How your voice could reveal hidden disease

Article Type
Changed

Most of us have two voice changes in our lifetime: First during puberty, as the vocal cords thicken and the voice box migrates down the throat. Then a second time as aging causes structural changes that may weaken the voice.

But for some of us, there’s another voice shift, when a disease begins or when our mental health declines.

This is why more doctors are looking into voice as a biomarker – something that tells you that a disease is present.

Vital signs like blood pressure or heart rate “can give a general idea of how sick we are. But they’re not specific to certain diseases,” says Yael Bensoussan, MD, director of the University of South Florida, Tampa’s Health Voice Center and the coprincipal investigator for the National Institutes of Health’s Voice as a Biomarker of Health project.

“We’re learning that there are patterns” in voice changes that can indicate a range of conditions, including diseases of the nervous system and mental illnesses, she says.

Speaking is complicated, involving everything from the lungs and voice box to the mouth and brain. “A breakdown in any of those parts can affect the voice,” says Maria Powell, PhD, an assistant professor of otolaryngology (the study of diseases of the ear and throat) at Vanderbilt University, Nashville, Tenn., who is working on the NIH project.

You or those around you may not notice the changes. But researchers say voice analysis as a standard part of patient care – akin to blood pressure checks or cholesterol tests – could help identify those who need medical attention earlier.

Often, all it takes is a smartphone – “something that’s cheap, off-the-shelf, and that everyone can use,” says Ariana Anderson, PhD, director of the University of California, Los Angeles, Laboratory of Computational Neuropsychology.

“You can provide voice data in your pajamas, on your couch,” says Frank Rudzicz, PhD, a computer scientist for the NIH project. “It doesn’t require very complicated or expensive equipment, and it doesn’t require a lot of expertise to obtain.” Plus, multiple samples can be collected over time, giving a more accurate picture of health than a single snapshot from, say, a cognitive test.

Over the next 4 years, the Voice as a Biomarker team will receive nearly $18 million to gather a massive amount of voice data. The goal is 20,000-30,000 samples, along with health data about each person being studied. The result will be a sprawling database scientists can use to develop algorithms linking health conditions to the way we speak.

For the first 2 years, new data will be collected exclusively via universities and high-volume clinics to control quality and accuracy. Eventually, people will be invited to submit their own voice recordings, creating a crowdsourced dataset. “Google, Alexa, Amazon – they have access to tons of voice data,” says Dr. Bensoussan. “But it’s not usable in a clinical way, because they don’t have the health information.”

Dr. Bensoussan and her colleagues hope to fill that void with advance voice screening apps, which could prove especially valuable in remote communities that lack access to specialists or as a tool for telemedicine. Down the line, wearable devices with voice analysis could alert people with chronic conditions when they need to see a doctor.

“The watch says, ‘I’ve analyzed your breathing and coughing, and today, you’re really not doing well. You should go to the hospital,’ ” says Dr. Bensoussan, envisioning a wearable for patients with COPD. “It could tell people early that things are declining.”

Artificial intelligence may be better than a brain at pinpointing the right disease. For example, slurred speech could indicate Parkinson’s, a stroke, or ALS, among other things.

“We can hold approximately seven pieces of information in our head at one time,” says Dr. Rudzicz. “It’s really hard for us to get a holistic picture using dozens or hundreds of variables at once.” But a computer can consider a whole range of vocal markers at the same time, piecing them together for a more accurate assessment.

“The goal is not to outperform a ... clinician,” says Dr. Bensoussan. Yet the potential is unmistakably there: In a recent study of patients with cancer of the larynx, an automated voice analysis tool more accurately flagged the disease than laryngologists did. 

“Algorithms have a larger training base,” says Dr. Anderson, who developed an app called ChatterBaby that analyzes infant cries. “We have a million samples at our disposal to train our algorithms. I don’t know if I’ve heard a million different babies crying in my life.”

So which health conditions show the most promise for voice analysis? The Voice as a Biomarker project will focus on five categories.
 

 

 

Voice disorders (cancers of the larynx, vocal fold paralysis, benign lesions on the larynx)

Obviously, vocal changes are a hallmark of these conditions, which cause things like breathiness or “roughness,” a type of vocal irregularity. Hoarseness that lasts at least 2 weeks is often one of the earliest signs of laryngeal cancer. Yet it can take months – one study found 16 weeks was the average – for patients to see a doctor after noticing the changes. Even then, laryngologists still misdiagnosed some cases of cancer when relying on vocal cues alone.

Now imagine a different scenario: The patient speaks into a smartphone app. An algorithm compares the vocal sample with the voices of laryngeal cancer patients. The app spits out the estimated odds of laryngeal cancer, helping providers decide whether to offer the patient specialist care.

Or consider spasmodic dysphonia, a neurological voice disorder that triggers spasms in the muscles of the voice box, causing a strained or breathy voice. Doctors who lack experience with vocal disorders may miss the condition. This is why diagnosis takes an average of nearly 4.5 years, according to a study in the Journal of Voice, and may include everything from allergy testing to psychiatric evaluation, says Dr. Powell. Artificial intelligence technology trained to recognize the disorder could help eliminate such unnecessary testing.
 

Neurological and neurodegenerative disorders (Alzheimer’s, Parkinson’s, stroke, ALS) 

For Alzheimer’s and Parkinson’s, “one of the first changes that’s notable is voice,” usually appearing before a formal diagnosis, says Anais Rameau, MD, an assistant professor of laryngology at Weill Cornell Medicine, New York, and another member of the NIH project. Parkinson’s may soften the voice or make it sound monotone, while Alzheimer’s disease may change the content of speech, leading to an uptick in “umms” and a preference for pronouns over nouns.

With Parkinson’s, vocal changes can occur decades before movement is affected. If doctors could detect the disease at this stage, before tremor emerged, they might be able to flag patients for early intervention, says Max Little, PhD, project director for the Parkinson’s Voice Initiative. “That is the ‘holy grail’ for finding an eventual cure.”

Again, the smartphone shows potential. In a 2022 Australian study, an AI-powered app was able to identify people with Parkinson’s based on brief voice recordings, although the sample size was small. On a larger scale, the Parkinson’s Voice Initiative collected some 17,000 samples from people across the world. “The aim was to remotely detect those with the condition using a telephone call,” says Dr. Little. It did so with about 65% accuracy. “While this is not accurate enough for clinical use, it shows the potential of the idea,” he says.

Dr. Rudzicz worked on the team behind Winterlight, an iPad app that analyzes 550 features of speech to detect dementia and Alzheimer’s (as well as mental illness). “We deployed it in long-term care facilities,” he says, identifying patients who need further review of their mental skills. Stroke is another area of interest, because slurred speech is a highly subjective measure, says Dr. Anderson. AI technology could provide a more objective evaluation.
 

 

 

Mood and psychiatric disorders (depression, schizophrenia, bipolar disorders)

No established biomarkers exist for diagnosing depression. Yet if you’re feeling down, there’s a good chance your friends can tell – even over the phone.

“We carry a lot of our mood in our voice,” says Dr. Powell. Bipolar disorder can also alter voice, making it louder and faster during manic periods, then slower and quieter during depressive bouts. The catatonic stage of schizophrenia often comes with “a very monotone, robotic voice,” says Dr. Anderson. “These are all something an algorithm can measure.”

Apps are already being used – often in research settings – to monitor voices during phone calls, analyzing rate, rhythm, volume, and pitch, to predict mood changes. For example, the PRIORI project at the University of Michigan is working on a smartphone app to identify mood changes in people with bipolar disorder, especially shifts that could increase suicide risk.

The content of speech may also offer clues. In a University of California, Los Angeles, study published in the journal PLoS One, people with mental illnesses answered computer-programmed questions (like “How have you been over the past few days?”) over the phone. An app analyzed their word choices, paying attention to how they changed over time. The researchers found that AI analysis of mood aligned well with doctors’ assessments and that some people in the study actually felt more comfortable talking to a computer.
 

Respiratory disorders (pneumonia, COPD)

Beyond talking, respiratory sounds like gasping or coughing may point to specific conditions. “Emphysema cough is different, COPD cough is different,” says Dr. Bensoussan. Researchers are trying to find out if COVID-19 has a distinct cough.

Breathing sounds can also serve as signposts. “There are different sounds when we can’t breathe,” says Dr. Bensoussan. One is called stridor, a high-pitched wheezing often resulting from a blocked airway. “I see tons of people [with stridor] misdiagnosed for years – they’ve been told they have asthma, but they don’t,” says Dr. Bensoussan. AI analysis of these sounds could help doctors more quickly identify respiratory disorders.
 

