For Yuk Ming Dennis Lo, BM BCh, DPhil, a 1996 paper showing the detection of tumor DNA in blood plasma would prove a turning point.

Since the 1960s, clinicians had been searching for a way to glimpse into a fetus’ genetic makeup without disturbing the pregnancy – a fascination Dr. Lo, at the time a graduate student in the United Kingdom, shared.

But the article triggered a thought. If cancer cells could release their DNA into blood plasma, then maybe fetuses could, too. “I had the strange thought that the cancer growing in the patients is a little bit like the placenta that has implanted into the uterus,” he told The New York Times.

The answer was yes. In 1997, having returned home to Hong Kong, Dr. Lo published a seminal article showing that cell-free fetal DNA could be detected in maternal blood. 

He went on to devise methods to detect markers for Down syndrome, creating a noninvasive test that is more than 99% accurate for ruling out the disorder, along with screenings for trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and other chromosome abnormalities.

With the commercial launch of noninvasive prenatal testing (NIPT) in 2011, health care centers around the world quickly embraced the technology as a safe alternative to more invasive methods, such as amniocentesis, for identifying fetal abnormalities. NIPT is now available in over 60 countries and is widely used by clinicians, according to the Lasker Foundation, which granted him the 2022 Lasker DeBakey Clinical Medical Research Award, along with a $250,000 prize.

“I am pleased that since its launch, noninvasive prenatal testing has become a standard of care,” Dr. Lo, chair of the department of chemical pathology at The Chinese University of Hong Kong, said in a video on the Lasker website. “It has also stimulated a global interest in the diagnostic applications of plasma DNA, especially in the area of cancer liquid biopsies and transplantation monitoring. I look forward to seeing these and other yet to be developed applications improving health care worldwide.” 

Dr. Lo’s work has inspired clinical advances and applications, including Rh factor assessments, innovations in cancer technology, transplantation, and beyond, according to Lasker.

Iris Krishna, MD, MPH, director of Perinatal Quality in the Emory Perinatal Center at Emory University School of Medicine, Atlanta, said Dr. Lo’s work has also provided opportunities to screen for other genetic disorders, such as microdeletion syndromes and single gene disorders

“As we continue to learn about the possibilities of this technology, it is imperative for the clinician to be knowledgeable of the benefits and limitations of cell-free DNA screening to be able to counsel their patients appropriately,” Dr. Krishna said.
 

A COVID clearinghouse

Lauren Gardner, PhD, professor in the department of civil and systems engineering at Johns Hopkins University, Baltimore, received the Lasker Bloomberg Public Service Award for her work on the Johns Hopkins’ COVID-19 dashboard, a critical tool for the dissemination of public health data in real time.

According to the Los Angeles Times, Ensheng Dong, Dr. Gardner’s graduate student, approached her about tracking cases of the emerging infection in his home country of China. Mr. Dong mined Chinese websites for early cases of COVID-19 and created online maps using the information. At Dr. Gardner’s suggestion, he expanded the database to include global data.

At the time, according to Lasker, no other institution was providing this information. The World Health Organization created summaries of daily COVID-19 counts, but the data were not as accessible. Dr. Gardner said timely and obtainable information was crucial to craft nimble and rational strategies for combating the pandemic.

“Given the amount of misinformation in circulation and the highly politicized nature of the COVID-19 public health crisis, our work enabled individuals to access the information they needed to make informed decisions to protect themselves, which was especially critical in those locations with delayed or nonexistent policies in place,” Dr. Gardner said in a statement.

Dr. Gardner said she was excited to pursue additional data-centric projects. “I am optimistic that in the future, timely public health information will become increasingly available, especially in times of crisis,” she said. “Moving forward, I am excited to build on our learnings from COVID-19 and transfer that knowledge to address other problems facing societies.”
 

New knowledge of cells, immunology, and disease

The 2022 Albert Lasker Basic Research Award honored three scientists who helped identify a family of proteins that connect cells and assist the immune system in attaching to its targets. The proteins, called integrins, are needed for cells to interact with each other to build complex structures in the body. They are also key to the process T cells undergo to recognize and attack cancer cells.

Awardees Richard O. Hynes, MA, PhD, distinguished professor of cancer research at Massachusetts Institute of Technology; Erkki Ruoslahti, MD, PhD, distinguished professor emeritus at Sanford Burnham Prebys Medical Discovery Institute, La Jolla, California; and Timothy A. Springer, PhD, professor of biological chemistry and molecular biology at Boston Children’s Hospital and Harvard Medical School, independently identified a cell-surface–associated protein that helps cells attach to the extracellular matrix.

“Many of the mysteries of how integrins work are only being discovered today,” Dr. Springer said in his acceptance remarks online.

The discoveries related to integrins have led to several clinical advances, including the development of drugs like the eyedrops lifitegrast, the biologic agent vedolizumab (made using integrins Springer discovered), and tirofiban, a medication used to hamper clotting in cardiovascular diseases.

