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The invisible effect medical notes could have on care

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Mon, 07/03/2023 - 12:16

 

In the mid-1990s, when Somnath Saha was a medical resident at the University of California, San Francisco, School of Medicine, he came across a cluster of studies showing that Black people with cardiovascular disease were treated less aggressively, compared with White people. The findings were “appalling” to the young physician who describes himself as a “Brown kid from suburban St. Louis, Missouri.”

Dr. Saha had experienced racism growing up, but was surprised to see such clear signs of inequity within the field of medicine. “There was an injustice happening in my own backyard,” he said.

Indeed, bias towards Black patients can be challenging because many doctors either don’t realize their biases or won’t admit to them. Dr. Saha, now a professor of medicine at Johns Hopkins University, likens implicit bias – unconscious judgments that can affect behavior – to “an invisible force.”

While numerous studies have found evidence of racial discrimination in medicine through patient reports, less is known about how implicit bias shows up in medical records, and how stigmatizing language in patient notes can affect the care that Black patients receive.

That’s part of the reason why, about 7 years ago, Dr. Saha began poring through medical records. For him, they offered a window into doctors’ feelings about their patients.

As part of his latest research, Dr. Saha’s team examined the records of nearly 19,000 patients, paying particular attention to negative descriptions that may influence a clinician’s decision-making. The data, which were recently presented at the 2023 American Association for the Advancement of Science annual meeting, aren’t yet published, but it suggests what researchers have long speculated: Doctors are more likely to use negative language when describing a Black patient than they are in describing a White patient. The notes provide, at times, a surprisingly candid view of how patients are perceived by doctors, and how their race may affect treatment.

The study adds to a concerning body of literature that explores how racial bias manifests in health care. Researchers like Dr. Saha are interested in how such prejudice leaves a paper trail, which can then reinforce negative stereotypes. Because medical notes get passed between physicians, Dr. Saha’s research suggests they can affect the health of Black patients down the line.

“The medical record is like a rap sheet, it stays with you,” Dr. Saha said, adding that “these things that we say about patients get eternalized.”

Research has long shown that Black patients experience worse health outcomes, compared with White patients, in part because of biased medical care. Black women, for example, are three times more likely to die from pregnancy-related complications, compared with White women. And Black patients often report feeling like physicians don’t listen to their needs or don’t believe their concerns.

Studies appear to back that up. Last year, researchers at the University of Washington found that non-Hispanic White children who went to the emergency room for migraines were more likely to receive pain medications, compared with children of color – even though the two groups reported similar pain scores. Other studies echo similar results for adults as well.

While Michael Sun, a resident physician at the University of Chicago, knew about such health disparities, by his own admission, he was naive about the biases in medical records. At that time, Dr. Sun had “no experience in the medical record, in documentation, or in physician language and culture,” he said.

But in Dr. Sun’s first year of medical school, his professor shared the story of a longtime patient, whom she had referred to an outside specialist. In his recollection, the professor regarded her patient in kind terms, having worked with her for some time to treat a chronic illness. But when she got the specialist’s notes back, she was confused by the description of her patient: Terms like “really difficult,” “noncompliant,” and “uninterested in their health.” This was not the patient she remembered.

“This, as a first-year medical student, really shocked me because I had taken at face value that any words used in notes were true, were valid, or rightfully used,” said Dr. Sun. “I realized all the ways that bias, untold stories, and unknown context may change the way that we view our patients.”

Like Dr. Saha, Dr. Sun became interested in how bias influenced the relationship between doctor and patient, and how these interactions were memorialized in the medical record. In a study published last year, he and his colleagues looked at more than 40,000 medical notes from 18,459 patients. Researchers first manually combed through the notes, then used this information to teach a machine learning algorithm to interpret the connotations of words. Compared with White patients, Black patients were about 2.5 times more likely to be described negatively, with terms like “challenging,” “angry,” and “noncompliant.”

Dr. Saha has used similar methodology – and found similar results – in his own research. For the study presented at the AAAS meeting, his team first read through more than 100,000 medical notes to identify language their team considered to be disparaging – which they chose based on a list of words and phrases from prior research. They then used machine learning to find those terms in medical notes, taking care to ensure context was considered. For example, if the word “aggressive” was used to describe a treatment plan, it was excluded from their analysis. But if “aggressive” was used to describe the patient, it was included.

Dr. Saha pointed to three categories of stigmatizing language that were the most pronounced: expressing doubt or disbelief in what the patient said, such as reporting they “claimed” to experience pain; insinuating that the patient was confrontational, using words like “belligerent” or combative;” and suggesting a patient was not cooperating with a doctor’s orders by saying they “refused” medical advice.

