MDedge Endocrinology

Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.

There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.

And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”

“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”

The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.

Living with a chronic illness is a challenge for any patient. But physicians who are diagnosed with chronic conditions face a unique set of personal and professional issues.

Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.

Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.

But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
 

What it takes to become a doctor when you have a chronic condition

In short, it’s not easy.

Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.

While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.

Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.

“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”

Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.

It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.

While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.

“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
 

Treating the individual

Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.

He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.

“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.

Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”

Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.

His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.

“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”

Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
 

‘I am not the doctor for you’

Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.

According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.

These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.

In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.

The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:

• Doctors complained about the “burden” of caring for a patient with a disability.
• They lacked the time or equipment, such as accessible exam tables or weight scales.
• They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
• They described being fearful of lawsuits under the Americans with Disabilities Act.

The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”

“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”

Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.

Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”

Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”

She later learned the legal term for her treatment: constructive dismissal.

“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”

Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
 

The fight for inclusion

Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.

“Does it really make sense?” he wanted to know.

The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.

Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?

Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.

Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.

“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
 

Soldiering on

Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.

Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.

Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..

She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”

The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.

“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”

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

Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.

There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.

And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”

“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”

The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.

Living with a chronic illness is a challenge for any patient. But physicians who are diagnosed with chronic conditions face a unique set of personal and professional issues.

Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.

Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.

But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
 

What it takes to become a doctor when you have a chronic condition

In short, it’s not easy.

Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.

While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.

Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.

“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”

Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.

It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.

While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.

“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
 

Treating the individual

Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.

He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.

“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.

Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”

Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.

His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.

“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”

Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
 

‘I am not the doctor for you’

Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.

According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.

These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.

In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.

The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:

• Doctors complained about the “burden” of caring for a patient with a disability.
• They lacked the time or equipment, such as accessible exam tables or weight scales.
• They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
• They described being fearful of lawsuits under the Americans with Disabilities Act.

The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”

“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”

Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.

Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”

Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”

She later learned the legal term for her treatment: constructive dismissal.

“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”

Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
 

The fight for inclusion

Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.

“Does it really make sense?” he wanted to know.

The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.

Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?

Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.

Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.

“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
 

Soldiering on

Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.

Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.

Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..

She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”

The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.

“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”

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

Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.

There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.

And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”

“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”

The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.

Living with a chronic illness is a challenge for any patient. But physicians who are diagnosed with chronic conditions face a unique set of personal and professional issues.

Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.

Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.

But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
 

What it takes to become a doctor when you have a chronic condition

In short, it’s not easy.

Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.

While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.

Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.

“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”

Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.

It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.

While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.

“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
 

Treating the individual

Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.

He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.

“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.

Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”

Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.

His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.

“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”

Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
 

‘I am not the doctor for you’

Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.

According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.

These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.

In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.

The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:

• Doctors complained about the “burden” of caring for a patient with a disability.
• They lacked the time or equipment, such as accessible exam tables or weight scales.
• They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
• They described being fearful of lawsuits under the Americans with Disabilities Act.

The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”

“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”

Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.

Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”

Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”

She later learned the legal term for her treatment: constructive dismissal.

“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”

Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
 

The fight for inclusion

Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.

“Does it really make sense?” he wanted to know.

The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.

Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?

Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.

Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.

“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
 

Soldiering on

Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.

Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.

Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..

She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”

The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.

“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”

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

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

The Food and Drug Administration is warning people to avoid using compounded medicines as substitutes for the popular weight loss and diabetes drugs Ozempic, Rybelsus, and Wegovy.

Compounded medicines are not FDA approved but are allowed to be made during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned that it has received reports of people experiencing “adverse events” after using compounded versions of the drugs. (The FDA did not provide details of those events or where the drugs involved were compounded.)

Agency officials are concerned that the compounded versions may contain ingredients that sound like the brand name drugs’ active ingredient, semaglutide, but are different because the ingredients are in salt form.

“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA warning stated. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

The agency said salt forms don’t meet the criteria for compounding during a shortage and sent a letter to the National Association of Boards of Pharmacy expressing “concerns with use of the salt forms in compounded products.”

Patients and health care providers should be aware that “compounded drugs are not FDA approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the FDA explained in its statement.

The Alliance for Pharmacy Compounding’s board of directors said in a statement that some compounders’ arguments for the suitability of semaglutide sodium are “worthy of discussion,” but the board did not endorse those arguments.

For people who use an online pharmacy, the FDA recommends checking the FDA’s website BeSafeRx to check its credentials.

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

The Food and Drug Administration is warning people to avoid using compounded medicines as substitutes for the popular weight loss and diabetes drugs Ozempic, Rybelsus, and Wegovy.

Compounded medicines are not FDA approved but are allowed to be made during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned that it has received reports of people experiencing “adverse events” after using compounded versions of the drugs. (The FDA did not provide details of those events or where the drugs involved were compounded.)

Agency officials are concerned that the compounded versions may contain ingredients that sound like the brand name drugs’ active ingredient, semaglutide, but are different because the ingredients are in salt form.

“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA warning stated. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

The agency said salt forms don’t meet the criteria for compounding during a shortage and sent a letter to the National Association of Boards of Pharmacy expressing “concerns with use of the salt forms in compounded products.”

Patients and health care providers should be aware that “compounded drugs are not FDA approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the FDA explained in its statement.

The Alliance for Pharmacy Compounding’s board of directors said in a statement that some compounders’ arguments for the suitability of semaglutide sodium are “worthy of discussion,” but the board did not endorse those arguments.

For people who use an online pharmacy, the FDA recommends checking the FDA’s website BeSafeRx to check its credentials.

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

The Food and Drug Administration is warning people to avoid using compounded medicines as substitutes for the popular weight loss and diabetes drugs Ozempic, Rybelsus, and Wegovy.

Compounded medicines are not FDA approved but are allowed to be made during an official drug shortage. Ozempic and Wegovy are currently on the FDA’s shortage list, but the federal agency warned that it has received reports of people experiencing “adverse events” after using compounded versions of the drugs. (The FDA did not provide details of those events or where the drugs involved were compounded.)

Agency officials are concerned that the compounded versions may contain ingredients that sound like the brand name drugs’ active ingredient, semaglutide, but are different because the ingredients are in salt form.

“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA warning stated. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

The agency said salt forms don’t meet the criteria for compounding during a shortage and sent a letter to the National Association of Boards of Pharmacy expressing “concerns with use of the salt forms in compounded products.”

Patients and health care providers should be aware that “compounded drugs are not FDA approved, and the agency does not verify the safety or effectiveness of compounded drugs,” the FDA explained in its statement.

The Alliance for Pharmacy Compounding’s board of directors said in a statement that some compounders’ arguments for the suitability of semaglutide sodium are “worthy of discussion,” but the board did not endorse those arguments.

For people who use an online pharmacy, the FDA recommends checking the FDA’s website BeSafeRx to check its credentials.

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

Endocrinologists report steady increases in pay in the Medscape Endocrinologist Compensation Report 2023, but more doctors dropped insurers that pay the least, compared with last year, and only about two-thirds of respondents say they would choose medicine again as a career if given the chance.

In the survey of more than 10,000 physicians in over 29 specialties, endocrinologists’ annual salaries were up by about 4% from last year’s average of $257,000, to $267,000.

Those earnings still place them in the lowest five specialties in terms of pay, above infectious diseases, family medicine, pediatrics, and public health and preventive medicine. The latter is at the bottom of the list, with average annual earnings of $249,000.

