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The Long, Controversial Search for a ‘Cancer Microbiome’
Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.
The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.
This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.
But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies?
Cancer Controversy
The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.
The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes.
“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.”
For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.
“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.”
The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?
This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom.
Dr. Salzberg described two major problems with Dr. Knight’s study.
“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”
Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.
Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.
Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed.
The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.
For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.
A 2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading.
It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.
Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed.
Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.”
Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions.
“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
Underdeveloped Technology
Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question.
For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies.
Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one.
Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said.
Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible.
“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.
Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.
Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.
“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said.
Influence on Cancer Treatment Outcomes
Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.
The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said.
Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.
“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost.
“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said.
In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said.
Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.
Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”
It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted.
No Consensus Yet
Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans.
It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges.
“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.
Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.
“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”
A version of this article appeared on Medscape.com.
Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.
The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.
This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.
But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies?
Cancer Controversy
The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.
The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes.
“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.”
For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.
“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.”
The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?
This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom.
Dr. Salzberg described two major problems with Dr. Knight’s study.
“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”
Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.
Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.
Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed.
The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.
For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.
A 2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading.
It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.
Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed.
Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.”
Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions.
“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
Underdeveloped Technology
Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question.
For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies.
Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one.
Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said.
Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible.
“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.
Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.
Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.
“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said.
Influence on Cancer Treatment Outcomes
Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.
The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said.
Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.
“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost.
“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said.
In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said.
Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.
Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”
It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted.
No Consensus Yet
Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans.
It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges.
“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.
Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.
“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”
A version of this article appeared on Medscape.com.
Last year, the controversy heightened when experts questioned a high-profile study — a 2020 analysis claiming that the tumors of 33 different cancers had their own unique microbiomes — on whether the “signature” of these bacterial compositions could help diagnose cancer.
The incident renewed the spotlight on “tumor microbiomes” because of the bold claims of the original paper and the strongly worded refutations of those claims. The broader field has focused primarily on ways the body’s microbiome interacts with cancers and cancer treatment.
This controversy has highlighted the challenges of making headway in a field where researchers may not even have the tools yet to puzzle-out the wide-ranging implications the microbiome holds for cancer diagnosis and treatment.
But it is also part of a provocative question within that larger field: whether tumors in the body, far from the natural microbiome in the gut, have their own thriving communities of bacteria, viruses, and fungi. And, if they do, how do those tumor microbiomes affect the development and progression of the cancer and the effectiveness of cancer therapies?
Cancer Controversy
The evidence is undeniable that some microbes can directly cause certain cancers and that the human gut microbiome can influence the effectiveness of certain therapies. Beyond that established science, however, the research has raised as many questions as answers about what we do and don’t know about microbiota and cancer.
The only confirmed microbiomes are on the skin and in the gut, mouth, and vagina, which are all areas with an easy direct route for bacteria to enter and grow in or on the body. A series of papers in recent years have suggested that other internal organs, and tumors within them, may have their own microbiomes.
“Whether microbes exist in tumors of internal organs beyond body surfaces exposed to the environment is a different matter,” said Ivan Vujkovic-Cvijin, PhD, an assistant professor of biomedical sciences and gastroenterology at Cedars-Sinai Medical Center in Los Angeles, whose lab studies how human gut microbes affect inflammatory diseases. “We’ve only recently had the tools to study that question on a molecular level, and the reported results have been conflicting.”
For example, research allegedly identified microbiota in the human placenta nearly one decade ago. But subsequent research contradicted those claims and showed that the source of the “placental microbiome” was actually contamination. Subsequent similar studies for other parts of the body faced the same scrutiny and, often, eventual debunking.
“Most likely, our immune system has undergone selective pressure to eliminate everything that crosses the gut barrier because there’s not much benefit to the body to have bacteria run amok in our internal organs,” Dr. Vujkovic-Cvijin said. “That can only disrupt the functioning of our tissues, to have an external organism living inside them.”
The controversy that erupted last summer, surrounding research from the lab of Rob Knight, PhD, at the University of California, San Diego, centered on a slightly different but related question: Could tumors harbor their own microbiomes?
This news organization spoke with two of the authors who published a paper contesting Dr. Knight’s findings: Steven Salzberg, PhD, a professor of biomedical engineering at John Hopkins Medicine, Baltimore, Maryland, and Abraham Gihawi, PhD, a research fellow at Norwich Medical School at the University of East Anglia in the United Kingdom.
Dr. Salzberg described two major problems with Dr. Knight’s study.
“What they found were false positives because of contamination in the database and flaws in their methods,” Dr. Salzberg said. “I can’t prove there’s no cancer microbiome, but I can say the cancer microbiomes that they reported don’t exist because the species they were finding aren’t there.”
Dr. Knight disagrees with Dr. Salzberg’s findings, noting that Dr. Salzberg and his co-authors did not examine the publicly available databases used in his study. In a written response, he said that his team’s examination of the database revealed that less than 1% of the microbial genomes overlapped with human ones and that removing them did not change their findings.
Dr. Knight also noted that his team could still “distinguish cancer types by their microbiome” even after running their analysis without the technique that Dr. Salzberg found fault with.
Dr. Salzberg said that the database linked above is not the one Dr. Knight’s study used, however. “The primary database in their study was never made public (it’s too large, they said), and it has/had about 69,000 genomes,” Dr. Salzberg said by email. “But even if we did, this is irrelevant. He’s trying to distract from the primary errors in their study,” which Dr. Salzberg said Dr. Knight’s team has not addressed.
The critiques Dr. Salzberg raised have been leveled at other studies investigating microbiomes specifically within tumors and independent of the body’s microbiome.
For example, a 2019 study in Nature described a fungal microbiome in pancreatic cancer that a Nature paper 4 years later directly contradicted, citing flaws that invalidated the original findings. A different 2019 study in Cell examined pancreatic tumor microbiota and patient outcomes, but it’s unclear whether the microorganisms moved from the gut to the pancreas or “constitute a durably colonized community that lives inside the tumor,” which remains a matter of debate, Dr. Vujkovic-Cvijin said.
A 2020 study in Science suggested diverse microbial communities in seven tumor types, but those findings were similarly called into question. That study stated that “bacteria were first detected in human tumors more than 100 years ago” and that “bacteria are well-known residents in human tumors,” but Dr. Salzberg considers those statements misleading.
It’s true that bacteria and viruses have been detected in tumors because “there’s very good evidence that an acute infection caused by a very small number of viruses and bacteria can cause a tumor,” Dr. Salzberg said. Human papillomavirus, for example, can cause six different types of cancer. Inflammation and ulcers caused by Helicobacter pylori may progress to stomach cancer, and Fusobacterium nucleatum and Enterococcus faecalis have been shown to contribute to colorectal cancer. Those examples differ from a microbiome; this “a community of bacteria and possibly other microscopic bugs, like fungi, that are happily living in the tumor” the same way microbes reside in our guts, he said.
Dr. Knight said that many bacteria his team identified “have been confirmed independently in subsequent work.” He acknowledged, however, that more research is needed.
Several of the contested studies above were among a lengthy list that Dr. Knight provided, noting that most of the disagreements “have two sides to them, and critiques from one particular group does not immediately invalidate a reported finding.”
Yet, many of the papers Dr. Knight listed are precisely the types that skeptics like Dr. Salzberg believe are too flawed to draw reliable conclusions.
