gels and lotions are at risk.
“The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls),” the FDA said in a letter to health care providers published Aug. 18.
The letter lists 25 products manufactured by Eco-Med that are sold by distributors in 10 different countries, including the United States and Canada. The list may not be completely comprehensive, the organization notes.
Eco-Med has ceased all operations and is no longer manufacturing or distributing products, according to the FDA statement. Both phone numbers listed for the company were not in operation at the time of reporting.
Beyond stopping use of and discarding Eco-Med products, the FDA recommends that health care providers and facilities stop purchases of Eco-Med products, contact distributors with product disposal questions, and follow professional society guidelines and CDC guidelines for ultrasound use and cleaning products. Providers are encouraged to report adverse events related to Eco-Med ultrasound gels or lotions through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
Though Eco-Med is listed as one of the “prominent players in the ultrasound gel market,” according to a June 2020 report by Grand View Research, the announcement will likely not cause many issues, Lauren Golding, MD, chair of the American College of Radiology Commission on Ultrasound, said in an interview.
“Fortunately, several companies produce ultrasound gel. Barring unforeseen circumstances, we do not expect this FDA action to have a widespread impact on patients’ access to ultrasound exams in the United States,” she said.
A version of this article first appeared on Medscape.com.
Earlier this month, the Centers for Disease Control and Prevention and the FDA announced an outbreak of at least 15 Bcc infections associated with contaminated ultrasound gel, and, according to the FDA, Eco-Med ultrasound gels have now been linked to at least 59 infections, 48 of which were blood infections.
On Aug. 4, the Canadian pharmaceutical company, based in Etobicoke, Ont., initiated a voluntary recall of certain lots of EcoGel 200 Ultrasound gel because of contamination with Bcc, but now the FDA warns that all Eco-Med’s ultrasound gels and lotions are at risk.
“The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls),” the FDA said in a letter to health care providers published Aug. 18.
The letter lists 25 products manufactured by Eco-Med that are sold by distributors in 10 different countries, including the United States and Canada. The list may not be completely comprehensive, the organization notes.
Eco-Med has ceased all operations and is no longer manufacturing or distributing products, according to the FDA statement. Both phone numbers listed for the company were not in operation at the time of reporting.
Beyond stopping use of and discarding Eco-Med products, the FDA recommends that health care providers and facilities stop purchases of Eco-Med products, contact distributors with product disposal questions, and follow professional society guidelines and CDC guidelines for ultrasound use and cleaning products. Providers are encouraged to report adverse events related to Eco-Med ultrasound gels or lotions through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
Though Eco-Med is listed as one of the “prominent players in the ultrasound gel market,” according to a June 2020 report by Grand View Research, the announcement will likely not cause many issues, Lauren Golding, MD, chair of the American College of Radiology Commission on Ultrasound, said in an interview.
“Fortunately, several companies produce ultrasound gel. Barring unforeseen circumstances, we do not expect this FDA action to have a widespread impact on patients’ access to ultrasound exams in the United States,” she said.
A version of this article first appeared on Medscape.com.
Dostarlimab indication broadened to all dMMR solid tumors
The agency approved the drug in April for dMMR recurrent or advanced endometrial cancer that has progressed during or following treatment with a platinum-containing regimen. The labeling notes that dMMR status for both indications must be determined through an FDA-approved test.
The accelerated approval “may be contingent upon verification and description of clinical benefit in a confirmatory” trial, the labeling says.
The new indication was based results from 209 patients in the GARNET trial. In that trial, the objective response rate was 41.6% across dMMR endometrial and other solid tumors. The complete response rate was 9.1%.
The median duration of response was 34.7 months. For 95% of patients who responded to treatment, the duration of response was 6 months or longer, according to a press release from the maker, GlaxoSmithKline.
In mismatch repair deficiency, tumors contain abnormalities that affect the proper repair of DNA. Prevalence in the United States is estimated to be 14%. The deficiency is particularly common in endometrial, colorectal, and other gastrointestinal cancers, the company said.
The drug was administered in GARNET as a 500-mg intravenous infusion every 3 weeks in four doses, followed by 1,000 mg once every 6 weeks until disease progression or unacceptable toxicity.
Common adverse events included fatigue/asthenia (42%), anemia (30%), diarrhea (25%), and nausea (22%). The most common grade 3 or 4 adverse reactions included anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury.
As with other PD-1/PD-L1 blockers, there’s also a possibility of severe and fatal immune-mediated adverse reactions in any organ system either during or after treatment, including immune-mediated pneumonitis, colitis, and hepatitis.
GlaxoSmithKline said it’s studying dostarlimab in earlier lines of treatment for endometrial cancer and in combination with other agents for other advanced/metastatic cancers.
A version of this article first appeared on Medscape.com.
The agency approved the drug in April for dMMR recurrent or advanced endometrial cancer that has progressed during or following treatment with a platinum-containing regimen. The labeling notes that dMMR status for both indications must be determined through an FDA-approved test.