Conversely, the top three specialties were plastic surgery, at an average of $619,000 per annum, followed by orthopedics, at $573,000, and cardiology, at $507,000.

Specialties in which the most significant changes in annual compensation occurred were led by oncology, with a 13% increase from 2022, followed by gastroenterology, with an 11% increase. On the opposite end, ophthalmologists experienced a 7% decline in earnings, while emergency medicine had a 6% decrease from 2022.

Since Medscape’s 2015 report, annual salaries for endocrinologists have increased by 36%. Similar patterns in compensation increases since 2015 occurred across all specialties. In contrast to some other specialties, endocrinologists did not experience a significant decline in earnings during the pandemic.

Across all specialties, men still earned more than women in the 2023 report – with a gap of 19% ($386,000 vs. $300,000). However, there appears to be progress, as the difference represents the lowest gender pay gap in 5 years.

This gradual improvement should likely continue as awareness of pay discrepancies grows and new generations emerge, said Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at AU/USA Medical Partnership, Athens, Ga., in the report.

“Due to efforts by many, some institutions and health care organizations have reviewed their salary lines and recognized the discrepancies not only between the sexes but also between new hires” and more established workers, she explained in the report.

“[The new hires] can be offered significantly more than those more senior physicians who have been working there for years and hired under a different pay structure,” she noted.

Nearly half of endocrinologists (45%) reported taking on extra work outside of their profession, up from 39% in the 2022 report. Among them, 31% reported other medical-related work, 8% reported “medical moonlighting,” 7% reported non–medical-related work, and 2% added more hours to their primary job as a physician.

Endocrinologists were in the lowest third of specialties in terms of their impressions of fair compensation, with only 45% reporting that they felt adequately paid. On the lowest end was infectious disease, with only 35% feeling their compensation is fair. By contrast, the highest response, 68%, was among psychiatrists.

Nevertheless, 85% of endocrinologists report that they would choose the same specialty again if given the chance. Responses ranged from 61% in internal medicine to 97% in plastic surgery.

Of note, fewer – 71% of endocrinologists – responded that they would choose medicine again, down from the 76% of endocrinologists who answered yes to the same question in 2022. At the bottom of the list was emergency medicine, with only 61% saying they would choose medicine again. The highest rates were in dermatology, at 86%, and allergy and immunology, at 84%.

In terms of time spent seeing patients, endocrinologists are more likely to see patients less than 30 hours per week, at 24%, compared with physicians overall, at 19%; 61% of endocrinologists report seeing patients 30-40 hours per week, versus 53% of all physicians.

Only 12% report seeing patients 41-50 hours per week, compared with 16% of all physicians. And 4% reported seeing patients 51 hours or more weekly, versus 11% of physicians overall.

The proportion of endocrinologists who reported that they would drop insurers that pay the least was notably up in the current report, at 25%, versus just 15% in the 2022 report; 22% indicated they would not drop insurers because “I need all payers”; 16% said no because “it’s inappropriate”; and the remainder responded no for other reasons.

Overall, the leading response by physicians for the most rewarding aspects of their job were “being good at what I am doing/finding answers, diagnoses,” reported by 32%, followed by “gratitude from/relationships with patients” (24%) and “making the world a better place (for example, helping others),” at 22%.

Conversely, the most challenging aspect, described by 20%, is “having so many rules and regulations,” followed by “difficulties getting fair reimbursement from or dealing with Medicare and/or other insurers (17%).”

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

Endocrinologists report steady increases in pay in the Medscape Endocrinologist Compensation Report 2023, but more doctors dropped insurers that pay the least, compared with last year, and only about two-thirds of respondents say they would choose medicine again as a career if given the chance.

In the survey of more than 10,000 physicians in over 29 specialties, endocrinologists’ annual salaries were up by about 4% from last year’s average of $257,000, to $267,000.

Those earnings still place them in the lowest five specialties in terms of pay, above infectious diseases, family medicine, pediatrics, and public health and preventive medicine. The latter is at the bottom of the list, with average annual earnings of $249,000.

Conversely, the top three specialties were plastic surgery, at an average of $619,000 per annum, followed by orthopedics, at $573,000, and cardiology, at $507,000.

Specialties in which the most significant changes in annual compensation occurred were led by oncology, with a 13% increase from 2022, followed by gastroenterology, with an 11% increase. On the opposite end, ophthalmologists experienced a 7% decline in earnings, while emergency medicine had a 6% decrease from 2022.

Since Medscape’s 2015 report, annual salaries for endocrinologists have increased by 36%. Similar patterns in compensation increases since 2015 occurred across all specialties. In contrast to some other specialties, endocrinologists did not experience a significant decline in earnings during the pandemic.

Across all specialties, men still earned more than women in the 2023 report – with a gap of 19% ($386,000 vs. $300,000). However, there appears to be progress, as the difference represents the lowest gender pay gap in 5 years.

This gradual improvement should likely continue as awareness of pay discrepancies grows and new generations emerge, said Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at AU/USA Medical Partnership, Athens, Ga., in the report.

“Due to efforts by many, some institutions and health care organizations have reviewed their salary lines and recognized the discrepancies not only between the sexes but also between new hires” and more established workers, she explained in the report.

“[The new hires] can be offered significantly more than those more senior physicians who have been working there for years and hired under a different pay structure,” she noted.

Nearly half of endocrinologists (45%) reported taking on extra work outside of their profession, up from 39% in the 2022 report. Among them, 31% reported other medical-related work, 8% reported “medical moonlighting,” 7% reported non–medical-related work, and 2% added more hours to their primary job as a physician.

Endocrinologists were in the lowest third of specialties in terms of their impressions of fair compensation, with only 45% reporting that they felt adequately paid. On the lowest end was infectious disease, with only 35% feeling their compensation is fair. By contrast, the highest response, 68%, was among psychiatrists.

Nevertheless, 85% of endocrinologists report that they would choose the same specialty again if given the chance. Responses ranged from 61% in internal medicine to 97% in plastic surgery.

Of note, fewer – 71% of endocrinologists – responded that they would choose medicine again, down from the 76% of endocrinologists who answered yes to the same question in 2022. At the bottom of the list was emergency medicine, with only 61% saying they would choose medicine again. The highest rates were in dermatology, at 86%, and allergy and immunology, at 84%.

In terms of time spent seeing patients, endocrinologists are more likely to see patients less than 30 hours per week, at 24%, compared with physicians overall, at 19%; 61% of endocrinologists report seeing patients 30-40 hours per week, versus 53% of all physicians.

Only 12% report seeing patients 41-50 hours per week, compared with 16% of all physicians. And 4% reported seeing patients 51 hours or more weekly, versus 11% of physicians overall.

The proportion of endocrinologists who reported that they would drop insurers that pay the least was notably up in the current report, at 25%, versus just 15% in the 2022 report; 22% indicated they would not drop insurers because “I need all payers”; 16% said no because “it’s inappropriate”; and the remainder responded no for other reasons.

Overall, the leading response by physicians for the most rewarding aspects of their job were “being good at what I am doing/finding answers, diagnoses,” reported by 32%, followed by “gratitude from/relationships with patients” (24%) and “making the world a better place (for example, helping others),” at 22%.

Conversely, the most challenging aspect, described by 20%, is “having so many rules and regulations,” followed by “difficulties getting fair reimbursement from or dealing with Medicare and/or other insurers (17%).”

