Thanks to Reddit, a New Diagnosis Is Bubbling Up Across the US

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Changed
Tue, 09/10/2024 - 13:11

 

In a video posted to Reddit, Lucie Rosenthal’s face starts focused and uncertain, looking intently into the camera, before it happens.

She releases a succinct, croak-like belch.

Then, it’s wide-eyed surprise, followed by rollicking laughter. “I got it!” the Denver resident says after what was her second burp ever.

“It’s really rocking my mind that I am fully introducing a new bodily function at 26 years old,” Ms. Rosenthal later told KFF Health News while working remotely, because, as great as the burping was, it was now happening uncontrollably. “Sorry, excuse me. Oh, my god. That was a burp. Did you hear it?”

Ms. Rosenthal is among more than a thousand people who have received a procedure to help them burp since 2019 when an Illinois doctor first reported the steps of the intervention in a medical journal.

The inability to belch can cause bloating, pain, gurgling in the neck and chest, and excessive flatulence as built-up air seeks an alternate exit route. One Reddit user described the gurgling sound as an “alien trying to escape me,” and pain like a heart attack that goes away with a fart.

The procedure has spread, primarily thanks to increasingly loud rumblings in the bowels of Reddit. Membership in a subreddit for people with or interested in the condition has ballooned to about 31,000 people, to become one of the platform’s larger groups.

Since 2019, the condition has had an official name: retrograde cricopharyngeus dysfunction, also known as “abelchia” or “no-burp syndrome.” The syndrome is caused by a quirk in the muscle that acts as the gatekeeper to the esophagus, the roughly 10-inch-long muscular tube that moves food between the throat and the stomach.

The procedure to fix it involves a doctor injecting 50 to 100 units of Botox — more than twice the amount often used to smooth forehead wrinkles — into the upper cricopharyngeal muscle.

Michael King, MD, the physician who treated Rosenthal, said he hadn’t heard of the disorder until 2020, when a teenager, armed with a list of academic papers found on Reddit, asked him to do the procedure.

It wasn’t a stretch. Dr. King, a laryngologist with Peak ENT and Voice Center, had been injecting Botox in the same muscle to treat people having a hard time swallowing after a stroke.

Now he’s among doctors from Norway to Thailand listed on the subreddit, r/noburp, as offering the procedure. Other doctors, commenters have noted, have occasionally laughed at them or made them feel they were being melodramatic.

To be fair, doctors and researchers don’t understand why the same muscle that lets food move down won’t let air move up.

“It’s very odd,” Dr. King said.

Doctors also aren’t sure why many patients keep burping long after the Botox wears off after a few months. Robert Bastian, MD, a laryngologist outside of Chicago, named the condition and came up with the procedure. He estimates he and his colleagues have treated about 1,800 people, charging about $4,000 a pop.

“We hear that in Southern California it’s $25,000, in Seattle $16,000, in New York City $25,000,” Dr. Bastian said.

Because insurance companies viewed Botox charges as a “red flag,” he said, his patients now pay $650 to cover the medication so it can be excluded from the insurance claims.

The pioneering patient is Daryl Moody, a car technician who has worked at the same Toyota dealership in Houston for half his life. The 34-year-old said that by 2015 he had become “desperate” for relief. The bloating and gurgling wasn’t just a painful shadow over his day; it was cramping his new hobby: skydiving.

“I hadn’t done anything fun or interesting with my life,” he said.

That is, until he tried skydiving. But as he gained altitude on the way up, his stomach would inflate like a bag of chips on a flight.

“I went to 10 doctors,” he said. “Nobody seemed to believe me that this problem even existed.”

Then he stumbled upon a YouTube video by Bastian describing how Botox injections can fix some throat conditions. Moody asked if Bastian could try it to cure his burping problem. Dr. Bastian agreed.

Mr. Moody’s insurance considered it “experimental and unnecessary,” he recalled, so he had to pay about $2,700 out of pocket.

“This is honestly going to change everything,” he posted on his Facebook page in December 2015, about his trip to Illinois.

The year after his procedure, Mr. Moody helped break a national record for participating in the largest group of people to skydive together while wearing wingsuits, those getups that turn people into flying squirrels. He has jumped about 400 times now.

People have been plagued by this issue for at least a few millennia. Two thousand years ago, the Roman philosopher Pliny the Elder described a man named Pomponius who could not belch. And 840 years ago, Johannes de Hauvilla included the tidbit in a poem, writing, “The steaming face of Pomponius could find no relief by belching.”

It took a few more centuries for clinical examples to pop up. In the 1980s, a few case reports in the United States described people who couldn’t burp and had no memory of vomiting. One woman, doctors wrote, was “unable to voluntarily belch along with her childhood friends when this was a popular game.”

The patients were in a great deal of pain, though doctors couldn’t find anything wrong with their anatomy. But the doctors confirmed using a method called manometry that patients’ upper esophageal sphincters simply would not relax — not after a meal of a sandwich, glass of milk, and candy bar, nor after doctors used a catheter to squirt several ounces of air beneath the stubborn valve.

André Smout, MD, PhD, a gastroenterologist at the University of Amsterdam in the Netherlands, said he read those reports when they came out.

“But we never saw the condition, so we didn’t believe that it existed in real life,” he said.

Dr. Smout’s doubts persisted until he and colleagues studied a small group of patients a few years ago. The researchers gave eight patients with a reported inability to burp a “belch provocation” in the form of carbonated water, and used pressure sensors to observe how their throats moved. Indeed, the air stayed trapped. A Botox injection resolved their problems by giving them the ability to burp, or, to use an academic term, eructate.

“We had to admit that it really existed,” Dr. Smout said.

He wrote in Current Opinion in Gastroenterology that the syndrome “may not be as rare as thought hitherto.” He credits Reddit with alerting patients and medical professionals to its existence.

But he wonders how often the treatment might cause a placebo effect. He pointed to studies finding that with conditions such as irritable bowel syndrome, 40% or more of patients who receive placebo treatment feel their symptoms improve. Awareness is also growing about “cyberchondria,” when people search desperately online for answers to their ailments — putting them at risk of unnecessary treatment or further distress.

In Denver, Ms. Rosenthal, the new burper, is open to the idea that the placebo effect could be at play for her. But even if that’s the case, she feels much better.

“I felt perpetual nausea, and that has subsided a lot since I got the procedure done,” she said. So has the bloating and stomach pain. She can drink a beer at happy hour and not feel ill.

She’s pleased insurance covered the procedure, and she’s getting a handle on the involuntary burping. She cannot, however, burp the alphabet.

“Not yet,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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In a video posted to Reddit, Lucie Rosenthal’s face starts focused and uncertain, looking intently into the camera, before it happens.

She releases a succinct, croak-like belch.

Then, it’s wide-eyed surprise, followed by rollicking laughter. “I got it!” the Denver resident says after what was her second burp ever.

“It’s really rocking my mind that I am fully introducing a new bodily function at 26 years old,” Ms. Rosenthal later told KFF Health News while working remotely, because, as great as the burping was, it was now happening uncontrollably. “Sorry, excuse me. Oh, my god. That was a burp. Did you hear it?”

Ms. Rosenthal is among more than a thousand people who have received a procedure to help them burp since 2019 when an Illinois doctor first reported the steps of the intervention in a medical journal.

The inability to belch can cause bloating, pain, gurgling in the neck and chest, and excessive flatulence as built-up air seeks an alternate exit route. One Reddit user described the gurgling sound as an “alien trying to escape me,” and pain like a heart attack that goes away with a fart.

The procedure has spread, primarily thanks to increasingly loud rumblings in the bowels of Reddit. Membership in a subreddit for people with or interested in the condition has ballooned to about 31,000 people, to become one of the platform’s larger groups.

Since 2019, the condition has had an official name: retrograde cricopharyngeus dysfunction, also known as “abelchia” or “no-burp syndrome.” The syndrome is caused by a quirk in the muscle that acts as the gatekeeper to the esophagus, the roughly 10-inch-long muscular tube that moves food between the throat and the stomach.

The procedure to fix it involves a doctor injecting 50 to 100 units of Botox — more than twice the amount often used to smooth forehead wrinkles — into the upper cricopharyngeal muscle.

Michael King, MD, the physician who treated Rosenthal, said he hadn’t heard of the disorder until 2020, when a teenager, armed with a list of academic papers found on Reddit, asked him to do the procedure.

It wasn’t a stretch. Dr. King, a laryngologist with Peak ENT and Voice Center, had been injecting Botox in the same muscle to treat people having a hard time swallowing after a stroke.

Now he’s among doctors from Norway to Thailand listed on the subreddit, r/noburp, as offering the procedure. Other doctors, commenters have noted, have occasionally laughed at them or made them feel they were being melodramatic.

To be fair, doctors and researchers don’t understand why the same muscle that lets food move down won’t let air move up.

“It’s very odd,” Dr. King said.

Doctors also aren’t sure why many patients keep burping long after the Botox wears off after a few months. Robert Bastian, MD, a laryngologist outside of Chicago, named the condition and came up with the procedure. He estimates he and his colleagues have treated about 1,800 people, charging about $4,000 a pop.

“We hear that in Southern California it’s $25,000, in Seattle $16,000, in New York City $25,000,” Dr. Bastian said.

Because insurance companies viewed Botox charges as a “red flag,” he said, his patients now pay $650 to cover the medication so it can be excluded from the insurance claims.

The pioneering patient is Daryl Moody, a car technician who has worked at the same Toyota dealership in Houston for half his life. The 34-year-old said that by 2015 he had become “desperate” for relief. The bloating and gurgling wasn’t just a painful shadow over his day; it was cramping his new hobby: skydiving.

“I hadn’t done anything fun or interesting with my life,” he said.

That is, until he tried skydiving. But as he gained altitude on the way up, his stomach would inflate like a bag of chips on a flight.

“I went to 10 doctors,” he said. “Nobody seemed to believe me that this problem even existed.”

Then he stumbled upon a YouTube video by Bastian describing how Botox injections can fix some throat conditions. Moody asked if Bastian could try it to cure his burping problem. Dr. Bastian agreed.

Mr. Moody’s insurance considered it “experimental and unnecessary,” he recalled, so he had to pay about $2,700 out of pocket.

“This is honestly going to change everything,” he posted on his Facebook page in December 2015, about his trip to Illinois.

The year after his procedure, Mr. Moody helped break a national record for participating in the largest group of people to skydive together while wearing wingsuits, those getups that turn people into flying squirrels. He has jumped about 400 times now.

People have been plagued by this issue for at least a few millennia. Two thousand years ago, the Roman philosopher Pliny the Elder described a man named Pomponius who could not belch. And 840 years ago, Johannes de Hauvilla included the tidbit in a poem, writing, “The steaming face of Pomponius could find no relief by belching.”