Pediatric voice and speech disorders (speech and language delays, autism)

Babies who later have autism cry differently as early as 6 months of age, which means an app like ChatterBaby could help flag children for early intervention, says Dr. Anderson. Autism is linked to several other diagnoses, such as epilepsy and sleep disorders. So analyzing an infant’s cry could prompt pediatricians to screen for a range of conditions.

ChatterBaby has been “incredibly accurate” in identifying when babies are in pain, says Dr. Anderson, because pain increases muscle tension, resulting in a louder, more energetic cry. The next goal: “We’re collecting voices from babies around the world,” she says, and then tracking those children for 7 years, looking to see if early vocal signs could predict developmental disorders. Vocal samples from young children could serve a similar purpose.
 

And that’s only the beginning

Eventually, AI technology may pick up disease-related voice changes that we can’t even hear. In a new Mayo Clinic study, certain vocal features detectable by AI – but not by the human ear – were linked to a three-fold increase in the likelihood of having plaque buildup in the arteries.

“Voice is a huge spectrum of vibrations,” explains study author Amir Lerman, MD. “We hear a very narrow range.” 

The researchers aren’t sure why heart disease alters voice, but the autonomic nervous system may play a role, because it regulates the voice box as well as blood pressure and heart rate. Dr. Lerman says other conditions, like diseases of the nerves and gut, may similarly alter the voice. Beyond patient screening, this discovery could help doctors adjust medication doses remotely, in line with these inaudible vocal signals.

“Hopefully, in the next few years, this is going to come to practice,” says Dr. Lerman.

Still, in the face of that hope, privacy concerns remain. Voice is an identifier that’s protected by the federal Health Insurance Portability and Accountability Act, which requires privacy of personal health information. That is a major reason why no large voice databases exist yet, says Dr. Bensoussan. (This makes collecting samples from children especially challenging.) Perhaps more concerning is the potential for diagnosing disease based on voice alone. “You could use that tool on anyone, including officials like the president,” says Dr. Rameau.

But the primary hurdle is the ethical sourcing of data to ensure a diversity of vocal samples. For the Voice as a Biomarker project, the researchers will establish voice quotas for different races and ethnicities, ensuring algorithms can accurately analyze a range of accents. Data from people with speech impediments will also be gathered.

Despite these challenges, researchers are optimistic. “Vocal analysis is going to be a great equalizer and improve health outcomes,” predicts Dr. Anderson. “I’m really happy that we are beginning to understand the strength of the voice.”

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

Publications
Topics
Sections

Most of us have two voice changes in our lifetime: First during puberty, as the vocal cords thicken and the voice box migrates down the throat. Then a second time as aging causes structural changes that may weaken the voice.

But for some of us, there’s another voice shift, when a disease begins or when our mental health declines.

This is why more doctors are looking into voice as a biomarker – something that tells you that a disease is present.

Vital signs like blood pressure or heart rate “can give a general idea of how sick we are. But they’re not specific to certain diseases,” says Yael Bensoussan, MD, director of the University of South Florida, Tampa’s Health Voice Center and the coprincipal investigator for the National Institutes of Health’s Voice as a Biomarker of Health project.

“We’re learning that there are patterns” in voice changes that can indicate a range of conditions, including diseases of the nervous system and mental illnesses, she says.

Speaking is complicated, involving everything from the lungs and voice box to the mouth and brain. “A breakdown in any of those parts can affect the voice,” says Maria Powell, PhD, an assistant professor of otolaryngology (the study of diseases of the ear and throat) at Vanderbilt University, Nashville, Tenn., who is working on the NIH project.

You or those around you may not notice the changes. But researchers say voice analysis as a standard part of patient care – akin to blood pressure checks or cholesterol tests – could help identify those who need medical attention earlier.

Often, all it takes is a smartphone – “something that’s cheap, off-the-shelf, and that everyone can use,” says Ariana Anderson, PhD, director of the University of California, Los Angeles, Laboratory of Computational Neuropsychology.

“You can provide voice data in your pajamas, on your couch,” says Frank Rudzicz, PhD, a computer scientist for the NIH project. “It doesn’t require very complicated or expensive equipment, and it doesn’t require a lot of expertise to obtain.” Plus, multiple samples can be collected over time, giving a more accurate picture of health than a single snapshot from, say, a cognitive test.

Over the next 4 years, the Voice as a Biomarker team will receive nearly $18 million to gather a massive amount of voice data. The goal is 20,000-30,000 samples, along with health data about each person being studied. The result will be a sprawling database scientists can use to develop algorithms linking health conditions to the way we speak.

For the first 2 years, new data will be collected exclusively via universities and high-volume clinics to control quality and accuracy. Eventually, people will be invited to submit their own voice recordings, creating a crowdsourced dataset. “Google, Alexa, Amazon – they have access to tons of voice data,” says Dr. Bensoussan. “But it’s not usable in a clinical way, because they don’t have the health information.”

Dr. Bensoussan and her colleagues hope to fill that void with advance voice screening apps, which could prove especially valuable in remote communities that lack access to specialists or as a tool for telemedicine. Down the line, wearable devices with voice analysis could alert people with chronic conditions when they need to see a doctor.

“The watch says, ‘I’ve analyzed your breathing and coughing, and today, you’re really not doing well. You should go to the hospital,’ ” says Dr. Bensoussan, envisioning a wearable for patients with COPD. “It could tell people early that things are declining.”

Artificial intelligence may be better than a brain at pinpointing the right disease. For example, slurred speech could indicate Parkinson’s, a stroke, or ALS, among other things.

“We can hold approximately seven pieces of information in our head at one time,” says Dr. Rudzicz. “It’s really hard for us to get a holistic picture using dozens or hundreds of variables at once.” But a computer can consider a whole range of vocal markers at the same time, piecing them together for a more accurate assessment.

“The goal is not to outperform a ... clinician,” says Dr. Bensoussan. Yet the potential is unmistakably there: In a recent study of patients with cancer of the larynx, an automated voice analysis tool more accurately flagged the disease than laryngologists did. 

“Algorithms have a larger training base,” says Dr. Anderson, who developed an app called ChatterBaby that analyzes infant cries. “We have a million samples at our disposal to train our algorithms. I don’t know if I’ve heard a million different babies crying in my life.”

So which health conditions show the most promise for voice analysis? The Voice as a Biomarker project will focus on five categories.
 

 

 

Voice disorders (cancers of the larynx, vocal fold paralysis, benign lesions on the larynx)

Obviously, vocal changes are a hallmark of these conditions, which cause things like breathiness or “roughness,” a type of vocal irregularity. Hoarseness that lasts at least 2 weeks is often one of the earliest signs of laryngeal cancer. Yet it can take months – one study found 16 weeks was the average – for patients to see a doctor after noticing the changes. Even then, laryngologists still misdiagnosed some cases of cancer when relying on vocal cues alone.

Now imagine a different scenario: The patient speaks into a smartphone app. An algorithm compares the vocal sample with the voices of laryngeal cancer patients. The app spits out the estimated odds of laryngeal cancer, helping providers decide whether to offer the patient specialist care.

Or consider spasmodic dysphonia, a neurological voice disorder that triggers spasms in the muscles of the voice box, causing a strained or breathy voice. Doctors who lack experience with vocal disorders may miss the condition. This is why diagnosis takes an average of nearly 4.5 years, according to a study in the Journal of Voice, and may include everything from allergy testing to psychiatric evaluation, says Dr. Powell. Artificial intelligence technology trained to recognize the disorder could help eliminate such unnecessary testing.
 

Neurological and neurodegenerative disorders (Alzheimer’s, Parkinson’s, stroke, ALS) 

For Alzheimer’s and Parkinson’s, “one of the first changes that’s notable is voice,” usually appearing before a formal diagnosis, says Anais Rameau, MD, an assistant professor of laryngology at Weill Cornell Medicine, New York, and another member of the NIH project. Parkinson’s may soften the voice or make it sound monotone, while Alzheimer’s disease may change the content of speech, leading to an uptick in “umms” and a preference for pronouns over nouns.

With Parkinson’s, vocal changes can occur decades before movement is affected. If doctors could detect the disease at this stage, before tremor emerged, they might be able to flag patients for early intervention, says Max Little, PhD, project director for the Parkinson’s Voice Initiative. “That is the ‘holy grail’ for finding an eventual cure.”