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

Endocrinologists report steady increases in pay in the Medscape Endocrinologist Compensation Report 2023, but more doctors dropped insurers that pay the least, compared with last year, and only about two-thirds of respondents say they would choose medicine again as a career if given the chance.

In the survey of more than 10,000 physicians in over 29 specialties, endocrinologists’ annual salaries were up by about 4% from last year’s average of $257,000, to $267,000.

Those earnings still place them in the lowest five specialties in terms of pay, above infectious diseases, family medicine, pediatrics, and public health and preventive medicine. The latter is at the bottom of the list, with average annual earnings of $249,000.

Conversely, the top three specialties were plastic surgery, at an average of $619,000 per annum, followed by orthopedics, at $573,000, and cardiology, at $507,000.

Specialties in which the most significant changes in annual compensation occurred were led by oncology, with a 13% increase from 2022, followed by gastroenterology, with an 11% increase. On the opposite end, ophthalmologists experienced a 7% decline in earnings, while emergency medicine had a 6% decrease from 2022.

Since Medscape’s 2015 report, annual salaries for endocrinologists have increased by 36%. Similar patterns in compensation increases since 2015 occurred across all specialties. In contrast to some other specialties, endocrinologists did not experience a significant decline in earnings during the pandemic.

Across all specialties, men still earned more than women in the 2023 report – with a gap of 19% ($386,000 vs. $300,000). However, there appears to be progress, as the difference represents the lowest gender pay gap in 5 years.

This gradual improvement should likely continue as awareness of pay discrepancies grows and new generations emerge, said Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at AU/USA Medical Partnership, Athens, Ga., in the report.

“Due to efforts by many, some institutions and health care organizations have reviewed their salary lines and recognized the discrepancies not only between the sexes but also between new hires” and more established workers, she explained in the report.

“[The new hires] can be offered significantly more than those more senior physicians who have been working there for years and hired under a different pay structure,” she noted.

Nearly half of endocrinologists (45%) reported taking on extra work outside of their profession, up from 39% in the 2022 report. Among them, 31% reported other medical-related work, 8% reported “medical moonlighting,” 7% reported non–medical-related work, and 2% added more hours to their primary job as a physician.

Endocrinologists were in the lowest third of specialties in terms of their impressions of fair compensation, with only 45% reporting that they felt adequately paid. On the lowest end was infectious disease, with only 35% feeling their compensation is fair. By contrast, the highest response, 68%, was among psychiatrists.

Nevertheless, 85% of endocrinologists report that they would choose the same specialty again if given the chance. Responses ranged from 61% in internal medicine to 97% in plastic surgery.

Of note, fewer – 71% of endocrinologists – responded that they would choose medicine again, down from the 76% of endocrinologists who answered yes to the same question in 2022. At the bottom of the list was emergency medicine, with only 61% saying they would choose medicine again. The highest rates were in dermatology, at 86%, and allergy and immunology, at 84%.

In terms of time spent seeing patients, endocrinologists are more likely to see patients less than 30 hours per week, at 24%, compared with physicians overall, at 19%; 61% of endocrinologists report seeing patients 30-40 hours per week, versus 53% of all physicians.

Only 12% report seeing patients 41-50 hours per week, compared with 16% of all physicians. And 4% reported seeing patients 51 hours or more weekly, versus 11% of physicians overall.

The proportion of endocrinologists who reported that they would drop insurers that pay the least was notably up in the current report, at 25%, versus just 15% in the 2022 report; 22% indicated they would not drop insurers because “I need all payers”; 16% said no because “it’s inappropriate”; and the remainder responded no for other reasons.

Overall, the leading response by physicians for the most rewarding aspects of their job were “being good at what I am doing/finding answers, diagnoses,” reported by 32%, followed by “gratitude from/relationships with patients” (24%) and “making the world a better place (for example, helping others),” at 22%.

Conversely, the most challenging aspect, described by 20%, is “having so many rules and regulations,” followed by “difficulties getting fair reimbursement from or dealing with Medicare and/or other insurers (17%).”

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

An experimental, proprietary cannabinoid-based drug in development for diabetic neuropathy outperformed pregabalin (Lyrica) in a clinical trial, achieving significant reduction in pain severity, new top-line results released by Zelira Therapeutics suggest.

“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.

“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.

The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.

The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).

Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.

For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.

For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.

For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.

The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.

Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”

The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.

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

An experimental, proprietary cannabinoid-based drug in development for diabetic neuropathy outperformed pregabalin (Lyrica) in a clinical trial, achieving significant reduction in pain severity, new top-line results released by Zelira Therapeutics suggest.

“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.

“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.

The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.

The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).

Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.

For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.

For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.

For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.

The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.

Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”

The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.

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

An experimental, proprietary cannabinoid-based drug in development for diabetic neuropathy outperformed pregabalin (Lyrica) in a clinical trial, achieving significant reduction in pain severity, new top-line results released by Zelira Therapeutics suggest.

“The implications of these results for patients are incredibly promising,” principal investigator Bryan Doner, DO, medical director of HealthyWays Integrated Wellness Solutions, Gibsonia, Pa., said in a news release.

“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica-level of pain relief,” he added.

The observational, nonblinded trial tested the efficacy, safety, and tolerability of ZLT-L-007 against pregabalin in 60 adults with diabetic nerve pain.

The study had three groups with 20 patients each (pregabalin alone, pregabalin plus ZLT-L-007, and ZLT-L-007 alone).

Top-line results show the study met its primary endpoint for change in daily pain severity as measured by the percent change from baseline at 30, 60, and 90 days on the Numerical Rating Scale.

For the pregabalin-only group, there was a reduction in symptom severity at all follow-up points, ranging from 20% to 35% (median percent change from baseline), the company said.

For the ZLT-L-007 only group, there was about a 33% reduction in symptom severity at 30 days, and 71% and 78% reduction, respectively, at 60 and 90 days, suggesting a larger improvement in symptom severity than with pregabalin alone, the company said.

For the pregabalin plus ZLT-L-007 group, there was a moderate 20% reduction in symptom severity at 30 days, but a larger reduction at 60 and 90 days (50% and 72%, respectively), which indicates substantially greater improvement in symptom severity than with pregabalin alone, the company said.

The study also met secondary endpoints, including significant decreases in daily pain severity as measured by the Visual Analog Scale and measurable changes in the short-form McGill Pain Questionnaire and Neuropathic Pain Symptom Inventory.

Dr. Doner noted that the top-line data showed “no serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout. This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”

The company plans to report additional insights from the full study, as they become available, during fiscal year 2023-2024.

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

Even the plague wanted to visit Stonehenge

We’re about to blow your mind: The history you learned in school was often inaccurate. Shocking, we know, so we’ll give you a minute to process this incredible news.

Better? Good. Now, let’s look back at high school European history. The Black Death, specifically. The common narrative is that the Mongols, while besieging a Crimean city belonging to the Genoese, catapulted dead bodies infected with some mystery disease that turned out to be the plague. The Genoese then brought the plague back to Italy, and from there, we all know the rest of the story.