It took a few more centuries for clinical examples to pop up. In the 1980s, a few case reports in the United States described people who couldn’t burp and had no memory of vomiting. One woman, doctors wrote, was “unable to voluntarily belch along with her childhood friends when this was a popular game.”

The patients were in a great deal of pain, though doctors couldn’t find anything wrong with their anatomy. But the doctors confirmed using a method called manometry that patients’ upper esophageal sphincters simply would not relax — not after a meal of a sandwich, glass of milk, and candy bar, nor after doctors used a catheter to squirt several ounces of air beneath the stubborn valve.

André Smout, MD, PhD, a gastroenterologist at the University of Amsterdam in the Netherlands, said he read those reports when they came out.

“But we never saw the condition, so we didn’t believe that it existed in real life,” he said.

Dr. Smout’s doubts persisted until he and colleagues studied a small group of patients a few years ago. The researchers gave eight patients with a reported inability to burp a “belch provocation” in the form of carbonated water, and used pressure sensors to observe how their throats moved. Indeed, the air stayed trapped. A Botox injection resolved their problems by giving them the ability to burp, or, to use an academic term, eructate.

“We had to admit that it really existed,” Dr. Smout said.

He wrote in Current Opinion in Gastroenterology that the syndrome “may not be as rare as thought hitherto.” He credits Reddit with alerting patients and medical professionals to its existence.

But he wonders how often the treatment might cause a placebo effect. He pointed to studies finding that with conditions such as irritable bowel syndrome, 40% or more of patients who receive placebo treatment feel their symptoms improve. Awareness is also growing about “cyberchondria,” when people search desperately online for answers to their ailments — putting them at risk of unnecessary treatment or further distress.

In Denver, Ms. Rosenthal, the new burper, is open to the idea that the placebo effect could be at play for her. But even if that’s the case, she feels much better.

“I felt perpetual nausea, and that has subsided a lot since I got the procedure done,” she said. So has the bloating and stomach pain. She can drink a beer at happy hour and not feel ill.

She’s pleased insurance covered the procedure, and she’s getting a handle on the involuntary burping. She cannot, however, burp the alphabet.

“Not yet,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

 

In a video posted to Reddit, Lucie Rosenthal’s face starts focused and uncertain, looking intently into the camera, before it happens.

She releases a succinct, croak-like belch.

Then, it’s wide-eyed surprise, followed by rollicking laughter. “I got it!” the Denver resident says after what was her second burp ever.

“It’s really rocking my mind that I am fully introducing a new bodily function at 26 years old,” Ms. Rosenthal later told KFF Health News while working remotely, because, as great as the burping was, it was now happening uncontrollably. “Sorry, excuse me. Oh, my god. That was a burp. Did you hear it?”

Ms. Rosenthal is among more than a thousand people who have received a procedure to help them burp since 2019 when an Illinois doctor first reported the steps of the intervention in a medical journal.

The inability to belch can cause bloating, pain, gurgling in the neck and chest, and excessive flatulence as built-up air seeks an alternate exit route. One Reddit user described the gurgling sound as an “alien trying to escape me,” and pain like a heart attack that goes away with a fart.

The procedure has spread, primarily thanks to increasingly loud rumblings in the bowels of Reddit. Membership in a subreddit for people with or interested in the condition has ballooned to about 31,000 people, to become one of the platform’s larger groups.

Since 2019, the condition has had an official name: retrograde cricopharyngeus dysfunction, also known as “abelchia” or “no-burp syndrome.” The syndrome is caused by a quirk in the muscle that acts as the gatekeeper to the esophagus, the roughly 10-inch-long muscular tube that moves food between the throat and the stomach.

The procedure to fix it involves a doctor injecting 50 to 100 units of Botox — more than twice the amount often used to smooth forehead wrinkles — into the upper cricopharyngeal muscle.

Michael King, MD, the physician who treated Rosenthal, said he hadn’t heard of the disorder until 2020, when a teenager, armed with a list of academic papers found on Reddit, asked him to do the procedure.

It wasn’t a stretch. Dr. King, a laryngologist with Peak ENT and Voice Center, had been injecting Botox in the same muscle to treat people having a hard time swallowing after a stroke.

Now he’s among doctors from Norway to Thailand listed on the subreddit, r/noburp, as offering the procedure. Other doctors, commenters have noted, have occasionally laughed at them or made them feel they were being melodramatic.

To be fair, doctors and researchers don’t understand why the same muscle that lets food move down won’t let air move up.

“It’s very odd,” Dr. King said.

Doctors also aren’t sure why many patients keep burping long after the Botox wears off after a few months. Robert Bastian, MD, a laryngologist outside of Chicago, named the condition and came up with the procedure. He estimates he and his colleagues have treated about 1,800 people, charging about $4,000 a pop.

“We hear that in Southern California it’s $25,000, in Seattle $16,000, in New York City $25,000,” Dr. Bastian said.

Because insurance companies viewed Botox charges as a “red flag,” he said, his patients now pay $650 to cover the medication so it can be excluded from the insurance claims.

The pioneering patient is Daryl Moody, a car technician who has worked at the same Toyota dealership in Houston for half his life. The 34-year-old said that by 2015 he had become “desperate” for relief. The bloating and gurgling wasn’t just a painful shadow over his day; it was cramping his new hobby: skydiving.

“I hadn’t done anything fun or interesting with my life,” he said.

That is, until he tried skydiving. But as he gained altitude on the way up, his stomach would inflate like a bag of chips on a flight.

“I went to 10 doctors,” he said. “Nobody seemed to believe me that this problem even existed.”

Then he stumbled upon a YouTube video by Bastian describing how Botox injections can fix some throat conditions. Moody asked if Bastian could try it to cure his burping problem. Dr. Bastian agreed.

Mr. Moody’s insurance considered it “experimental and unnecessary,” he recalled, so he had to pay about $2,700 out of pocket.

“This is honestly going to change everything,” he posted on his Facebook page in December 2015, about his trip to Illinois.

The year after his procedure, Mr. Moody helped break a national record for participating in the largest group of people to skydive together while wearing wingsuits, those getups that turn people into flying squirrels. He has jumped about 400 times now.

People have been plagued by this issue for at least a few millennia. Two thousand years ago, the Roman philosopher Pliny the Elder described a man named Pomponius who could not belch. And 840 years ago, Johannes de Hauvilla included the tidbit in a poem, writing, “The steaming face of Pomponius could find no relief by belching.”

It took a few more centuries for clinical examples to pop up. In the 1980s, a few case reports in the United States described people who couldn’t burp and had no memory of vomiting. One woman, doctors wrote, was “unable to voluntarily belch along with her childhood friends when this was a popular game.”

The patients were in a great deal of pain, though doctors couldn’t find anything wrong with their anatomy. But the doctors confirmed using a method called manometry that patients’ upper esophageal sphincters simply would not relax — not after a meal of a sandwich, glass of milk, and candy bar, nor after doctors used a catheter to squirt several ounces of air beneath the stubborn valve.

André Smout, MD, PhD, a gastroenterologist at the University of Amsterdam in the Netherlands, said he read those reports when they came out.

“But we never saw the condition, so we didn’t believe that it existed in real life,” he said.

Dr. Smout’s doubts persisted until he and colleagues studied a small group of patients a few years ago. The researchers gave eight patients with a reported inability to burp a “belch provocation” in the form of carbonated water, and used pressure sensors to observe how their throats moved. Indeed, the air stayed trapped. A Botox injection resolved their problems by giving them the ability to burp, or, to use an academic term, eructate.

“We had to admit that it really existed,” Dr. Smout said.

He wrote in Current Opinion in Gastroenterology that the syndrome “may not be as rare as thought hitherto.” He credits Reddit with alerting patients and medical professionals to its existence.

But he wonders how often the treatment might cause a placebo effect. He pointed to studies finding that with conditions such as irritable bowel syndrome, 40% or more of patients who receive placebo treatment feel their symptoms improve. Awareness is also growing about “cyberchondria,” when people search desperately online for answers to their ailments — putting them at risk of unnecessary treatment or further distress.

In Denver, Ms. Rosenthal, the new burper, is open to the idea that the placebo effect could be at play for her. But even if that’s the case, she feels much better.

“I felt perpetual nausea, and that has subsided a lot since I got the procedure done,” she said. So has the bloating and stomach pain. She can drink a beer at happy hour and not feel ill.

She’s pleased insurance covered the procedure, and she’s getting a handle on the involuntary burping. She cannot, however, burp the alphabet.

“Not yet,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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AI in Medicine Sparks Excitement, Concerns From Experts

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Changed
Tue, 09/10/2024 - 13:00

 

— At the European Respiratory Society (ERS) 2024 Congress, experts discussed the benefits and risks of artificial intelligence (AI) in medicine and explored ethical implications and practical challenges.

With over 600 AI-enabled medical devices registered with the US Food and Drug Administration (FDA) since 2020, AI is rapidly pervading healthcare systems. But like any other medical device, AI tools must be thoroughly assessed and follow strict regulations.

Joshua Hatherley, PhD, a postdoctoral fellow at the School of Philosophy and History of Ideas at Aarhus University in Denmark, said the traditional bioethical principles — autonomy, beneficence, nonmaleficence, and justice — remain a crucial framework for assessing ethics regarding the use of AI tools in medicine. However, he said the emerging fifth principle of “explainability” has gained attention due to the unique characteristics of AI systems.

“Everyone is excited about AI right now, but there are many open questions about how much we can trust it and to what extent we can use it,” Ana Catalina Hernandez Padilla, a clinical researcher at the Université de Limoges, France, told this news organization. 

Joseph Alderman, MBChB, an AI and digital health clinical research fellow at the Institute of Inflammation and Ageing at the University of Birmingham, UK, said these are undoubtedly exciting times to work in AI and health, but he believes clinicians should be “part of the story” and advocate for AI that is safe, effective, and equitable.
 

The Pros

Dr. Alderman said AI has huge potential to improve healthcare and patients’ experiences. 

One interesting area in which AI is being applied is the informed consent process. Conversational AI models, like large language models, can provide patients with a time-unlimited platform to discuss risks, benefits, and recommendations, potentially improving understanding and patient engagement. AI systems can also predict the preferences of noncommunicative patients by analyzing their social media and medical data, which may improve surrogate decision-making and ensure treatment aligns with patient preferences, Dr. Hatherley explained.

Another significant benefit is AI’s capacity to improve patient outcomes through better resource allocation. For example, AI can help optimize the allocation of hospital beds, leading to more efficient use of resources and improved patient health outcomes. 

AI systems can reduce medical errors and enhance diagnosis or treatment plans through large-scale data analysis, leading to faster and more accurate decision-making. It can handle administrative tasks, reducing clinician burnout and allowing healthcare professionals to focus more on patient care.