Again, the smartphone shows potential. In a 2022 Australian study, an AI-powered app was able to identify people with Parkinson’s based on brief voice recordings, although the sample size was small. On a larger scale, the Parkinson’s Voice Initiative collected some 17,000 samples from people across the world. “The aim was to remotely detect those with the condition using a telephone call,” says Dr. Little. It did so with about 65% accuracy. “While this is not accurate enough for clinical use, it shows the potential of the idea,” he says.

Dr. Rudzicz worked on the team behind Winterlight, an iPad app that analyzes 550 features of speech to detect dementia and Alzheimer’s (as well as mental illness). “We deployed it in long-term care facilities,” he says, identifying patients who need further review of their mental skills. Stroke is another area of interest, because slurred speech is a highly subjective measure, says Dr. Anderson. AI technology could provide a more objective evaluation.
 

 

 

Mood and psychiatric disorders (depression, schizophrenia, bipolar disorders)

No established biomarkers exist for diagnosing depression. Yet if you’re feeling down, there’s a good chance your friends can tell – even over the phone.

“We carry a lot of our mood in our voice,” says Dr. Powell. Bipolar disorder can also alter voice, making it louder and faster during manic periods, then slower and quieter during depressive bouts. The catatonic stage of schizophrenia often comes with “a very monotone, robotic voice,” says Dr. Anderson. “These are all something an algorithm can measure.”

Apps are already being used – often in research settings – to monitor voices during phone calls, analyzing rate, rhythm, volume, and pitch, to predict mood changes. For example, the PRIORI project at the University of Michigan is working on a smartphone app to identify mood changes in people with bipolar disorder, especially shifts that could increase suicide risk.

The content of speech may also offer clues. In a University of California, Los Angeles, study published in the journal PLoS One, people with mental illnesses answered computer-programmed questions (like “How have you been over the past few days?”) over the phone. An app analyzed their word choices, paying attention to how they changed over time. The researchers found that AI analysis of mood aligned well with doctors’ assessments and that some people in the study actually felt more comfortable talking to a computer.
 

Respiratory disorders (pneumonia, COPD)

Beyond talking, respiratory sounds like gasping or coughing may point to specific conditions. “Emphysema cough is different, COPD cough is different,” says Dr. Bensoussan. Researchers are trying to find out if COVID-19 has a distinct cough.

Breathing sounds can also serve as signposts. “There are different sounds when we can’t breathe,” says Dr. Bensoussan. One is called stridor, a high-pitched wheezing often resulting from a blocked airway. “I see tons of people [with stridor] misdiagnosed for years – they’ve been told they have asthma, but they don’t,” says Dr. Bensoussan. AI analysis of these sounds could help doctors more quickly identify respiratory disorders.
 

Pediatric voice and speech disorders (speech and language delays, autism)

Babies who later have autism cry differently as early as 6 months of age, which means an app like ChatterBaby could help flag children for early intervention, says Dr. Anderson. Autism is linked to several other diagnoses, such as epilepsy and sleep disorders. So analyzing an infant’s cry could prompt pediatricians to screen for a range of conditions.

ChatterBaby has been “incredibly accurate” in identifying when babies are in pain, says Dr. Anderson, because pain increases muscle tension, resulting in a louder, more energetic cry. The next goal: “We’re collecting voices from babies around the world,” she says, and then tracking those children for 7 years, looking to see if early vocal signs could predict developmental disorders. Vocal samples from young children could serve a similar purpose.
 

And that’s only the beginning

Eventually, AI technology may pick up disease-related voice changes that we can’t even hear. In a new Mayo Clinic study, certain vocal features detectable by AI – but not by the human ear – were linked to a three-fold increase in the likelihood of having plaque buildup in the arteries.

“Voice is a huge spectrum of vibrations,” explains study author Amir Lerman, MD. “We hear a very narrow range.” 

The researchers aren’t sure why heart disease alters voice, but the autonomic nervous system may play a role, because it regulates the voice box as well as blood pressure and heart rate. Dr. Lerman says other conditions, like diseases of the nerves and gut, may similarly alter the voice. Beyond patient screening, this discovery could help doctors adjust medication doses remotely, in line with these inaudible vocal signals.

“Hopefully, in the next few years, this is going to come to practice,” says Dr. Lerman.

Still, in the face of that hope, privacy concerns remain. Voice is an identifier that’s protected by the federal Health Insurance Portability and Accountability Act, which requires privacy of personal health information. That is a major reason why no large voice databases exist yet, says Dr. Bensoussan. (This makes collecting samples from children especially challenging.) Perhaps more concerning is the potential for diagnosing disease based on voice alone. “You could use that tool on anyone, including officials like the president,” says Dr. Rameau.

But the primary hurdle is the ethical sourcing of data to ensure a diversity of vocal samples. For the Voice as a Biomarker project, the researchers will establish voice quotas for different races and ethnicities, ensuring algorithms can accurately analyze a range of accents. Data from people with speech impediments will also be gathered.

Despite these challenges, researchers are optimistic. “Vocal analysis is going to be a great equalizer and improve health outcomes,” predicts Dr. Anderson. “I’m really happy that we are beginning to understand the strength of the voice.”

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

Most of us have two voice changes in our lifetime: First during puberty, as the vocal cords thicken and the voice box migrates down the throat. Then a second time as aging causes structural changes that may weaken the voice.

But for some of us, there’s another voice shift, when a disease begins or when our mental health declines.

This is why more doctors are looking into voice as a biomarker – something that tells you that a disease is present.

Vital signs like blood pressure or heart rate “can give a general idea of how sick we are. But they’re not specific to certain diseases,” says Yael Bensoussan, MD, director of the University of South Florida, Tampa’s Health Voice Center and the coprincipal investigator for the National Institutes of Health’s Voice as a Biomarker of Health project.

“We’re learning that there are patterns” in voice changes that can indicate a range of conditions, including diseases of the nervous system and mental illnesses, she says.

Speaking is complicated, involving everything from the lungs and voice box to the mouth and brain. “A breakdown in any of those parts can affect the voice,” says Maria Powell, PhD, an assistant professor of otolaryngology (the study of diseases of the ear and throat) at Vanderbilt University, Nashville, Tenn., who is working on the NIH project.

You or those around you may not notice the changes. But researchers say voice analysis as a standard part of patient care – akin to blood pressure checks or cholesterol tests – could help identify those who need medical attention earlier.

Often, all it takes is a smartphone – “something that’s cheap, off-the-shelf, and that everyone can use,” says Ariana Anderson, PhD, director of the University of California, Los Angeles, Laboratory of Computational Neuropsychology.

“You can provide voice data in your pajamas, on your couch,” says Frank Rudzicz, PhD, a computer scientist for the NIH project. “It doesn’t require very complicated or expensive equipment, and it doesn’t require a lot of expertise to obtain.” Plus, multiple samples can be collected over time, giving a more accurate picture of health than a single snapshot from, say, a cognitive test.

Over the next 4 years, the Voice as a Biomarker team will receive nearly $18 million to gather a massive amount of voice data. The goal is 20,000-30,000 samples, along with health data about each person being studied. The result will be a sprawling database scientists can use to develop algorithms linking health conditions to the way we speak.

For the first 2 years, new data will be collected exclusively via universities and high-volume clinics to control quality and accuracy. Eventually, people will be invited to submit their own voice recordings, creating a crowdsourced dataset. “Google, Alexa, Amazon – they have access to tons of voice data,” says Dr. Bensoussan. “But it’s not usable in a clinical way, because they don’t have the health information.”

Dr. Bensoussan and her colleagues hope to fill that void with advance voice screening apps, which could prove especially valuable in remote communities that lack access to specialists or as a tool for telemedicine. Down the line, wearable devices with voice analysis could alert people with chronic conditions when they need to see a doctor.

“The watch says, ‘I’ve analyzed your breathing and coughing, and today, you’re really not doing well. You should go to the hospital,’ ” says Dr. Bensoussan, envisioning a wearable for patients with COPD. “It could tell people early that things are declining.”

Artificial intelligence may be better than a brain at pinpointing the right disease. For example, slurred speech could indicate Parkinson’s, a stroke, or ALS, among other things.

“We can hold approximately seven pieces of information in our head at one time,” says Dr. Rudzicz. “It’s really hard for us to get a holistic picture using dozens or hundreds of variables at once.” But a computer can consider a whole range of vocal markers at the same time, piecing them together for a more accurate assessment.

“The goal is not to outperform a ... clinician,” says Dr. Bensoussan. Yet the potential is unmistakably there: In a recent study of patients with cancer of the larynx, an automated voice analysis tool more accurately flagged the disease than laryngologists did. 

“Algorithms have a larger training base,” says Dr. Anderson, who developed an app called ChatterBaby that analyzes infant cries. “We have a million samples at our disposal to train our algorithms. I don’t know if I’ve heard a million different babies crying in my life.”