Ian Hodkinson, I.D.Hodkinson@ljmu.ac.uk

The Black Death was certainly extremely important to the development of modern Europe as we know it, but the history books gloss over the much longer history of the plague. Yersinia pestis did not suddenly appear unbidden in a Mongol war camp in 1347. The Black Death wasn’t even the first horrific, continent-wide pandemic caused by the plague; the Plague of Justinian 800 years earlier crippled the Byzantine Empire during an expansionist phase and killed anywhere between 15 million and 100 million.

Today, though, LOTME looks even deeper into history, nearly beyond even history itself, back into the depths of early Bronze Age northern Europe. Specifically, to two ancient burial sites in England, where researchers have identified three 4,000-year-old cases of Y. pestis, the first recorded incidence of the disease in Britain.

Two of the individuals, identified through analysis of dental pulp, were young children buried at a mass grave in Somerset, while the third, a middle-aged woman, was found in a ring cairn in Cumbria. These sites are hundreds of miles apart, yet carbon dating suggests all three people lived and died at roughly the same time. The strain found is very similar to other samples of plague found across central and western Europe starting around 3,000 BCE, suggesting a single, easily spread disease affecting a large area in a relatively small period of time. In other words, a pandemic. Even in these ancient times, the world was connected. Not even the island of Britain could escape.

Beyond that though, the research helps confirm the cyclical nature of the plague; over time, it loses its effectiveness and goes into hiding, only to mutate and come roaring back. This is a story with absolutely no relevance at all to the modern world. Nope, no plagues or pandemics going around right now, no viruses fading into the background in any way. What a ridiculous inference to make.
 

Uncovering the invisible with artificial intelligence

This week in “What Else Can AI Do?” new research shows that a computer program can reveal brain injury that couldn’t be seen before with typical MRI.

The hot new AI, birthed by researchers at New York University, could potentially be a game changer by linking repeated head impacts with tiny, structural changes in the brains of athletes who have not been diagnosed with a concussion. By using machine learning to train the AI, the researchers were, for the first time, able to distinguish the brain of athletes who played contact sports (football, soccer, lacrosse) from those participating in noncontact sports such as baseball, basketball, and cross-country.

Andrea Danti/Thinkstock

How did they do it? The investigators “designed statistical techniques that gave their computer program the ability to ‘learn’ how to predict exposure to repeated head impacts using mathematical models,” they explained in a written statement. Adding in data from the MRI scans of 81 male athletes with no known concussion diagnosis and the ability to identify unusual brain features between athletes with and without head trauma allowed the AI to predict results with accuracy even Miss Cleo would envy.

“This method may provide an important diagnostic tool not only for concussion, but also for detecting the damage that stems from subtler and more frequent head impacts,” said lead author Junbo Chen, an engineering doctoral candidate at NYU. That could make this new AI a valuable asset to science and medicine.

There are many things the human brain can do that AI can’t, and delegation could be one of them. Examining the data that represent the human brain in minute detail? Maybe we leave that to the machine.
 

Talk about your field promotions

If you’re a surgeon doing an amputation, the list of possible assistants pretty much starts and ends in only one place: Not the closest available janitor.

That may seem like an oddly obvious thing for us to say, but there’s at least one former Mainz (Germany) University Hospital physician who really needed to get this bit of advice before he attempted an unassisted toe amputation back in October of 2020. Yes, that does seem like kind of a long time ago for us to be reporting it now, but the details of the incident only just came to light a few days ago, thanks to German public broadcaster SWR.

Ente75/Wikipedia

Since it was just a toe, the surgeon thought he could perform the operation without any help. The toe, unfortunately, had other plans. The partially anesthetized patient got restless in the operating room, but with no actual trained nurse in the vicinity, the surgeon asked the closest available person – that would be the janitor – to lend a hand.

The surgical manager heard about these goings-on and got to the operating room too late to stop the procedure but soon enough to see the cleaning staffer “at the operating table with a bloody suction cup and a bloody compress in their hands,” SWR recently reported.

The incident was reported to the hospital’s medical director and the surgeon was fired, but since the patient experienced no complications not much fuss was made about it at the time.

Well, guess what? It’s toe-tally our job to make a fuss about these kinds of things. Or could it be that our job, much like the surgeon’s employment and the patient’s digit, is here toe-day and gone toe-morrow?

Even the plague wanted to visit Stonehenge

We’re about to blow your mind: The history you learned in school was often inaccurate. Shocking, we know, so we’ll give you a minute to process this incredible news.

Better? Good. Now, let’s look back at high school European history. The Black Death, specifically. The common narrative is that the Mongols, while besieging a Crimean city belonging to the Genoese, catapulted dead bodies infected with some mystery disease that turned out to be the plague. The Genoese then brought the plague back to Italy, and from there, we all know the rest of the story.

Ian Hodkinson, I.D.Hodkinson@ljmu.ac.uk

The Black Death was certainly extremely important to the development of modern Europe as we know it, but the history books gloss over the much longer history of the plague. Yersinia pestis did not suddenly appear unbidden in a Mongol war camp in 1347. The Black Death wasn’t even the first horrific, continent-wide pandemic caused by the plague; the Plague of Justinian 800 years earlier crippled the Byzantine Empire during an expansionist phase and killed anywhere between 15 million and 100 million.

Today, though, LOTME looks even deeper into history, nearly beyond even history itself, back into the depths of early Bronze Age northern Europe. Specifically, to two ancient burial sites in England, where researchers have identified three 4,000-year-old cases of Y. pestis, the first recorded incidence of the disease in Britain.

Two of the individuals, identified through analysis of dental pulp, were young children buried at a mass grave in Somerset, while the third, a middle-aged woman, was found in a ring cairn in Cumbria. These sites are hundreds of miles apart, yet carbon dating suggests all three people lived and died at roughly the same time. The strain found is very similar to other samples of plague found across central and western Europe starting around 3,000 BCE, suggesting a single, easily spread disease affecting a large area in a relatively small period of time. In other words, a pandemic. Even in these ancient times, the world was connected. Not even the island of Britain could escape.

Beyond that though, the research helps confirm the cyclical nature of the plague; over time, it loses its effectiveness and goes into hiding, only to mutate and come roaring back. This is a story with absolutely no relevance at all to the modern world. Nope, no plagues or pandemics going around right now, no viruses fading into the background in any way. What a ridiculous inference to make.
 

Uncovering the invisible with artificial intelligence

This week in “What Else Can AI Do?” new research shows that a computer program can reveal brain injury that couldn’t be seen before with typical MRI.

The hot new AI, birthed by researchers at New York University, could potentially be a game changer by linking repeated head impacts with tiny, structural changes in the brains of athletes who have not been diagnosed with a concussion. By using machine learning to train the AI, the researchers were, for the first time, able to distinguish the brain of athletes who played contact sports (football, soccer, lacrosse) from those participating in noncontact sports such as baseball, basketball, and cross-country.

Andrea Danti/Thinkstock

How did they do it? The investigators “designed statistical techniques that gave their computer program the ability to ‘learn’ how to predict exposure to repeated head impacts using mathematical models,” they explained in a written statement. Adding in data from the MRI scans of 81 male athletes with no known concussion diagnosis and the ability to identify unusual brain features between athletes with and without head trauma allowed the AI to predict results with accuracy even Miss Cleo would envy.

“This method may provide an important diagnostic tool not only for concussion, but also for detecting the damage that stems from subtler and more frequent head impacts,” said lead author Junbo Chen, an engineering doctoral candidate at NYU. That could make this new AI a valuable asset to science and medicine.