“I think many agree that microbes may exist within tumors that are exposed to the environment, like tumors of the skin, gut, and mouth,” Dr. Vujkovic-Cvijin said. It’s less clear, however, whether tumors further from the body’s microbiome harbor any microbes or where they came from if they do. Microbial signals in organs elsewhere in the body become faint quickly, he said.
Underdeveloped Technology
Though Dr. Salzberg said that the concept of a tumor microbiome is “implausible” because there’s no easy route for bacteria to reach internal organs, it’s unclear whether scientists have the technology yet to adequately answer this question.
For one thing, samples in these types of studies are typically “ultra-low biomass samples, where the signal — the amount of microbes in the sample — is so low that it’s comparable to how much would be expected to be found in reagents and environmental contamination through processing,” Dr. Vujkovic-Cvijin explained. Many polymerases used to amplify a DNA signal, for example, are made in bacteria and may retain trace amounts identified in these studies.
Dr. Knight agreed that low biomass is a challenge in this field but is not an unsurmountable one.
Another challenge is that study samples, as with Dr. Knight’s work, were collected during routine surgeries without the intent to find a microbial signal. Simply using a scalpel to cut through the skin means cutting through a layer of bacteria, and surgery rooms are not designed to eliminate all bacteria. Some work has even shown there is a “hospital microbiome,” so “you can easily have that creep into your signal and mistake it for tumor-resident bacteria,” Dr. Vujkovic-Cvijin said.
Dr. Knight asserted that the samples are taken under sterile conditions, but other researchers do not think the level of sterility necessary for completely clean samples is possible.
“Just because it’s in your sample doesn’t mean it was in your tumor,” Dr. Gihawi said.
Even if scientists can retrieve a reliable sample without contamination, analyzing it requires comparing the genetic material to existing databases of microbial genomes. Yet, contamination and misclassification of genetic sequences can be problems in those reference genomes too, Dr. Gihawi explained.
Machine learning algorithms have a role in interpreting data, but “we need to be careful of what we use them for,” he added.
“These techniques are in their infancy, and we’re starting to chase them down, which is why we need to move microbiome research in a way that can be used clinically,” Dr. Gihawi said.
Influence on Cancer Treatment Outcomes
Again, however, the question of whether microbiomes exist within tumors is only one slice of the much larger field looking at microbiomes and cancer, including its influence on cancer treatment outcomes. Although much remains to be learned, less controversy exists over the thousands of studies in the past two decades that have gradually revealed how the body’s microbiome can affect both the course of a cancer and the effectiveness of different treatments.
The growing research showing the importance of the gut microbiome in cancer treatments is not surprising given its role in immunity more broadly. Because the human immune system must recognize and defend against microbes, the microbiome helps train it, Dr. Vujkovic-Cvijin said.
Some bacteria can escape the gut — a phenomenon called bacterial translocation — and may aid in fighting tumors. To grow large enough to be seen on imaging, tumors need to evolve several abilities, such as growing enough vascularization to receive blood flow and shutting down local immune responses.
“Any added boost, like immunotherapy, has a chance of breaking through that immune forcefield and killing the tumor cells,” Dr. Vujkovic-Cvijin said. Escaped gut bacteria may provide that boost.
“There’s a lot of evidence that depletion of the gut microbiome impairs immunotherapy and chemotherapy. The thinking behind some of those studies is that gut microbes can cross the gut barrier and when they do, they activate the immune system,” he said.
In mice engineered to have sterile guts, for example, the lack of bacteria results in less effective immune systems, Dr. Vujkovic-Cvijin pointed out. A host of research has shown that antibiotic exposure during and even 6 months before immunotherapy dramatically reduces survival rates. “That’s pretty convincing to me that gut microbes are important,” he said.
Dr. Vujkovic-Cvijin cautioned that there continues to be controversy on understanding which bacteria are important for response to immunotherapy. “The field is still in its infancy in terms of understanding which bacteria are most important for these effects,” he said.
Dr. Knight suggested that escaped bacteria may be the genesis of the ones that he and other researchers believe exist in tumors. “Because tumor microbes must come from somewhere, it is to be expected that some of those microbes will be co-opted from body-site specific commensals.”
It’s also possible that metabolites released from gut bacteria escape the gut and could theoretically affect distant tumor growth, Dr. Gihawi said. The most promising avenue of research in this area is metabolites being used as biomarkers, added Dr. Gihawi, whose lab published research on a link between bacteria detected in men’s urine and a more aggressive subset of prostate cancers. But that research is not far enough along to develop lab tests for clinical use, he noted.
No Consensus Yet
Even before the controversy erupted around Dr. Knight’s research, he co-founded the company Micronoma to develop cancer tests based on his microbe findings. The company has raised $17.5 million from private investors as of August 2023 and received the US Food and Drug Administration’s Breakthrough Device designation, allowing the firm to fast-track clinical trials testing the technology. The recent critiques have not changed the company’s plans.
It’s safe to say that scientists will continue to research and debate the possibility of tumor microbiomes until a consensus emerges.
“The field is evolving and studies testing the reproducibility of tumor-resident microbial signals are essential for developing our understanding in this area,” Dr. Vujkovic-Cvijin said.
Even if that path ultimately leads nowhere, as Dr. Salzberg expects, research into microbiomes and cancer has plenty of other directions to go.
“I’m actually quite an optimist,” Dr. Gihawi said. “I think there’s a lot of scope for some really good research here, especially in the sites where we know there is a strong microbiome, such as the gastrointestinal tract.”
A version of this article appeared on Medscape.com.
Prospect of Better Hours, Less Burnout Fuels Locum Tenens
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.
In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.
The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).
“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.
“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”
These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:
- Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
- Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
- Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
- The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.
Trying Locum Tenens Early in Career
According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.
In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.
Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).
“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”
A version of this article appeared on Medscape.com.
This Tech Will Change Your Practice Sooner Than You Think
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.
1. Artificial Intelligence (AI) Medical Scribes
You may already be using this or, at the very least, have heard about it.
Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.
“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.
Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”
Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.
“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”
Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”
2. Three-Dimensional (3D) Printing
Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.
“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”
Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.
“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.
The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.
3. Drones
For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.
Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.
Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.
“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.
According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.
4. Portable Ultrasound
Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.
AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.
“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.
More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.
5. Virtual Reality (VR)
When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.
“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.
Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.
“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”
Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.
Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.
A version of this article appeared on Medscape.com.
Childhood Weight-Related Trauma Can Last into Adulthood
This can continue to be the case as long as two decades after the childhood experiences.
“Internalised weight stigma” happens when a person adopts negative obesity-related stereotypes, such as thinking they are less attractive, less competent, or less valuable as a person due to their weight, even in situations where their BMI suggests such a view is not valid.
Researchers at the universities of Bristol and Leeds, with colleagues at institutions interested in weight and mental health issues, analyzed the link between internalised weight stigma in adulthood and adolescent experiences and social circumstances. Their work used data obtained as part of Bristol University’s ongoing Children of the 90s project. This recruited thousands of pregnant women between 1990 and 1991, and has now followed the health of them and their families for more than 30 years.
The investigation, published in The Lancet Regional Health, examined differences in internalised weight stigma in more than 4000 people aged 31 years, focusing on effects of sex, ethnicity, socioeconomic factors, sexual orientation, and family and wider social influences in childhood and adolescence. The data were obtained from responses to 11 targeted questions included within the more general questionnaire completed by Children of the 90s participants when aged 31.