So which health conditions show the most promise for voice analysis? The Voice as a Biomarker project will focus on five categories.
 

 

 

Voice disorders (cancers of the larynx, vocal fold paralysis, benign lesions on the larynx)

Obviously, vocal changes are a hallmark of these conditions, which cause things like breathiness or “roughness,” a type of vocal irregularity. Hoarseness that lasts at least 2 weeks is often one of the earliest signs of laryngeal cancer. Yet it can take months – one study found 16 weeks was the average – for patients to see a doctor after noticing the changes. Even then, laryngologists still misdiagnosed some cases of cancer when relying on vocal cues alone.

Now imagine a different scenario: The patient speaks into a smartphone app. An algorithm compares the vocal sample with the voices of laryngeal cancer patients. The app spits out the estimated odds of laryngeal cancer, helping providers decide whether to offer the patient specialist care.

Or consider spasmodic dysphonia, a neurological voice disorder that triggers spasms in the muscles of the voice box, causing a strained or breathy voice. Doctors who lack experience with vocal disorders may miss the condition. This is why diagnosis takes an average of nearly 4.5 years, according to a study in the Journal of Voice, and may include everything from allergy testing to psychiatric evaluation, says Dr. Powell. Artificial intelligence technology trained to recognize the disorder could help eliminate such unnecessary testing.
 

Neurological and neurodegenerative disorders (Alzheimer’s, Parkinson’s, stroke, ALS) 

For Alzheimer’s and Parkinson’s, “one of the first changes that’s notable is voice,” usually appearing before a formal diagnosis, says Anais Rameau, MD, an assistant professor of laryngology at Weill Cornell Medicine, New York, and another member of the NIH project. Parkinson’s may soften the voice or make it sound monotone, while Alzheimer’s disease may change the content of speech, leading to an uptick in “umms” and a preference for pronouns over nouns.

With Parkinson’s, vocal changes can occur decades before movement is affected. If doctors could detect the disease at this stage, before tremor emerged, they might be able to flag patients for early intervention, says Max Little, PhD, project director for the Parkinson’s Voice Initiative. “That is the ‘holy grail’ for finding an eventual cure.”

Again, the smartphone shows potential. In a 2022 Australian study, an AI-powered app was able to identify people with Parkinson’s based on brief voice recordings, although the sample size was small. On a larger scale, the Parkinson’s Voice Initiative collected some 17,000 samples from people across the world. “The aim was to remotely detect those with the condition using a telephone call,” says Dr. Little. It did so with about 65% accuracy. “While this is not accurate enough for clinical use, it shows the potential of the idea,” he says.

Dr. Rudzicz worked on the team behind Winterlight, an iPad app that analyzes 550 features of speech to detect dementia and Alzheimer’s (as well as mental illness). “We deployed it in long-term care facilities,” he says, identifying patients who need further review of their mental skills. Stroke is another area of interest, because slurred speech is a highly subjective measure, says Dr. Anderson. AI technology could provide a more objective evaluation.
 

 

 

Mood and psychiatric disorders (depression, schizophrenia, bipolar disorders)

No established biomarkers exist for diagnosing depression. Yet if you’re feeling down, there’s a good chance your friends can tell – even over the phone.

“We carry a lot of our mood in our voice,” says Dr. Powell. Bipolar disorder can also alter voice, making it louder and faster during manic periods, then slower and quieter during depressive bouts. The catatonic stage of schizophrenia often comes with “a very monotone, robotic voice,” says Dr. Anderson. “These are all something an algorithm can measure.”

Apps are already being used – often in research settings – to monitor voices during phone calls, analyzing rate, rhythm, volume, and pitch, to predict mood changes. For example, the PRIORI project at the University of Michigan is working on a smartphone app to identify mood changes in people with bipolar disorder, especially shifts that could increase suicide risk.

The content of speech may also offer clues. In a University of California, Los Angeles, study published in the journal PLoS One, people with mental illnesses answered computer-programmed questions (like “How have you been over the past few days?”) over the phone. An app analyzed their word choices, paying attention to how they changed over time. The researchers found that AI analysis of mood aligned well with doctors’ assessments and that some people in the study actually felt more comfortable talking to a computer.
 

Respiratory disorders (pneumonia, COPD)

Beyond talking, respiratory sounds like gasping or coughing may point to specific conditions. “Emphysema cough is different, COPD cough is different,” says Dr. Bensoussan. Researchers are trying to find out if COVID-19 has a distinct cough.

Breathing sounds can also serve as signposts. “There are different sounds when we can’t breathe,” says Dr. Bensoussan. One is called stridor, a high-pitched wheezing often resulting from a blocked airway. “I see tons of people [with stridor] misdiagnosed for years – they’ve been told they have asthma, but they don’t,” says Dr. Bensoussan. AI analysis of these sounds could help doctors more quickly identify respiratory disorders.
 

Pediatric voice and speech disorders (speech and language delays, autism)

Babies who later have autism cry differently as early as 6 months of age, which means an app like ChatterBaby could help flag children for early intervention, says Dr. Anderson. Autism is linked to several other diagnoses, such as epilepsy and sleep disorders. So analyzing an infant’s cry could prompt pediatricians to screen for a range of conditions.

ChatterBaby has been “incredibly accurate” in identifying when babies are in pain, says Dr. Anderson, because pain increases muscle tension, resulting in a louder, more energetic cry. The next goal: “We’re collecting voices from babies around the world,” she says, and then tracking those children for 7 years, looking to see if early vocal signs could predict developmental disorders. Vocal samples from young children could serve a similar purpose.
 

And that’s only the beginning

Eventually, AI technology may pick up disease-related voice changes that we can’t even hear. In a new Mayo Clinic study, certain vocal features detectable by AI – but not by the human ear – were linked to a three-fold increase in the likelihood of having plaque buildup in the arteries.

“Voice is a huge spectrum of vibrations,” explains study author Amir Lerman, MD. “We hear a very narrow range.” 

The researchers aren’t sure why heart disease alters voice, but the autonomic nervous system may play a role, because it regulates the voice box as well as blood pressure and heart rate. Dr. Lerman says other conditions, like diseases of the nerves and gut, may similarly alter the voice. Beyond patient screening, this discovery could help doctors adjust medication doses remotely, in line with these inaudible vocal signals.

“Hopefully, in the next few years, this is going to come to practice,” says Dr. Lerman.

Still, in the face of that hope, privacy concerns remain. Voice is an identifier that’s protected by the federal Health Insurance Portability and Accountability Act, which requires privacy of personal health information. That is a major reason why no large voice databases exist yet, says Dr. Bensoussan. (This makes collecting samples from children especially challenging.) Perhaps more concerning is the potential for diagnosing disease based on voice alone. “You could use that tool on anyone, including officials like the president,” says Dr. Rameau.

But the primary hurdle is the ethical sourcing of data to ensure a diversity of vocal samples. For the Voice as a Biomarker project, the researchers will establish voice quotas for different races and ethnicities, ensuring algorithms can accurately analyze a range of accents. Data from people with speech impediments will also be gathered.

Despite these challenges, researchers are optimistic. “Vocal analysis is going to be a great equalizer and improve health outcomes,” predicts Dr. Anderson. “I’m really happy that we are beginning to understand the strength of the voice.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Telemedicine increases access to care and optimizes practice revenue

Article Type
Changed

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7

Dr. Russ R. Arjal

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9

 

 

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

 

 

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

Publications
Topics
Sections

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7

Dr. Russ R. Arjal

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9

 

 

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

 

 

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.

We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? Data are emerging that virtual care can reduce expensive and unnecessary emergency room visits, help effectively manage chronic disease, address disparities in care, and increase access to specialty care.3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
 

As GI demand outpaces supply, it’s time to consider alternative channels of care

The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7

Dr. Russ R. Arjal

Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
 

The case for virtual GI care

Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9

 

 

In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10

Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12

Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
 

Financial implications

Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.

The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14

While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.

Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
 

Overcoming obstacles

Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.

 

 

In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).

Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
 

The ultimate aim: Better patient outcomes

Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.

Change can be hard, but it will come

The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.

The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.

As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
 

Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).

References

1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.

2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.

3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.

4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.

5. See id.

6. See id.

7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.

8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).

9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.

10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.

11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.

12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.

13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.

14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.

15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

How a cheap liver drug may be the key to preventing COVID

Article Type
Changed

 

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics


That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?

The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.

Courtesy Nature


As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.

Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?

They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.

Courtesy Nature


So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies

Courtesy Nature


Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.