The accelerated approval “may be contingent upon verification and description of clinical benefit in a confirmatory” trial, the labeling says.
The new indication was based results from 209 patients in the GARNET trial. In that trial, the objective response rate was 41.6% across dMMR endometrial and other solid tumors. The complete response rate was 9.1%.
The median duration of response was 34.7 months. For 95% of patients who responded to treatment, the duration of response was 6 months or longer, according to a press release from the maker, GlaxoSmithKline.
In mismatch repair deficiency, tumors contain abnormalities that affect the proper repair of DNA. Prevalence in the United States is estimated to be 14%. The deficiency is particularly common in endometrial, colorectal, and other gastrointestinal cancers, the company said.
The drug was administered in GARNET as a 500-mg intravenous infusion every 3 weeks in four doses, followed by 1,000 mg once every 6 weeks until disease progression or unacceptable toxicity.
Common adverse events included fatigue/asthenia (42%), anemia (30%), diarrhea (25%), and nausea (22%). The most common grade 3 or 4 adverse reactions included anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury.
As with other PD-1/PD-L1 blockers, there’s also a possibility of severe and fatal immune-mediated adverse reactions in any organ system either during or after treatment, including immune-mediated pneumonitis, colitis, and hepatitis.
GlaxoSmithKline said it’s studying dostarlimab in earlier lines of treatment for endometrial cancer and in combination with other agents for other advanced/metastatic cancers.
A version of this article first appeared on Medscape.com.
The agency approved the drug in April for dMMR recurrent or advanced endometrial cancer that has progressed during or following treatment with a platinum-containing regimen. The labeling notes that dMMR status for both indications must be determined through an FDA-approved test.
The accelerated approval “may be contingent upon verification and description of clinical benefit in a confirmatory” trial, the labeling says.
The new indication was based results from 209 patients in the GARNET trial. In that trial, the objective response rate was 41.6% across dMMR endometrial and other solid tumors. The complete response rate was 9.1%.
The median duration of response was 34.7 months. For 95% of patients who responded to treatment, the duration of response was 6 months or longer, according to a press release from the maker, GlaxoSmithKline.
In mismatch repair deficiency, tumors contain abnormalities that affect the proper repair of DNA. Prevalence in the United States is estimated to be 14%. The deficiency is particularly common in endometrial, colorectal, and other gastrointestinal cancers, the company said.
The drug was administered in GARNET as a 500-mg intravenous infusion every 3 weeks in four doses, followed by 1,000 mg once every 6 weeks until disease progression or unacceptable toxicity.
Common adverse events included fatigue/asthenia (42%), anemia (30%), diarrhea (25%), and nausea (22%). The most common grade 3 or 4 adverse reactions included anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury.
As with other PD-1/PD-L1 blockers, there’s also a possibility of severe and fatal immune-mediated adverse reactions in any organ system either during or after treatment, including immune-mediated pneumonitis, colitis, and hepatitis.
GlaxoSmithKline said it’s studying dostarlimab in earlier lines of treatment for endometrial cancer and in combination with other agents for other advanced/metastatic cancers.
A version of this article first appeared on Medscape.com.
FDA OKs belzutifan for cancers tied to von Hippel–Lindau disease
Belzutifan is a selective small-molecule inhibitor of hypoxia-inducible factor and a first-in-class drug.
The new approval is based on safety and efficacy results from the ongoing Study 004, an open-label clinical trial involving 61 patients with VHL-associated RCC with at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNETs.
Patients received belzutifan 120 mg once daily until disease progression or unacceptable toxicity.
The overall response rate, which was the study’s primary endpoint, was 49% in patients with VHL-associated RCC. Additional efficacy endpoints included duration of response (DoR), which was not reached. So far, 56% of responders had DoR of at least 12 months. The median time to response was 8 months.
Among the patients in the study with other VHL-associated non-RCC tumors, 24 patients with CNS hemangioblastomas had an ORR of 63%, and 12 patients with pNETs had an ORR of 83%. Median DoR was not reached,with 73% and 50% of patients having response durations of at least 12 months for CNS hemangioblastomas and pNET, respectively.
The most common adverse reactions (≥20% of patients), according to the FDA, were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
Notably, anemia and hypoxia from belzutifan use can be severe. In Study 004, anemia occurred in 90% of patients and 7% had grade 3 anemia. Patients should be transfused as clinically indicated. Erythropoiesis-stimulating agents for anemia are not recommended in patients treated with belzutifan. In Study 004, hypoxia occurred in 1.6% of patients.
Belzutifan can render some hormonal contraceptives ineffective, and belzutifan exposure during pregnancy can cause embryo-fetal harm; see full prescribing information for Welireg.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application. The application was granted priority review by the FDA.
A version of this article first appeared on Medscape.com.
Belzutifan is a selective small-molecule inhibitor of hypoxia-inducible factor and a first-in-class drug.
The new approval is based on safety and efficacy results from the ongoing Study 004, an open-label clinical trial involving 61 patients with VHL-associated RCC with at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNETs.