“We’ve known for some time that in health care we sometimes use language that can be confusing or even insulting,” Matthew Wynia, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, wrote in an email to Undark. But he noted that research such as Dr. Saha’s has drawn attention to a previously overlooked issue. Describing a patient as “noncompliant” with medications, he said, “makes it sound like the patient is intentionally refusing to follow advice when, in fact, there are many reasons why people might not be able to follow our advice and intentional refusal isn’t even a very common one.”

Dr. Saha noted that, if a patient isn’t taking their medication, it’s important that doctors note that, so that the next physician doesn’t overprescribe them. But the concern, he said, is whether doctors are using these terms appropriately and for the right reasons because of the implications they have for patients.

If a doctor portrays their patient negatively, Dr. Saha said, it can “trigger the next clinician to read them and formulate a potentially negative opinion about that patient” before they’ve even had a chance to interact.

Still, stigmatizing language is only one small piece of the puzzle. What also matters, Dr. Saha said, is how those words can have an impact on care. In prior work, Dr. Saha has shown how implicit and, in some cases, explicit bias, affects a patient’s treatment recommendations.

In a 2018 study, Dr. Saha, along with his wife, Mary Catherine Beach – also a professor at Johns Hopkins University – combed through reports of patients with sickle cell anemia. Their team focused on that particular population since sickle cell patients are some of the most stigmatized in the health care system: Most patients are Black and many require regular doses of opioids for pain management.

In the notes, they found numerous examples of details that were irrelevant to patients’ health concerns: phrases like “girlfriend requests bus token,” “cursing at nurse,” “girlfriend on bed with shoes on,” and “narcotic dependent.”

Dr. Saha and Dr. Beach wanted to see how these remarks might influence a physician’s treatment recommendations, so they used vignettes they had found in the medical records of sickle cell patients. They showed either a vignette which had described patients negatively, or one that was edited with neutral language. Then they asked medical students and residents about the dose of pain medication they would hypothetically recommend. Dr. Beach said that the purpose was to see how what she called “dog whistles about social class or race or something that would make the person seem less educated” would impact treatment recommendations.

The study found that medical notes with stigmatizing language were associated with “less aggressive management of the patient’s pain.” Doctors who read the stigmatizing language chart notes prescribed less pain medication to patients even in cases when they commented that their pain was a 10 out of 10.

“The fact that we were able to show that this bias transmits to the next doctor has been the thing that I think motivates doctors to take it seriously,” said Dr. Beach.

Pain management has become a focal point for researchers because many of the most glaring racial tropes about patient care have revolved around pain. In 2016, a study conducted at the University of Virginia found that half of the 418 medical students and residents surveyed endorsed false beliefs about Black patients. For example, that “Blacks’ nerve endings are less sensitive than whites” and “Blacks’ skin is thicker than whites.” What’s more, those who endorsed these false beliefs also rated Black patients’ pain as lower than White patients’.

Antoinette M. Schoenthaler, a professor of population health and medicine at New York University and associate director of research at the school’s Institute for Excellence in Health Equity, said that disparities in pain management are pervasive and widespread across the medical profession. They seep into treatments for sickle cell anemia, but also prenatal care. As a result, she said, Black patients across the board are often fearful of attending appointments.

“Patients of color go into an appointment with feelings of heightened anxiety because they’re expecting mistreatment,” said Dr. Schoenthaler. “We’ve seen minoritized patients have higher blood pressure in the context of a clinical visit because of these expectations of anxiety and fear, and disappointment.”

Disparities in health care between Black and White patients is a complex issue – one which can’t be solved by addressing medical records alone. But, for researchers like Dr. Saha, Dr. Beach, and Dr. Sun, they can offer a road map that outlines where differences in care begin. The words a clinician uses sets the path for how a patient may be treated in the future.

One way to combat implicit bias, Dr. Saha suggested, is to use an algorithm that identifies stigmatizing language to “give hospital departments or clinicians report cards on how much of this language that they’re using.” By benchmarking averages against one another, clinicians could know if they’re using stigmatizing language at an above average rate. This is something he is considering for future research.

When clinicians are made aware of their biases – when the unconscious becomes conscious – Dr. Saha told Undark that he’s optimistic they’ll work to change them: “We’re using language that we’ve used forever without realizing the potential impact that it has on patient care.”

This article originated on Undark. A version of this article appeared on Medscape.com.

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In the mid-1990s, when Somnath Saha was a medical resident at the University of California, San Francisco, School of Medicine, he came across a cluster of studies showing that Black people with cardiovascular disease were treated less aggressively, compared with White people. The findings were “appalling” to the young physician who describes himself as a “Brown kid from suburban St. Louis, Missouri.”

Dr. Saha had experienced racism growing up, but was surprised to see such clear signs of inequity within the field of medicine. “There was an injustice happening in my own backyard,” he said.