AI also promises to advance health equity by improving access to quality care in underserved areas. In rural hospitals or developing countries, AI can help fill gaps in clinical expertise, potentially leveling the playing field in access to healthcare.
 

The Cons

Despite its potential, AI in medicine presents several risks that require careful ethical considerations. One primary concern is the possibility of embedded bias in AI systems.

For example, AI-driven advice from an AI agent may prioritize certain outcomes, such as survival, based on broad standards rather than unique patient values, potentially misaligning with the preferences of patients who value quality of life over longevity. “That may interfere with patients’ autonomous decisions,” Dr. Hatherley said.

AI systems also have limited generalizability. Models trained on a specific patient population may perform poorly when applied to different groups due to changes in demographic or clinical characteristics. This can result in less accurate or inappropriate recommendations in real-world settings. “These technologies work on the very narrow population on which the tool was developed but might not necessarily work in the real world,” said Dr. Alderman.

Another significant risk is algorithmic bias, which can worsen health disparities. AI models trained on biased datasets may perpetuate or exacerbate existing inequities in healthcare delivery, leading to suboptimal care for marginalized populations. “We have evidence of algorithms directly discriminating against people with certain characteristics,” Dr. Alderman said.
 

 

 

AI’s Black Box

AI systems, particularly those utilizing deep learning, often function as “black boxes,” meaning their internal decision-making processes are opaque and difficult to interpret. Dr. Hatherley said this lack of transparency raises significant concerns about trust and accountability in clinical decision-making. 

While Explainable AI methods have been developed to offer insights into how these systems generate their recommendations, these explanations frequently fail to capture the reasoning process entirely. Dr. Hatherley explained that this is similar to using a pharmaceutical medicine without a clear understanding of the mechanisms for which it works.

This opacity in AI decision-making can lead to mistrust among clinicians and patients, limiting its effective use in healthcare. “We don’t really know how to interpret the information it provides,” Ms. Hernandez said. 

She said while younger clinicians might be more open to testing the waters with AI tools, older practitioners still prefer to trust their own senses while looking at a patient as a whole and observing the evolution of their disease. “They are not just ticking boxes. They interpret all these variables together to make a medical decision,” she said.

“I am really optimistic about the future of AI,” Dr. Hatherley concluded. “There are still many challenges to overcome, but, ultimately, it’s not enough to talk about how AI should be adapted to human beings. We also need to talk about how humans should adapt to AI.”

Dr. Hatherley, Dr. Alderman, and Ms. Hernandez have reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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— At the European Respiratory Society (ERS) 2024 Congress, experts discussed the benefits and risks of artificial intelligence (AI) in medicine and explored ethical implications and practical challenges.

With over 600 AI-enabled medical devices registered with the US Food and Drug Administration (FDA) since 2020, AI is rapidly pervading healthcare systems. But like any other medical device, AI tools must be thoroughly assessed and follow strict regulations.

Joshua Hatherley, PhD, a postdoctoral fellow at the School of Philosophy and History of Ideas at Aarhus University in Denmark, said the traditional bioethical principles — autonomy, beneficence, nonmaleficence, and justice — remain a crucial framework for assessing ethics regarding the use of AI tools in medicine. However, he said the emerging fifth principle of “explainability” has gained attention due to the unique characteristics of AI systems.

“Everyone is excited about AI right now, but there are many open questions about how much we can trust it and to what extent we can use it,” Ana Catalina Hernandez Padilla, a clinical researcher at the Université de Limoges, France, told this news organization. 

Joseph Alderman, MBChB, an AI and digital health clinical research fellow at the Institute of Inflammation and Ageing at the University of Birmingham, UK, said these are undoubtedly exciting times to work in AI and health, but he believes clinicians should be “part of the story” and advocate for AI that is safe, effective, and equitable.
 

The Pros

Dr. Alderman said AI has huge potential to improve healthcare and patients’ experiences. 

One interesting area in which AI is being applied is the informed consent process. Conversational AI models, like large language models, can provide patients with a time-unlimited platform to discuss risks, benefits, and recommendations, potentially improving understanding and patient engagement. AI systems can also predict the preferences of noncommunicative patients by analyzing their social media and medical data, which may improve surrogate decision-making and ensure treatment aligns with patient preferences, Dr. Hatherley explained.

Another significant benefit is AI’s capacity to improve patient outcomes through better resource allocation. For example, AI can help optimize the allocation of hospital beds, leading to more efficient use of resources and improved patient health outcomes. 

AI systems can reduce medical errors and enhance diagnosis or treatment plans through large-scale data analysis, leading to faster and more accurate decision-making. It can handle administrative tasks, reducing clinician burnout and allowing healthcare professionals to focus more on patient care.

AI also promises to advance health equity by improving access to quality care in underserved areas. In rural hospitals or developing countries, AI can help fill gaps in clinical expertise, potentially leveling the playing field in access to healthcare.
 

The Cons

Despite its potential, AI in medicine presents several risks that require careful ethical considerations. One primary concern is the possibility of embedded bias in AI systems.

For example, AI-driven advice from an AI agent may prioritize certain outcomes, such as survival, based on broad standards rather than unique patient values, potentially misaligning with the preferences of patients who value quality of life over longevity. “That may interfere with patients’ autonomous decisions,” Dr. Hatherley said.

AI systems also have limited generalizability. Models trained on a specific patient population may perform poorly when applied to different groups due to changes in demographic or clinical characteristics. This can result in less accurate or inappropriate recommendations in real-world settings. “These technologies work on the very narrow population on which the tool was developed but might not necessarily work in the real world,” said Dr. Alderman.

Another significant risk is algorithmic bias, which can worsen health disparities. AI models trained on biased datasets may perpetuate or exacerbate existing inequities in healthcare delivery, leading to suboptimal care for marginalized populations. “We have evidence of algorithms directly discriminating against people with certain characteristics,” Dr. Alderman said.
 

 

 

AI’s Black Box

AI systems, particularly those utilizing deep learning, often function as “black boxes,” meaning their internal decision-making processes are opaque and difficult to interpret. Dr. Hatherley said this lack of transparency raises significant concerns about trust and accountability in clinical decision-making. 

While Explainable AI methods have been developed to offer insights into how these systems generate their recommendations, these explanations frequently fail to capture the reasoning process entirely. Dr. Hatherley explained that this is similar to using a pharmaceutical medicine without a clear understanding of the mechanisms for which it works.

This opacity in AI decision-making can lead to mistrust among clinicians and patients, limiting its effective use in healthcare. “We don’t really know how to interpret the information it provides,” Ms. Hernandez said. 

She said while younger clinicians might be more open to testing the waters with AI tools, older practitioners still prefer to trust their own senses while looking at a patient as a whole and observing the evolution of their disease. “They are not just ticking boxes. They interpret all these variables together to make a medical decision,” she said.

“I am really optimistic about the future of AI,” Dr. Hatherley concluded. “There are still many challenges to overcome, but, ultimately, it’s not enough to talk about how AI should be adapted to human beings. We also need to talk about how humans should adapt to AI.”

Dr. Hatherley, Dr. Alderman, and Ms. Hernandez have reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

 

— At the European Respiratory Society (ERS) 2024 Congress, experts discussed the benefits and risks of artificial intelligence (AI) in medicine and explored ethical implications and practical challenges.

With over 600 AI-enabled medical devices registered with the US Food and Drug Administration (FDA) since 2020, AI is rapidly pervading healthcare systems. But like any other medical device, AI tools must be thoroughly assessed and follow strict regulations.

Joshua Hatherley, PhD, a postdoctoral fellow at the School of Philosophy and History of Ideas at Aarhus University in Denmark, said the traditional bioethical principles — autonomy, beneficence, nonmaleficence, and justice — remain a crucial framework for assessing ethics regarding the use of AI tools in medicine. However, he said the emerging fifth principle of “explainability” has gained attention due to the unique characteristics of AI systems.

“Everyone is excited about AI right now, but there are many open questions about how much we can trust it and to what extent we can use it,” Ana Catalina Hernandez Padilla, a clinical researcher at the Université de Limoges, France, told this news organization. 

Joseph Alderman, MBChB, an AI and digital health clinical research fellow at the Institute of Inflammation and Ageing at the University of Birmingham, UK, said these are undoubtedly exciting times to work in AI and health, but he believes clinicians should be “part of the story” and advocate for AI that is safe, effective, and equitable.
 

The Pros

Dr. Alderman said AI has huge potential to improve healthcare and patients’ experiences. 

One interesting area in which AI is being applied is the informed consent process. Conversational AI models, like large language models, can provide patients with a time-unlimited platform to discuss risks, benefits, and recommendations, potentially improving understanding and patient engagement. AI systems can also predict the preferences of noncommunicative patients by analyzing their social media and medical data, which may improve surrogate decision-making and ensure treatment aligns with patient preferences, Dr. Hatherley explained.

Another significant benefit is AI’s capacity to improve patient outcomes through better resource allocation. For example, AI can help optimize the allocation of hospital beds, leading to more efficient use of resources and improved patient health outcomes. 

AI systems can reduce medical errors and enhance diagnosis or treatment plans through large-scale data analysis, leading to faster and more accurate decision-making. It can handle administrative tasks, reducing clinician burnout and allowing healthcare professionals to focus more on patient care.

AI also promises to advance health equity by improving access to quality care in underserved areas. In rural hospitals or developing countries, AI can help fill gaps in clinical expertise, potentially leveling the playing field in access to healthcare.
 

The Cons

Despite its potential, AI in medicine presents several risks that require careful ethical considerations. One primary concern is the possibility of embedded bias in AI systems.

For example, AI-driven advice from an AI agent may prioritize certain outcomes, such as survival, based on broad standards rather than unique patient values, potentially misaligning with the preferences of patients who value quality of life over longevity. “That may interfere with patients’ autonomous decisions,” Dr. Hatherley said.

AI systems also have limited generalizability. Models trained on a specific patient population may perform poorly when applied to different groups due to changes in demographic or clinical characteristics. This can result in less accurate or inappropriate recommendations in real-world settings. “These technologies work on the very narrow population on which the tool was developed but might not necessarily work in the real world,” said Dr. Alderman.

Another significant risk is algorithmic bias, which can worsen health disparities. AI models trained on biased datasets may perpetuate or exacerbate existing inequities in healthcare delivery, leading to suboptimal care for marginalized populations. “We have evidence of algorithms directly discriminating against people with certain characteristics,” Dr. Alderman said.
 

 

 

AI’s Black Box

AI systems, particularly those utilizing deep learning, often function as “black boxes,” meaning their internal decision-making processes are opaque and difficult to interpret. Dr. Hatherley said this lack of transparency raises significant concerns about trust and accountability in clinical decision-making. 

While Explainable AI methods have been developed to offer insights into how these systems generate their recommendations, these explanations frequently fail to capture the reasoning process entirely. Dr. Hatherley explained that this is similar to using a pharmaceutical medicine without a clear understanding of the mechanisms for which it works.