Patients received belzutifan 120 mg once daily until disease progression or unacceptable toxicity.
The overall response rate, which was the study’s primary endpoint, was 49% in patients with VHL-associated RCC. Additional efficacy endpoints included duration of response (DoR), which was not reached. So far, 56% of responders had DoR of at least 12 months. The median time to response was 8 months.
Among the patients in the study with other VHL-associated non-RCC tumors, 24 patients with CNS hemangioblastomas had an ORR of 63%, and 12 patients with pNETs had an ORR of 83%. Median DoR was not reached,with 73% and 50% of patients having response durations of at least 12 months for CNS hemangioblastomas and pNET, respectively.
The most common adverse reactions (≥20% of patients), according to the FDA, were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
Notably, anemia and hypoxia from belzutifan use can be severe. In Study 004, anemia occurred in 90% of patients and 7% had grade 3 anemia. Patients should be transfused as clinically indicated. Erythropoiesis-stimulating agents for anemia are not recommended in patients treated with belzutifan. In Study 004, hypoxia occurred in 1.6% of patients.
Belzutifan can render some hormonal contraceptives ineffective, and belzutifan exposure during pregnancy can cause embryo-fetal harm; see full prescribing information for Welireg.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application. The application was granted priority review by the FDA.
A version of this article first appeared on Medscape.com.
Belzutifan is a selective small-molecule inhibitor of hypoxia-inducible factor and a first-in-class drug.
The new approval is based on safety and efficacy results from the ongoing Study 004, an open-label clinical trial involving 61 patients with VHL-associated RCC with at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and pNETs.
Patients received belzutifan 120 mg once daily until disease progression or unacceptable toxicity.
The overall response rate, which was the study’s primary endpoint, was 49% in patients with VHL-associated RCC. Additional efficacy endpoints included duration of response (DoR), which was not reached. So far, 56% of responders had DoR of at least 12 months. The median time to response was 8 months.
Among the patients in the study with other VHL-associated non-RCC tumors, 24 patients with CNS hemangioblastomas had an ORR of 63%, and 12 patients with pNETs had an ORR of 83%. Median DoR was not reached,with 73% and 50% of patients having response durations of at least 12 months for CNS hemangioblastomas and pNET, respectively.
The most common adverse reactions (≥20% of patients), according to the FDA, were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
Notably, anemia and hypoxia from belzutifan use can be severe. In Study 004, anemia occurred in 90% of patients and 7% had grade 3 anemia. Patients should be transfused as clinically indicated. Erythropoiesis-stimulating agents for anemia are not recommended in patients treated with belzutifan. In Study 004, hypoxia occurred in 1.6% of patients.
Belzutifan can render some hormonal contraceptives ineffective, and belzutifan exposure during pregnancy can cause embryo-fetal harm; see full prescribing information for Welireg.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application. The application was granted priority review by the FDA.
A version of this article first appeared on Medscape.com.
‘Countdown to zero’: Endocrine disruptors and worldwide sperm counts
In medical school, I remember thinking that telling a patient “you have cancer” would be the most professionally challenging phrase I would ever utter. And don’t get me wrong – it certainly isn’t easy; but, compared with telling someone “you are infertile,” it’s a cakewalk.
Maybe it’s because people “have” cancer and cancer is something you “fight.” Or maybe because, unlike infertility, cancer has become a part of public life (think lapel pins and support groups) and is now easier to accept. On the other hand, someone “is” infertile. The condition is a source of embarrassment for the couple and is often hidden from society.
Here’s another concerning point of contrast: While the overall rate of cancer death has declined since the early 1990s, infertility is increasing. Reports now show that one in six couples have problems conceiving and the use of assisted reproductive technologies is increasing by 5%-10% per year. Many theories exist to explain these trends, chief among them the rise in average maternal age and the increasing incidence of obesity, as well as various other male- and female-specific factors.
But interestingly, recent data suggest that the most male of all male-specific factors – total sperm count – may be specifically to blame.
According to a recent meta-analysis, the average total sperm count in men declined by 59.3% between 1973 and 2011. While these data certainly have limitations – including the exclusion of non-English publications, the reliance on total sperm count and not sperm motility, and the potential bias of those patients willing to give a semen sample – the overall trend nevertheless seems to be clearly downward. What’s more concerning, if you believe the data presented, is that there does not appear to be a leveling off of the downward curve in total sperm count.
Think about that last statement. At the current rate of decline, the average sperm count will be zero in 2045. One of the lead authors on the meta-analysis, Hagai Levine, MD, MPH, goes so far as to state, “We should hope for the best and prepare for the worst.”
As a matter of personal philosophy, I’m not a huge fan of end-of-the-world predictions because they tend not to come true (think Montanism back in the 2nd century; the 2012 Mayan calendar scare; or my personal favorite, the Prophet Hen of Leeds). On the other hand, the overall trend of decreased total sperm count in the English-speaking world seems to be true and it raises the interesting question of why.