Effects Unrelated to Weight
Social epidemiologist Amanda Hughes, BSc, MSc, PhD, at the MRC Epidemiology Unit in Bristol Medical School, first author of the research report, said that the study “was not about what weight you think you are, but about how that relates to your view of yourself as a human being.” She explained that the research identified factors that led to higher levels of long-term internalised weight stigma in adults two decades after negative experiences in childhood or youth, “regardless of what their actual weight was.” Even people in the acceptable BMI range had levels of internalised weight stigma that were associated with experiences around two decades earlier.
The headline finding of the study was that those most at risk of developing internalised weight stigma were females, sexual minorities, and people experiencing socioeconomic disadvantage. People who as teenagers felt pressure to lose weight from family, wider social interactions, or the media were also at elevated risk.
“There are definitely inequalities in who was affected by this psychologically,” Dr. Hughes said, and the inequalities were associated with the sex, nonheterosexuality, or socioeconomic circumstances, rather than being explained by differences in BMI. The differences in the psychological impact of negative early-life weight-related experiences, such as pressure from family, teasing, bullying, and general weight-shaming, showed up even among people of the same weight.
Dr. Hughes emphasized that the new value of this research comes from its sample size, the general spread of people sampled, and the long length of time over which the relationships between experiences and effects were analyzed. Previous evidence, globally, has come from small and nonrepresentative samples, such as psychology undergraduates or people engaged in weight management programs.
Rebecca Puhl, PhD, professor of human development and family sciences at Connecticut University, an internationally prominent researcher of internalized weight stigma issues, said: “This study adds new insights to the increasing evidence on internalised weight bias. Their findings that internalised weight bias is elevated among individuals with sexual minority identities and those with socioeconomically disadvantaged backgrounds highlight the importance of addressing weight stigma and its consequences among populations with multiple stigmatised identities.” She added that the findings “reiterate the need for far-reaching stigma reduction interventions.” Dr. Puhl was not involved in this study.
Promote Healthy, Not Thin
Dr. Hughes stressed that interventions to address the issue, by efforts to change attitudes in family life, the media, and other approaches, should continue to promote healthy weight management amongst youngsters, while avoiding the dangers of inappropriate stigma and the resulting mental health problems.
“The crucial thing is … don’t frame [nutritional guidance] in terms of: if you do these things you’ll be thinner and thinner is better,” Dr. Hughes said. She stressed that the most important approach is to promote good nutrition for health, without making it all about being thin.
Dr. Hughes said there are many further things the researchers would like to do to take their work forward, including getting a more detailed look at the psychological processes involved and the relationship between internalised weight stigma and other aspects of mental health.
Dr. Hughes has no relevant interests to disclose. Dr. Puhl has no relevant interests to disclose, but is currently receiving funding from Eli Lilly.
A version of this article appeared on Medscape.com.
This can continue to be the case as long as two decades after the childhood experiences.
“Internalised weight stigma” happens when a person adopts negative obesity-related stereotypes, such as thinking they are less attractive, less competent, or less valuable as a person due to their weight, even in situations where their BMI suggests such a view is not valid.
Researchers at the universities of Bristol and Leeds, with colleagues at institutions interested in weight and mental health issues, analyzed the link between internalised weight stigma in adulthood and adolescent experiences and social circumstances. Their work used data obtained as part of Bristol University’s ongoing Children of the 90s project. This recruited thousands of pregnant women between 1990 and 1991, and has now followed the health of them and their families for more than 30 years.
The investigation, published in The Lancet Regional Health, examined differences in internalised weight stigma in more than 4000 people aged 31 years, focusing on effects of sex, ethnicity, socioeconomic factors, sexual orientation, and family and wider social influences in childhood and adolescence. The data were obtained from responses to 11 targeted questions included within the more general questionnaire completed by Children of the 90s participants when aged 31.
Effects Unrelated to Weight
Social epidemiologist Amanda Hughes, BSc, MSc, PhD, at the MRC Epidemiology Unit in Bristol Medical School, first author of the research report, said that the study “was not about what weight you think you are, but about how that relates to your view of yourself as a human being.” She explained that the research identified factors that led to higher levels of long-term internalised weight stigma in adults two decades after negative experiences in childhood or youth, “regardless of what their actual weight was.” Even people in the acceptable BMI range had levels of internalised weight stigma that were associated with experiences around two decades earlier.
The headline finding of the study was that those most at risk of developing internalised weight stigma were females, sexual minorities, and people experiencing socioeconomic disadvantage. People who as teenagers felt pressure to lose weight from family, wider social interactions, or the media were also at elevated risk.
“There are definitely inequalities in who was affected by this psychologically,” Dr. Hughes said, and the inequalities were associated with the sex, nonheterosexuality, or socioeconomic circumstances, rather than being explained by differences in BMI. The differences in the psychological impact of negative early-life weight-related experiences, such as pressure from family, teasing, bullying, and general weight-shaming, showed up even among people of the same weight.
Dr. Hughes emphasized that the new value of this research comes from its sample size, the general spread of people sampled, and the long length of time over which the relationships between experiences and effects were analyzed. Previous evidence, globally, has come from small and nonrepresentative samples, such as psychology undergraduates or people engaged in weight management programs.
Rebecca Puhl, PhD, professor of human development and family sciences at Connecticut University, an internationally prominent researcher of internalized weight stigma issues, said: “This study adds new insights to the increasing evidence on internalised weight bias. Their findings that internalised weight bias is elevated among individuals with sexual minority identities and those with socioeconomically disadvantaged backgrounds highlight the importance of addressing weight stigma and its consequences among populations with multiple stigmatised identities.” She added that the findings “reiterate the need for far-reaching stigma reduction interventions.” Dr. Puhl was not involved in this study.
Promote Healthy, Not Thin
Dr. Hughes stressed that interventions to address the issue, by efforts to change attitudes in family life, the media, and other approaches, should continue to promote healthy weight management amongst youngsters, while avoiding the dangers of inappropriate stigma and the resulting mental health problems.
“The crucial thing is … don’t frame [nutritional guidance] in terms of: if you do these things you’ll be thinner and thinner is better,” Dr. Hughes said. She stressed that the most important approach is to promote good nutrition for health, without making it all about being thin.
Dr. Hughes said there are many further things the researchers would like to do to take their work forward, including getting a more detailed look at the psychological processes involved and the relationship between internalised weight stigma and other aspects of mental health.
Dr. Hughes has no relevant interests to disclose. Dr. Puhl has no relevant interests to disclose, but is currently receiving funding from Eli Lilly.
A version of this article appeared on Medscape.com.
This can continue to be the case as long as two decades after the childhood experiences.
“Internalised weight stigma” happens when a person adopts negative obesity-related stereotypes, such as thinking they are less attractive, less competent, or less valuable as a person due to their weight, even in situations where their BMI suggests such a view is not valid.
Researchers at the universities of Bristol and Leeds, with colleagues at institutions interested in weight and mental health issues, analyzed the link between internalised weight stigma in adulthood and adolescent experiences and social circumstances. Their work used data obtained as part of Bristol University’s ongoing Children of the 90s project. This recruited thousands of pregnant women between 1990 and 1991, and has now followed the health of them and their families for more than 30 years.