This opacity in AI decision-making can lead to mistrust among clinicians and patients, limiting its effective use in healthcare. “We don’t really know how to interpret the information it provides,” Ms. Hernandez said. 

She said while younger clinicians might be more open to testing the waters with AI tools, older practitioners still prefer to trust their own senses while looking at a patient as a whole and observing the evolution of their disease. “They are not just ticking boxes. They interpret all these variables together to make a medical decision,” she said.

“I am really optimistic about the future of AI,” Dr. Hatherley concluded. “There are still many challenges to overcome, but, ultimately, it’s not enough to talk about how AI should be adapted to human beings. We also need to talk about how humans should adapt to AI.”

Dr. Hatherley, Dr. Alderman, and Ms. Hernandez have reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Survival Rate in Bilateral Lung and Heart-Lung Transplants Comparable

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Changed
Tue, 09/10/2024 - 12:49

 

Survival rates at 1 and 5 years for patients with pulmonary arterial hypertension (PAH) who receive bilateral lung and heart-lung transplants are similar, said researchers presenting at the European Respiratory Society (ERS) 2024 International Congress.

Transplant for end-stage PAH remains an important treatment option. Heart-lung transplantation plummeted from 91.7% to 21.4% between 1991 and 2014. Yet in the United States and Europe, PAH is the second most common reason to perform a heart-lung transplant, said Baharan Zarrabian, DO, a pulmonologist at the Mayo Clinic in Rochester, Minnesota.

Over the past decades, physicians have debated whether to opt for a bilateral lung or a heart-lung transplant. However, there is currently a lack of definitive cardiac indicators to guide the decision between the two procedures in patients with PAH.

While the lung condition has cardiac ramifications, some experts suggest that the heart can repair itself over time after a bilateral lung transplant.
 

No Survival Difference Between Bilateral Lung and Heart-Lung Transplants

Researchers compared the outcomes of bilateral lung transplantation with those of combined heart-lung transplantation in patients with PAH. They used data from the Organ Procurement and Transplantation Network, focusing on adult patients with PAH without congenital or structural cardiac abnormalities who underwent transplantation between June 2004 and September 2022.

The study included 918 patients, with the majority (84.6%) receiving bilateral lung transplants and 15.4% receiving heart-lung transplants. Pretransplant mean pulmonary arterial pressure and pulmonary vascular resistance were similar between the two groups. However, those who received bilateral lung transplants had higher cardiac output and lower pulmonary capillary wedge pressure than those who received heart-lung transplants. A higher percentage of heart-lung transplant recipients required extracorporeal membrane oxygenation (ECMO) before transplantation, while bilateral lung transplant recipients had longer median ischemic times.

Despite these differences in pretransplant characteristics and surgical factors, researchers found no significant difference in survival outcomes between the two groups at the 1-year and 5-year marks. Similarly, graft survival rates at 1 and 5 years posttransplant did not differ significantly between the two groups.

A higher proportion of patients who received bilateral lung transplant were on ECMO and remained intubated at 72 hours. “That did not translate into a worse outcome later on,” Dr. Zarrabian said.
 

Cardiac Recovery Post-Bilateral Lung Transplant

Saskia Bos, MD, PhD, a respiratory consultant, lung transplant physician, and transplant pulmonologist at University Hospitals Leuven, Belgium, who was not involved in the study, told this news organization that doctors have historically preferred combined heart-lung transplantation. The decision was motivated by a lack of understanding regarding whether the heart could remodel on its own. “Now we know that the right ventricle, which is the most affected part of the heart in pulmonary hypertension, has a huge ability to readapt to the new situation after just bilateral lung transplantation,” she said.

Bos suggested that in cases where a patient has pulmonary hypertension without any structural heart defects and where the left side of the heart is functioning normally, doctors can opt for a bilateral lung transplant rather than a combined heart-lung transplant. The right ventricle, typically the only part of the heart affected by the condition, can recover once the pulmonary hypertension is addressed through lung transplantation, she explained.

The advantage of bilateral lung transplantation over a heart-lung transplant is that the donor’s heart remains available for someone else.

“The recommendation is that physicians opt for a bilateral lung transplant,” Dr. Zarrabian concluded. “But we need to make that decision on a case-by-case basis because we still don’t know what are the cardiac parameters that we need to look for before the transplant to decide whether or not they should receive a bilateral lung or a heart-lung.”

Dr. Zarrabian and Dr. Bos reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Survival rates at 1 and 5 years for patients with pulmonary arterial hypertension (PAH) who receive bilateral lung and heart-lung transplants are similar, said researchers presenting at the European Respiratory Society (ERS) 2024 International Congress.

Transplant for end-stage PAH remains an important treatment option. Heart-lung transplantation plummeted from 91.7% to 21.4% between 1991 and 2014. Yet in the United States and Europe, PAH is the second most common reason to perform a heart-lung transplant, said Baharan Zarrabian, DO, a pulmonologist at the Mayo Clinic in Rochester, Minnesota.

Over the past decades, physicians have debated whether to opt for a bilateral lung or a heart-lung transplant. However, there is currently a lack of definitive cardiac indicators to guide the decision between the two procedures in patients with PAH.

While the lung condition has cardiac ramifications, some experts suggest that the heart can repair itself over time after a bilateral lung transplant.
 

No Survival Difference Between Bilateral Lung and Heart-Lung Transplants

Researchers compared the outcomes of bilateral lung transplantation with those of combined heart-lung transplantation in patients with PAH. They used data from the Organ Procurement and Transplantation Network, focusing on adult patients with PAH without congenital or structural cardiac abnormalities who underwent transplantation between June 2004 and September 2022.

The study included 918 patients, with the majority (84.6%) receiving bilateral lung transplants and 15.4% receiving heart-lung transplants. Pretransplant mean pulmonary arterial pressure and pulmonary vascular resistance were similar between the two groups. However, those who received bilateral lung transplants had higher cardiac output and lower pulmonary capillary wedge pressure than those who received heart-lung transplants. A higher percentage of heart-lung transplant recipients required extracorporeal membrane oxygenation (ECMO) before transplantation, while bilateral lung transplant recipients had longer median ischemic times.

Despite these differences in pretransplant characteristics and surgical factors, researchers found no significant difference in survival outcomes between the two groups at the 1-year and 5-year marks. Similarly, graft survival rates at 1 and 5 years posttransplant did not differ significantly between the two groups.

A higher proportion of patients who received bilateral lung transplant were on ECMO and remained intubated at 72 hours. “That did not translate into a worse outcome later on,” Dr. Zarrabian said.
 

Cardiac Recovery Post-Bilateral Lung Transplant

Saskia Bos, MD, PhD, a respiratory consultant, lung transplant physician, and transplant pulmonologist at University Hospitals Leuven, Belgium, who was not involved in the study, told this news organization that doctors have historically preferred combined heart-lung transplantation. The decision was motivated by a lack of understanding regarding whether the heart could remodel on its own. “Now we know that the right ventricle, which is the most affected part of the heart in pulmonary hypertension, has a huge ability to readapt to the new situation after just bilateral lung transplantation,” she said.

Bos suggested that in cases where a patient has pulmonary hypertension without any structural heart defects and where the left side of the heart is functioning normally, doctors can opt for a bilateral lung transplant rather than a combined heart-lung transplant. The right ventricle, typically the only part of the heart affected by the condition, can recover once the pulmonary hypertension is addressed through lung transplantation, she explained.

The advantage of bilateral lung transplantation over a heart-lung transplant is that the donor’s heart remains available for someone else.

“The recommendation is that physicians opt for a bilateral lung transplant,” Dr. Zarrabian concluded. “But we need to make that decision on a case-by-case basis because we still don’t know what are the cardiac parameters that we need to look for before the transplant to decide whether or not they should receive a bilateral lung or a heart-lung.”

Dr. Zarrabian and Dr. Bos reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

 

Survival rates at 1 and 5 years for patients with pulmonary arterial hypertension (PAH) who receive bilateral lung and heart-lung transplants are similar, said researchers presenting at the European Respiratory Society (ERS) 2024 International Congress.

Transplant for end-stage PAH remains an important treatment option. Heart-lung transplantation plummeted from 91.7% to 21.4% between 1991 and 2014. Yet in the United States and Europe, PAH is the second most common reason to perform a heart-lung transplant, said Baharan Zarrabian, DO, a pulmonologist at the Mayo Clinic in Rochester, Minnesota.

Over the past decades, physicians have debated whether to opt for a bilateral lung or a heart-lung transplant. However, there is currently a lack of definitive cardiac indicators to guide the decision between the two procedures in patients with PAH.

While the lung condition has cardiac ramifications, some experts suggest that the heart can repair itself over time after a bilateral lung transplant.
 

No Survival Difference Between Bilateral Lung and Heart-Lung Transplants

Researchers compared the outcomes of bilateral lung transplantation with those of combined heart-lung transplantation in patients with PAH. They used data from the Organ Procurement and Transplantation Network, focusing on adult patients with PAH without congenital or structural cardiac abnormalities who underwent transplantation between June 2004 and September 2022.

The study included 918 patients, with the majority (84.6%) receiving bilateral lung transplants and 15.4% receiving heart-lung transplants. Pretransplant mean pulmonary arterial pressure and pulmonary vascular resistance were similar between the two groups. However, those who received bilateral lung transplants had higher cardiac output and lower pulmonary capillary wedge pressure than those who received heart-lung transplants. A higher percentage of heart-lung transplant recipients required extracorporeal membrane oxygenation (ECMO) before transplantation, while bilateral lung transplant recipients had longer median ischemic times.

Despite these differences in pretransplant characteristics and surgical factors, researchers found no significant difference in survival outcomes between the two groups at the 1-year and 5-year marks. Similarly, graft survival rates at 1 and 5 years posttransplant did not differ significantly between the two groups.

A higher proportion of patients who received bilateral lung transplant were on ECMO and remained intubated at 72 hours. “That did not translate into a worse outcome later on,” Dr. Zarrabian said.
 

Cardiac Recovery Post-Bilateral Lung Transplant

Saskia Bos, MD, PhD, a respiratory consultant, lung transplant physician, and transplant pulmonologist at University Hospitals Leuven, Belgium, who was not involved in the study, told this news organization that doctors have historically preferred combined heart-lung transplantation. The decision was motivated by a lack of understanding regarding whether the heart could remodel on its own. “Now we know that the right ventricle, which is the most affected part of the heart in pulmonary hypertension, has a huge ability to readapt to the new situation after just bilateral lung transplantation,” she said.

Bos suggested that in cases where a patient has pulmonary hypertension without any structural heart defects and where the left side of the heart is functioning normally, doctors can opt for a bilateral lung transplant rather than a combined heart-lung transplant. The right ventricle, typically the only part of the heart affected by the condition, can recover once the pulmonary hypertension is addressed through lung transplantation, she explained.