According to the Mayo Clinic, causes of decreased sperm count include everything from anatomical factors (like varicoceles and ejaculatory issues) and lifestyle issues (such as recreational drugs, weight gain, and emotional stress) to environmental exposures (heavy metal or radiation). The senior author of the aforementioned meta-analysis, Shanna Swan, PhD, has championed another theory: the widespread exposure to endocrine-disrupting chemicals in everyday plastics.
It turns out that at least two chemicals used in the plastics industry, bisphenol A and phthalates, can mimic the effect of estrogen when ingested into the body. Even low levels of these chemicals in our bodies can lead to health problems.
Consider for a moment the presence of plastics in your life: the plastic wrappings on your food, plastic containers for shampoos and beauty products, and even the coatings of our oral supplements. A study by the Centers for Disease Control and Prevention looked at the urine of people participating in the National Health and Nutrition Examination Survey and found detectable concentrations of both of these chemicals in nearly all participants.
In 2045, I intend to be retired. But in the meantime, I think we all need to be aware of the potential impact that various endocrine-disrupting chemicals could be having on humanity. We need more research. If indeed the connection between endocrine disruptors and decreased sperm count is borne out, changes in our environmental exposure to these chemicals need to be made.
Henry Rosevear, MD, is a private-practice urologist based in Colorado Springs. He comes from a long line of doctors, but before entering medicine he served in the U.S. Navy as an officer aboard the USS Pittsburgh, a fast-attack submarine based out of New London, Conn. During his time in the Navy, he served in two deployments to the Persian Gulf, including combat experience as part of Operation Iraqi Freedom. Dr. Rosevear disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
In medical school, I remember thinking that telling a patient “you have cancer” would be the most professionally challenging phrase I would ever utter. And don’t get me wrong – it certainly isn’t easy; but, compared with telling someone “you are infertile,” it’s a cakewalk.
Maybe it’s because people “have” cancer and cancer is something you “fight.” Or maybe because, unlike infertility, cancer has become a part of public life (think lapel pins and support groups) and is now easier to accept. On the other hand, someone “is” infertile. The condition is a source of embarrassment for the couple and is often hidden from society.
Here’s another concerning point of contrast: While the overall rate of cancer death has declined since the early 1990s, infertility is increasing. Reports now show that one in six couples have problems conceiving and the use of assisted reproductive technologies is increasing by 5%-10% per year. Many theories exist to explain these trends, chief among them the rise in average maternal age and the increasing incidence of obesity, as well as various other male- and female-specific factors.
But interestingly, recent data suggest that the most male of all male-specific factors – total sperm count – may be specifically to blame.
According to a recent meta-analysis, the average total sperm count in men declined by 59.3% between 1973 and 2011. While these data certainly have limitations – including the exclusion of non-English publications, the reliance on total sperm count and not sperm motility, and the potential bias of those patients willing to give a semen sample – the overall trend nevertheless seems to be clearly downward. What’s more concerning, if you believe the data presented, is that there does not appear to be a leveling off of the downward curve in total sperm count.
Think about that last statement. At the current rate of decline, the average sperm count will be zero in 2045. One of the lead authors on the meta-analysis, Hagai Levine, MD, MPH, goes so far as to state, “We should hope for the best and prepare for the worst.”
As a matter of personal philosophy, I’m not a huge fan of end-of-the-world predictions because they tend not to come true (think Montanism back in the 2nd century; the 2012 Mayan calendar scare; or my personal favorite, the Prophet Hen of Leeds). On the other hand, the overall trend of decreased total sperm count in the English-speaking world seems to be true and it raises the interesting question of why.
According to the Mayo Clinic, causes of decreased sperm count include everything from anatomical factors (like varicoceles and ejaculatory issues) and lifestyle issues (such as recreational drugs, weight gain, and emotional stress) to environmental exposures (heavy metal or radiation). The senior author of the aforementioned meta-analysis, Shanna Swan, PhD, has championed another theory: the widespread exposure to endocrine-disrupting chemicals in everyday plastics.
It turns out that at least two chemicals used in the plastics industry, bisphenol A and phthalates, can mimic the effect of estrogen when ingested into the body. Even low levels of these chemicals in our bodies can lead to health problems.
Consider for a moment the presence of plastics in your life: the plastic wrappings on your food, plastic containers for shampoos and beauty products, and even the coatings of our oral supplements. A study by the Centers for Disease Control and Prevention looked at the urine of people participating in the National Health and Nutrition Examination Survey and found detectable concentrations of both of these chemicals in nearly all participants.
In 2045, I intend to be retired. But in the meantime, I think we all need to be aware of the potential impact that various endocrine-disrupting chemicals could be having on humanity. We need more research. If indeed the connection between endocrine disruptors and decreased sperm count is borne out, changes in our environmental exposure to these chemicals need to be made.