The investigation, published in The Lancet Regional Health, examined differences in internalised weight stigma in more than 4000 people aged 31 years, focusing on effects of sex, ethnicity, socioeconomic factors, sexual orientation, and family and wider social influences in childhood and adolescence. The data were obtained from responses to 11 targeted questions included within the more general questionnaire completed by Children of the 90s participants when aged 31.
Effects Unrelated to Weight
Social epidemiologist Amanda Hughes, BSc, MSc, PhD, at the MRC Epidemiology Unit in Bristol Medical School, first author of the research report, said that the study “was not about what weight you think you are, but about how that relates to your view of yourself as a human being.” She explained that the research identified factors that led to higher levels of long-term internalised weight stigma in adults two decades after negative experiences in childhood or youth, “regardless of what their actual weight was.” Even people in the acceptable BMI range had levels of internalised weight stigma that were associated with experiences around two decades earlier.
The headline finding of the study was that those most at risk of developing internalised weight stigma were females, sexual minorities, and people experiencing socioeconomic disadvantage. People who as teenagers felt pressure to lose weight from family, wider social interactions, or the media were also at elevated risk.
“There are definitely inequalities in who was affected by this psychologically,” Dr. Hughes said, and the inequalities were associated with the sex, nonheterosexuality, or socioeconomic circumstances, rather than being explained by differences in BMI. The differences in the psychological impact of negative early-life weight-related experiences, such as pressure from family, teasing, bullying, and general weight-shaming, showed up even among people of the same weight.
Dr. Hughes emphasized that the new value of this research comes from its sample size, the general spread of people sampled, and the long length of time over which the relationships between experiences and effects were analyzed. Previous evidence, globally, has come from small and nonrepresentative samples, such as psychology undergraduates or people engaged in weight management programs.
Rebecca Puhl, PhD, professor of human development and family sciences at Connecticut University, an internationally prominent researcher of internalized weight stigma issues, said: “This study adds new insights to the increasing evidence on internalised weight bias. Their findings that internalised weight bias is elevated among individuals with sexual minority identities and those with socioeconomically disadvantaged backgrounds highlight the importance of addressing weight stigma and its consequences among populations with multiple stigmatised identities.” She added that the findings “reiterate the need for far-reaching stigma reduction interventions.” Dr. Puhl was not involved in this study.
Promote Healthy, Not Thin
Dr. Hughes stressed that interventions to address the issue, by efforts to change attitudes in family life, the media, and other approaches, should continue to promote healthy weight management amongst youngsters, while avoiding the dangers of inappropriate stigma and the resulting mental health problems.
“The crucial thing is … don’t frame [nutritional guidance] in terms of: if you do these things you’ll be thinner and thinner is better,” Dr. Hughes said. She stressed that the most important approach is to promote good nutrition for health, without making it all about being thin.
Dr. Hughes said there are many further things the researchers would like to do to take their work forward, including getting a more detailed look at the psychological processes involved and the relationship between internalised weight stigma and other aspects of mental health.
Dr. Hughes has no relevant interests to disclose. Dr. Puhl has no relevant interests to disclose, but is currently receiving funding from Eli Lilly.
A version of this article appeared on Medscape.com.
FROM THE LANCET REGIONAL HEALTH
Digital Inhaler Discontinuations: Not Enough Uptake of Device
On the heels of the January 2024 announcement by GlaxoSmithKline that its Flovent inhalers are being discontinued, Teva’s recent announcement that it will discontinue U.S. distribution of its Digihaler® products is adding concern and complication to patients’ and physicians’ efforts to manage asthma symptoms.
“It is unfortunate to hear that more asthma inhalers are being discontinued,” Asthma and Allergy Foundation of America (AAFA) President and CEO Kenneth Mendez, said in an interview. The impact of Teva’s June 1 discontinuations of its Digihaler portfolio (ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler), he added, is only partially softened by Teva’s reassurance that its still-available RespiClick devices deliver the same drug formulations via the same devices as the ProAir and AirDuo products — because they lack the innovative digital component. “The Teva Digihaler portfolio had offered an innovative approach to encourage adherence to treatment by integrating a digital solution with an inhaler.”
Digital App Companion to Inhaler
The digital components of the AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and ArmonAir Digihaler (fluticasone propionate) inhalation powder, both maintenance inhalers for patients 12-years or older with asthma, include built-in Bluetooth® wireless technology that connects to a companion mobile app. Their triggers for recording data on inhaler use are either the opening of the inhaler cap or the patient’s inhalation. The devices detect, record, and store data on inhaler use and peak inspiratory flow.
Also, they can remind the patient as to how often the devices have been used, measure inspiratory flow rates, and indicate when inhalation technique may need improvement. Data are then directly sent to the Digihaler app via Bluetooth technology, giving discretion to patients as to whether or not their data will be shared with health care providers.
When patients share their digital inhaler device-recorded data, Teva sources state, providers can more objectively assess the patients’ inhaler use patterns and habits to determine if they are using them as prescribed, and through inspiratory flow rates, judge whether or not patients may need inhaler technique coaching.
Possibility for Objective Data
“I was excited about the Digihaler when it was first launched,” said Maureen George, RN, PhD, of Columbia University School of Nursing, New York, “because it gave very good objective feedback on patients’ inhaler technique through peak inspiratory flow. It showed whether they missed doses or if there were patterns of increased use with increased symptoms.
“Inhaled medications are the only therapy that — if you inaccurately administer them — you don’t actually get any drug, at all,” she said in an interview. “If you don’t get the drug into the target organ, the lungs, you don’t get symptom relief, nor disease remission. Actually, most patients use their devices incorrectly, and most healthcare professionals can’t demonstrate correct delivery technique. At the pharmacy, you’re unlikely to see a real pharmacist, and more likely to see just a cashier. No other product that I know of has offered that degree of sophistication in terms of the different steps of inhaler technique.”
CONNECT2: Better Asthma Control at 24 Weeks
Benefits in asthma control for the Digihaler System have been confirmed recently in clinical research. The CONNECT2 trial compared asthma control with the Digihaler System (DS) versus standard of care (SoC) in patients 13 years or older with uncontrolled asthma (Asthma Control Test [ACT] score < 19). Investigators randomized them open-label 4:3 to the DS (n = 210) or SoC (n = 181) for 24 weeks. Primary endpoint assessment of the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥ 20 or increase from baseline of ≥ 3 units at week 24) revealed an 88.7% higher probability that DS patients would have greater odds of achieving asthma control improvement at week 24, with 35% higher odds of asthma control in the DS group. Also, clinician-participant interactions, mostly addressing poor inhaler technique, were more frequent in the DS group. Six-month adherence was good (68.6%, vs 79.2% at month 1), and reliever use at month 6 was decreased by 38.2% from baseline in the DS group.
Lack of Inhaler Uptake
“It made me sad to hear that it was going away. It’s a device that should have been useful,” Dr. George said, “but the wonderful features that could have come at an individual level or at a population health level just were never realized. I don’t think it was from lack of trying on the company’s part, but when it was launched, insurance companies wouldn’t pay the extra cost that comes with having an integrated electronic monitoring device. They weren’t convinced that the return on investment down the road from improved disease control and fewer very expensive acute hospitalizations was worth it. So the uptake was poor.”