Indeed, bias towards Black patients can be challenging because many doctors either don’t realize their biases or won’t admit to them. Dr. Saha, now a professor of medicine at Johns Hopkins University, likens implicit bias – unconscious judgments that can affect behavior – to “an invisible force.”

While numerous studies have found evidence of racial discrimination in medicine through patient reports, less is known about how implicit bias shows up in medical records, and how stigmatizing language in patient notes can affect the care that Black patients receive.

That’s part of the reason why, about 7 years ago, Dr. Saha began poring through medical records. For him, they offered a window into doctors’ feelings about their patients.

As part of his latest research, Dr. Saha’s team examined the records of nearly 19,000 patients, paying particular attention to negative descriptions that may influence a clinician’s decision-making. The data, which were recently presented at the 2023 American Association for the Advancement of Science annual meeting, aren’t yet published, but it suggests what researchers have long speculated: Doctors are more likely to use negative language when describing a Black patient than they are in describing a White patient. The notes provide, at times, a surprisingly candid view of how patients are perceived by doctors, and how their race may affect treatment.

The study adds to a concerning body of literature that explores how racial bias manifests in health care. Researchers like Dr. Saha are interested in how such prejudice leaves a paper trail, which can then reinforce negative stereotypes. Because medical notes get passed between physicians, Dr. Saha’s research suggests they can affect the health of Black patients down the line.

“The medical record is like a rap sheet, it stays with you,” Dr. Saha said, adding that “these things that we say about patients get eternalized.”

Research has long shown that Black patients experience worse health outcomes, compared with White patients, in part because of biased medical care. Black women, for example, are three times more likely to die from pregnancy-related complications, compared with White women. And Black patients often report feeling like physicians don’t listen to their needs or don’t believe their concerns.

Studies appear to back that up. Last year, researchers at the University of Washington found that non-Hispanic White children who went to the emergency room for migraines were more likely to receive pain medications, compared with children of color – even though the two groups reported similar pain scores. Other studies echo similar results for adults as well.

While Michael Sun, a resident physician at the University of Chicago, knew about such health disparities, by his own admission, he was naive about the biases in medical records. At that time, Dr. Sun had “no experience in the medical record, in documentation, or in physician language and culture,” he said.

But in Dr. Sun’s first year of medical school, his professor shared the story of a longtime patient, whom she had referred to an outside specialist. In his recollection, the professor regarded her patient in kind terms, having worked with her for some time to treat a chronic illness. But when she got the specialist’s notes back, she was confused by the description of her patient: Terms like “really difficult,” “noncompliant,” and “uninterested in their health.” This was not the patient she remembered.

“This, as a first-year medical student, really shocked me because I had taken at face value that any words used in notes were true, were valid, or rightfully used,” said Dr. Sun. “I realized all the ways that bias, untold stories, and unknown context may change the way that we view our patients.”

Like Dr. Saha, Dr. Sun became interested in how bias influenced the relationship between doctor and patient, and how these interactions were memorialized in the medical record. In a study published last year, he and his colleagues looked at more than 40,000 medical notes from 18,459 patients. Researchers first manually combed through the notes, then used this information to teach a machine learning algorithm to interpret the connotations of words. Compared with White patients, Black patients were about 2.5 times more likely to be described negatively, with terms like “challenging,” “angry,” and “noncompliant.”

Dr. Saha has used similar methodology – and found similar results – in his own research. For the study presented at the AAAS meeting, his team first read through more than 100,000 medical notes to identify language their team considered to be disparaging – which they chose based on a list of words and phrases from prior research. They then used machine learning to find those terms in medical notes, taking care to ensure context was considered. For example, if the word “aggressive” was used to describe a treatment plan, it was excluded from their analysis. But if “aggressive” was used to describe the patient, it was included.

Dr. Saha pointed to three categories of stigmatizing language that were the most pronounced: expressing doubt or disbelief in what the patient said, such as reporting they “claimed” to experience pain; insinuating that the patient was confrontational, using words like “belligerent” or combative;” and suggesting a patient was not cooperating with a doctor’s orders by saying they “refused” medical advice.

“We’ve known for some time that in health care we sometimes use language that can be confusing or even insulting,” Matthew Wynia, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, wrote in an email to Undark. But he noted that research such as Dr. Saha’s has drawn attention to a previously overlooked issue. Describing a patient as “noncompliant” with medications, he said, “makes it sound like the patient is intentionally refusing to follow advice when, in fact, there are many reasons why people might not be able to follow our advice and intentional refusal isn’t even a very common one.”

Dr. Saha noted that, if a patient isn’t taking their medication, it’s important that doctors note that, so that the next physician doesn’t overprescribe them. But the concern, he said, is whether doctors are using these terms appropriately and for the right reasons because of the implications they have for patients.