There are many things the human brain can do that AI can’t, and delegation could be one of them. Examining the data that represent the human brain in minute detail? Maybe we leave that to the machine.
 

Talk about your field promotions

If you’re a surgeon doing an amputation, the list of possible assistants pretty much starts and ends in only one place: Not the closest available janitor.

That may seem like an oddly obvious thing for us to say, but there’s at least one former Mainz (Germany) University Hospital physician who really needed to get this bit of advice before he attempted an unassisted toe amputation back in October of 2020. Yes, that does seem like kind of a long time ago for us to be reporting it now, but the details of the incident only just came to light a few days ago, thanks to German public broadcaster SWR.

Ente75/Wikipedia

Since it was just a toe, the surgeon thought he could perform the operation without any help. The toe, unfortunately, had other plans. The partially anesthetized patient got restless in the operating room, but with no actual trained nurse in the vicinity, the surgeon asked the closest available person – that would be the janitor – to lend a hand.

The surgical manager heard about these goings-on and got to the operating room too late to stop the procedure but soon enough to see the cleaning staffer “at the operating table with a bloody suction cup and a bloody compress in their hands,” SWR recently reported.

The incident was reported to the hospital’s medical director and the surgeon was fired, but since the patient experienced no complications not much fuss was made about it at the time.

Well, guess what? It’s toe-tally our job to make a fuss about these kinds of things. Or could it be that our job, much like the surgeon’s employment and the patient’s digit, is here toe-day and gone toe-morrow?

Even the plague wanted to visit Stonehenge

We’re about to blow your mind: The history you learned in school was often inaccurate. Shocking, we know, so we’ll give you a minute to process this incredible news.

Better? Good. Now, let’s look back at high school European history. The Black Death, specifically. The common narrative is that the Mongols, while besieging a Crimean city belonging to the Genoese, catapulted dead bodies infected with some mystery disease that turned out to be the plague. The Genoese then brought the plague back to Italy, and from there, we all know the rest of the story.

Ian Hodkinson, I.D.Hodkinson@ljmu.ac.uk

The Black Death was certainly extremely important to the development of modern Europe as we know it, but the history books gloss over the much longer history of the plague. Yersinia pestis did not suddenly appear unbidden in a Mongol war camp in 1347. The Black Death wasn’t even the first horrific, continent-wide pandemic caused by the plague; the Plague of Justinian 800 years earlier crippled the Byzantine Empire during an expansionist phase and killed anywhere between 15 million and 100 million.

Today, though, LOTME looks even deeper into history, nearly beyond even history itself, back into the depths of early Bronze Age northern Europe. Specifically, to two ancient burial sites in England, where researchers have identified three 4,000-year-old cases of Y. pestis, the first recorded incidence of the disease in Britain.

Two of the individuals, identified through analysis of dental pulp, were young children buried at a mass grave in Somerset, while the third, a middle-aged woman, was found in a ring cairn in Cumbria. These sites are hundreds of miles apart, yet carbon dating suggests all three people lived and died at roughly the same time. The strain found is very similar to other samples of plague found across central and western Europe starting around 3,000 BCE, suggesting a single, easily spread disease affecting a large area in a relatively small period of time. In other words, a pandemic. Even in these ancient times, the world was connected. Not even the island of Britain could escape.

Beyond that though, the research helps confirm the cyclical nature of the plague; over time, it loses its effectiveness and goes into hiding, only to mutate and come roaring back. This is a story with absolutely no relevance at all to the modern world. Nope, no plagues or pandemics going around right now, no viruses fading into the background in any way. What a ridiculous inference to make.
 

Uncovering the invisible with artificial intelligence

This week in “What Else Can AI Do?” new research shows that a computer program can reveal brain injury that couldn’t be seen before with typical MRI.

The hot new AI, birthed by researchers at New York University, could potentially be a game changer by linking repeated head impacts with tiny, structural changes in the brains of athletes who have not been diagnosed with a concussion. By using machine learning to train the AI, the researchers were, for the first time, able to distinguish the brain of athletes who played contact sports (football, soccer, lacrosse) from those participating in noncontact sports such as baseball, basketball, and cross-country.

Andrea Danti/Thinkstock

How did they do it? The investigators “designed statistical techniques that gave their computer program the ability to ‘learn’ how to predict exposure to repeated head impacts using mathematical models,” they explained in a written statement. Adding in data from the MRI scans of 81 male athletes with no known concussion diagnosis and the ability to identify unusual brain features between athletes with and without head trauma allowed the AI to predict results with accuracy even Miss Cleo would envy.

“This method may provide an important diagnostic tool not only for concussion, but also for detecting the damage that stems from subtler and more frequent head impacts,” said lead author Junbo Chen, an engineering doctoral candidate at NYU. That could make this new AI a valuable asset to science and medicine.

There are many things the human brain can do that AI can’t, and delegation could be one of them. Examining the data that represent the human brain in minute detail? Maybe we leave that to the machine.
 

Talk about your field promotions

If you’re a surgeon doing an amputation, the list of possible assistants pretty much starts and ends in only one place: Not the closest available janitor.

That may seem like an oddly obvious thing for us to say, but there’s at least one former Mainz (Germany) University Hospital physician who really needed to get this bit of advice before he attempted an unassisted toe amputation back in October of 2020. Yes, that does seem like kind of a long time ago for us to be reporting it now, but the details of the incident only just came to light a few days ago, thanks to German public broadcaster SWR.

Ente75/Wikipedia

Since it was just a toe, the surgeon thought he could perform the operation without any help. The toe, unfortunately, had other plans. The partially anesthetized patient got restless in the operating room, but with no actual trained nurse in the vicinity, the surgeon asked the closest available person – that would be the janitor – to lend a hand.

The surgical manager heard about these goings-on and got to the operating room too late to stop the procedure but soon enough to see the cleaning staffer “at the operating table with a bloody suction cup and a bloody compress in their hands,” SWR recently reported.

The incident was reported to the hospital’s medical director and the surgeon was fired, but since the patient experienced no complications not much fuss was made about it at the time.

Well, guess what? It’s toe-tally our job to make a fuss about these kinds of things. Or could it be that our job, much like the surgeon’s employment and the patient’s digit, is here toe-day and gone toe-morrow?

Nearly one in five U.S. adults with type 2 diabetes but without symptoms of cardiovascular disease (CVD) have a clinically meaningful elevation of a marker of cardiac damage – namely, high-sensitivity cardiac troponin T (hs-cTnT) – based on data from a representative sample of more than 10,000 U.S. adults.

The finding suggests hs-cTnT maybe a useful marker for adults with diabetes who could benefit from more aggressive CVD risk reduction despite having no clinical indications of CVD.

The results “highlight the substantial burden of subclinical CVD in persons with diabetes and emphasize the importance of early detection and treatment of CVD for this high-risk population,” say the authors of the research, published in the Journal of the American Heart Association.

Johns Hopkins University

“This is the first study to examine subclinical CVD, defined by elevated cardiac biomarkers, in a nationally representative population of adults with or without diabetes. It provides novel information on the high burden of subclinical CVD [in American adults with diabetes] and the potential utility of hs-cTnT for monitoring this risk in people with diabetes,” said Elizabeth Selvin, PhD, senior author and a professor of epidemiology at Johns Hopkins University, Baltimore.