Where does this leave patients? Mr. Mendez stated, “It is imperative that people using Teva’s Digihaler products to treat their asthma reach out to their provider now to determine the best alternative treatment options. Unfortunately, when GSK discontinued Flovent, some people using that inhaler were transitioned to the ArmonAir Digihaler. Also, some formularies do not cover the authorized generic of Flovent, forcing patients to change treatment.”
The AAFA press release of April 15 lists in detail available alternatives to Teva’s discontinued devices, naming quick-relief inhalers and inhaled corticosteroids, noting where dosing, devices, or active ingredients are at variance from the Teva products. The AAFA document also lists and describes inhaler device types (metered dose inhaler, breath actuated inhaler, dry powder inhaler and soft mist inhaler) and their differences in detail.
On the heels of the January 2024 announcement by GlaxoSmithKline that its Flovent inhalers are being discontinued, Teva’s recent announcement that it will discontinue U.S. distribution of its Digihaler® products is adding concern and complication to patients’ and physicians’ efforts to manage asthma symptoms.
“It is unfortunate to hear that more asthma inhalers are being discontinued,” Asthma and Allergy Foundation of America (AAFA) President and CEO Kenneth Mendez, said in an interview. The impact of Teva’s June 1 discontinuations of its Digihaler portfolio (ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler), he added, is only partially softened by Teva’s reassurance that its still-available RespiClick devices deliver the same drug formulations via the same devices as the ProAir and AirDuo products — because they lack the innovative digital component. “The Teva Digihaler portfolio had offered an innovative approach to encourage adherence to treatment by integrating a digital solution with an inhaler.”
Digital App Companion to Inhaler
The digital components of the AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and ArmonAir Digihaler (fluticasone propionate) inhalation powder, both maintenance inhalers for patients 12-years or older with asthma, include built-in Bluetooth® wireless technology that connects to a companion mobile app. Their triggers for recording data on inhaler use are either the opening of the inhaler cap or the patient’s inhalation. The devices detect, record, and store data on inhaler use and peak inspiratory flow.
Also, they can remind the patient as to how often the devices have been used, measure inspiratory flow rates, and indicate when inhalation technique may need improvement. Data are then directly sent to the Digihaler app via Bluetooth technology, giving discretion to patients as to whether or not their data will be shared with health care providers.
When patients share their digital inhaler device-recorded data, Teva sources state, providers can more objectively assess the patients’ inhaler use patterns and habits to determine if they are using them as prescribed, and through inspiratory flow rates, judge whether or not patients may need inhaler technique coaching.
Possibility for Objective Data
“I was excited about the Digihaler when it was first launched,” said Maureen George, RN, PhD, of Columbia University School of Nursing, New York, “because it gave very good objective feedback on patients’ inhaler technique through peak inspiratory flow. It showed whether they missed doses or if there were patterns of increased use with increased symptoms.
“Inhaled medications are the only therapy that — if you inaccurately administer them — you don’t actually get any drug, at all,” she said in an interview. “If you don’t get the drug into the target organ, the lungs, you don’t get symptom relief, nor disease remission. Actually, most patients use their devices incorrectly, and most healthcare professionals can’t demonstrate correct delivery technique. At the pharmacy, you’re unlikely to see a real pharmacist, and more likely to see just a cashier. No other product that I know of has offered that degree of sophistication in terms of the different steps of inhaler technique.”
CONNECT2: Better Asthma Control at 24 Weeks
Benefits in asthma control for the Digihaler System have been confirmed recently in clinical research. The CONNECT2 trial compared asthma control with the Digihaler System (DS) versus standard of care (SoC) in patients 13 years or older with uncontrolled asthma (Asthma Control Test [ACT] score < 19). Investigators randomized them open-label 4:3 to the DS (n = 210) or SoC (n = 181) for 24 weeks. Primary endpoint assessment of the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥ 20 or increase from baseline of ≥ 3 units at week 24) revealed an 88.7% higher probability that DS patients would have greater odds of achieving asthma control improvement at week 24, with 35% higher odds of asthma control in the DS group. Also, clinician-participant interactions, mostly addressing poor inhaler technique, were more frequent in the DS group. Six-month adherence was good (68.6%, vs 79.2% at month 1), and reliever use at month 6 was decreased by 38.2% from baseline in the DS group.
Lack of Inhaler Uptake
“It made me sad to hear that it was going away. It’s a device that should have been useful,” Dr. George said, “but the wonderful features that could have come at an individual level or at a population health level just were never realized. I don’t think it was from lack of trying on the company’s part, but when it was launched, insurance companies wouldn’t pay the extra cost that comes with having an integrated electronic monitoring device. They weren’t convinced that the return on investment down the road from improved disease control and fewer very expensive acute hospitalizations was worth it. So the uptake was poor.”
Where does this leave patients? Mr. Mendez stated, “It is imperative that people using Teva’s Digihaler products to treat their asthma reach out to their provider now to determine the best alternative treatment options. Unfortunately, when GSK discontinued Flovent, some people using that inhaler were transitioned to the ArmonAir Digihaler. Also, some formularies do not cover the authorized generic of Flovent, forcing patients to change treatment.”
The AAFA press release of April 15 lists in detail available alternatives to Teva’s discontinued devices, naming quick-relief inhalers and inhaled corticosteroids, noting where dosing, devices, or active ingredients are at variance from the Teva products. The AAFA document also lists and describes inhaler device types (metered dose inhaler, breath actuated inhaler, dry powder inhaler and soft mist inhaler) and their differences in detail.
On the heels of the January 2024 announcement by GlaxoSmithKline that its Flovent inhalers are being discontinued, Teva’s recent announcement that it will discontinue U.S. distribution of its Digihaler® products is adding concern and complication to patients’ and physicians’ efforts to manage asthma symptoms.
“It is unfortunate to hear that more asthma inhalers are being discontinued,” Asthma and Allergy Foundation of America (AAFA) President and CEO Kenneth Mendez, said in an interview. The impact of Teva’s June 1 discontinuations of its Digihaler portfolio (ProAir Digihaler, AirDuo Digihaler, and ArmonAir Digihaler), he added, is only partially softened by Teva’s reassurance that its still-available RespiClick devices deliver the same drug formulations via the same devices as the ProAir and AirDuo products — because they lack the innovative digital component. “The Teva Digihaler portfolio had offered an innovative approach to encourage adherence to treatment by integrating a digital solution with an inhaler.”
Digital App Companion to Inhaler
The digital components of the AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and ArmonAir Digihaler (fluticasone propionate) inhalation powder, both maintenance inhalers for patients 12-years or older with asthma, include built-in Bluetooth® wireless technology that connects to a companion mobile app. Their triggers for recording data on inhaler use are either the opening of the inhaler cap or the patient’s inhalation. The devices detect, record, and store data on inhaler use and peak inspiratory flow.
Also, they can remind the patient as to how often the devices have been used, measure inspiratory flow rates, and indicate when inhalation technique may need improvement. Data are then directly sent to the Digihaler app via Bluetooth technology, giving discretion to patients as to whether or not their data will be shared with health care providers.
When patients share their digital inhaler device-recorded data, Teva sources state, providers can more objectively assess the patients’ inhaler use patterns and habits to determine if they are using them as prescribed, and through inspiratory flow rates, judge whether or not patients may need inhaler technique coaching.