If a doctor portrays their patient negatively, Dr. Saha said, it can “trigger the next clinician to read them and formulate a potentially negative opinion about that patient” before they’ve even had a chance to interact.

Still, stigmatizing language is only one small piece of the puzzle. What also matters, Dr. Saha said, is how those words can have an impact on care. In prior work, Dr. Saha has shown how implicit and, in some cases, explicit bias, affects a patient’s treatment recommendations.

In a 2018 study, Dr. Saha, along with his wife, Mary Catherine Beach – also a professor at Johns Hopkins University – combed through reports of patients with sickle cell anemia. Their team focused on that particular population since sickle cell patients are some of the most stigmatized in the health care system: Most patients are Black and many require regular doses of opioids for pain management.

In the notes, they found numerous examples of details that were irrelevant to patients’ health concerns: phrases like “girlfriend requests bus token,” “cursing at nurse,” “girlfriend on bed with shoes on,” and “narcotic dependent.”

Dr. Saha and Dr. Beach wanted to see how these remarks might influence a physician’s treatment recommendations, so they used vignettes they had found in the medical records of sickle cell patients. They showed either a vignette which had described patients negatively, or one that was edited with neutral language. Then they asked medical students and residents about the dose of pain medication they would hypothetically recommend. Dr. Beach said that the purpose was to see how what she called “dog whistles about social class or race or something that would make the person seem less educated” would impact treatment recommendations.

The study found that medical notes with stigmatizing language were associated with “less aggressive management of the patient’s pain.” Doctors who read the stigmatizing language chart notes prescribed less pain medication to patients even in cases when they commented that their pain was a 10 out of 10.

“The fact that we were able to show that this bias transmits to the next doctor has been the thing that I think motivates doctors to take it seriously,” said Dr. Beach.

Pain management has become a focal point for researchers because many of the most glaring racial tropes about patient care have revolved around pain. In 2016, a study conducted at the University of Virginia found that half of the 418 medical students and residents surveyed endorsed false beliefs about Black patients. For example, that “Blacks’ nerve endings are less sensitive than whites” and “Blacks’ skin is thicker than whites.” What’s more, those who endorsed these false beliefs also rated Black patients’ pain as lower than White patients’.

Antoinette M. Schoenthaler, a professor of population health and medicine at New York University and associate director of research at the school’s Institute for Excellence in Health Equity, said that disparities in pain management are pervasive and widespread across the medical profession. They seep into treatments for sickle cell anemia, but also prenatal care. As a result, she said, Black patients across the board are often fearful of attending appointments.

“Patients of color go into an appointment with feelings of heightened anxiety because they’re expecting mistreatment,” said Dr. Schoenthaler. “We’ve seen minoritized patients have higher blood pressure in the context of a clinical visit because of these expectations of anxiety and fear, and disappointment.”

Disparities in health care between Black and White patients is a complex issue – one which can’t be solved by addressing medical records alone. But, for researchers like Dr. Saha, Dr. Beach, and Dr. Sun, they can offer a road map that outlines where differences in care begin. The words a clinician uses sets the path for how a patient may be treated in the future.

One way to combat implicit bias, Dr. Saha suggested, is to use an algorithm that identifies stigmatizing language to “give hospital departments or clinicians report cards on how much of this language that they’re using.” By benchmarking averages against one another, clinicians could know if they’re using stigmatizing language at an above average rate. This is something he is considering for future research.

When clinicians are made aware of their biases – when the unconscious becomes conscious – Dr. Saha told Undark that he’s optimistic they’ll work to change them: “We’re using language that we’ve used forever without realizing the potential impact that it has on patient care.”

This article originated on Undark. A version of this article appeared on Medscape.com.

 

In the mid-1990s, when Somnath Saha was a medical resident at the University of California, San Francisco, School of Medicine, he came across a cluster of studies showing that Black people with cardiovascular disease were treated less aggressively, compared with White people. The findings were “appalling” to the young physician who describes himself as a “Brown kid from suburban St. Louis, Missouri.”

Dr. Saha had experienced racism growing up, but was surprised to see such clear signs of inequity within the field of medicine. “There was an injustice happening in my own backyard,” he said.

Indeed, bias towards Black patients can be challenging because many doctors either don’t realize their biases or won’t admit to them. Dr. Saha, now a professor of medicine at Johns Hopkins University, likens implicit bias – unconscious judgments that can affect behavior – to “an invisible force.”

While numerous studies have found evidence of racial discrimination in medicine through patient reports, less is known about how implicit bias shows up in medical records, and how stigmatizing language in patient notes can affect the care that Black patients receive.