The advantage of bilateral lung transplantation over a heart-lung transplant is that the donor’s heart remains available for someone else.

“The recommendation is that physicians opt for a bilateral lung transplant,” Dr. Zarrabian concluded. “But we need to make that decision on a case-by-case basis because we still don’t know what are the cardiac parameters that we need to look for before the transplant to decide whether or not they should receive a bilateral lung or a heart-lung.”

Dr. Zarrabian and Dr. Bos reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Controversy Surrounds Optimal Treatment for High-Risk Pulmonary Embolism

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Tue, 09/10/2024 - 12:28

 



— The optimal course of treatment when managing acute, high-risk pulmonary embolism (PE) remains a contentious topic among respiratory specialists.

Systemic thrombolysis, specifically using recombinant tissue plasminogen activator (rtPA), is the current gold standard treatment for high-risk PE. However, the real-world application is less straightforward due to patient complexities. Some clinicians believe that advances in mechanical and surgical techniques have made rtPA a thing of the past. Others think there is still insufficient evidence to support alternatives as the standard of care.

Here at the European Respiratory Society (ERS) 2024 Congress, respiratory specialists presented contrasting viewpoints and the latest evidence on each side of the issue to provide a comprehensive framework for navigating the complex decision-making process required for effective treatment.

“High-risk PE is a mechanical problem and thus needs a mechanical solution,” said Parth M. Rali, MD, an associate professor in thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia.

“The marketing on some of the mechanical techniques is very impressive,” said Olivier Sanchez, MD, a pulmonologist in the Department of Pneumology and Intensive Care at the Georges Pompidou European Hospital in France. “But what is the evidence of such treatment in the setting of pulmonary embolism?”
 

The Case Against rtPA as the Standard of Care

High-risk PE typically involves hemodynamically unstable patients presenting with conditions such as low blood pressure, cardiac arrest, or the need for mechanical circulatory support. There is a spectrum of severity within high-risk PE, making it a complex condition to manage, especially since many patients have comorbidities like anemia or active cancer, complicating treatment. “It’s a very dynamic and fluid condition, and we can’t take for granted that rtPA is a standard of care,” Dr. Rali said.

Alternative treatments such as catheter-directed therapies, extracorporeal membrane oxygenation (ECMO), and surgical embolectomy are emerging as promising options, especially for patients who do not respond to or cannot receive rtPA. Mechanical treatments offer benefits in reducing clot burden and stabilizing patients, but they come with their own challenges.

ECMO can stabilize patients who are in shock or cardiac arrest, buying time for the clot to resolve or for further interventions like surgery or catheter-based treatments, said Dr. Rali. However, it is an invasive procedure requiring cannulation of large blood vessels, often involving significant resources and expertise.

Catheter-directed thrombolysis is a minimally invasive technique where a catheter is inserted directly into the pulmonary artery to deliver thrombolytic drugs at lower doses. This method allows for more targeted treatment of the clot, reducing the risk for systemic bleeding that comes with higher doses of thrombolytic agents used in systemic therapy, Dr. Rali explained. 

Dr. Rali reported results from the FLAME study, which investigated the effectiveness of FlowTriever mechanical thrombectomy compared with conventional therapies for high-risk PE. This prospective, multicenter observational study enrolled 53 patients in the FlowTriever arm and 61 in the context arm, which included patients treated with systemic thrombolysis or anticoagulation. The primary endpoint, a composite of adverse in-hospital outcomes, was reached in 17% of FlowTriever patients, significantly lower than the 32% performance goal and the 63.9% rate in the context arm. In-hospital mortality was dramatically lower in the FlowTriever arm (1.9%) compared to the context arm (29.5%). 

When catheter-based treatment fails, surgical pulmonary embolectomy is a last-resort option. “Only a minority of the high-risk PE [patients] would qualify for rtPA without harmful side effects,” Dr. Rali concluded. “So think wise before you pull your trigger.” 
 

 

 

rtPA Not a Matter of the Past

In high-risk PE, the therapeutic priority is rapid hemodynamic stabilization and restoration of pulmonary blood flow to prevent cardiovascular collapse. Systemic thrombolysis acts quickly, reducing pulmonary vascular resistance and obstruction within hours, said Dr. Sanchez. 

Presenting at the ERS Congress, he reported numerous studies, including 15 randomized controlled trials that demonstrated its effectiveness in high-risk PE. The PEITHO trial, in particular, demonstrated the ability of systemic thrombolysis to reduce all-cause mortality and hemodynamic collapse within 7 days. 

However, this benefit comes at the cost of increased bleeding risk, including a 10% rate of major bleeding and a 2% risk for intracranial hemorrhage. “These data come from old studies using invasive diagnostic procedures, and with current diagnostic procedures, the rate of bleeding is probably lower,” Dr. Sanchez said. The risk of bleeding is also related to the type of thrombolytic agent, with tenecteplase being strongly associated with a higher risk of bleeding, while alteplase shows no increase in the risk of major bleeding, he added. New strategies like reduced-dose thrombolysis offer comparable efficacy and improved safety, as demonstrated in ongoing trials like  PEITHO-3, which aim to optimize the balance between efficacy and bleeding risk. Dr. Sanchez is the lead investigator of the PEITHO-3 study.

While rtPA might not be optimal for all patients, Dr. Sanchez thinks there is not enough evidence to replace it as a first-line treatment.

Existing studies on catheter-directed therapies often focus on surrogate endpoints, such as right-to-left ventricular ratio changes, rather than clinical outcomes like mortality, he said. Retrospective data suggest that catheter-directed therapies may reduce in-hospital mortality compared with systemic therapies, but they also increase the risk of intracranial bleeding, post-procedure complications, and device-related events.

Sanchez mentioned the same FLAME study described by Dr. Rali, which reported a 23% rate of device-related complications and 11% major bleeding in patients treated with catheter-directed therapies. 

“Systemic thrombolysis remains the first treatment of choice,” Dr. Sanchez concluded. “The use of catheter-directed treatment should be discussed as an alternative in case of contraindications.”
 

The Debate Continues

Numerous ongoing clinical studies, such as the FLARE trial, will address gaps in evidence and refine treatment protocols, potentially reshaping the standard of care in high-risk PE in the near future by providing new data on the efficacy and safety of existing and emerging therapies.

“The coming data will make it clearer what the best option is,” said Thamer Al Khouzaie, MD, a pulmonary medicine consultant at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia. For now, he said, systemic thrombolysis remains the best option for most patients because it is widely available, easily administered with intravenous infusion, and at a limited cost. Catheter-directed treatment and surgical options are only available in specialized centers, require expertise and training, and are also very expensive.

Dr. Rali, Dr. Sanchez, and Dr. Khouzaie report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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— The optimal course of treatment when managing acute, high-risk pulmonary embolism (PE) remains a contentious topic among respiratory specialists.

Systemic thrombolysis, specifically using recombinant tissue plasminogen activator (rtPA), is the current gold standard treatment for high-risk PE. However, the real-world application is less straightforward due to patient complexities. Some clinicians believe that advances in mechanical and surgical techniques have made rtPA a thing of the past. Others think there is still insufficient evidence to support alternatives as the standard of care.

Here at the European Respiratory Society (ERS) 2024 Congress, respiratory specialists presented contrasting viewpoints and the latest evidence on each side of the issue to provide a comprehensive framework for navigating the complex decision-making process required for effective treatment.

“High-risk PE is a mechanical problem and thus needs a mechanical solution,” said Parth M. Rali, MD, an associate professor in thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia.

“The marketing on some of the mechanical techniques is very impressive,” said Olivier Sanchez, MD, a pulmonologist in the Department of Pneumology and Intensive Care at the Georges Pompidou European Hospital in France. “But what is the evidence of such treatment in the setting of pulmonary embolism?”
 

The Case Against rtPA as the Standard of Care

High-risk PE typically involves hemodynamically unstable patients presenting with conditions such as low blood pressure, cardiac arrest, or the need for mechanical circulatory support. There is a spectrum of severity within high-risk PE, making it a complex condition to manage, especially since many patients have comorbidities like anemia or active cancer, complicating treatment. “It’s a very dynamic and fluid condition, and we can’t take for granted that rtPA is a standard of care,” Dr. Rali said.

Alternative treatments such as catheter-directed therapies, extracorporeal membrane oxygenation (ECMO), and surgical embolectomy are emerging as promising options, especially for patients who do not respond to or cannot receive rtPA. Mechanical treatments offer benefits in reducing clot burden and stabilizing patients, but they come with their own challenges.

ECMO can stabilize patients who are in shock or cardiac arrest, buying time for the clot to resolve or for further interventions like surgery or catheter-based treatments, said Dr. Rali. However, it is an invasive procedure requiring cannulation of large blood vessels, often involving significant resources and expertise.

Catheter-directed thrombolysis is a minimally invasive technique where a catheter is inserted directly into the pulmonary artery to deliver thrombolytic drugs at lower doses. This method allows for more targeted treatment of the clot, reducing the risk for systemic bleeding that comes with higher doses of thrombolytic agents used in systemic therapy, Dr. Rali explained. 

Dr. Rali reported results from the FLAME study, which investigated the effectiveness of FlowTriever mechanical thrombectomy compared with conventional therapies for high-risk PE. This prospective, multicenter observational study enrolled 53 patients in the FlowTriever arm and 61 in the context arm, which included patients treated with systemic thrombolysis or anticoagulation. The primary endpoint, a composite of adverse in-hospital outcomes, was reached in 17% of FlowTriever patients, significantly lower than the 32% performance goal and the 63.9% rate in the context arm. In-hospital mortality was dramatically lower in the FlowTriever arm (1.9%) compared to the context arm (29.5%). 

When catheter-based treatment fails, surgical pulmonary embolectomy is a last-resort option. “Only a minority of the high-risk PE [patients] would qualify for rtPA without harmful side effects,” Dr. Rali concluded. “So think wise before you pull your trigger.” 
 

 

 

rtPA Not a Matter of the Past

In high-risk PE, the therapeutic priority is rapid hemodynamic stabilization and restoration of pulmonary blood flow to prevent cardiovascular collapse. Systemic thrombolysis acts quickly, reducing pulmonary vascular resistance and obstruction within hours, said Dr. Sanchez. 

Presenting at the ERS Congress, he reported numerous studies, including 15 randomized controlled trials that demonstrated its effectiveness in high-risk PE. The PEITHO trial, in particular, demonstrated the ability of systemic thrombolysis to reduce all-cause mortality and hemodynamic collapse within 7 days. 