Henry Rosevear, MD, is a private-practice urologist based in Colorado Springs. He comes from a long line of doctors, but before entering medicine he served in the U.S. Navy as an officer aboard the USS Pittsburgh, a fast-attack submarine based out of New London, Conn. During his time in the Navy, he served in two deployments to the Persian Gulf, including combat experience as part of Operation Iraqi Freedom. Dr. Rosevear disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
In medical school, I remember thinking that telling a patient “you have cancer” would be the most professionally challenging phrase I would ever utter. And don’t get me wrong – it certainly isn’t easy; but, compared with telling someone “you are infertile,” it’s a cakewalk.
Maybe it’s because people “have” cancer and cancer is something you “fight.” Or maybe because, unlike infertility, cancer has become a part of public life (think lapel pins and support groups) and is now easier to accept. On the other hand, someone “is” infertile. The condition is a source of embarrassment for the couple and is often hidden from society.
Here’s another concerning point of contrast: While the overall rate of cancer death has declined since the early 1990s, infertility is increasing. Reports now show that one in six couples have problems conceiving and the use of assisted reproductive technologies is increasing by 5%-10% per year. Many theories exist to explain these trends, chief among them the rise in average maternal age and the increasing incidence of obesity, as well as various other male- and female-specific factors.
But interestingly, recent data suggest that the most male of all male-specific factors – total sperm count – may be specifically to blame.
According to a recent meta-analysis, the average total sperm count in men declined by 59.3% between 1973 and 2011. While these data certainly have limitations – including the exclusion of non-English publications, the reliance on total sperm count and not sperm motility, and the potential bias of those patients willing to give a semen sample – the overall trend nevertheless seems to be clearly downward. What’s more concerning, if you believe the data presented, is that there does not appear to be a leveling off of the downward curve in total sperm count.
Think about that last statement. At the current rate of decline, the average sperm count will be zero in 2045. One of the lead authors on the meta-analysis, Hagai Levine, MD, MPH, goes so far as to state, “We should hope for the best and prepare for the worst.”
As a matter of personal philosophy, I’m not a huge fan of end-of-the-world predictions because they tend not to come true (think Montanism back in the 2nd century; the 2012 Mayan calendar scare; or my personal favorite, the Prophet Hen of Leeds). On the other hand, the overall trend of decreased total sperm count in the English-speaking world seems to be true and it raises the interesting question of why.
According to the Mayo Clinic, causes of decreased sperm count include everything from anatomical factors (like varicoceles and ejaculatory issues) and lifestyle issues (such as recreational drugs, weight gain, and emotional stress) to environmental exposures (heavy metal or radiation). The senior author of the aforementioned meta-analysis, Shanna Swan, PhD, has championed another theory: the widespread exposure to endocrine-disrupting chemicals in everyday plastics.
It turns out that at least two chemicals used in the plastics industry, bisphenol A and phthalates, can mimic the effect of estrogen when ingested into the body. Even low levels of these chemicals in our bodies can lead to health problems.
Consider for a moment the presence of plastics in your life: the plastic wrappings on your food, plastic containers for shampoos and beauty products, and even the coatings of our oral supplements. A study by the Centers for Disease Control and Prevention looked at the urine of people participating in the National Health and Nutrition Examination Survey and found detectable concentrations of both of these chemicals in nearly all participants.
In 2045, I intend to be retired. But in the meantime, I think we all need to be aware of the potential impact that various endocrine-disrupting chemicals could be having on humanity. We need more research. If indeed the connection between endocrine disruptors and decreased sperm count is borne out, changes in our environmental exposure to these chemicals need to be made.
Henry Rosevear, MD, is a private-practice urologist based in Colorado Springs. He comes from a long line of doctors, but before entering medicine he served in the U.S. Navy as an officer aboard the USS Pittsburgh, a fast-attack submarine based out of New London, Conn. During his time in the Navy, he served in two deployments to the Persian Gulf, including combat experience as part of Operation Iraqi Freedom. Dr. Rosevear disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.
New recommendations address ME/CFS diagnosis and management
New consensus recommendations address diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), with advice that may also be helpful for patients with lingering symptoms following acute COVID-19 infection.
The document was published online Aug. 25, 2021, in the Mayo Clinic Proceedings by the 23-member U.S. ME/CFS Clinician Coalition, headed by Lucinda Bateman, MD, of the Bateman Horne Center of Excellence, Salt Lake City. The document is the culmination of work that began with a summit held at the center in March 2018.
The target audience is both generalist and specialist health care providers. While ME/CFS is estimated to affect up to 2.5 million Americans, more than 90% are either undiagnosed or misdiagnosed with other conditions such as depression. And those who are diagnosed often receive inappropriate, outdated treatments such as psychotherapy and exercise prescriptions.
“Despite myalgic encephalomyelitis/chronic fatigue syndrome affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful,” Dr. Bateman and colleagues wrote.
The urgency of appropriate recognition and management of ME/CFS has increased as growing numbers of people are exhibiting signs and symptoms of ME/CFS following acute COVID-19 infection. This isn’t surprising because the illness has long been linked to other infections, including Epstein-Barr virus, the authors noted.