That’s part of the reason why, about 7 years ago, Dr. Saha began poring through medical records. For him, they offered a window into doctors’ feelings about their patients.

As part of his latest research, Dr. Saha’s team examined the records of nearly 19,000 patients, paying particular attention to negative descriptions that may influence a clinician’s decision-making. The data, which were recently presented at the 2023 American Association for the Advancement of Science annual meeting, aren’t yet published, but it suggests what researchers have long speculated: Doctors are more likely to use negative language when describing a Black patient than they are in describing a White patient. The notes provide, at times, a surprisingly candid view of how patients are perceived by doctors, and how their race may affect treatment.

The study adds to a concerning body of literature that explores how racial bias manifests in health care. Researchers like Dr. Saha are interested in how such prejudice leaves a paper trail, which can then reinforce negative stereotypes. Because medical notes get passed between physicians, Dr. Saha’s research suggests they can affect the health of Black patients down the line.

“The medical record is like a rap sheet, it stays with you,” Dr. Saha said, adding that “these things that we say about patients get eternalized.”

Research has long shown that Black patients experience worse health outcomes, compared with White patients, in part because of biased medical care. Black women, for example, are three times more likely to die from pregnancy-related complications, compared with White women. And Black patients often report feeling like physicians don’t listen to their needs or don’t believe their concerns.

Studies appear to back that up. Last year, researchers at the University of Washington found that non-Hispanic White children who went to the emergency room for migraines were more likely to receive pain medications, compared with children of color – even though the two groups reported similar pain scores. Other studies echo similar results for adults as well.

While Michael Sun, a resident physician at the University of Chicago, knew about such health disparities, by his own admission, he was naive about the biases in medical records. At that time, Dr. Sun had “no experience in the medical record, in documentation, or in physician language and culture,” he said.

But in Dr. Sun’s first year of medical school, his professor shared the story of a longtime patient, whom she had referred to an outside specialist. In his recollection, the professor regarded her patient in kind terms, having worked with her for some time to treat a chronic illness. But when she got the specialist’s notes back, she was confused by the description of her patient: Terms like “really difficult,” “noncompliant,” and “uninterested in their health.” This was not the patient she remembered.

“This, as a first-year medical student, really shocked me because I had taken at face value that any words used in notes were true, were valid, or rightfully used,” said Dr. Sun. “I realized all the ways that bias, untold stories, and unknown context may change the way that we view our patients.”

Like Dr. Saha, Dr. Sun became interested in how bias influenced the relationship between doctor and patient, and how these interactions were memorialized in the medical record. In a study published last year, he and his colleagues looked at more than 40,000 medical notes from 18,459 patients. Researchers first manually combed through the notes, then used this information to teach a machine learning algorithm to interpret the connotations of words. Compared with White patients, Black patients were about 2.5 times more likely to be described negatively, with terms like “challenging,” “angry,” and “noncompliant.”

Dr. Saha has used similar methodology – and found similar results – in his own research. For the study presented at the AAAS meeting, his team first read through more than 100,000 medical notes to identify language their team considered to be disparaging – which they chose based on a list of words and phrases from prior research. They then used machine learning to find those terms in medical notes, taking care to ensure context was considered. For example, if the word “aggressive” was used to describe a treatment plan, it was excluded from their analysis. But if “aggressive” was used to describe the patient, it was included.

Dr. Saha pointed to three categories of stigmatizing language that were the most pronounced: expressing doubt or disbelief in what the patient said, such as reporting they “claimed” to experience pain; insinuating that the patient was confrontational, using words like “belligerent” or combative;” and suggesting a patient was not cooperating with a doctor’s orders by saying they “refused” medical advice.

“We’ve known for some time that in health care we sometimes use language that can be confusing or even insulting,” Matthew Wynia, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, wrote in an email to Undark. But he noted that research such as Dr. Saha’s has drawn attention to a previously overlooked issue. Describing a patient as “noncompliant” with medications, he said, “makes it sound like the patient is intentionally refusing to follow advice when, in fact, there are many reasons why people might not be able to follow our advice and intentional refusal isn’t even a very common one.”

Dr. Saha noted that, if a patient isn’t taking their medication, it’s important that doctors note that, so that the next physician doesn’t overprescribe them. But the concern, he said, is whether doctors are using these terms appropriately and for the right reasons because of the implications they have for patients.

If a doctor portrays their patient negatively, Dr. Saha said, it can “trigger the next clinician to read them and formulate a potentially negative opinion about that patient” before they’ve even had a chance to interact.

Still, stigmatizing language is only one small piece of the puzzle. What also matters, Dr. Saha said, is how those words can have an impact on care. In prior work, Dr. Saha has shown how implicit and, in some cases, explicit bias, affects a patient’s treatment recommendations.