However, this benefit comes at the cost of increased bleeding risk, including a 10% rate of major bleeding and a 2% risk for intracranial hemorrhage. “These data come from old studies using invasive diagnostic procedures, and with current diagnostic procedures, the rate of bleeding is probably lower,” Dr. Sanchez said. The risk of bleeding is also related to the type of thrombolytic agent, with tenecteplase being strongly associated with a higher risk of bleeding, while alteplase shows no increase in the risk of major bleeding, he added. New strategies like reduced-dose thrombolysis offer comparable efficacy and improved safety, as demonstrated in ongoing trials like  PEITHO-3, which aim to optimize the balance between efficacy and bleeding risk. Dr. Sanchez is the lead investigator of the PEITHO-3 study.

While rtPA might not be optimal for all patients, Dr. Sanchez thinks there is not enough evidence to replace it as a first-line treatment.

Existing studies on catheter-directed therapies often focus on surrogate endpoints, such as right-to-left ventricular ratio changes, rather than clinical outcomes like mortality, he said. Retrospective data suggest that catheter-directed therapies may reduce in-hospital mortality compared with systemic therapies, but they also increase the risk of intracranial bleeding, post-procedure complications, and device-related events.

Sanchez mentioned the same FLAME study described by Dr. Rali, which reported a 23% rate of device-related complications and 11% major bleeding in patients treated with catheter-directed therapies. 

“Systemic thrombolysis remains the first treatment of choice,” Dr. Sanchez concluded. “The use of catheter-directed treatment should be discussed as an alternative in case of contraindications.”
 

The Debate Continues

Numerous ongoing clinical studies, such as the FLARE trial, will address gaps in evidence and refine treatment protocols, potentially reshaping the standard of care in high-risk PE in the near future by providing new data on the efficacy and safety of existing and emerging therapies.

“The coming data will make it clearer what the best option is,” said Thamer Al Khouzaie, MD, a pulmonary medicine consultant at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia. For now, he said, systemic thrombolysis remains the best option for most patients because it is widely available, easily administered with intravenous infusion, and at a limited cost. Catheter-directed treatment and surgical options are only available in specialized centers, require expertise and training, and are also very expensive.

Dr. Rali, Dr. Sanchez, and Dr. Khouzaie report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

 



— The optimal course of treatment when managing acute, high-risk pulmonary embolism (PE) remains a contentious topic among respiratory specialists.

Systemic thrombolysis, specifically using recombinant tissue plasminogen activator (rtPA), is the current gold standard treatment for high-risk PE. However, the real-world application is less straightforward due to patient complexities. Some clinicians believe that advances in mechanical and surgical techniques have made rtPA a thing of the past. Others think there is still insufficient evidence to support alternatives as the standard of care.

Here at the European Respiratory Society (ERS) 2024 Congress, respiratory specialists presented contrasting viewpoints and the latest evidence on each side of the issue to provide a comprehensive framework for navigating the complex decision-making process required for effective treatment.

“High-risk PE is a mechanical problem and thus needs a mechanical solution,” said Parth M. Rali, MD, an associate professor in thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia.

“The marketing on some of the mechanical techniques is very impressive,” said Olivier Sanchez, MD, a pulmonologist in the Department of Pneumology and Intensive Care at the Georges Pompidou European Hospital in France. “But what is the evidence of such treatment in the setting of pulmonary embolism?”
 

The Case Against rtPA as the Standard of Care

High-risk PE typically involves hemodynamically unstable patients presenting with conditions such as low blood pressure, cardiac arrest, or the need for mechanical circulatory support. There is a spectrum of severity within high-risk PE, making it a complex condition to manage, especially since many patients have comorbidities like anemia or active cancer, complicating treatment. “It’s a very dynamic and fluid condition, and we can’t take for granted that rtPA is a standard of care,” Dr. Rali said.

Alternative treatments such as catheter-directed therapies, extracorporeal membrane oxygenation (ECMO), and surgical embolectomy are emerging as promising options, especially for patients who do not respond to or cannot receive rtPA. Mechanical treatments offer benefits in reducing clot burden and stabilizing patients, but they come with their own challenges.

ECMO can stabilize patients who are in shock or cardiac arrest, buying time for the clot to resolve or for further interventions like surgery or catheter-based treatments, said Dr. Rali. However, it is an invasive procedure requiring cannulation of large blood vessels, often involving significant resources and expertise.

Catheter-directed thrombolysis is a minimally invasive technique where a catheter is inserted directly into the pulmonary artery to deliver thrombolytic drugs at lower doses. This method allows for more targeted treatment of the clot, reducing the risk for systemic bleeding that comes with higher doses of thrombolytic agents used in systemic therapy, Dr. Rali explained. 

Dr. Rali reported results from the FLAME study, which investigated the effectiveness of FlowTriever mechanical thrombectomy compared with conventional therapies for high-risk PE. This prospective, multicenter observational study enrolled 53 patients in the FlowTriever arm and 61 in the context arm, which included patients treated with systemic thrombolysis or anticoagulation. The primary endpoint, a composite of adverse in-hospital outcomes, was reached in 17% of FlowTriever patients, significantly lower than the 32% performance goal and the 63.9% rate in the context arm. In-hospital mortality was dramatically lower in the FlowTriever arm (1.9%) compared to the context arm (29.5%). 

When catheter-based treatment fails, surgical pulmonary embolectomy is a last-resort option. “Only a minority of the high-risk PE [patients] would qualify for rtPA without harmful side effects,” Dr. Rali concluded. “So think wise before you pull your trigger.” 
 

 

 

rtPA Not a Matter of the Past

In high-risk PE, the therapeutic priority is rapid hemodynamic stabilization and restoration of pulmonary blood flow to prevent cardiovascular collapse. Systemic thrombolysis acts quickly, reducing pulmonary vascular resistance and obstruction within hours, said Dr. Sanchez. 

Presenting at the ERS Congress, he reported numerous studies, including 15 randomized controlled trials that demonstrated its effectiveness in high-risk PE. The PEITHO trial, in particular, demonstrated the ability of systemic thrombolysis to reduce all-cause mortality and hemodynamic collapse within 7 days. 

However, this benefit comes at the cost of increased bleeding risk, including a 10% rate of major bleeding and a 2% risk for intracranial hemorrhage. “These data come from old studies using invasive diagnostic procedures, and with current diagnostic procedures, the rate of bleeding is probably lower,” Dr. Sanchez said. The risk of bleeding is also related to the type of thrombolytic agent, with tenecteplase being strongly associated with a higher risk of bleeding, while alteplase shows no increase in the risk of major bleeding, he added. New strategies like reduced-dose thrombolysis offer comparable efficacy and improved safety, as demonstrated in ongoing trials like  PEITHO-3, which aim to optimize the balance between efficacy and bleeding risk. Dr. Sanchez is the lead investigator of the PEITHO-3 study.

While rtPA might not be optimal for all patients, Dr. Sanchez thinks there is not enough evidence to replace it as a first-line treatment.

Existing studies on catheter-directed therapies often focus on surrogate endpoints, such as right-to-left ventricular ratio changes, rather than clinical outcomes like mortality, he said. Retrospective data suggest that catheter-directed therapies may reduce in-hospital mortality compared with systemic therapies, but they also increase the risk of intracranial bleeding, post-procedure complications, and device-related events.

Sanchez mentioned the same FLAME study described by Dr. Rali, which reported a 23% rate of device-related complications and 11% major bleeding in patients treated with catheter-directed therapies. 

“Systemic thrombolysis remains the first treatment of choice,” Dr. Sanchez concluded. “The use of catheter-directed treatment should be discussed as an alternative in case of contraindications.”
 

The Debate Continues

Numerous ongoing clinical studies, such as the FLARE trial, will address gaps in evidence and refine treatment protocols, potentially reshaping the standard of care in high-risk PE in the near future by providing new data on the efficacy and safety of existing and emerging therapies.

“The coming data will make it clearer what the best option is,” said Thamer Al Khouzaie, MD, a pulmonary medicine consultant at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia. For now, he said, systemic thrombolysis remains the best option for most patients because it is widely available, easily administered with intravenous infusion, and at a limited cost. Catheter-directed treatment and surgical options are only available in specialized centers, require expertise and training, and are also very expensive.

Dr. Rali, Dr. Sanchez, and Dr. Khouzaie report no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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GI Involvement Often Present at Time of Pediatric Lupus Diagnosis or Soon After

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TOPLINE:

Gastrointestinal involvement is common in childhood-onset lupus, with more than half of the patients presenting with gastrointestinal symptoms at diagnosis. Abdominal pain and elevated hepatic transaminases are the most common initial signs.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study to explore the prevalence and characteristics of gastrointestinal involvement in childhood-onset systemic lupus erythematosus (SLE).
  • They included 123 patients aged ≤ 18 years (82.1% girls) with childhood-onset SLE from 16 referral departments of pediatric rheumatology in Turkey who showed gastrointestinal system (GIS) involvement either during diagnosis or the course of the disease.
  • The mean age at diagnosis was 12.5 years, and the median follow-up duration was 44.5 months.
  • Demographic information, clinical manifestations, laboratory findings, radiological and endoscopic assessments, histopathologic analyses, treatments, and clinical outcomes were retrospectively extracted from patient records; disease activity and cumulative organ damage were also assessed.

TAKEAWAY:

  • At the time of SLE diagnosis, 63.4% of patients presented with gastrointestinal involvement, while others (36.6%) developed gastrointestinal symptoms after a median of 12 months.
  • Abdominal pain was the most common initial symptom, observed in 62.6% of patients, followed by elevated hepatic transaminases in 56.9%.
  • The most common type of gastrointestinal involvement was autoimmune hepatitis (25.2%), followed by hepatic steatosis (13%), and lupus hepatitis (11.3%).
  • The gastrointestinal manifestations were directly attributed to SLE in 82 patients, were drug related in 35 patients, and caused by comorbidities in 6 patients.

IN PRACTICE:

“It is crucial to consider SLE in the differential diagnosis of GIS [gastrointestinal system] manifestations in children. The inclusion of GIS involvement as a new diagnostic criterion may be warranted, given its potential prevalence that might be higher than currently recognized,” the authors wrote.

SOURCE:

This study was led by Hafize Emine Sönmez, MD, Department of Pediatric Rheumatology, Kocaeli University, İzmit, Turkey, and was published online in Lupus

LIMITATIONS:

The retrospective nature of the study may have limited the ability to establish causality between gastrointestinal symptoms and SLE. This study also did not include a comparison between patients with childhood-onset SLE with gastrointestinal involvement and those without. Moreover, the study relied on patient records for data collection, which may have introduced bias.