Courtesy Nature


Of course, mice aren’t humans either. So the researchers didn’t stop there.

To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.

Courtesy Dr. F. Perry Wilson


They didn’t stop there.

Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.

courtesy Nature


Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.

Courtesy Nature


Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.

But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.

For Medscape, I’m Perry Wilson.

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

Publications
Topics
Sections

 

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics


That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?

The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.

Courtesy Nature


As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.

Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?

They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.

Courtesy Nature


So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies

Courtesy Nature


Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.

Courtesy Nature


Of course, mice aren’t humans either. So the researchers didn’t stop there.

To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.

Courtesy Dr. F. Perry Wilson


They didn’t stop there.

Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.

courtesy Nature


Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.

Courtesy Nature


Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.

But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.

For Medscape, I’m Perry Wilson.

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

 

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics


That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?

The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.

Courtesy Nature


As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.

Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?

They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.

Courtesy Nature


So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies

Courtesy Nature


Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.

Courtesy Nature


Of course, mice aren’t humans either. So the researchers didn’t stop there.

To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.

Courtesy Dr. F. Perry Wilson


They didn’t stop there.

Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.

courtesy Nature


Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.

Courtesy Nature


Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.

But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.

For Medscape, I’m Perry Wilson.

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Everyone wins when losers get paid

Article Type
Changed

 

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

 

 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Publications
Topics
Sections

 

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

 

 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

 

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

 

 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

ASH 2022: New clinical data challenge long-held assumptions

Article Type
Changed

In addition to the latest news in clinical care and drug development, some eyebrow-raising findings that challenge long-held, untested assumptions are promised from the annual meeting of the American Society of Hematology.

The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
 

“Feeding Our Patients Gruel”

Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).

“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”

He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”

Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
 

Practice-changing data

ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).

Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
 

Premature aging in HL survivors

ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).

“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”

Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
 

 

 

Inherited thrombophilia and miscarriage

Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).

“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.

Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.

Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).

“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

In addition to the latest news in clinical care and drug development, some eyebrow-raising findings that challenge long-held, untested assumptions are promised from the annual meeting of the American Society of Hematology.

The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
 

“Feeding Our Patients Gruel”

Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).

“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”

He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”

Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
 

Practice-changing data

ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).

Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
 

Premature aging in HL survivors

ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).

“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”

Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
 

 

 

Inherited thrombophilia and miscarriage

Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).

“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.

Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.

Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).

“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”

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

In addition to the latest news in clinical care and drug development, some eyebrow-raising findings that challenge long-held, untested assumptions are promised from the annual meeting of the American Society of Hematology.

The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
 

“Feeding Our Patients Gruel”

Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).

“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”

He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”

Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
 

Practice-changing data

ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).

Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
 

Premature aging in HL survivors

ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).

“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”

Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
 

 

 

Inherited thrombophilia and miscarriage

Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).

“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.

Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.

Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).

“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ASH 2022

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Review gives weight to supplements for hair loss

Article Type
Changed

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

Publications
Topics
Sections

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

Dr. Arash Mostaghimi

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”



For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin Dzinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Dr. Eva Simmons-O'Brien

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

 

 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

Dr. Lynne Goldberg

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Nurturing a Satisfying Career in Dermatology

Article Type
Changed
Display Headline
Nurturing a Satisfying Career in Dermatology

The residents of our program asked me to serve as their commencement speaker in June. Since I was retiring from my position as department chair, this touching honor seemed a fitting capstone for my career. It gave me the opportunity to reflect on the enormity of the changes that have occurred between my graduation from residency in 1983 and the current time, which is marked by disruption from the digital revolution and the COVID-19 pandemic. Throughout this 40-year period, there were times of external global turmoil, economic instability, significant changes in the business of medicine, stressful changes in documentation of competency and certification, and the difficult transition to electronic medical records. Another epidemic—AIDS—changed surgical practices. During my residency, we did biopsies without wearing gloves or masks. Gloves were added to protect the person doing the procedure as well as to prevent spread of disease to other patients, not to reduce the infection rate for the patient undergoing the procedure. Of course, change in the last 40 years also occurred outside of work and included various familial stresses. The irritations of daily life easily mounted up to being overwhelming. However, I had gone to work every day for 40 years, seeking to do my best for my patients and my colleagues and the staff with whom I worked, sometimes feeling successful and sometimes feeling incompetent. Some days went smoothly, and some days were filled with challenges that I could not begin to imagine how I would solve. I have a habit of seeing problems rather than successes, which creates its own difficulties. I did, however, grab opportunities that continually improved my practice of medicine and allowed me to serve in several professional positions as well as in leadership positions of multiple professional societies. As I prepared the commencement address, I realized that the totality of my career was very satisfying.

The Merriam-Webster dictionary definition of satisfying is “producing pleasure or contentment by providing what is needed or wanted.”1 My use of the word means that my career over the long term has pleased me—maybe not some of the people I reported to, but rather me.

My approach to my career can be summarized in 3 words: purpose, serendipity, and curiosity.

The first element is purpose. Job satisfaction generally is associated with work being aligned with values, an appreciation that you are accomplishing the purpose with which you set out on your journey. It is not associated with every day being wonderful and problem free or every task being completed without setbacks or complications. The reality of working is not that every moment brings pure happiness or that every task fulfills a passion. How does a person ensure that the days add up to be satisfying? Start with values. Why did you decide to pursue medical school? Some may have chosen it for economic security, but there are many ways to achieve economic security. Maybe being a physician feeds into the family lore, but families generally have broad ranges of acceptable careers. Maybe it appealed scientifically, but a PhD in biology also fulfills that interest. Maybe it is that you noticed respect for physicians in the community when you were growing up, but that is changing and does not represent an internal value anyway. Consider your values carefully, write them down, and keep them at the forefront of the day. Go back to them consciously any time you have a rough day and understand why you are doing what you are doing. When you are 55 years old and going through your umpteenth change in reimbursement process, go back to the day you decided on medicine as a career. Focus on your values as the grounding for your purpose. Also note that purpose is different than goals. Some goals will be reached, and some will not. Goals change with external realities and/ or internal factors. Purpose and values remain the same if we have thoughtfully identified them.

The second element is serendipity. Serendipity often is thought of as luck, as karma, as being in the right place at the right time. It feels random, and at first glance it appears that purpose and serendipity are complete opposites and do not intersect. Serendipity is, however, not just luck. It is an ability to distinguish events and observations in meaningful ways. It is a close relative of creativity and benefits from sloppiness, playfulness, tinkering, and discussion. It cannot exist in a vacuum. History is replete with serendipitous discoveries. It is thought that James Watson and Francis Crick would never have been able to elucidate the nature of DNA without sharing offices with people with whom they argued daily. In fact, figuring out the DNA structure was not even the main focus of their laboratories. It was just a side angle that several people loved to think about. Appreciating serendipity by being truly open to opportunities that are out on the wings brings experiences that are deeply rewarding even if not planned. I had no idea at all, no plan, no goal of serving as president of the American Academy of Dermatology or as Department Chair, and yet these happened. These experiences have allowed me to work on my purpose as I have defined it. How can you harness serendipity in your own life? My philosophy may be somewhat simple, but I think if you show up every day doing the best job you can at the tasks on hand, doors will appear, at odd intervals and in odd directions. You must be open enough and in tune with your purpose to an extent that you can sense the direction in which to turn and what doorways through which to walk.

The third element is curiosity. One definition is that curiosity is the motivation to learn new information. Another definition is that curiosity is a special form of information seeking distinguished by the fact that it is internally motivated. We are all familiar with intellectual curiosity. For example, a patient has a basal cell carcinoma on the upper back. What does the literature say about the cure rates of various treatments for that particular tumor? In addition, we can be curious about other things as well. Is it a really small tumor? How was it found and why is the patient anxious? Why does it make me irritated that the patient is worried about such a small, easily treated tumor? Or is it a large neglected tumor? Why was it not treated before? Why does it make me sad that it is so large? Why does it annoy me that I have a difficult situation to manage? Being able to define an emotional reaction by being curious about its presence helps us manage destructive responses and promote more positive outcomes. This curiosity is related to emotional intelligence and is mindfully harnessed by effective leaders. Curiosity will get you through tough days when your office team is stressed and the tough years that are complicated by professional and personal challenges.

Curiosity also will help you identify your purpose and harness serendipity, and so we come full circle with our 3 elements: purpose, serendipity, and curiosity.