In a 2018 study, Dr. Saha, along with his wife, Mary Catherine Beach – also a professor at Johns Hopkins University – combed through reports of patients with sickle cell anemia. Their team focused on that particular population since sickle cell patients are some of the most stigmatized in the health care system: Most patients are Black and many require regular doses of opioids for pain management.

In the notes, they found numerous examples of details that were irrelevant to patients’ health concerns: phrases like “girlfriend requests bus token,” “cursing at nurse,” “girlfriend on bed with shoes on,” and “narcotic dependent.”

Dr. Saha and Dr. Beach wanted to see how these remarks might influence a physician’s treatment recommendations, so they used vignettes they had found in the medical records of sickle cell patients. They showed either a vignette which had described patients negatively, or one that was edited with neutral language. Then they asked medical students and residents about the dose of pain medication they would hypothetically recommend. Dr. Beach said that the purpose was to see how what she called “dog whistles about social class or race or something that would make the person seem less educated” would impact treatment recommendations.

The study found that medical notes with stigmatizing language were associated with “less aggressive management of the patient’s pain.” Doctors who read the stigmatizing language chart notes prescribed less pain medication to patients even in cases when they commented that their pain was a 10 out of 10.

“The fact that we were able to show that this bias transmits to the next doctor has been the thing that I think motivates doctors to take it seriously,” said Dr. Beach.

Pain management has become a focal point for researchers because many of the most glaring racial tropes about patient care have revolved around pain. In 2016, a study conducted at the University of Virginia found that half of the 418 medical students and residents surveyed endorsed false beliefs about Black patients. For example, that “Blacks’ nerve endings are less sensitive than whites” and “Blacks’ skin is thicker than whites.” What’s more, those who endorsed these false beliefs also rated Black patients’ pain as lower than White patients’.

Antoinette M. Schoenthaler, a professor of population health and medicine at New York University and associate director of research at the school’s Institute for Excellence in Health Equity, said that disparities in pain management are pervasive and widespread across the medical profession. They seep into treatments for sickle cell anemia, but also prenatal care. As a result, she said, Black patients across the board are often fearful of attending appointments.

“Patients of color go into an appointment with feelings of heightened anxiety because they’re expecting mistreatment,” said Dr. Schoenthaler. “We’ve seen minoritized patients have higher blood pressure in the context of a clinical visit because of these expectations of anxiety and fear, and disappointment.”

Disparities in health care between Black and White patients is a complex issue – one which can’t be solved by addressing medical records alone. But, for researchers like Dr. Saha, Dr. Beach, and Dr. Sun, they can offer a road map that outlines where differences in care begin. The words a clinician uses sets the path for how a patient may be treated in the future.

One way to combat implicit bias, Dr. Saha suggested, is to use an algorithm that identifies stigmatizing language to “give hospital departments or clinicians report cards on how much of this language that they’re using.” By benchmarking averages against one another, clinicians could know if they’re using stigmatizing language at an above average rate. This is something he is considering for future research.

When clinicians are made aware of their biases – when the unconscious becomes conscious – Dr. Saha told Undark that he’s optimistic they’ll work to change them: “We’re using language that we’ve used forever without realizing the potential impact that it has on patient care.”

This article originated on Undark. A version of this article appeared on Medscape.com.

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Med students, doctor groups react to SCOTUS affirmative action ban

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Mon, 07/03/2023 - 11:08

 

The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.  

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.

“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement. The AAMC said it was “deeply disappointed” in the court’s decision and will continue to pursue efforts to improve diversity among medical students and physicians.

The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.

“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.

The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.

Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”

Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”

Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.

The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.

Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.

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

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The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.  

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.

“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement. The AAMC said it was “deeply disappointed” in the court’s decision and will continue to pursue efforts to improve diversity among medical students and physicians.

The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.

“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.

The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.

Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”

Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”

Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.

The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.

Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.

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

 

The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.  

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.

“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement. The AAMC said it was “deeply disappointed” in the court’s decision and will continue to pursue efforts to improve diversity among medical students and physicians.

The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.

“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.

The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.

Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”

Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”

Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.

The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.

Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.

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

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Hairy moles may contain the cure for baldness: Study

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Changed
Mon, 07/03/2023 - 10:42

 

Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 



The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

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Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 



The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

 

Researchers may have discovered the elusive cure to baldness in an unlikely place: Those unsightly hairs that sometimes grow out of skin moles.

The researchers found that a specific molecule in those hairy moles “causes normally dormant and diminutive hair follicles to activate their stem cells for robust growth of long and thick hairs,” lead researcher Maksim Plikus, PhD, professor of developmental and cell biology at the University of California, Irvine, said in a statement.