“What we are seeing is that many people with type 2 diabetes who have not had a heart attack or a history of cardiovascular disease are at high risk for cardiovascular complications,” added Dr. Selvin in an AHA press release. “When we look at the whole population of people diagnosed with type 2 diabetes, about 27 million adults in the U.S., according to the [Centers for Disease Control and Prevention], some are at low risk and some are at high risk for cardiovascular disease, so the open question is: ‘Who is most at risk?’ These cardiac biomarkers give us a window into cardiovascular risk in people who otherwise might not be recognized as highest risk.”

“Our results provide evidence to support use of cardiac biomarkers for routine risk monitoring in high-risk populations such as people with diabetes,” Dr. Selvin noted in an interview.
 

Need for aggressive CVD risk reduction

The findings also indicate that people with diabetes and an elevated hs-cTnT “should be targeted for aggressive cardiovascular risk reduction, including lifestyle interventions, weight loss, and treatment with statins, blood pressure medications, and cardioprotective therapies such as sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagonlike peptide-1 (GLP-1) receptor agonists,” Dr. Selvin added.

“Cholesterol is often the factor that we target to reduce the risk of cardiovascular disease in people with type 2 diabetes,” she observed. “However, type 2 diabetes may have a direct effect on the heart not related to cholesterol levels. If type 2 diabetes is directly causing damage to the small vessels in the heart unrelated to cholesterol plaque buildup, then cholesterol-lowering medications are not going to prevent cardiac damage,” Dr. Selvin explained. “Our research suggests that additional non–statin-related therapies are needed to lower the cardiovascular disease risk in people with type 2 diabetes.”

However, she noted that a necessary step prior to formally recommending such a strategy is to run clinical trials to assess the efficacy of specific treatments, such as SGLT-2 inhibitors and GLP-1 agonists, in people with diabetes and elevated hs-cTnT.

“Randomized controlled trials would be best to test the relevance of measuring these biomarkers to assess risk in asymptomatic people with diabetes,” as well as prospective study of the value of hs-cTnT to guide treatment, commented Robert H. Eckel, MD, an endocrinologist affiliated with the University of Colorado at Denver, Aurora.

“I doubt measurements [of hs-cTnT] would be reimbursed [by third-party payers] if carried out without such outcome data,” he added.

Dr. Eckel also highlights the need to further validate in additional cohorts the link between elevations in hs-cTnT and CVD events in adults with diabetes, and to confirm that elevated levels of another cardiac biomarker – N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) – do not work as well as troponin as a risk marker for people with diabetes, another finding of the study.
 

ADA report already recommends testing these biomarkers for HF

However, a consensus report published in 2022 by the American Diabetes Association laid out the case for routinely and regularly measuring levels of both high sensitivity cardiac troponin and natriuretic peptides in people with diabetes for early identification of incident heart failure.

“Among individuals with diabetes, measurement of a natriuretic peptide or high-sensitivity cardiac troponin is recommended on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure,” noted the ADA consensus report on heart failure.

The new study run by Dr. Selvin and coauthors used data collected by the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004 from U.S. adults who were at least 20 years old and had no history of CVD: myocardial infarction, stroke, coronary heart disease, or heart failure. This included 9,273 people without diabetes and 1,031 with diabetes, defined as a prior diagnosis or hemoglobin A1c of at least 6.5%.

“Cardiovascular risk varies substantially in adults with type 2 diabetes, highlighting the need for accurate risk stratification,” the authors observed.

All study participants had recorded measures of hs-cTnT and NT-proBNP.

The researchers considered an hs-cTnT level of greater than 14 ng/L and an NT-proBNP level of greater than 125 pg/mL as indicators of subclinical CVD.

The crude prevalence of elevated NT-proBNP was 33.4% among those with diabetes and 16.1% in those without diabetes. Elevated hs-cTnT occurred in 19% of those with diabetes and in 5% of those without diabetes. Elevated levels of both markers existed in 9% of those with diabetes and in 3% of those without diabetes.

“Approximately one in three adults with diabetes had subclinical CVD, with 19% having elevated levels of hs-cTnT, 23% having elevated NT-proBNP, and 9% having elevations in both cardiac biomarkers,” the researchers noted.
 

Diabetes linked with a doubled prevalence of elevated hs-cTnT 

After adjustment for several demographic variables as well as traditional CVD risk factors, people with diabetes had a significant 98% higher rate of elevated hs-cTnT, compared with those without diabetes. But after similar adjustments, the rate of elevated NT-proBNP was significantly lower among people with diabetes, compared with controls, by a relative reduction of 24%.

“Our findings suggest that, in people with diabetes, hs-cTnT may be more useful [than NT-proBNP] for general risk monitoring, as its interpretation is less complicated,” said Dr. Selvin, who explained that “NT-proBNP is affected by overweight and obesity.”

In people with diabetes, the age-adjusted prevalence of elevated hs-cTnT ran higher in those with longer duration diabetes, and in those with less well-controlled diabetes based on a higher level of A1c. Neither of these factors showed any significant relationship with measured levels of NT-proBNP.

Further analysis linked the NHANES findings during 1999-2004 with U.S. national death records through the end of 2019. This showed that elevated levels of both hs-cTnT and NT-proBNP significantly linked with subsequently higher rates of all-cause mortality among people with diabetes. Elevated hs-cTnT linked with a 77% increased mortality and NT-proBNP linked with a 78% increased rate, compared with people with diabetes and no elevations in these markers, after adjustment for demographic variables and CVD risk factors.

However, for the outcome of cardiovascular death, elevated hs-cTnT linked with a nonsignificant 54% relative increase, while elevated NT-proBNP linked with a significant 2.46-fold relative increase.

The study “adds new data on biomarkers that are not routinely measured in asymptomatic people with or without diabetes” and the relationships of these markers to CVD mortality and all-cause mortality, Dr. Eckel concluded.

The study received no commercial funding, but used reagents donated by Abbott Laboratories, Ortho Clinical Diagnostics, Roche Diagnostics, and Siemens Healthcare Diagnostics. Dr. Selvin and Dr. Eckel had no disclosures.

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

Nearly one in five U.S. adults with type 2 diabetes but without symptoms of cardiovascular disease (CVD) have a clinically meaningful elevation of a marker of cardiac damage – namely, high-sensitivity cardiac troponin T (hs-cTnT) – based on data from a representative sample of more than 10,000 U.S. adults.

The finding suggests hs-cTnT maybe a useful marker for adults with diabetes who could benefit from more aggressive CVD risk reduction despite having no clinical indications of CVD.

The results “highlight the substantial burden of subclinical CVD in persons with diabetes and emphasize the importance of early detection and treatment of CVD for this high-risk population,” say the authors of the research, published in the Journal of the American Heart Association.

Johns Hopkins University

“This is the first study to examine subclinical CVD, defined by elevated cardiac biomarkers, in a nationally representative population of adults with or without diabetes. It provides novel information on the high burden of subclinical CVD [in American adults with diabetes] and the potential utility of hs-cTnT for monitoring this risk in people with diabetes,” said Elizabeth Selvin, PhD, senior author and a professor of epidemiology at Johns Hopkins University, Baltimore.