Possibility for Objective Data
“I was excited about the Digihaler when it was first launched,” said Maureen George, RN, PhD, of Columbia University School of Nursing, New York, “because it gave very good objective feedback on patients’ inhaler technique through peak inspiratory flow. It showed whether they missed doses or if there were patterns of increased use with increased symptoms.
“Inhaled medications are the only therapy that — if you inaccurately administer them — you don’t actually get any drug, at all,” she said in an interview. “If you don’t get the drug into the target organ, the lungs, you don’t get symptom relief, nor disease remission. Actually, most patients use their devices incorrectly, and most healthcare professionals can’t demonstrate correct delivery technique. At the pharmacy, you’re unlikely to see a real pharmacist, and more likely to see just a cashier. No other product that I know of has offered that degree of sophistication in terms of the different steps of inhaler technique.”
CONNECT2: Better Asthma Control at 24 Weeks
Benefits in asthma control for the Digihaler System have been confirmed recently in clinical research. The CONNECT2 trial compared asthma control with the Digihaler System (DS) versus standard of care (SoC) in patients 13 years or older with uncontrolled asthma (Asthma Control Test [ACT] score < 19). Investigators randomized them open-label 4:3 to the DS (n = 210) or SoC (n = 181) for 24 weeks. Primary endpoint assessment of the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥ 20 or increase from baseline of ≥ 3 units at week 24) revealed an 88.7% higher probability that DS patients would have greater odds of achieving asthma control improvement at week 24, with 35% higher odds of asthma control in the DS group. Also, clinician-participant interactions, mostly addressing poor inhaler technique, were more frequent in the DS group. Six-month adherence was good (68.6%, vs 79.2% at month 1), and reliever use at month 6 was decreased by 38.2% from baseline in the DS group.
Lack of Inhaler Uptake
“It made me sad to hear that it was going away. It’s a device that should have been useful,” Dr. George said, “but the wonderful features that could have come at an individual level or at a population health level just were never realized. I don’t think it was from lack of trying on the company’s part, but when it was launched, insurance companies wouldn’t pay the extra cost that comes with having an integrated electronic monitoring device. They weren’t convinced that the return on investment down the road from improved disease control and fewer very expensive acute hospitalizations was worth it. So the uptake was poor.”
Where does this leave patients? Mr. Mendez stated, “It is imperative that people using Teva’s Digihaler products to treat their asthma reach out to their provider now to determine the best alternative treatment options. Unfortunately, when GSK discontinued Flovent, some people using that inhaler were transitioned to the ArmonAir Digihaler. Also, some formularies do not cover the authorized generic of Flovent, forcing patients to change treatment.”
The AAFA press release of April 15 lists in detail available alternatives to Teva’s discontinued devices, naming quick-relief inhalers and inhaled corticosteroids, noting where dosing, devices, or active ingredients are at variance from the Teva products. The AAFA document also lists and describes inhaler device types (metered dose inhaler, breath actuated inhaler, dry powder inhaler and soft mist inhaler) and their differences in detail.
Will Changing the Term Obesity Reduce Stigma?
ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.
One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.
The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.
The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.
Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.
“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.
Spotlight on Adiposity
An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.
The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.”
Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”
“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity.
Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.”
Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.
‘Biological Injustices’
Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.
“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.
Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).
Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.
“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.
Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.
One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.
The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.
The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.
Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.
“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.
Spotlight on Adiposity
An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.
The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.”
Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”
“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity.
Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.”
Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.
‘Biological Injustices’
Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.
“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.
Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).
Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.
“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.
Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
ASUNCIÓN, PARAGUAY — The Lancet Diabetes & Endocrinology’s Commission for the Definition and Diagnosis of Clinical Obesity will soon publish criteria for distinguishing between clinical obesity and other preclinical phases. The criteria are intended to limit the negative connotations and misunderstandings associated with the word obesity and to clearly convey the idea that it is a disease and not just a condition that increases the risk for other pathologies.
One of the two Latin American experts on the 60-member commission, Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Center at the Oswaldo Cruz German Hospital in São Paulo, Brazil, discussed this effort with this news organization.
The proposal being finalized would acknowledge a preclinical stage of obesity characterized by alterations in cells or tissues that lead to changes in organ structure, but not function. This stage can be measured by body mass index (BMI) or waist circumference.
The clinical stage occurs when “obesity already affects [the function of] organs, tissues, and functions like mobility. Here, it is a disease per se. And an active disease requires treatment,” said Dr. Cohen. The health risks associated with excess adiposity have already materialized and can be objectively documented through specific signs and symptoms.
Various experts from Latin America who participated in the XV Congress of the Latin American Obesity Societies (FLASO) and II Paraguayan Obesity Congress expressed to this news organization their reservations about the proposed name change and its practical effects. They highlighted the pros and cons of various terminologies that had been considered in recent years.
“Stigma undoubtedly exists. There’s also no doubt that this stigma and daily pressure on a person’s self-esteem influence behavior and condition a poor future clinical outcome because they promote denial of the disease. Healthcare professionals can make these mistakes. But I’m not sure that changing the name of a known disease will make a difference,” said Rafael Figueredo Grijalba, MD, president of FLASO and director of the Nutrition program at the Faculty of Health Sciences of the Nuestra Señora de la Asunción Catholic University in Paraguay.
Spotlight on Adiposity
An alternative term for obesity proposed in 2016 by what is now the American Association of Clinical Endocrinology and by the American College of Endocrinology is “adiposity-based chronic disease (ABCD).” This designation “is on the right track,” said Violeta Jiménez, MD, internal medicine and endocrinology specialist at the Clinical Hospital of the National University of Asunción and the Comprehensive Diabetes Care Network of the Paraguay Social Security Institute.
The word obese is perceived as an insult, and the health impact of obesity is related to the quantity, distribution, and function of adipose tissue, said Dr. Jiménez. The BMI, the most used parameter in practice to determine overweight and obesity, “does not predict excess adiposity or determine a disease here and now, just as waist circumference does not confirm the condition.”
Will the public be attracted to ABCD? What disease do these initials refer to, asked Dr. Jiménez. “What I like about the term ABCD is that it is not solely based on weight. It brings up the issue that a person who may not have obesity by BMI has adiposity and therefore has a disease brewing inside them.”
“Any obesity denomination is useful as long as the impact of comorbidities is taken into account, as well as the fact that it is not an aesthetic problem and treatment will be escalated aiming to benefit not only weight loss but also comorbidities,” said Paul Camperos Sánchez, MD, internal medicine and endocrinology specialist and head of research at La Trinidad Teaching Medical Center in Caracas, Venezuela, and former president of the Venezuelan Association for the Study of Obesity.
Dr. Camperos Sánchez added that the classification of overweight and obesity into grades on the basis of BMI, which is recognized by the World Health Organization, “is the most known and for me remains the most comfortable. I will accept any other approach, but in my clinical practice, I continue to do it this way.”
Fundamentally, knowledge can reduce social stigma and even prejudice from the medical community itself. “We must be respectful and compassionate and understand well what we are treating and the best way to approach each patient with realistic expectations. Evaluate whether, in addition to medication or intensive lifestyle changes, behavioral interventions or physiotherapy are required. If you don’t manage it well and find it challenging, perhaps that’s why we see so much stigmatization or humiliation of the patient. And that has nothing to do with the name [of the disease],” said Dr. Camperos Sánchez.