The findings could lead to new treatments for the hair loss condition known as androgenetic alopecia, which researchers said occurs in both men and women. It is also known as male-pattern baldness in men. 



The global team led by researchers at the university analyzed hair follicle stem cells and discovered that a molecule called osteopontin drives accelerated hair growth. Stem cells can develop into different kinds of cells, whether they are in the body or in a laboratory, and are often involved in regenerative or repair processes, according to the Mayo Clinic.

This latest study, published in the journal Nature, was done on mice. A drug company cofounded by Dr. Plikus said in a news release that it had further tested the hair growth technique on human hair follicles, and “the researchers were able to induce new growth by human hair follicles in a robust preclinical model.” The company, Amplifica, said in the release that it has an exclusive licensing agreement with the university for the new hair growth “inventions” described in the newly published findings.

Hair loss from androgenetic alopecia occurs in two out of every three men, according to the Cleveland Clinic. Amplifica said the condition affects an estimated 50 million men and 30 million women in the United States. 

The hair loss and thinning can begin as early as the late teens, the Cleveland Clinic says. The condition is progressive and can follow a specific pattern, such as the hairline creating an “M” or “U” shape midway through the process toward complete baldness on the top of the head, with a remaining thin band of hair around the sides of the head.

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

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For psoriasis, review finds several biosimilars as safe and effective as biologics

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Mon, 07/03/2023 - 08:18

 

The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

 

 

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.

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The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

 

 

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.

 

The effectiveness and safety of biosimilars for psoriasis appear to be similar to the originator biologics, reported the authors of a review of studies comparing the two.

“This systematic review found that there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators of adalimumab, etanercept, infliximab, and ustekinumab for the treatment of psoriasis,” senior study author and clinical lecturer Zenas Z. N. Yiu, MBChB, PhD, and his colleagues at the University of Manchester, England, wrote in JAMA Dermatology.“The biosimilars evaluated in this study could be considered alongside originators for biologic-naive patients to improve the accessibility of biological treatments,” they added. “Switching patients currently on originators to biosimilars could be considered where clinically appropriate to reduce treatment costs.”

Biologics versus biosimilars

In contrast to most chemically synthesized drugs, biologics are created from living organisms, and they have complex structures that can vary slightly from batch to batch, Luigi Naldi, MD, director of the department of dermatology of Ospedale San Bortolo, Vicenza, Italy, and Antonio Addis, PharmD, researcher in the department of epidemiology, Regione Lazio, in Rome, wrote in an accompanying editorial.

Once the patent on the “originator” biologic expires, U.S. and European regulators allow other manufacturers to develop similar molecules – biosimilars – through an abbreviated approval process. If the results of a limited number of equivalence or noninferiority clinical trials are acceptable, registration for all the indications of the originator is allowed for its biosimilars. Referring to the expense of biologics, Dr. Naldi and Dr. Addis noted that in the United States, “biologics comprise less than 3% of the volume of drugs on the market, but account for more than one-third of all drug spending.”

Systematic review

Dr. Yiu and his colleagues queried standard medical research databases in August 2022, and included 14 randomized clinical trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) in their review.

Twelve trials compared biosimilars vs. originators in originator-naive patients, and 11 trials compared switching from originators to biosimilars vs. continuous treatment with the originator.

The researchers found the following:

At week 16, mean PASI75 (Psoriasis Area and Severity Index) response rates ranges from 60.7% to 90.6% for adalimumab biosimilars, vs. 61.5% to 91.7% for the originator. Mean PASI75 responses for the two etanercept biosimilars were 56.1% and 76.7% vs. 55.5% and 73.4% for the originator. In the ustekinumab study, mean PASI75 responses were 86.1% for the biosimilar vs. 84.0% for the originator.

At week 52, mean PASI75 responses were between 86.3% and 92.8% for adalimumab biosimilars vs. 84.9% and 93.9% for the originator. In the one comparison of an etanercept biosimilar, mean PAS175 responses were 80.9% for the biosimilar vs. 82.9% for the originator.

In studies involving patients switching from the originator to a biosimilar vs. continuing treatment with the originator, 32-week response rates ranged from 87.0% to 91.3% for adalimumab biosimilars and from 88.2% to 93.2% for the originator. In the one ustekinumab study, the 32-week mean PASI75 response was 92.6% after switching from the originator to a biosimilar vs. 92.9% with continuous treatment with the originator.

At week 52, mean PASI75 responses to adalimumab were between 84.2% and 94.8% for patients who switched to biosimilars and between 88.1% and 93.9% for those who stayed on the originator.

At week 52, in all the randomized trials, the incidence of adverse events and serious adverse events among those who switched to the biosimilar and those who continued with the originator were similar. Two cohort studies showed similar safety outcomes between originators and biosimilars, but one reported more adverse events in patients who switched to adalimumab biosimilars (P = .04).