The document covers the epidemiology, impact, and prognosis of ME/CFS, as well as etiology and pathophysiology. “Scientific studies demonstrate multiple dysfunctional organ systems, including neuro, immune, and metabolic, in ME/CFS. These findings are not explained merely by deconditioning,” document coauthor Lily Chu, MD, an independent consultant in Burlingame, Calif., said in an interview.
The document reviews the 2015 U.S. Institute of Medicine (now Academy of Medicine) diagnostic criteria that are now also recommended by the Centers for Disease Control and Prevention. They are based on four main symptoms: substantial reduction or impairment in the ability to engage in preillness levels of occupational, educational, social or personal activities for longer than 6 months; postexertional malaise, a worsening of all current symptoms, that patients often describe as a “crash”; unrefreshing sleep; and cognitive impairment and/or orthostatic intolerance.
“The new diagnostic criteria focusing on the key symptom of postexertional malaise rather than chronic fatigue, which is common in many conditions, may make the diagnostic process quicker and more accurate. Diagnosis now is both an inclusionary and not just exclusionary process, so it’s not necessary to eliminate all causes of fatigue. Diagnose patients who fit the criteria and be alert for it in people with persistent symptoms post COVID,” Dr. Chu said.
The document provides advice for taking a clinical history to obtain the information necessary for making the diagnosis, including use of laboratory testing to rule out other conditions. Physical exams, while they may not reveal specific abnormalities, may help in identifying comorbidities and ruling out alternative diagnoses.
A long list of nonpharmacologic and pharmacologic treatment and management approaches is offered for each of the individual core and common ME/CFS symptoms, including postexertional malaise, orthostatic intolerance, sleep issues, cognitive dysfunction and fatigue, immune dysfunction, pain, and gastrointestinal issues.
The document recommends against using the “outdated standard of care” cognitive-behavioral therapy and graded exercise therapy as primary treatments for the illness. Instead, the authors recommend teaching patients “pacing,” an individualized approach to energy conservation aimed at minimizing the frequency, duration, and severity of postexertional malaise.
Clinicians are also advised to assess patients’ daily living needs and provide support, including acquiring handicap placards, work or school accommodations, and disability benefits.
“There are things clinicians can do now to help patients even without a disease-modifying treatment. These are actions they are already familiar with and carry out for people with other chronic diseases, which often have limited treatment options as well. Don’t underestimate the importance and value of supportive care for patients.” Dr. Chu said.
The recommendations are based primarily on clinical expertise because there are very few randomized trials, and much of the evidence from other types of trials has been flawed, document coauthor Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.
“The sad reality is there aren’t very many large randomized clinical trials with this illness and so what a group of very experienced clinicians did was to gather their collective experience and report it as that. It’s largely uncontrolled experience, but from people who have seen a lot of patients, for what it’s worth to the medical community.”
Dr. Komaroff also advised that clinicians watch out for ME/CFS in patients with long COVID. “If we find that those called long COVID meet ME/CFS criteria, the reason for knowing that is that there are already some treatments that according to experienced clinicians are helpful for ME/CFS, and it would be perfectly appropriate to try some of them in long COVID, particularly the ones that have minimal adverse reactions.”
The guidelines project was supported by the Open Medicine Foundation. Dr. Komaroff reported receiving personal fees from Serimmune outside the submitted work. Dr. Chu has no disclosures.
New consensus recommendations address diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), with advice that may also be helpful for patients with lingering symptoms following acute COVID-19 infection.
The document was published online Aug. 25, 2021, in the Mayo Clinic Proceedings by the 23-member U.S. ME/CFS Clinician Coalition, headed by Lucinda Bateman, MD, of the Bateman Horne Center of Excellence, Salt Lake City. The document is the culmination of work that began with a summit held at the center in March 2018.
The target audience is both generalist and specialist health care providers. While ME/CFS is estimated to affect up to 2.5 million Americans, more than 90% are either undiagnosed or misdiagnosed with other conditions such as depression. And those who are diagnosed often receive inappropriate, outdated treatments such as psychotherapy and exercise prescriptions.
“Despite myalgic encephalomyelitis/chronic fatigue syndrome affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful,” Dr. Bateman and colleagues wrote.
The urgency of appropriate recognition and management of ME/CFS has increased as growing numbers of people are exhibiting signs and symptoms of ME/CFS following acute COVID-19 infection. This isn’t surprising because the illness has long been linked to other infections, including Epstein-Barr virus, the authors noted.
The document covers the epidemiology, impact, and prognosis of ME/CFS, as well as etiology and pathophysiology. “Scientific studies demonstrate multiple dysfunctional organ systems, including neuro, immune, and metabolic, in ME/CFS. These findings are not explained merely by deconditioning,” document coauthor Lily Chu, MD, an independent consultant in Burlingame, Calif., said in an interview.