“What we are seeing is that many people with type 2 diabetes who have not had a heart attack or a history of cardiovascular disease are at high risk for cardiovascular complications,” added Dr. Selvin in an AHA press release. “When we look at the whole population of people diagnosed with type 2 diabetes, about 27 million adults in the U.S., according to the [Centers for Disease Control and Prevention], some are at low risk and some are at high risk for cardiovascular disease, so the open question is: ‘Who is most at risk?’ These cardiac biomarkers give us a window into cardiovascular risk in people who otherwise might not be recognized as highest risk.”

“Our results provide evidence to support use of cardiac biomarkers for routine risk monitoring in high-risk populations such as people with diabetes,” Dr. Selvin noted in an interview.
 

Need for aggressive CVD risk reduction

The findings also indicate that people with diabetes and an elevated hs-cTnT “should be targeted for aggressive cardiovascular risk reduction, including lifestyle interventions, weight loss, and treatment with statins, blood pressure medications, and cardioprotective therapies such as sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagonlike peptide-1 (GLP-1) receptor agonists,” Dr. Selvin added.

“Cholesterol is often the factor that we target to reduce the risk of cardiovascular disease in people with type 2 diabetes,” she observed. “However, type 2 diabetes may have a direct effect on the heart not related to cholesterol levels. If type 2 diabetes is directly causing damage to the small vessels in the heart unrelated to cholesterol plaque buildup, then cholesterol-lowering medications are not going to prevent cardiac damage,” Dr. Selvin explained. “Our research suggests that additional non–statin-related therapies are needed to lower the cardiovascular disease risk in people with type 2 diabetes.”

However, she noted that a necessary step prior to formally recommending such a strategy is to run clinical trials to assess the efficacy of specific treatments, such as SGLT-2 inhibitors and GLP-1 agonists, in people with diabetes and elevated hs-cTnT.

“Randomized controlled trials would be best to test the relevance of measuring these biomarkers to assess risk in asymptomatic people with diabetes,” as well as prospective study of the value of hs-cTnT to guide treatment, commented Robert H. Eckel, MD, an endocrinologist affiliated with the University of Colorado at Denver, Aurora.

“I doubt measurements [of hs-cTnT] would be reimbursed [by third-party payers] if carried out without such outcome data,” he added.

Dr. Eckel also highlights the need to further validate in additional cohorts the link between elevations in hs-cTnT and CVD events in adults with diabetes, and to confirm that elevated levels of another cardiac biomarker – N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) – do not work as well as troponin as a risk marker for people with diabetes, another finding of the study.
 

ADA report already recommends testing these biomarkers for HF

However, a consensus report published in 2022 by the American Diabetes Association laid out the case for routinely and regularly measuring levels of both high sensitivity cardiac troponin and natriuretic peptides in people with diabetes for early identification of incident heart failure.

“Among individuals with diabetes, measurement of a natriuretic peptide or high-sensitivity cardiac troponin is recommended on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure,” noted the ADA consensus report on heart failure.

The new study run by Dr. Selvin and coauthors used data collected by the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004 from U.S. adults who were at least 20 years old and had no history of CVD: myocardial infarction, stroke, coronary heart disease, or heart failure. This included 9,273 people without diabetes and 1,031 with diabetes, defined as a prior diagnosis or hemoglobin A1c of at least 6.5%.

“Cardiovascular risk varies substantially in adults with type 2 diabetes, highlighting the need for accurate risk stratification,” the authors observed.

All study participants had recorded measures of hs-cTnT and NT-proBNP.

The researchers considered an hs-cTnT level of greater than 14 ng/L and an NT-proBNP level of greater than 125 pg/mL as indicators of subclinical CVD.

The crude prevalence of elevated NT-proBNP was 33.4% among those with diabetes and 16.1% in those without diabetes. Elevated hs-cTnT occurred in 19% of those with diabetes and in 5% of those without diabetes. Elevated levels of both markers existed in 9% of those with diabetes and in 3% of those without diabetes.

“Approximately one in three adults with diabetes had subclinical CVD, with 19% having elevated levels of hs-cTnT, 23% having elevated NT-proBNP, and 9% having elevations in both cardiac biomarkers,” the researchers noted.
 

Diabetes linked with a doubled prevalence of elevated hs-cTnT 

After adjustment for several demographic variables as well as traditional CVD risk factors, people with diabetes had a significant 98% higher rate of elevated hs-cTnT, compared with those without diabetes. But after similar adjustments, the rate of elevated NT-proBNP was significantly lower among people with diabetes, compared with controls, by a relative reduction of 24%.

“Our findings suggest that, in people with diabetes, hs-cTnT may be more useful [than NT-proBNP] for general risk monitoring, as its interpretation is less complicated,” said Dr. Selvin, who explained that “NT-proBNP is affected by overweight and obesity.”

In people with diabetes, the age-adjusted prevalence of elevated hs-cTnT ran higher in those with longer duration diabetes, and in those with less well-controlled diabetes based on a higher level of A1c. Neither of these factors showed any significant relationship with measured levels of NT-proBNP.

Further analysis linked the NHANES findings during 1999-2004 with U.S. national death records through the end of 2019. This showed that elevated levels of both hs-cTnT and NT-proBNP significantly linked with subsequently higher rates of all-cause mortality among people with diabetes. Elevated hs-cTnT linked with a 77% increased mortality and NT-proBNP linked with a 78% increased rate, compared with people with diabetes and no elevations in these markers, after adjustment for demographic variables and CVD risk factors.

However, for the outcome of cardiovascular death, elevated hs-cTnT linked with a nonsignificant 54% relative increase, while elevated NT-proBNP linked with a significant 2.46-fold relative increase.

The study “adds new data on biomarkers that are not routinely measured in asymptomatic people with or without diabetes” and the relationships of these markers to CVD mortality and all-cause mortality, Dr. Eckel concluded.

The study received no commercial funding, but used reagents donated by Abbott Laboratories, Ortho Clinical Diagnostics, Roche Diagnostics, and Siemens Healthcare Diagnostics. Dr. Selvin and Dr. Eckel had no disclosures.

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

Nearly one in five U.S. adults with type 2 diabetes but without symptoms of cardiovascular disease (CVD) have a clinically meaningful elevation of a marker of cardiac damage – namely, high-sensitivity cardiac troponin T (hs-cTnT) – based on data from a representative sample of more than 10,000 U.S. adults.

The finding suggests hs-cTnT maybe a useful marker for adults with diabetes who could benefit from more aggressive CVD risk reduction despite having no clinical indications of CVD.

The results “highlight the substantial burden of subclinical CVD in persons with diabetes and emphasize the importance of early detection and treatment of CVD for this high-risk population,” say the authors of the research, published in the Journal of the American Heart Association.

Johns Hopkins University

“This is the first study to examine subclinical CVD, defined by elevated cardiac biomarkers, in a nationally representative population of adults with or without diabetes. It provides novel information on the high burden of subclinical CVD [in American adults with diabetes] and the potential utility of hs-cTnT for monitoring this risk in people with diabetes,” said Elizabeth Selvin, PhD, senior author and a professor of epidemiology at Johns Hopkins University, Baltimore.

“What we are seeing is that many people with type 2 diabetes who have not had a heart attack or a history of cardiovascular disease are at high risk for cardiovascular complications,” added Dr. Selvin in an AHA press release. “When we look at the whole population of people diagnosed with type 2 diabetes, about 27 million adults in the U.S., according to the [Centers for Disease Control and Prevention], some are at low risk and some are at high risk for cardiovascular disease, so the open question is: ‘Who is most at risk?’ These cardiac biomarkers give us a window into cardiovascular risk in people who otherwise might not be recognized as highest risk.”