Three clinical trials showed low risk for bias, 11 had moderate risk, and all cohort studies had moderate to high risk for bias.

 

 

Experts weigh in

Asked to comment on the study, Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University, Winston-Salem, N.C., told this news organization that he expects that the results will affect patient care.

However, he added, “I believe the decision of whether to use a biosimilar instead of the originator biologic may be more in the hands of the insurers than in the hands of physicians and patients.

“Biologics for psoriasis are so complicated that even the originator products vary from batch to batch. A biosimilar is basically like another batch of the innovative product,” explained Dr. Feldman, who was not involved in the study. “If we’re comfortable with patients being on different batches of the innovator product, we probably should be comfortable with them being on a biosimilar, as we have more evidence for the similarity of the biosimilar than we do for the current batch of the originator product.”

Aída Lugo-Somolinos, MD, professor of dermatology and director of the Contact Dermatitis Clinic at the University of North Carolina, Chapel Hill, said that “biologics have become the treatment of choice for moderate to severe psoriasis, and the use of biosimilars may be an alternative to reduce psoriasis treatment costs.

“Unfortunately, this study included a comparison of the existing biosimilars, which are drugs that are not the first line of treatment for psoriasis any longer,” added Dr. Lugo-Somolinos, who was not involved in the study.

Neil J. Korman, MD, PhD, professor of dermatology and codirector of the Skin Study Center at Case Western Reserve University, Cleveland, said the study was an important systematic review.

“This is a very timely publication because in the United States, several biosimilars are reaching the market in 2023,” he said. “The costs of the originator biologics are extraordinarily high, and the promise of biosimilars is that their costs will be significantly lower.”

Because all the studies were short term, Dr. Korman, who was not involved in the study, joins the study authors in recommending further related research into the long-term safety and efficacy of these agents.

Dr. Feldman, as well as one study author and one editorial author, reported relevant relationships with various pharmaceutical companies, including those that develop biosimilars. The remaining study authors, as well as Dr. Lugo-Somolinos and Dr. Korman, reported no relevant relationships. The study was funded by the Psoriasis Association and supported by the NIHR (National Institute for Health and Care Research) Manchester Biomedical Research Centre. All outside experts commented by email.

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Residency match process under scrutiny again, this time by AMA

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Fri, 06/30/2023 - 13:15

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

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The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

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Does colchicine have a role in treating excess ASCVD risk in patients with chronic inflammatory conditions?

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Changed
Thu, 08/10/2023 - 12:41

The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

Dr. Christie Bartels, chief of rheumatology at the University of Wisconsin--Madison
University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

Dr. Joel Gelfand, the James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania, Philadelphia
University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Dr. Edward Loftus Jr., the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn.
Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

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The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

Dr. Christie Bartels, chief of rheumatology at the University of Wisconsin--Madison
University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

Dr. Joel Gelfand, the James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania, Philadelphia
University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Dr. Edward Loftus Jr., the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn.
Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

Dr. Christie Bartels, chief of rheumatology at the University of Wisconsin--Madison
University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

Dr. Joel Gelfand, the James J. Leyden Professor of Dermatology and Epidemiology at the University of Pennsylvania, Philadelphia
University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Dr. Edward Loftus Jr., the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn.
Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

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Placebo effect can be found in a cup of coffee

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Changed
Thu, 06/29/2023 - 09:15

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

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The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

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Physician suicide roundtable: 8 important initiatives that can help 

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Changed
Mon, 07/03/2023 - 12:48

Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

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Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

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Study points to need to improve identification of culprit in SJS/TEN cases

Article Type
Changed
Wed, 06/28/2023 - 13:26

In the absence of a formal diagnostic test for Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), the current approach employed by most clinicians tends to overlabel patients as allergic to drugs that are unlikely to be the cause, results from a small retrospective cohort study demonstrated.

“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”

Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”

To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.

The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.

To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”

In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.



Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.

They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”

“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”

Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”

Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.

The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.

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In the absence of a formal diagnostic test for Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), the current approach employed by most clinicians tends to overlabel patients as allergic to drugs that are unlikely to be the cause, results from a small retrospective cohort study demonstrated.

“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”

Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”

To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.

The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.

To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”

In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.



Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.

They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”

“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”

Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”

Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.

The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.

In the absence of a formal diagnostic test for Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), the current approach employed by most clinicians tends to overlabel patients as allergic to drugs that are unlikely to be the cause, results from a small retrospective cohort study demonstrated.

“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”

Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”

To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.

The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.

To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”

In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.



Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.

They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.

Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”

“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”

Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”

Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.

The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.

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New law allows international medical graduates to bypass U.S. residency

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Changed
Tue, 06/27/2023 - 09:29

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

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Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

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