The document reviews the 2015 U.S. Institute of Medicine (now Academy of Medicine) diagnostic criteria that are now also recommended by the Centers for Disease Control and Prevention. They are based on four main symptoms: substantial reduction or impairment in the ability to engage in preillness levels of occupational, educational, social or personal activities for longer than 6 months; postexertional malaise, a worsening of all current symptoms, that patients often describe as a “crash”; unrefreshing sleep; and cognitive impairment and/or orthostatic intolerance.
“The new diagnostic criteria focusing on the key symptom of postexertional malaise rather than chronic fatigue, which is common in many conditions, may make the diagnostic process quicker and more accurate. Diagnosis now is both an inclusionary and not just exclusionary process, so it’s not necessary to eliminate all causes of fatigue. Diagnose patients who fit the criteria and be alert for it in people with persistent symptoms post COVID,” Dr. Chu said.
The document provides advice for taking a clinical history to obtain the information necessary for making the diagnosis, including use of laboratory testing to rule out other conditions. Physical exams, while they may not reveal specific abnormalities, may help in identifying comorbidities and ruling out alternative diagnoses.
A long list of nonpharmacologic and pharmacologic treatment and management approaches is offered for each of the individual core and common ME/CFS symptoms, including postexertional malaise, orthostatic intolerance, sleep issues, cognitive dysfunction and fatigue, immune dysfunction, pain, and gastrointestinal issues.
The document recommends against using the “outdated standard of care” cognitive-behavioral therapy and graded exercise therapy as primary treatments for the illness. Instead, the authors recommend teaching patients “pacing,” an individualized approach to energy conservation aimed at minimizing the frequency, duration, and severity of postexertional malaise.
Clinicians are also advised to assess patients’ daily living needs and provide support, including acquiring handicap placards, work or school accommodations, and disability benefits.
“There are things clinicians can do now to help patients even without a disease-modifying treatment. These are actions they are already familiar with and carry out for people with other chronic diseases, which often have limited treatment options as well. Don’t underestimate the importance and value of supportive care for patients.” Dr. Chu said.
The recommendations are based primarily on clinical expertise because there are very few randomized trials, and much of the evidence from other types of trials has been flawed, document coauthor Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.
“The sad reality is there aren’t very many large randomized clinical trials with this illness and so what a group of very experienced clinicians did was to gather their collective experience and report it as that. It’s largely uncontrolled experience, but from people who have seen a lot of patients, for what it’s worth to the medical community.”
Dr. Komaroff also advised that clinicians watch out for ME/CFS in patients with long COVID. “If we find that those called long COVID meet ME/CFS criteria, the reason for knowing that is that there are already some treatments that according to experienced clinicians are helpful for ME/CFS, and it would be perfectly appropriate to try some of them in long COVID, particularly the ones that have minimal adverse reactions.”
The guidelines project was supported by the Open Medicine Foundation. Dr. Komaroff reported receiving personal fees from Serimmune outside the submitted work. Dr. Chu has no disclosures.
New consensus recommendations address diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), with advice that may also be helpful for patients with lingering symptoms following acute COVID-19 infection.
The document was published online Aug. 25, 2021, in the Mayo Clinic Proceedings by the 23-member U.S. ME/CFS Clinician Coalition, headed by Lucinda Bateman, MD, of the Bateman Horne Center of Excellence, Salt Lake City. The document is the culmination of work that began with a summit held at the center in March 2018.
The target audience is both generalist and specialist health care providers. While ME/CFS is estimated to affect up to 2.5 million Americans, more than 90% are either undiagnosed or misdiagnosed with other conditions such as depression. And those who are diagnosed often receive inappropriate, outdated treatments such as psychotherapy and exercise prescriptions.
“Despite myalgic encephalomyelitis/chronic fatigue syndrome affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful,” Dr. Bateman and colleagues wrote.
The urgency of appropriate recognition and management of ME/CFS has increased as growing numbers of people are exhibiting signs and symptoms of ME/CFS following acute COVID-19 infection. This isn’t surprising because the illness has long been linked to other infections, including Epstein-Barr virus, the authors noted.
The document covers the epidemiology, impact, and prognosis of ME/CFS, as well as etiology and pathophysiology. “Scientific studies demonstrate multiple dysfunctional organ systems, including neuro, immune, and metabolic, in ME/CFS. These findings are not explained merely by deconditioning,” document coauthor Lily Chu, MD, an independent consultant in Burlingame, Calif., said in an interview.
The document reviews the 2015 U.S. Institute of Medicine (now Academy of Medicine) diagnostic criteria that are now also recommended by the Centers for Disease Control and Prevention. They are based on four main symptoms: substantial reduction or impairment in the ability to engage in preillness levels of occupational, educational, social or personal activities for longer than 6 months; postexertional malaise, a worsening of all current symptoms, that patients often describe as a “crash”; unrefreshing sleep; and cognitive impairment and/or orthostatic intolerance.