My wish for all of you is that when you are at the tail end of your career, you will look back and say, “This has been a great ride.” I am very grateful that I can acknowledge this for myself. I have been so fortunate to have found dermatology, where I can go to work every day making a difference for patients in a stimulating environment with good colleagues. One of my values is to try and make life better in some way for everyone around me, even if it is just a smile at the start of the workday. As I look back, this value has allowed me to meet interesting people, hear fascinating stories, make good friends, and have enduring relationships. I have held onto fellow travelers, and we have supported each other through tough times as well as celebrated together the good times.

Nurturing a satisfying career includes these essential fundamentals. First, accept the reality of constant change. Second, develop productive relationships with fellow travelers. And third and most importantly, go forth with purpose, serendipity, and curiosity.

References
  1. Merriam-Webster. Satisfying. Merriam-Webster.com Dictionary. Accessed November 18, 2022. https://www.merriam-webster.com/dictionary/satisfying
Article PDF
Author and Disclosure Information

From Lahey Clinic, Burlington, Massachusetts.

The author reports no conflict of interest.

Correspondence: Suzanne M. Olbricht, MD, Department of Dermatology, Lahey Clinic, 1 Essex Center Dr, Peabody, MA 01960.

Issue
Cutis - 110(6)
Publications
Topics
Page Number
294-295
Sections
Author and Disclosure Information

From Lahey Clinic, Burlington, Massachusetts.

The author reports no conflict of interest.

Correspondence: Suzanne M. Olbricht, MD, Department of Dermatology, Lahey Clinic, 1 Essex Center Dr, Peabody, MA 01960.

Author and Disclosure Information

From Lahey Clinic, Burlington, Massachusetts.

The author reports no conflict of interest.

Correspondence: Suzanne M. Olbricht, MD, Department of Dermatology, Lahey Clinic, 1 Essex Center Dr, Peabody, MA 01960.

Article PDF
Article PDF

The residents of our program asked me to serve as their commencement speaker in June. Since I was retiring from my position as department chair, this touching honor seemed a fitting capstone for my career. It gave me the opportunity to reflect on the enormity of the changes that have occurred between my graduation from residency in 1983 and the current time, which is marked by disruption from the digital revolution and the COVID-19 pandemic. Throughout this 40-year period, there were times of external global turmoil, economic instability, significant changes in the business of medicine, stressful changes in documentation of competency and certification, and the difficult transition to electronic medical records. Another epidemic—AIDS—changed surgical practices. During my residency, we did biopsies without wearing gloves or masks. Gloves were added to protect the person doing the procedure as well as to prevent spread of disease to other patients, not to reduce the infection rate for the patient undergoing the procedure. Of course, change in the last 40 years also occurred outside of work and included various familial stresses. The irritations of daily life easily mounted up to being overwhelming. However, I had gone to work every day for 40 years, seeking to do my best for my patients and my colleagues and the staff with whom I worked, sometimes feeling successful and sometimes feeling incompetent. Some days went smoothly, and some days were filled with challenges that I could not begin to imagine how I would solve. I have a habit of seeing problems rather than successes, which creates its own difficulties. I did, however, grab opportunities that continually improved my practice of medicine and allowed me to serve in several professional positions as well as in leadership positions of multiple professional societies. As I prepared the commencement address, I realized that the totality of my career was very satisfying.

The Merriam-Webster dictionary definition of satisfying is “producing pleasure or contentment by providing what is needed or wanted.”1 My use of the word means that my career over the long term has pleased me—maybe not some of the people I reported to, but rather me.

My approach to my career can be summarized in 3 words: purpose, serendipity, and curiosity.

The first element is purpose. Job satisfaction generally is associated with work being aligned with values, an appreciation that you are accomplishing the purpose with which you set out on your journey. It is not associated with every day being wonderful and problem free or every task being completed without setbacks or complications. The reality of working is not that every moment brings pure happiness or that every task fulfills a passion. How does a person ensure that the days add up to be satisfying? Start with values. Why did you decide to pursue medical school? Some may have chosen it for economic security, but there are many ways to achieve economic security. Maybe being a physician feeds into the family lore, but families generally have broad ranges of acceptable careers. Maybe it appealed scientifically, but a PhD in biology also fulfills that interest. Maybe it is that you noticed respect for physicians in the community when you were growing up, but that is changing and does not represent an internal value anyway. Consider your values carefully, write them down, and keep them at the forefront of the day. Go back to them consciously any time you have a rough day and understand why you are doing what you are doing. When you are 55 years old and going through your umpteenth change in reimbursement process, go back to the day you decided on medicine as a career. Focus on your values as the grounding for your purpose. Also note that purpose is different than goals. Some goals will be reached, and some will not. Goals change with external realities and/ or internal factors. Purpose and values remain the same if we have thoughtfully identified them.

The second element is serendipity. Serendipity often is thought of as luck, as karma, as being in the right place at the right time. It feels random, and at first glance it appears that purpose and serendipity are complete opposites and do not intersect. Serendipity is, however, not just luck. It is an ability to distinguish events and observations in meaningful ways. It is a close relative of creativity and benefits from sloppiness, playfulness, tinkering, and discussion. It cannot exist in a vacuum. History is replete with serendipitous discoveries. It is thought that James Watson and Francis Crick would never have been able to elucidate the nature of DNA without sharing offices with people with whom they argued daily. In fact, figuring out the DNA structure was not even the main focus of their laboratories. It was just a side angle that several people loved to think about. Appreciating serendipity by being truly open to opportunities that are out on the wings brings experiences that are deeply rewarding even if not planned. I had no idea at all, no plan, no goal of serving as president of the American Academy of Dermatology or as Department Chair, and yet these happened. These experiences have allowed me to work on my purpose as I have defined it. How can you harness serendipity in your own life? My philosophy may be somewhat simple, but I think if you show up every day doing the best job you can at the tasks on hand, doors will appear, at odd intervals and in odd directions. You must be open enough and in tune with your purpose to an extent that you can sense the direction in which to turn and what doorways through which to walk.

The third element is curiosity. One definition is that curiosity is the motivation to learn new information. Another definition is that curiosity is a special form of information seeking distinguished by the fact that it is internally motivated. We are all familiar with intellectual curiosity. For example, a patient has a basal cell carcinoma on the upper back. What does the literature say about the cure rates of various treatments for that particular tumor? In addition, we can be curious about other things as well. Is it a really small tumor? How was it found and why is the patient anxious? Why does it make me irritated that the patient is worried about such a small, easily treated tumor? Or is it a large neglected tumor? Why was it not treated before? Why does it make me sad that it is so large? Why does it annoy me that I have a difficult situation to manage? Being able to define an emotional reaction by being curious about its presence helps us manage destructive responses and promote more positive outcomes. This curiosity is related to emotional intelligence and is mindfully harnessed by effective leaders. Curiosity will get you through tough days when your office team is stressed and the tough years that are complicated by professional and personal challenges.

Curiosity also will help you identify your purpose and harness serendipity, and so we come full circle with our 3 elements: purpose, serendipity, and curiosity.

My wish for all of you is that when you are at the tail end of your career, you will look back and say, “This has been a great ride.” I am very grateful that I can acknowledge this for myself. I have been so fortunate to have found dermatology, where I can go to work every day making a difference for patients in a stimulating environment with good colleagues. One of my values is to try and make life better in some way for everyone around me, even if it is just a smile at the start of the workday. As I look back, this value has allowed me to meet interesting people, hear fascinating stories, make good friends, and have enduring relationships. I have held onto fellow travelers, and we have supported each other through tough times as well as celebrated together the good times.

Nurturing a satisfying career includes these essential fundamentals. First, accept the reality of constant change. Second, develop productive relationships with fellow travelers. And third and most importantly, go forth with purpose, serendipity, and curiosity.

The residents of our program asked me to serve as their commencement speaker in June. Since I was retiring from my position as department chair, this touching honor seemed a fitting capstone for my career. It gave me the opportunity to reflect on the enormity of the changes that have occurred between my graduation from residency in 1983 and the current time, which is marked by disruption from the digital revolution and the COVID-19 pandemic. Throughout this 40-year period, there were times of external global turmoil, economic instability, significant changes in the business of medicine, stressful changes in documentation of competency and certification, and the difficult transition to electronic medical records. Another epidemic—AIDS—changed surgical practices. During my residency, we did biopsies without wearing gloves or masks. Gloves were added to protect the person doing the procedure as well as to prevent spread of disease to other patients, not to reduce the infection rate for the patient undergoing the procedure. Of course, change in the last 40 years also occurred outside of work and included various familial stresses. The irritations of daily life easily mounted up to being overwhelming. However, I had gone to work every day for 40 years, seeking to do my best for my patients and my colleagues and the staff with whom I worked, sometimes feeling successful and sometimes feeling incompetent. Some days went smoothly, and some days were filled with challenges that I could not begin to imagine how I would solve. I have a habit of seeing problems rather than successes, which creates its own difficulties. I did, however, grab opportunities that continually improved my practice of medicine and allowed me to serve in several professional positions as well as in leadership positions of multiple professional societies. As I prepared the commencement address, I realized that the totality of my career was very satisfying.