‘Biological Injustices’
Julio Montero, MD, nutritionist, president of the Argentine Society of Obesity and Eating Disorders, and former president of FLASO, told this news organization that the topic of nomenclatures “provides a lot of grounds for debate,” but he prefers the term “clinical obesity” because it has a medical meaning, is appropriate for statistical purposes, better conveys the concept of obesity as a disease, and distinguishes patients who have high weight or a spherical figure but may be free of weight-dependent conditions.
“Clinical obesity suggests that it is a person with high weight who has health problems and life expectancy issues related to excessive corpulence (weight-fat). The addition of the adjective clinical suggests that the patient has been evaluated by phenotype, fat distribution, hypertension, blood glucose, triglycerides, apnea, cardiac dilation, and mechanical problems, and based on that analysis, the diagnosis has been made,” said Dr. Montero.
Other positive aspects of the designation include not assuming that comorbidities are a direct consequence of adipose tissue accumulation because “lean mass often increases in patients with obesity, and diet and sedentary lifestyle also have an influence” nor does the term exclude people with central obesity. On the other hand, it does not propose a specific weight or fat that defines the disease, just like BMI does (which defines obesity but not its clinical consequences).
Regarding the proposed term ABCD, Montero pointed out that it focuses the diagnosis on the concept that adipose fat and adipocyte function are protagonists of the disease in question, even though there are chronic metabolic diseases like gout, porphyrias, and type 1 diabetes that do not depend on adiposity.
“ABCD also involves some degree of biological injustice, since femorogluteal adiposity (aside from aesthetic problems and excluding possible mechanical effects) is normal and healthy during pregnancy, lactation, growth, or situations of food scarcity risk, among others. Besides, it is an expression that is difficult to interpret for the untrained professional and even more so for communication to the population,” Dr. Montero concluded.
Dr. Cohen, Dr. Figueredo Grijalba, Dr. Jiménez, Dr. Camperos Sánchez, and Dr. Montero declared no relevant financial conflicts of interest.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Dramatic Increase in College Student Suicide Rates
TOPLINE:
, a new study by the National Collegiate Athletic Association (NCAA) found.
METHODOLOGY:
- Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
- Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
- They utilized linear and quadratic fits between year and suicide incidence for men and women.
- Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
TAKEAWAY:
- Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
- Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
- The overall incidence of suicide was 1:71 per 145 AYs.
- Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
- Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.
IN PRACTICE:
“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”
SOURCE:
Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.
LIMITATIONS:
There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
, a new study by the National Collegiate Athletic Association (NCAA) found.
METHODOLOGY:
- Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
- Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
- They utilized linear and quadratic fits between year and suicide incidence for men and women.
- Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
TAKEAWAY:
- Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
- Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
- The overall incidence of suicide was 1:71 per 145 AYs.
- Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
- Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.
IN PRACTICE:
“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”
SOURCE:
Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.
LIMITATIONS:
There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
, a new study by the National Collegiate Athletic Association (NCAA) found.
METHODOLOGY:
- Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
- Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
- They utilized linear and quadratic fits between year and suicide incidence for men and women.
- Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
TAKEAWAY:
- Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
- Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
- The overall incidence of suicide was 1:71 per 145 AYs.
- Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
- Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.
IN PRACTICE:
“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”
SOURCE:
Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.
LIMITATIONS:
There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Gene Therapy for Dystrophic EB: Extension Study Results Reported
and no new safety signals were identified.
The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.
In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.
In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.
The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).
Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.
Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.
Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.
In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.
Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.
and no new safety signals were identified.
The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.
In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.
In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.
The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).
Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.
Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.
Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.
In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.
Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.
and no new safety signals were identified.
The results were presented by Amy S. Paller, MD, during a late-breaking session at the annual meeting of the American Academy of Dermatology.
In May 2023, beremagene geperpavec, marketed as Vyjuvek (formerly known as B-VEC) was approved by the US Food and Drug Administration (FDA) for the treatment of wounds in patients 6 months of age and older with DEB, a rare genetic blistering disorder caused by COL7A1 gene variants. The therapy uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure. It is designed to be used repetitively, to heal a single wound, or on more than one wound.
In the pivotal study of patients with DEB, the gene therapy, delivered in a topical gel, was administered once a week for 6 months to one wound and placebo was applied to another wound for each participant. The proportion of wounds treated with beremagene geperpavec that healed was significantly higher than among placebo-treated wounds at 3 and 6 months (68% vs. 23% at 3 months, P = .003) and 65% vs. 26% at 6 months (P = .012), with no serious adverse events related to treatment.
The prospective, open label, uncontrolled extension study included 24 patients from the phase 3 study and 23 treatment-naive patients from five US sites. Their mean age was 16 years (range, 6 months to 46 years).
Of the 47 patients, 29 (62%) were on treatment for more than 1 year (the longest was about 2 years), and the mean duration of treatment was 475 days; 5 patients withdrew from the study for reasons not related to treatment.
Their types of adverse events (AEs) were similar to those seen in the phase 3 study and were consistent with what would be expected in patients with DEB, said Dr. Paller, professor and chair of dermatology, Northwestern University, Chicago. One patient experienced two wound hemorrhages that were possibly related to treatment, but there were no treatment-related AEs, no deaths or treatment discontinuations because of an AE, and no serious AEs thought to be related to treatment.
Wounds that were evaluated in the phase 3 study showed “a high durability of closure with continued treatment,” according to Dr. Paller. There were enough data on 19 of the 24 patients who had been in the phase 3 trial to evaluate wound closure, defined as “complete wound closure based on comparison to the exact wound area selected at baseline” at the beginning of the phase 3 study.
In the extension study, wound closure rates were almost 90% at baseline, 84.2% at 3 months, 61.1% at 6 months, 82.4% at 9 months, and 62.5% at 12 months, which was comparable to the rates observed in the third (86.4%) and sixth (73.7%) months of the phase 3 study, Dr. Paller said.
Patient-reported outcomes indicated that quality of life and satisfaction with treatment were preserved with continued treatment.The extension study was terminated in July 2023, after FDA approval, when patients could be transitioned to the commercially available treatment.Dr. Paller disclosed being an investigator (funds to institution) for multiple pharmaceutical companies, including the manufacturer of beremagene geperpavec, Krystal Biotech, which funded the study.
FROM AAD 2024
Girls Catching Up With Boys in Substance Use
, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.
The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.
Principal findings included:
- Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
- Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
- Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
- Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.
Traditional Gender Gap Narrowing or Reversing
Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.
She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”
“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”
The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
Vaping Is an Emerging Public Health Concern
Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”
The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”
Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
Substance Use Trends May Be Stabilizing or Rising Again
Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.
“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.
However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
Multiple Influences on Adolescent Substance Abuse
Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.
However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.
“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”
Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.
“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”
“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
Policy Efforts Must Be Targeted
“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”
Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”
A version of this article appeared on Medscape.com.
, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.
The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.
Principal findings included:
- Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
- Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
- Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
- Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.
Traditional Gender Gap Narrowing or Reversing
Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.
She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”
“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”
The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
Vaping Is an Emerging Public Health Concern
Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”
The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”
Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
Substance Use Trends May Be Stabilizing or Rising Again
Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.
“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.
However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
Multiple Influences on Adolescent Substance Abuse
Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.