DISCLOSURES:

This study did not receive any financial support. The authors declared no potential conflict of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Gastrointestinal involvement is common in childhood-onset lupus, with more than half of the patients presenting with gastrointestinal symptoms at diagnosis. Abdominal pain and elevated hepatic transaminases are the most common initial signs.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study to explore the prevalence and characteristics of gastrointestinal involvement in childhood-onset systemic lupus erythematosus (SLE).
  • They included 123 patients aged ≤ 18 years (82.1% girls) with childhood-onset SLE from 16 referral departments of pediatric rheumatology in Turkey who showed gastrointestinal system (GIS) involvement either during diagnosis or the course of the disease.
  • The mean age at diagnosis was 12.5 years, and the median follow-up duration was 44.5 months.
  • Demographic information, clinical manifestations, laboratory findings, radiological and endoscopic assessments, histopathologic analyses, treatments, and clinical outcomes were retrospectively extracted from patient records; disease activity and cumulative organ damage were also assessed.

TAKEAWAY:

  • At the time of SLE diagnosis, 63.4% of patients presented with gastrointestinal involvement, while others (36.6%) developed gastrointestinal symptoms after a median of 12 months.
  • Abdominal pain was the most common initial symptom, observed in 62.6% of patients, followed by elevated hepatic transaminases in 56.9%.
  • The most common type of gastrointestinal involvement was autoimmune hepatitis (25.2%), followed by hepatic steatosis (13%), and lupus hepatitis (11.3%).
  • The gastrointestinal manifestations were directly attributed to SLE in 82 patients, were drug related in 35 patients, and caused by comorbidities in 6 patients.

IN PRACTICE:

“It is crucial to consider SLE in the differential diagnosis of GIS [gastrointestinal system] manifestations in children. The inclusion of GIS involvement as a new diagnostic criterion may be warranted, given its potential prevalence that might be higher than currently recognized,” the authors wrote.

SOURCE:

This study was led by Hafize Emine Sönmez, MD, Department of Pediatric Rheumatology, Kocaeli University, İzmit, Turkey, and was published online in Lupus

LIMITATIONS:

The retrospective nature of the study may have limited the ability to establish causality between gastrointestinal symptoms and SLE. This study also did not include a comparison between patients with childhood-onset SLE with gastrointestinal involvement and those without. Moreover, the study relied on patient records for data collection, which may have introduced bias.

DISCLOSURES:

This study did not receive any financial support. The authors declared no potential conflict of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Gastrointestinal involvement is common in childhood-onset lupus, with more than half of the patients presenting with gastrointestinal symptoms at diagnosis. Abdominal pain and elevated hepatic transaminases are the most common initial signs.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study to explore the prevalence and characteristics of gastrointestinal involvement in childhood-onset systemic lupus erythematosus (SLE).
  • They included 123 patients aged ≤ 18 years (82.1% girls) with childhood-onset SLE from 16 referral departments of pediatric rheumatology in Turkey who showed gastrointestinal system (GIS) involvement either during diagnosis or the course of the disease.
  • The mean age at diagnosis was 12.5 years, and the median follow-up duration was 44.5 months.
  • Demographic information, clinical manifestations, laboratory findings, radiological and endoscopic assessments, histopathologic analyses, treatments, and clinical outcomes were retrospectively extracted from patient records; disease activity and cumulative organ damage were also assessed.

TAKEAWAY:

  • At the time of SLE diagnosis, 63.4% of patients presented with gastrointestinal involvement, while others (36.6%) developed gastrointestinal symptoms after a median of 12 months.
  • Abdominal pain was the most common initial symptom, observed in 62.6% of patients, followed by elevated hepatic transaminases in 56.9%.
  • The most common type of gastrointestinal involvement was autoimmune hepatitis (25.2%), followed by hepatic steatosis (13%), and lupus hepatitis (11.3%).
  • The gastrointestinal manifestations were directly attributed to SLE in 82 patients, were drug related in 35 patients, and caused by comorbidities in 6 patients.

IN PRACTICE:

“It is crucial to consider SLE in the differential diagnosis of GIS [gastrointestinal system] manifestations in children. The inclusion of GIS involvement as a new diagnostic criterion may be warranted, given its potential prevalence that might be higher than currently recognized,” the authors wrote.

SOURCE:

This study was led by Hafize Emine Sönmez, MD, Department of Pediatric Rheumatology, Kocaeli University, İzmit, Turkey, and was published online in Lupus

LIMITATIONS:

The retrospective nature of the study may have limited the ability to establish causality between gastrointestinal symptoms and SLE. This study also did not include a comparison between patients with childhood-onset SLE with gastrointestinal involvement and those without. Moreover, the study relied on patient records for data collection, which may have introduced bias.

DISCLOSURES:

This study did not receive any financial support. The authors declared no potential conflict of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Not Kidding: Yellow Dye 5 May Lead to Invisibility

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Tue, 09/10/2024 - 12:16

 

The same dye that gives Twinkies their yellowish hue could be the key to invisibility. 

Applying the dye to lab mice made their skin temporarily transparent, allowing Stanford University researchers to observe the rodents’ digestive system, muscle fibers, and blood vessels, according to a study published in Science.

“It’s a stunning result,” said senior author Guosong Hong, PhD, who is assistant professor of materials science and engineering at Stanford University in California. “If the same technique could be applied to humans, it could offer a variety of benefits in biology, diagnostics, and even cosmetics.” 

The work drew upon optical concepts first described in the early 20th century to form a surprising theory: Applying a light-absorbing substance could render skin transparent by reducing the chaotic scattering of light as it strikes proteins, fats, and water in tissue. 

A search for a suitable light absorber led to FD&C Yellow 5, also called tartrazine, a synthetic color additive certified by the Food and Drug Administration (FDA) for use in foods, cosmetics, and medications. 

Rubbed on live mice (after areas of fur were removed using a drugstore depilatory cream), tartrazine rendered skin on their bellies, hind legs, and heads transparent within 5 minutes. With the naked eye, the researchers watched a mouse’s intestines, bladder, and liver at work. Using a microscope, they observed muscle fibers and saw blood vessels in a living mouse’s brain — all without making incisions. Transparency faded quickly when the dye was washed off.

Someday, the concept could be used in doctors’ offices and hospitals, Dr. Hong said. 

“Instead of relying on invasive biopsies, doctors might be able to diagnose deep-seated tumors by simply examining a person’s tissue without the need for invasive surgical removal,” he said. “This technique could potentially make blood draws less painful by helping phlebotomists easily locate veins under the skin. It could also enhance procedures like laser tattoo removal by allowing more precise targeting of the pigment beneath the skin.”
 

From Cake Frosting to Groundbreaking Research

Yellow 5 food dye can be found in everything from cereal, soda, spices, and cake frosting to lipstick, mouthwash, shampoo, dietary supplements, and house paint. Although it’s in some topical medications, more research is needed before it could be used in human diagnostics, said Christopher J. Rowlands, PhD, a senior lecturer in the Department of Bioengineering at Imperial College London, England, where he studies biophotonic instrumentation — ways to image structures inside the body more quickly and clearly. 

But the finding could prove useful in research. In a commentary published in Science, Dr. Rowlands and his colleague Jon Gorecki, PhD, an experimental optical physicist also at Imperial College London, noted that the dye could be an alternative to other optical clearing agents currently used in lab studies, such as glycerol, fructose, or acetic acid. Advantages are the effect is reversible and works at lower concentrations with fewer side effects. This could broaden the types of studies possible in lab animals, so researchers don’t have to rely on naturally transparent creatures like nematodes and zebrafish. 

The dye could also be paired with imaging techniques such as MRI or electron microscopy. 

“Imaging techniques all have pros and cons,” Dr. Rowlands said. “MRI can see all the way through the body albeit with limited resolution and contrast. Electron microscopy has excellent resolution but limited compatibility with live tissue and penetration depth. Optical microscopy has subcellular resolution, the ability to label things, excellent biocompatibility but less than 1 millimeter of penetration depth. This clearing method will give a substantial boost to optical imaging for medicine and biology.”

The discovery could improve the depth imaging equipment can achieve by tenfold, according to the commentary. 

Brain research especially stands to benefit. “Neurobiology in particular will have great use for combinations of multiphoton, optogenetics, and tissue clearing to record and control neural activity over (potentially) the whole mouse brain,” he said.
 

Refraction, Absorption, and The Invisible Man

The dye discovery has distant echoes in H.G. Wells’ 1897 novel The Invisible Man, Dr. Rowlands noted. In the book, a serum makes the main character invisible by changing the light scattering — or refractive index (RI) — of his cells to match the air around him.

The Stanford engineers looked to the past for inspiration, but not to fiction. They turned to a concept first described in the 1920s called the Kramers-Kronig relations, a mathematical principle that can be applied to relationships between the way light is refracted and absorbed in different materials. They also read up on Lorentz oscillation, which describes how electrons and atoms inside molecules react to light. 

They reasoned that light-absorbing compounds could equalize the differences between the light-scattering properties of proteins, lipids, and water that make skin opaque. 

With that, the search was on. The study’s first author, postdoctoral researcher Zihao Ou, PhD, began testing strong dyes to find a candidate. Tartrazine was a front-runner. 

“We found that dye molecules are more efficient in raising the refractive index of water than conventional RI-matching agents, thus resulting in transparency at a much lower concentration,” Dr. Hong said. “The underlying physics, explained by the Lorentz oscillator model and Kramers-Kronig relations, reveals that conventional RI matching agents like fructose are not as efficient because they are not ‘colored’ enough.”
 

What’s Next

Though the dye is already in products that people consume and apply to their skin, medical use is years away. In some people, tartrazine can cause skin or respiratory reactions. 

The National Science Foundation (NSF), which helped fund the research, posted a home or classroom activity related to the work on its website. It involves painting a tartrazine solution on a thin slice of raw chicken breast, making it transparent. The experiment should only be done while wearing a mask, eye protection, lab coat, and lab-quality nitrile gloves for protection, according to the NSF.

Meanwhile, Dr. Hong said his lab is looking for new compounds that will improve visibility through transparent skin, removing a red tone seen in the current experiments. And they’re looking for ways to induce cells to make their own “see-through” compounds. 

“We are exploring methods for cells to express intensely absorbing molecules endogenously, enabling genetically encoded tissue transparency in live animals,” he said.

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

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The same dye that gives Twinkies their yellowish hue could be the key to invisibility. 

Applying the dye to lab mice made their skin temporarily transparent, allowing Stanford University researchers to observe the rodents’ digestive system, muscle fibers, and blood vessels, according to a study published in Science.

“It’s a stunning result,” said senior author Guosong Hong, PhD, who is assistant professor of materials science and engineering at Stanford University in California. “If the same technique could be applied to humans, it could offer a variety of benefits in biology, diagnostics, and even cosmetics.” 

The work drew upon optical concepts first described in the early 20th century to form a surprising theory: Applying a light-absorbing substance could render skin transparent by reducing the chaotic scattering of light as it strikes proteins, fats, and water in tissue. 