The Merriam-Webster dictionary definition of satisfying is “producing pleasure or contentment by providing what is needed or wanted.”1 My use of the word means that my career over the long term has pleased me—maybe not some of the people I reported to, but rather me.

My approach to my career can be summarized in 3 words: purpose, serendipity, and curiosity.

The first element is purpose. Job satisfaction generally is associated with work being aligned with values, an appreciation that you are accomplishing the purpose with which you set out on your journey. It is not associated with every day being wonderful and problem free or every task being completed without setbacks or complications. The reality of working is not that every moment brings pure happiness or that every task fulfills a passion. How does a person ensure that the days add up to be satisfying? Start with values. Why did you decide to pursue medical school? Some may have chosen it for economic security, but there are many ways to achieve economic security. Maybe being a physician feeds into the family lore, but families generally have broad ranges of acceptable careers. Maybe it appealed scientifically, but a PhD in biology also fulfills that interest. Maybe it is that you noticed respect for physicians in the community when you were growing up, but that is changing and does not represent an internal value anyway. Consider your values carefully, write them down, and keep them at the forefront of the day. Go back to them consciously any time you have a rough day and understand why you are doing what you are doing. When you are 55 years old and going through your umpteenth change in reimbursement process, go back to the day you decided on medicine as a career. Focus on your values as the grounding for your purpose. Also note that purpose is different than goals. Some goals will be reached, and some will not. Goals change with external realities and/ or internal factors. Purpose and values remain the same if we have thoughtfully identified them.

The second element is serendipity. Serendipity often is thought of as luck, as karma, as being in the right place at the right time. It feels random, and at first glance it appears that purpose and serendipity are complete opposites and do not intersect. Serendipity is, however, not just luck. It is an ability to distinguish events and observations in meaningful ways. It is a close relative of creativity and benefits from sloppiness, playfulness, tinkering, and discussion. It cannot exist in a vacuum. History is replete with serendipitous discoveries. It is thought that James Watson and Francis Crick would never have been able to elucidate the nature of DNA without sharing offices with people with whom they argued daily. In fact, figuring out the DNA structure was not even the main focus of their laboratories. It was just a side angle that several people loved to think about. Appreciating serendipity by being truly open to opportunities that are out on the wings brings experiences that are deeply rewarding even if not planned. I had no idea at all, no plan, no goal of serving as president of the American Academy of Dermatology or as Department Chair, and yet these happened. These experiences have allowed me to work on my purpose as I have defined it. How can you harness serendipity in your own life? My philosophy may be somewhat simple, but I think if you show up every day doing the best job you can at the tasks on hand, doors will appear, at odd intervals and in odd directions. You must be open enough and in tune with your purpose to an extent that you can sense the direction in which to turn and what doorways through which to walk.

The third element is curiosity. One definition is that curiosity is the motivation to learn new information. Another definition is that curiosity is a special form of information seeking distinguished by the fact that it is internally motivated. We are all familiar with intellectual curiosity. For example, a patient has a basal cell carcinoma on the upper back. What does the literature say about the cure rates of various treatments for that particular tumor? In addition, we can be curious about other things as well. Is it a really small tumor? How was it found and why is the patient anxious? Why does it make me irritated that the patient is worried about such a small, easily treated tumor? Or is it a large neglected tumor? Why was it not treated before? Why does it make me sad that it is so large? Why does it annoy me that I have a difficult situation to manage? Being able to define an emotional reaction by being curious about its presence helps us manage destructive responses and promote more positive outcomes. This curiosity is related to emotional intelligence and is mindfully harnessed by effective leaders. Curiosity will get you through tough days when your office team is stressed and the tough years that are complicated by professional and personal challenges.

Curiosity also will help you identify your purpose and harness serendipity, and so we come full circle with our 3 elements: purpose, serendipity, and curiosity.

My wish for all of you is that when you are at the tail end of your career, you will look back and say, “This has been a great ride.” I am very grateful that I can acknowledge this for myself. I have been so fortunate to have found dermatology, where I can go to work every day making a difference for patients in a stimulating environment with good colleagues. One of my values is to try and make life better in some way for everyone around me, even if it is just a smile at the start of the workday. As I look back, this value has allowed me to meet interesting people, hear fascinating stories, make good friends, and have enduring relationships. I have held onto fellow travelers, and we have supported each other through tough times as well as celebrated together the good times.

Nurturing a satisfying career includes these essential fundamentals. First, accept the reality of constant change. Second, develop productive relationships with fellow travelers. And third and most importantly, go forth with purpose, serendipity, and curiosity.

References
  1. Merriam-Webster. Satisfying. Merriam-Webster.com Dictionary. Accessed November 18, 2022. https://www.merriam-webster.com/dictionary/satisfying
References
  1. Merriam-Webster. Satisfying. Merriam-Webster.com Dictionary. Accessed November 18, 2022. https://www.merriam-webster.com/dictionary/satisfying
Issue
Cutis - 110(6)
Issue
Cutis - 110(6)
Page Number
294-295
Page Number
294-295
Publications
Publications
Topics
Article Type
Display Headline
Nurturing a Satisfying Career in Dermatology
Display Headline
Nurturing a Satisfying Career in Dermatology
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

What is the diagnosis?

Article Type
Changed

Syphilis 

Although extremely rare, we checked a Venereal Disease Research Laboratory PCR, the results of which came back positive. A Treponema pallidum hemagglutination assay also returned positive with titers 1:5120 (ULN, < 1:80), confirming the diagnosis of syphilis. During his hospitalization, the patient developed a syphilitic skin rash on his back, chest, palms, feet, and soles (Figure C). The patient was started on penicillin G, 4 million units intravenously every 4 hours. The fever broke 36 hours after antibiotic initiation and 48 hours later, his bilirubin started to downtrend, followed by the alkaline phosphatase and GGT 3 days later. His rash completely disappeared 5 days after antibiotic initiation. He received a total of 2 weeks of penicillin G intravenously at 24 million units a day and his liver enzymes normalized 7 weeks later. 


Syphilitic hepatitis is extremely rare and occurs in 0.2% of patients with secondary syphilis.1 There are few cases of syphilitic hepatitis in HIV carriers reported in the literature. Of the described cases, only two patients had an undetectable viral load.2,3 The clinical presentation of syphilitic hepatitis includes jaundice, pruritus, nausea, and vomiting, in addition to generalized symptoms of fatigue, malaise, and weight loss. Biochemically, alkaline phosphatase and GGT are predominantly elevated with mild elevation in the transaminases. Few cases describe an elevation in the bilirubin. Diagnosis is made based on treponemal testing and/or evaluation of tissue for spirochetes on liver biopsy. The majority of cases used penicillin G with excellent response. Doxycycline was also used in one case and ceftriaxone was used in another. 

In our case, the patient had several other possible reasons for his liver enzyme elevation, including drug-induced liver injury, cocaine, and alcohol use, which could have contributed to his disturbed liver enzymes. The steady improvement in his cholestatic liver enzymes, fever, and rash, shortly after the initiation of penicillin G indicates that syphilis was the cause of his hepatitis. Given the improvement in his symptoms and biochemical markers, we refrained from obtaining a liver biopsy.

References 

1. Lee M., Wang C., Dorer R. et al. A great masquerader: Acute syphilitic hepatitis. Dig Dis Sci. 2013;58:923-5. 
2. Mullick CJ. Liappis A.P. Benator D.A. et al. Syphilitic hepatitis in HIV-infected patients: A report of 7 cases and review of the literature. Clin Infect Dis. 2004;39:e100-e105. 
3. German MN. Matkowskyj K.A. Hoffman R.J. et al. A case of syphilitic hepatitis in an HIV-infected patient. Hum Pathol. 2018;79:184-7.

Publications
Topics
Sections

Syphilis 

Although extremely rare, we checked a Venereal Disease Research Laboratory PCR, the results of which came back positive. A Treponema pallidum hemagglutination assay also returned positive with titers 1:5120 (ULN, < 1:80), confirming the diagnosis of syphilis. During his hospitalization, the patient developed a syphilitic skin rash on his back, chest, palms, feet, and soles (Figure C). The patient was started on penicillin G, 4 million units intravenously every 4 hours. The fever broke 36 hours after antibiotic initiation and 48 hours later, his bilirubin started to downtrend, followed by the alkaline phosphatase and GGT 3 days later. His rash completely disappeared 5 days after antibiotic initiation. He received a total of 2 weeks of penicillin G intravenously at 24 million units a day and his liver enzymes normalized 7 weeks later. 