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

For Yuk Ming Dennis Lo, BM BCh, DPhil, a 1996 paper showing the detection of tumor DNA in blood plasma would prove a turning point.

Since the 1960s, clinicians had been searching for a way to glimpse into a fetus’ genetic makeup without disturbing the pregnancy – a fascination Dr. Lo, at the time a graduate student in the United Kingdom, shared.

But the article triggered a thought. If cancer cells could release their DNA into blood plasma, then maybe fetuses could, too. “I had the strange thought that the cancer growing in the patients is a little bit like the placenta that has implanted into the uterus,” he told The New York Times.

The answer was yes. In 1997, having returned home to Hong Kong, Dr. Lo published a seminal article showing that cell-free fetal DNA could be detected in maternal blood. 

He went on to devise methods to detect markers for Down syndrome, creating a noninvasive test that is more than 99% accurate for ruling out the disorder, along with screenings for trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and other chromosome abnormalities.

With the commercial launch of noninvasive prenatal testing (NIPT) in 2011, health care centers around the world quickly embraced the technology as a safe alternative to more invasive methods, such as amniocentesis, for identifying fetal abnormalities. NIPT is now available in over 60 countries and is widely used by clinicians, according to the Lasker Foundation, which granted him the 2022 Lasker DeBakey Clinical Medical Research Award, along with a $250,000 prize.

“I am pleased that since its launch, noninvasive prenatal testing has become a standard of care,” Dr. Lo, chair of the department of chemical pathology at The Chinese University of Hong Kong, said in a video on the Lasker website. “It has also stimulated a global interest in the diagnostic applications of plasma DNA, especially in the area of cancer liquid biopsies and transplantation monitoring. I look forward to seeing these and other yet to be developed applications improving health care worldwide.” 

Dr. Lo’s work has inspired clinical advances and applications, including Rh factor assessments, innovations in cancer technology, transplantation, and beyond, according to Lasker.

Iris Krishna, MD, MPH, director of Perinatal Quality in the Emory Perinatal Center at Emory University School of Medicine, Atlanta, said Dr. Lo’s work has also provided opportunities to screen for other genetic disorders, such as microdeletion syndromes and single gene disorders

“As we continue to learn about the possibilities of this technology, it is imperative for the clinician to be knowledgeable of the benefits and limitations of cell-free DNA screening to be able to counsel their patients appropriately,” Dr. Krishna said.
 

A COVID clearinghouse

Lauren Gardner, PhD, professor in the department of civil and systems engineering at Johns Hopkins University, Baltimore, received the Lasker Bloomberg Public Service Award for her work on the Johns Hopkins’ COVID-19 dashboard, a critical tool for the dissemination of public health data in real time.

According to the Los Angeles Times, Ensheng Dong, Dr. Gardner’s graduate student, approached her about tracking cases of the emerging infection in his home country of China. Mr. Dong mined Chinese websites for early cases of COVID-19 and created online maps using the information. At Dr. Gardner’s suggestion, he expanded the database to include global data.

At the time, according to Lasker, no other institution was providing this information. The World Health Organization created summaries of daily COVID-19 counts, but the data were not as accessible. Dr. Gardner said timely and obtainable information was crucial to craft nimble and rational strategies for combating the pandemic.

“Given the amount of misinformation in circulation and the highly politicized nature of the COVID-19 public health crisis, our work enabled individuals to access the information they needed to make informed decisions to protect themselves, which was especially critical in those locations with delayed or nonexistent policies in place,” Dr. Gardner said in a statement.

Dr. Gardner said she was excited to pursue additional data-centric projects. “I am optimistic that in the future, timely public health information will become increasingly available, especially in times of crisis,” she said. “Moving forward, I am excited to build on our learnings from COVID-19 and transfer that knowledge to address other problems facing societies.”
 

New knowledge of cells, immunology, and disease

The 2022 Albert Lasker Basic Research Award honored three scientists who helped identify a family of proteins that connect cells and assist the immune system in attaching to its targets. The proteins, called integrins, are needed for cells to interact with each other to build complex structures in the body. They are also key to the process T cells undergo to recognize and attack cancer cells.

Awardees Richard O. Hynes, MA, PhD, distinguished professor of cancer research at Massachusetts Institute of Technology; Erkki Ruoslahti, MD, PhD, distinguished professor emeritus at Sanford Burnham Prebys Medical Discovery Institute, La Jolla, California; and Timothy A. Springer, PhD, professor of biological chemistry and molecular biology at Boston Children’s Hospital and Harvard Medical School, independently identified a cell-surface–associated protein that helps cells attach to the extracellular matrix.

“Many of the mysteries of how integrins work are only being discovered today,” Dr. Springer said in his acceptance remarks online.

The discoveries related to integrins have led to several clinical advances, including the development of drugs like the eyedrops lifitegrast, the biologic agent vedolizumab (made using integrins Springer discovered), and tirofiban, a medication used to hamper clotting in cardiovascular diseases.