“The new diagnostic criteria focusing on the key symptom of postexertional malaise rather than chronic fatigue, which is common in many conditions, may make the diagnostic process quicker and more accurate. Diagnosis now is both an inclusionary and not just exclusionary process, so it’s not necessary to eliminate all causes of fatigue. Diagnose patients who fit the criteria and be alert for it in people with persistent symptoms post COVID,” Dr. Chu said.
The document provides advice for taking a clinical history to obtain the information necessary for making the diagnosis, including use of laboratory testing to rule out other conditions. Physical exams, while they may not reveal specific abnormalities, may help in identifying comorbidities and ruling out alternative diagnoses.
A long list of nonpharmacologic and pharmacologic treatment and management approaches is offered for each of the individual core and common ME/CFS symptoms, including postexertional malaise, orthostatic intolerance, sleep issues, cognitive dysfunction and fatigue, immune dysfunction, pain, and gastrointestinal issues.
The document recommends against using the “outdated standard of care” cognitive-behavioral therapy and graded exercise therapy as primary treatments for the illness. Instead, the authors recommend teaching patients “pacing,” an individualized approach to energy conservation aimed at minimizing the frequency, duration, and severity of postexertional malaise.
Clinicians are also advised to assess patients’ daily living needs and provide support, including acquiring handicap placards, work or school accommodations, and disability benefits.
“There are things clinicians can do now to help patients even without a disease-modifying treatment. These are actions they are already familiar with and carry out for people with other chronic diseases, which often have limited treatment options as well. Don’t underestimate the importance and value of supportive care for patients.” Dr. Chu said.
The recommendations are based primarily on clinical expertise because there are very few randomized trials, and much of the evidence from other types of trials has been flawed, document coauthor Anthony L. Komaroff, MD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.
“The sad reality is there aren’t very many large randomized clinical trials with this illness and so what a group of very experienced clinicians did was to gather their collective experience and report it as that. It’s largely uncontrolled experience, but from people who have seen a lot of patients, for what it’s worth to the medical community.”
Dr. Komaroff also advised that clinicians watch out for ME/CFS in patients with long COVID. “If we find that those called long COVID meet ME/CFS criteria, the reason for knowing that is that there are already some treatments that according to experienced clinicians are helpful for ME/CFS, and it would be perfectly appropriate to try some of them in long COVID, particularly the ones that have minimal adverse reactions.”
The guidelines project was supported by the Open Medicine Foundation. Dr. Komaroff reported receiving personal fees from Serimmune outside the submitted work. Dr. Chu has no disclosures.
FROM THE MAYO CLINIC PROCEEDINGS
Not so fast food
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As long as I can remember, children have been notoriously wasteful when dining in school cafeterias. Even those children who bring their own food often return home in the afternoon with their lunches half eaten. Not surprisingly, the food tossed out is often the healthier portion of the meal. Schools have tried a variety of strategies to curb this wastage, including using volunteer student monitors to police and encourage ecologically based recycling.
The authors of a recent study published on JAMA Network Open observed that when elementary and middle-school students were allowed a 20-minute seated lunch period they consumed more food and there was significantly less waste of fruits and vegetable compared with when the students’ lunch period was limited to 10 minutes. Interestingly, there was no difference in the beverage and entrée consumption when the lunch period was doubled.
The authors postulate that younger children may not have acquired the dexterity to feed themselves optimally in the shorter lunch period. I’m not sure I buy that argument. It may be simply that the children ate and drank their favorites first and needed a bit more time to allow their little guts to move things along. But, regardless of the explanation, the investigators’ observations deserve further study.
When I was in high school our lunch period was a full hour, which allowed me to make the half mile walk to home and back to eat a home-prepared meal. The noon hour was when school clubs and committees met and there was a full schedule of diversions to fill out the hour. I don’t recall the seated portion of the lunch period having any time restriction.
By the time my own children were in middle school, lunch periods lasted no longer than 20 minutes. I was not surprised to learn from this recent study that in some schools the seated lunch period has been shortened to 10 minutes. In some cases the truncated lunch periods are a response to space and time limitations. I fear that occasionally, educators and administrators have found it so difficult to keep young children who are accustomed to watching television while they eat engaged that the periods have been shortened to minimize the chaos.
Here in Maine, the governor has just announced plans to offer free breakfast and lunch to every student in response to a federal initiative. If we intend to make nutrition a cornerstone of the educational process this study from the University of Illinois at Urbana-Champaign suggests that we must do more than simply provide the food at no cost. We must somehow carve out more time in the day for the children to eat a healthy diet.
But, where is this time going to come from? Many school systems have already cannibalized physical education to the point that most children are not getting a healthy amount of exercise. It is unfortunate that we have come to expect public school systems to solve all of our societal ills and compensate for less-than-healthy home environments. But that is the reality. If we think nutrition and physical activity are important components of our children’s educations then we must make the time necessary to provide them.
Will this mean longer school days? And will those longer days cost money? You bet they will, but that may be the price we have to pay for healthier, better educated children.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].