However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.
“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”
Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.
“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”
“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
Policy Efforts Must Be Targeted
“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”
Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”
A version of this article appeared on Medscape.com.
, warned the authors of a new report detailing trends across several regions between 2018 and 2022. The latest 4-yearly Health Behaviour in School-Aged Children study, in collaboration with the World Health Organization (WHO) Regional Office for Europe, concluded that substance use remains “a crucial public health problem among adolescents” despite overall declines in smoking, alcohol, and cannabis use.
The new report: A focus on adolescent substance use in Europe, central Asia, and Canada, detailed substance use among adolescents aged 11, 13, and 15 years across 44 countries and regions in Europe, Central Asia, and Canada in the 2021-2022 school-based survey.
Principal findings included:
- Cigarette smoking: Lifetime smoking declined between 2018 and 2022, particularly among 13-year-old boys and 15-year-old boys and girls. There was also a small but significant decrease in current smoking among 15-year-old boys.
- Alcohol use: Lifetime use decreased overall in boys between 2018 and 2022, particularly among 15-year-olds. An increase was observed among 11- and 13-year-old girls but not 15-year-old girls. There was a small but significant decrease in the proportion of current drinkers among 15-year-old boys, with no change among 11- and 13-year-old boys. Current alcohol use increased among girls in all age groups.
- Cannabis use: Lifetime use among 15-year-olds decreased slightly from 14% to 12% between 2018 and 2022, while 6% of 15-year-olds reported having used cannabis in the previous 30 days.
- Vaping: In 2022 vapes (e-cigarettes) were more popular among adolescents than conventional tobacco cigarettes.
Traditional Gender Gap Narrowing or Reversing
Report coauthor Judith Brown from the University of Glasgow, Glasgow, Scotland, and a project manager for the Scottish survey, said that “there was an overall increase in current alcohol use and drunkenness among older girls” despite the overall decrease in boys’ alcohol use.
She explained: “Substance use has traditionally been more prevalent among boys, and the survey findings confirm a well-established gender difference, with higher prevalence in boys than in girls among 11-year-olds. By the age of 13, however, gender differences diminish or even disappear in many countries and regions.”
“Among 15-year-olds, girls often reported more frequent substance use than boys. While this pattern has been known for cigarette smoking in many countries and regions for about two decades, especially among 15-year-olds, it is a new phenomenon for behaviors related to other substances (such as alcohol consumption and drunkenness) in most countries and regions. Historically, prevalence for these behaviors has been higher among boys than girls.”
The new survey results highlight this gender reversal for several substances, she said. “Cannabis is the only substance for which both lifetime and current use is consistently higher in boys.”
Vaping Is an Emerging Public Health Concern
Dr. Brown added that the 2022 survey was the first time that vaping data had been collected from all countries. Although this is against the background of continuing decreases in smoking rates, “researchers suggest the transition to e-cigarettes, as a more popular choice than conventional cigarettes, highlights an urgent need for more targeted interventions to address this emerging public health concern.”
The report authors commented that because young people’s brains are still developing, they are “very sensitive to substances such as nicotine,” making it “easier for them to get hooked.”
Margreet de Looze, PhD, assistant professor of interdisciplinary social science at Utrecht University in Utrecht, the Netherlands, agreed with the authors’ concerns. “Vaping is extremely attractive for young people,” she said, “because the taste is more attractive than that of traditional cigarettes.” Until recently, many people were not aware of health hazards attached to vaping. “While more research is needed, vaping may function as a first step toward tobacco use and is hazardous for young people’s health. Therefore, it should be strongly discouraged.”
Substance Use Trends May Be Stabilizing or Rising Again
Increased awareness of the harmful effects of alcohol for adolescent development is also one postulated reason for declining adolescent alcohol consumption in both Europe and North America over the past two decades, which Dr. de Looze’s research has explored. Her work has also noted the “growing trend” of young people abstaining from alcohol altogether and some evidence of reductions in adolescent risk behaviors more generally, including early sexual initiation and juvenile crime.
“It may be good to realize that, in fact, the current generation of youth in many respects is healthier and reports less risky health behaviors as compared to previous generations,” she said.
However, “The declining trend in adolescent substance use that took place in many countries since the beginning of the 21st century seems to have stabilized, and moreover, in some countries and subgroups of adolescents, substance use appears to be on the rise again.” She cited particularly an overall increase in current alcohol use and drunkenness among older girls between 2018 and 2022. “It appears that, especially for girls, recent trends over time are less favorable as compared with boys.”
Multiple Influences on Adolescent Substance Abuse
Peer group influences are known to come to the fore during adolescence, and Dr. de Looze added that the early 21st century saw marked reductions in adolescent face-to-face contacts with their peers due to the rise in digital communications. “Adolescents typically use substances in the presence of peers (and in the absence of adults/parents), as it increases their status in their peer group.” Reduced in person interactions with friends may therefore have contributed to the earlier decline in substance use.
However, her team had found that adolescents who spend much time online with friends often also spend much time with friends offline. “They are what you could call the ‘social’ youth, who just spend much time with peers, be it offline or online,” she said. “More research is needed to disentangle exactly how, what kind, for whom the digital environment may be related to young people’s substance use,” she said.
“We also see that young people actively select their friends. So, if you are curious and a bit of a sensation-seeker yourself, you are more likely to become friends with youth who are just like you, and together, you may be more likely to try out substances.”
Factors underlying adolescent substance use and differences between countries are influenced by a complex interplay of factors, said Carina Ferreira-Borges, PhD, regional adviser for alcohol, illicit drugs, and prison health at the WHO Regional Office for Europe.
“Prevention measures definitely play a critical role in reducing substance use,” she said, “but other factors, such as cultural norms and socioeconomic conditions, also significantly impact these patterns.”
“Variations in substance use among countries can be attributed to different levels of implemented polices, public health initiatives, and the extent to which substance use is normalized or stigmatized within each society.”
Policy Efforts Must Be Targeted
“To address these disparities effectively, interventions and population-level policies need to be culturally adapted and target the specific environments where substance use is normalized among adolescents. By understanding and modifying the broader context in which young people make choices about substance use, we can better influence their behavior and health outcomes.”
Dr. de Looze cautioned, “In the past two decades, public health efforts in many countries have focused on reducing young people’s engagement in substance use. It is important that these efforts continue, as every year a new generation of youth is born. If public health efforts do not continue to focus on supporting a healthy lifestyle among young people, it should not come as a surprise that rates start or continue to rise again.”
A version of this article appeared on Medscape.com.
FDA Requests More Information for RDEB Rx Under Review
The Food and Drug Administration (RDEB), requesting more information from the manufacturer.
Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.
On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.
The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.
The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (RDEB), requesting more information from the manufacturer.
Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.
On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.
The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.
The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (RDEB), requesting more information from the manufacturer.
Pz-cel, which comprises autologous, COL7A1 gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient’s skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in the COL7A1 gene that “results in the inability to produce type VII collagen,” a press release from the manufacturer noted.
On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved. According to a press release from the company, the information pertains to validation requirements for certain manufacturing and release testing methods, including some that were observed during the FDA’s pre-licensing inspection.
The complete response letter did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company.
The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotal phase 3 VIITAL study and a phase 1/2a study in patients with RDEB.
A version of this article first appeared on Medscape.com.