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

For Yuk Ming Dennis Lo, BM BCh, DPhil, a 1996 paper showing the detection of tumor DNA in blood plasma would prove a turning point.

Since the 1960s, clinicians had been searching for a way to glimpse into a fetus’ genetic makeup without disturbing the pregnancy – a fascination Dr. Lo, at the time a graduate student in the United Kingdom, shared.

But the article triggered a thought. If cancer cells could release their DNA into blood plasma, then maybe fetuses could, too. “I had the strange thought that the cancer growing in the patients is a little bit like the placenta that has implanted into the uterus,” he told The New York Times.

The answer was yes. In 1997, having returned home to Hong Kong, Dr. Lo published a seminal article showing that cell-free fetal DNA could be detected in maternal blood. 

He went on to devise methods to detect markers for Down syndrome, creating a noninvasive test that is more than 99% accurate for ruling out the disorder, along with screenings for trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and other chromosome abnormalities.

With the commercial launch of noninvasive prenatal testing (NIPT) in 2011, health care centers around the world quickly embraced the technology as a safe alternative to more invasive methods, such as amniocentesis, for identifying fetal abnormalities. NIPT is now available in over 60 countries and is widely used by clinicians, according to the Lasker Foundation, which granted him the 2022 Lasker DeBakey Clinical Medical Research Award, along with a $250,000 prize.

“I am pleased that since its launch, noninvasive prenatal testing has become a standard of care,” Dr. Lo, chair of the department of chemical pathology at The Chinese University of Hong Kong, said in a video on the Lasker website. “It has also stimulated a global interest in the diagnostic applications of plasma DNA, especially in the area of cancer liquid biopsies and transplantation monitoring. I look forward to seeing these and other yet to be developed applications improving health care worldwide.” 

Dr. Lo’s work has inspired clinical advances and applications, including Rh factor assessments, innovations in cancer technology, transplantation, and beyond, according to Lasker.

Iris Krishna, MD, MPH, director of Perinatal Quality in the Emory Perinatal Center at Emory University School of Medicine, Atlanta, said Dr. Lo’s work has also provided opportunities to screen for other genetic disorders, such as microdeletion syndromes and single gene disorders

“As we continue to learn about the possibilities of this technology, it is imperative for the clinician to be knowledgeable of the benefits and limitations of cell-free DNA screening to be able to counsel their patients appropriately,” Dr. Krishna said.
 

A COVID clearinghouse

Lauren Gardner, PhD, professor in the department of civil and systems engineering at Johns Hopkins University, Baltimore, received the Lasker Bloomberg Public Service Award for her work on the Johns Hopkins’ COVID-19 dashboard, a critical tool for the dissemination of public health data in real time.

According to the Los Angeles Times, Ensheng Dong, Dr. Gardner’s graduate student, approached her about tracking cases of the emerging infection in his home country of China. Mr. Dong mined Chinese websites for early cases of COVID-19 and created online maps using the information. At Dr. Gardner’s suggestion, he expanded the database to include global data.

At the time, according to Lasker, no other institution was providing this information. The World Health Organization created summaries of daily COVID-19 counts, but the data were not as accessible. Dr. Gardner said timely and obtainable information was crucial to craft nimble and rational strategies for combating the pandemic.

“Given the amount of misinformation in circulation and the highly politicized nature of the COVID-19 public health crisis, our work enabled individuals to access the information they needed to make informed decisions to protect themselves, which was especially critical in those locations with delayed or nonexistent policies in place,” Dr. Gardner said in a statement.

Dr. Gardner said she was excited to pursue additional data-centric projects. “I am optimistic that in the future, timely public health information will become increasingly available, especially in times of crisis,” she said. “Moving forward, I am excited to build on our learnings from COVID-19 and transfer that knowledge to address other problems facing societies.”
 

New knowledge of cells, immunology, and disease

The 2022 Albert Lasker Basic Research Award honored three scientists who helped identify a family of proteins that connect cells and assist the immune system in attaching to its targets. The proteins, called integrins, are needed for cells to interact with each other to build complex structures in the body. They are also key to the process T cells undergo to recognize and attack cancer cells.

Awardees Richard O. Hynes, MA, PhD, distinguished professor of cancer research at Massachusetts Institute of Technology; Erkki Ruoslahti, MD, PhD, distinguished professor emeritus at Sanford Burnham Prebys Medical Discovery Institute, La Jolla, California; and Timothy A. Springer, PhD, professor of biological chemistry and molecular biology at Boston Children’s Hospital and Harvard Medical School, independently identified a cell-surface–associated protein that helps cells attach to the extracellular matrix.

“Many of the mysteries of how integrins work are only being discovered today,” Dr. Springer said in his acceptance remarks online.

The discoveries related to integrins have led to several clinical advances, including the development of drugs like the eyedrops lifitegrast, the biologic agent vedolizumab (made using integrins Springer discovered), and tirofiban, a medication used to hamper clotting in cardiovascular diseases.

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

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

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

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

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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