A search for a suitable light absorber led to FD&C Yellow 5, also called tartrazine, a synthetic color additive certified by the Food and Drug Administration (FDA) for use in foods, cosmetics, and medications. 

Rubbed on live mice (after areas of fur were removed using a drugstore depilatory cream), tartrazine rendered skin on their bellies, hind legs, and heads transparent within 5 minutes. With the naked eye, the researchers watched a mouse’s intestines, bladder, and liver at work. Using a microscope, they observed muscle fibers and saw blood vessels in a living mouse’s brain — all without making incisions. Transparency faded quickly when the dye was washed off.

Someday, the concept could be used in doctors’ offices and hospitals, Dr. Hong said. 

“Instead of relying on invasive biopsies, doctors might be able to diagnose deep-seated tumors by simply examining a person’s tissue without the need for invasive surgical removal,” he said. “This technique could potentially make blood draws less painful by helping phlebotomists easily locate veins under the skin. It could also enhance procedures like laser tattoo removal by allowing more precise targeting of the pigment beneath the skin.”
 

From Cake Frosting to Groundbreaking Research

Yellow 5 food dye can be found in everything from cereal, soda, spices, and cake frosting to lipstick, mouthwash, shampoo, dietary supplements, and house paint. Although it’s in some topical medications, more research is needed before it could be used in human diagnostics, said Christopher J. Rowlands, PhD, a senior lecturer in the Department of Bioengineering at Imperial College London, England, where he studies biophotonic instrumentation — ways to image structures inside the body more quickly and clearly. 

But the finding could prove useful in research. In a commentary published in Science, Dr. Rowlands and his colleague Jon Gorecki, PhD, an experimental optical physicist also at Imperial College London, noted that the dye could be an alternative to other optical clearing agents currently used in lab studies, such as glycerol, fructose, or acetic acid. Advantages are the effect is reversible and works at lower concentrations with fewer side effects. This could broaden the types of studies possible in lab animals, so researchers don’t have to rely on naturally transparent creatures like nematodes and zebrafish. 

The dye could also be paired with imaging techniques such as MRI or electron microscopy. 

“Imaging techniques all have pros and cons,” Dr. Rowlands said. “MRI can see all the way through the body albeit with limited resolution and contrast. Electron microscopy has excellent resolution but limited compatibility with live tissue and penetration depth. Optical microscopy has subcellular resolution, the ability to label things, excellent biocompatibility but less than 1 millimeter of penetration depth. This clearing method will give a substantial boost to optical imaging for medicine and biology.”

The discovery could improve the depth imaging equipment can achieve by tenfold, according to the commentary. 

Brain research especially stands to benefit. “Neurobiology in particular will have great use for combinations of multiphoton, optogenetics, and tissue clearing to record and control neural activity over (potentially) the whole mouse brain,” he said.
 

Refraction, Absorption, and The Invisible Man

The dye discovery has distant echoes in H.G. Wells’ 1897 novel The Invisible Man, Dr. Rowlands noted. In the book, a serum makes the main character invisible by changing the light scattering — or refractive index (RI) — of his cells to match the air around him.

The Stanford engineers looked to the past for inspiration, but not to fiction. They turned to a concept first described in the 1920s called the Kramers-Kronig relations, a mathematical principle that can be applied to relationships between the way light is refracted and absorbed in different materials. They also read up on Lorentz oscillation, which describes how electrons and atoms inside molecules react to light. 

They reasoned that light-absorbing compounds could equalize the differences between the light-scattering properties of proteins, lipids, and water that make skin opaque. 

With that, the search was on. The study’s first author, postdoctoral researcher Zihao Ou, PhD, began testing strong dyes to find a candidate. Tartrazine was a front-runner. 

“We found that dye molecules are more efficient in raising the refractive index of water than conventional RI-matching agents, thus resulting in transparency at a much lower concentration,” Dr. Hong said. “The underlying physics, explained by the Lorentz oscillator model and Kramers-Kronig relations, reveals that conventional RI matching agents like fructose are not as efficient because they are not ‘colored’ enough.”
 

What’s Next

Though the dye is already in products that people consume and apply to their skin, medical use is years away. In some people, tartrazine can cause skin or respiratory reactions. 

The National Science Foundation (NSF), which helped fund the research, posted a home or classroom activity related to the work on its website. It involves painting a tartrazine solution on a thin slice of raw chicken breast, making it transparent. The experiment should only be done while wearing a mask, eye protection, lab coat, and lab-quality nitrile gloves for protection, according to the NSF.

Meanwhile, Dr. Hong said his lab is looking for new compounds that will improve visibility through transparent skin, removing a red tone seen in the current experiments. And they’re looking for ways to induce cells to make their own “see-through” compounds. 

“We are exploring methods for cells to express intensely absorbing molecules endogenously, enabling genetically encoded tissue transparency in live animals,” he said.

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

 

The same dye that gives Twinkies their yellowish hue could be the key to invisibility. 

Applying the dye to lab mice made their skin temporarily transparent, allowing Stanford University researchers to observe the rodents’ digestive system, muscle fibers, and blood vessels, according to a study published in Science.

“It’s a stunning result,” said senior author Guosong Hong, PhD, who is assistant professor of materials science and engineering at Stanford University in California. “If the same technique could be applied to humans, it could offer a variety of benefits in biology, diagnostics, and even cosmetics.” 

The work drew upon optical concepts first described in the early 20th century to form a surprising theory: Applying a light-absorbing substance could render skin transparent by reducing the chaotic scattering of light as it strikes proteins, fats, and water in tissue. 

A search for a suitable light absorber led to FD&C Yellow 5, also called tartrazine, a synthetic color additive certified by the Food and Drug Administration (FDA) for use in foods, cosmetics, and medications. 

Rubbed on live mice (after areas of fur were removed using a drugstore depilatory cream), tartrazine rendered skin on their bellies, hind legs, and heads transparent within 5 minutes. With the naked eye, the researchers watched a mouse’s intestines, bladder, and liver at work. Using a microscope, they observed muscle fibers and saw blood vessels in a living mouse’s brain — all without making incisions. Transparency faded quickly when the dye was washed off.

Someday, the concept could be used in doctors’ offices and hospitals, Dr. Hong said. 

“Instead of relying on invasive biopsies, doctors might be able to diagnose deep-seated tumors by simply examining a person’s tissue without the need for invasive surgical removal,” he said. “This technique could potentially make blood draws less painful by helping phlebotomists easily locate veins under the skin. It could also enhance procedures like laser tattoo removal by allowing more precise targeting of the pigment beneath the skin.”
 

From Cake Frosting to Groundbreaking Research

Yellow 5 food dye can be found in everything from cereal, soda, spices, and cake frosting to lipstick, mouthwash, shampoo, dietary supplements, and house paint. Although it’s in some topical medications, more research is needed before it could be used in human diagnostics, said Christopher J. Rowlands, PhD, a senior lecturer in the Department of Bioengineering at Imperial College London, England, where he studies biophotonic instrumentation — ways to image structures inside the body more quickly and clearly. 

But the finding could prove useful in research. In a commentary published in Science, Dr. Rowlands and his colleague Jon Gorecki, PhD, an experimental optical physicist also at Imperial College London, noted that the dye could be an alternative to other optical clearing agents currently used in lab studies, such as glycerol, fructose, or acetic acid. Advantages are the effect is reversible and works at lower concentrations with fewer side effects. This could broaden the types of studies possible in lab animals, so researchers don’t have to rely on naturally transparent creatures like nematodes and zebrafish. 

The dye could also be paired with imaging techniques such as MRI or electron microscopy. 

“Imaging techniques all have pros and cons,” Dr. Rowlands said. “MRI can see all the way through the body albeit with limited resolution and contrast. Electron microscopy has excellent resolution but limited compatibility with live tissue and penetration depth. Optical microscopy has subcellular resolution, the ability to label things, excellent biocompatibility but less than 1 millimeter of penetration depth. This clearing method will give a substantial boost to optical imaging for medicine and biology.”

The discovery could improve the depth imaging equipment can achieve by tenfold, according to the commentary. 

Brain research especially stands to benefit. “Neurobiology in particular will have great use for combinations of multiphoton, optogenetics, and tissue clearing to record and control neural activity over (potentially) the whole mouse brain,” he said.
 

Refraction, Absorption, and The Invisible Man

The dye discovery has distant echoes in H.G. Wells’ 1897 novel The Invisible Man, Dr. Rowlands noted. In the book, a serum makes the main character invisible by changing the light scattering — or refractive index (RI) — of his cells to match the air around him.

The Stanford engineers looked to the past for inspiration, but not to fiction. They turned to a concept first described in the 1920s called the Kramers-Kronig relations, a mathematical principle that can be applied to relationships between the way light is refracted and absorbed in different materials. They also read up on Lorentz oscillation, which describes how electrons and atoms inside molecules react to light. 

They reasoned that light-absorbing compounds could equalize the differences between the light-scattering properties of proteins, lipids, and water that make skin opaque. 

With that, the search was on. The study’s first author, postdoctoral researcher Zihao Ou, PhD, began testing strong dyes to find a candidate. Tartrazine was a front-runner. 

“We found that dye molecules are more efficient in raising the refractive index of water than conventional RI-matching agents, thus resulting in transparency at a much lower concentration,” Dr. Hong said. “The underlying physics, explained by the Lorentz oscillator model and Kramers-Kronig relations, reveals that conventional RI matching agents like fructose are not as efficient because they are not ‘colored’ enough.”
 

What’s Next

Though the dye is already in products that people consume and apply to their skin, medical use is years away. In some people, tartrazine can cause skin or respiratory reactions. 

The National Science Foundation (NSF), which helped fund the research, posted a home or classroom activity related to the work on its website. It involves painting a tartrazine solution on a thin slice of raw chicken breast, making it transparent. The experiment should only be done while wearing a mask, eye protection, lab coat, and lab-quality nitrile gloves for protection, according to the NSF.

Meanwhile, Dr. Hong said his lab is looking for new compounds that will improve visibility through transparent skin, removing a red tone seen in the current experiments. And they’re looking for ways to induce cells to make their own “see-through” compounds. 

“We are exploring methods for cells to express intensely absorbing molecules endogenously, enabling genetically encoded tissue transparency in live animals,” he said.

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

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Why More Doctors Are Joining Unions

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Tue, 09/10/2024 - 12:16

 

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

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With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

 

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

 

 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

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Acne: Positive Outcomes Described With Laser Treatment

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Tue, 09/10/2024 - 12:17

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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Topical Tapinarof and Roflumilast for Psoriasis: Where Do they Fit In?

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Tue, 09/10/2024 - 11:51

 

. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

 

. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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Topical Treatment Provides a Noninvasive Option for Pyogenic Granuloma in Children

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Changed
Tue, 09/10/2024 - 11:24

 

— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

 

— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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