Syphilitic hepatitis is extremely rare and occurs in 0.2% of patients with secondary syphilis.1 There are few cases of syphilitic hepatitis in HIV carriers reported in the literature. Of the described cases, only two patients had an undetectable viral load.2,3 The clinical presentation of syphilitic hepatitis includes jaundice, pruritus, nausea, and vomiting, in addition to generalized symptoms of fatigue, malaise, and weight loss. Biochemically, alkaline phosphatase and GGT are predominantly elevated with mild elevation in the transaminases. Few cases describe an elevation in the bilirubin. Diagnosis is made based on treponemal testing and/or evaluation of tissue for spirochetes on liver biopsy. The majority of cases used penicillin G with excellent response. Doxycycline was also used in one case and ceftriaxone was used in another. 

In our case, the patient had several other possible reasons for his liver enzyme elevation, including drug-induced liver injury, cocaine, and alcohol use, which could have contributed to his disturbed liver enzymes. The steady improvement in his cholestatic liver enzymes, fever, and rash, shortly after the initiation of penicillin G indicates that syphilis was the cause of his hepatitis. Given the improvement in his symptoms and biochemical markers, we refrained from obtaining a liver biopsy.

References 

1. Lee M., Wang C., Dorer R. et al. A great masquerader: Acute syphilitic hepatitis. Dig Dis Sci. 2013;58:923-5. 
2. Mullick CJ. Liappis A.P. Benator D.A. et al. Syphilitic hepatitis in HIV-infected patients: A report of 7 cases and review of the literature. Clin Infect Dis. 2004;39:e100-e105. 
3. German MN. Matkowskyj K.A. Hoffman R.J. et al. A case of syphilitic hepatitis in an HIV-infected patient. Hum Pathol. 2018;79:184-7.

Syphilis 

Although extremely rare, we checked a Venereal Disease Research Laboratory PCR, the results of which came back positive. A Treponema pallidum hemagglutination assay also returned positive with titers 1:5120 (ULN, < 1:80), confirming the diagnosis of syphilis. During his hospitalization, the patient developed a syphilitic skin rash on his back, chest, palms, feet, and soles (Figure C). The patient was started on penicillin G, 4 million units intravenously every 4 hours. The fever broke 36 hours after antibiotic initiation and 48 hours later, his bilirubin started to downtrend, followed by the alkaline phosphatase and GGT 3 days later. His rash completely disappeared 5 days after antibiotic initiation. He received a total of 2 weeks of penicillin G intravenously at 24 million units a day and his liver enzymes normalized 7 weeks later. 


Syphilitic hepatitis is extremely rare and occurs in 0.2% of patients with secondary syphilis.1 There are few cases of syphilitic hepatitis in HIV carriers reported in the literature. Of the described cases, only two patients had an undetectable viral load.2,3 The clinical presentation of syphilitic hepatitis includes jaundice, pruritus, nausea, and vomiting, in addition to generalized symptoms of fatigue, malaise, and weight loss. Biochemically, alkaline phosphatase and GGT are predominantly elevated with mild elevation in the transaminases. Few cases describe an elevation in the bilirubin. Diagnosis is made based on treponemal testing and/or evaluation of tissue for spirochetes on liver biopsy. The majority of cases used penicillin G with excellent response. Doxycycline was also used in one case and ceftriaxone was used in another. 

In our case, the patient had several other possible reasons for his liver enzyme elevation, including drug-induced liver injury, cocaine, and alcohol use, which could have contributed to his disturbed liver enzymes. The steady improvement in his cholestatic liver enzymes, fever, and rash, shortly after the initiation of penicillin G indicates that syphilis was the cause of his hepatitis. Given the improvement in his symptoms and biochemical markers, we refrained from obtaining a liver biopsy.

References 

1. Lee M., Wang C., Dorer R. et al. A great masquerader: Acute syphilitic hepatitis. Dig Dis Sci. 2013;58:923-5. 
2. Mullick CJ. Liappis A.P. Benator D.A. et al. Syphilitic hepatitis in HIV-infected patients: A report of 7 cases and review of the literature. Clin Infect Dis. 2004;39:e100-e105. 
3. German MN. Matkowskyj K.A. Hoffman R.J. et al. A case of syphilitic hepatitis in an HIV-infected patient. Hum Pathol. 2018;79:184-7.

Publications
Publications
Topics
Article Type
Sections
Questionnaire Body

A 48-year-old man with HIV infection (PCR undetectable CD4 483) who used cocaine and was a heavy user of alcohol presented with jaundice, fever, and acute-onset left-upper quadrant abdominal pain. The pain was exacerbated by breathing. He had associated intermittent fevers and weight loss starting 3 weeks before presentation. He denied chest pain, nausea, vomiting, or a change in bowel habits. Home medications included dolutegravir, emtricitabine, tenofovir disoproxil fumarate, and recent intake of tamoxifen, clomiphene, and chorionic gonadotropin to counteract the effects of anabolic steroids that were used 4 months before presentation. 

On examination, his temperature was 39°C, he was jaundiced, and he had icteric sclera. The abdomen was soft and nondistended with minimal left-upper quadrant tenderness. Blood work showed a white blood cell count of 7,800/mcL, hemoglobin of 12.2 g/dL, platelets of 378,000/mcL, alanine aminotransferase 236 IU/L (upper limit of normal [ULN], 65 IU/L), aspartate aminotransferase 166 IU/L (ULN, 50 IU/L), total bilirubin 3.4 mg/dL (ULN, 1.2 mg/dL), direct bilirubin 2.6 mg/dL (ULN, 0.3 mg/dL), alkaline phosphatase 1,064 IU/L (ULN, 120 IU/L), gamma-glutamyl transferase (GGT) of 655 (ULN, 50 IU/L), protein of 73 g/L, and albumin of 34 g/L. Lipase, lactate dehydrogenase, and international normalized ratio were normal. Blood smear was unrevealing. A contrasted computed tomography scan showed multiple subcentimetric mesenteric and multiple retroperitoneal lymph nodes, the largest of which was 1.3 cm in the aortocaval area. All medications were discontinued. Hepatitis A, B, and C serologies were negative, including hepatitis B and C PCR. Epstein-Barr virus IgM was negative and cytomegalovirus IgM was equivocal. 


During this hospitalization, his cholestatic liver enzymes continued to rise, reaching a maximum value of total bilirubin of 7.8 mg/dL, direct bilirubin of 6.5 mg/dL, and 3 days later, alkaline phosphatase of 1,637 IU/L and GGT of 1,171 IU/L. Alanine aminotransferase and aspartate aminotransferase slowly downtrended during the hospitalization. Magnetic resonance cholangiopancreatography showed an edematous enlarged liver with minimal peripheral intrahepatic dilatation without an obstructing mass or extrahepatic biliary ductal dilatation (Figure A). Comprehensive autoimmune hepatic serology, iron studies, ceruloplasmin, and alpha-1 antitrypsin labs were negative. The patient remained febrile, so a positron emission tomography computed tomography scan was done and it showed active and enlarged (2.8-cm) portocaval and porta hepatis lymph nodes. Bone marrow biopsy showed no lymphoproliferative disorder, but there was a small poorly formed granuloma (Figure B, between the arrows). 

What other testing would you obtain to evaluate this patient's fever and abnormal liver enzymes?

Article Source

Previously published in Gastroenterology

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Un-Gate On Date
Use ProPublica
CFC Schedule Remove Status
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Diagnosed too late

Article Type
Changed

It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment, we had to have a serious talk about death and dying and the goals of care. She died soon after our talk.

Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.

We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.

In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.

I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.

These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.

We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.

It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.

A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.

When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.


Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
 

This article was updated 12/7/22.

Publications
Topics
Sections

It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment, we had to have a serious talk about death and dying and the goals of care. She died soon after our talk.

Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.

We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.

In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.

I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.

These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.

We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.

It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.

A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.

When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.


Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
 

This article was updated 12/7/22.

It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment, we had to have a serious talk about death and dying and the goals of care. She died soon after our talk.

Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.

We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.

In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.

I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.

These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.

We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.

It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.

A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.

When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.


Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
 

This article was updated 12/7/22.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Study comparing surgical and N95 masks sparks concern

Article Type
Changed

 

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

Publications
Topics
Sections

 

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

 

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ANNALS OF INTERNAL MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article