“Our results provide evidence to support use of cardiac biomarkers for routine risk monitoring in high-risk populations such as people with diabetes,” Dr. Selvin noted in an interview.
 

Need for aggressive CVD risk reduction

The findings also indicate that people with diabetes and an elevated hs-cTnT “should be targeted for aggressive cardiovascular risk reduction, including lifestyle interventions, weight loss, and treatment with statins, blood pressure medications, and cardioprotective therapies such as sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagonlike peptide-1 (GLP-1) receptor agonists,” Dr. Selvin added.

“Cholesterol is often the factor that we target to reduce the risk of cardiovascular disease in people with type 2 diabetes,” she observed. “However, type 2 diabetes may have a direct effect on the heart not related to cholesterol levels. If type 2 diabetes is directly causing damage to the small vessels in the heart unrelated to cholesterol plaque buildup, then cholesterol-lowering medications are not going to prevent cardiac damage,” Dr. Selvin explained. “Our research suggests that additional non–statin-related therapies are needed to lower the cardiovascular disease risk in people with type 2 diabetes.”

However, she noted that a necessary step prior to formally recommending such a strategy is to run clinical trials to assess the efficacy of specific treatments, such as SGLT-2 inhibitors and GLP-1 agonists, in people with diabetes and elevated hs-cTnT.

“Randomized controlled trials would be best to test the relevance of measuring these biomarkers to assess risk in asymptomatic people with diabetes,” as well as prospective study of the value of hs-cTnT to guide treatment, commented Robert H. Eckel, MD, an endocrinologist affiliated with the University of Colorado at Denver, Aurora.

“I doubt measurements [of hs-cTnT] would be reimbursed [by third-party payers] if carried out without such outcome data,” he added.

Dr. Eckel also highlights the need to further validate in additional cohorts the link between elevations in hs-cTnT and CVD events in adults with diabetes, and to confirm that elevated levels of another cardiac biomarker – N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) – do not work as well as troponin as a risk marker for people with diabetes, another finding of the study.
 

ADA report already recommends testing these biomarkers for HF

However, a consensus report published in 2022 by the American Diabetes Association laid out the case for routinely and regularly measuring levels of both high sensitivity cardiac troponin and natriuretic peptides in people with diabetes for early identification of incident heart failure.

“Among individuals with diabetes, measurement of a natriuretic peptide or high-sensitivity cardiac troponin is recommended on at least a yearly basis to identify the earliest heart failure stages and implement strategies to prevent transition to symptomatic heart failure,” noted the ADA consensus report on heart failure.

The new study run by Dr. Selvin and coauthors used data collected by the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004 from U.S. adults who were at least 20 years old and had no history of CVD: myocardial infarction, stroke, coronary heart disease, or heart failure. This included 9,273 people without diabetes and 1,031 with diabetes, defined as a prior diagnosis or hemoglobin A1c of at least 6.5%.

“Cardiovascular risk varies substantially in adults with type 2 diabetes, highlighting the need for accurate risk stratification,” the authors observed.

All study participants had recorded measures of hs-cTnT and NT-proBNP.

The researchers considered an hs-cTnT level of greater than 14 ng/L and an NT-proBNP level of greater than 125 pg/mL as indicators of subclinical CVD.

The crude prevalence of elevated NT-proBNP was 33.4% among those with diabetes and 16.1% in those without diabetes. Elevated hs-cTnT occurred in 19% of those with diabetes and in 5% of those without diabetes. Elevated levels of both markers existed in 9% of those with diabetes and in 3% of those without diabetes.

“Approximately one in three adults with diabetes had subclinical CVD, with 19% having elevated levels of hs-cTnT, 23% having elevated NT-proBNP, and 9% having elevations in both cardiac biomarkers,” the researchers noted.
 

Diabetes linked with a doubled prevalence of elevated hs-cTnT 

After adjustment for several demographic variables as well as traditional CVD risk factors, people with diabetes had a significant 98% higher rate of elevated hs-cTnT, compared with those without diabetes. But after similar adjustments, the rate of elevated NT-proBNP was significantly lower among people with diabetes, compared with controls, by a relative reduction of 24%.

“Our findings suggest that, in people with diabetes, hs-cTnT may be more useful [than NT-proBNP] for general risk monitoring, as its interpretation is less complicated,” said Dr. Selvin, who explained that “NT-proBNP is affected by overweight and obesity.”

In people with diabetes, the age-adjusted prevalence of elevated hs-cTnT ran higher in those with longer duration diabetes, and in those with less well-controlled diabetes based on a higher level of A1c. Neither of these factors showed any significant relationship with measured levels of NT-proBNP.

Further analysis linked the NHANES findings during 1999-2004 with U.S. national death records through the end of 2019. This showed that elevated levels of both hs-cTnT and NT-proBNP significantly linked with subsequently higher rates of all-cause mortality among people with diabetes. Elevated hs-cTnT linked with a 77% increased mortality and NT-proBNP linked with a 78% increased rate, compared with people with diabetes and no elevations in these markers, after adjustment for demographic variables and CVD risk factors.

However, for the outcome of cardiovascular death, elevated hs-cTnT linked with a nonsignificant 54% relative increase, while elevated NT-proBNP linked with a significant 2.46-fold relative increase.

The study “adds new data on biomarkers that are not routinely measured in asymptomatic people with or without diabetes” and the relationships of these markers to CVD mortality and all-cause mortality, Dr. Eckel concluded.

The study received no commercial funding, but used reagents donated by Abbott Laboratories, Ortho Clinical Diagnostics, Roche Diagnostics, and Siemens Healthcare Diagnostics. Dr. Selvin and Dr. Eckel had no disclosures.

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

CHICAGO – Only 1%-3% of patients who have had bariatric surgery take Food and Drug Administration–approved antiobesity medications even though 25% of patients experience significant weight regain within a few years of surgery, according to a study presented at the annual Digestive Disease Week® meeting.

Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”

“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.

Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.

And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.

“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.

The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.

He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.

The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.

The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”

“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.

Dr. Firkins had no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – Only 1%-3% of patients who have had bariatric surgery take Food and Drug Administration–approved antiobesity medications even though 25% of patients experience significant weight regain within a few years of surgery, according to a study presented at the annual Digestive Disease Week® meeting.

Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”

“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.

Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.

And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.

“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.

The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.

He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.

The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.

The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”

“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.

Dr. Firkins had no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – Only 1%-3% of patients who have had bariatric surgery take Food and Drug Administration–approved antiobesity medications even though 25% of patients experience significant weight regain within a few years of surgery, according to a study presented at the annual Digestive Disease Week® meeting.

Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”

“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.

Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.

And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.

“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.

The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.

He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.

The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.

The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”

“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.

Dr. Firkins had no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.

The goal of creating the obesity types and test is to increase chances of losing weight and improving health and well-being versus a one-strategy-fits-all approach. It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity. 

Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.

This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).

“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. 

Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website. 

A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023. 

The other obesity categories are:

• “Hungry brain,” where the brain does not recognize signals that the stomach is full
• “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
• “Slow burn,” where people have a slow metabolism and low energy level

People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
 

Some things to consider

While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted. 

University of Texas Southwestern Medical Center

“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.

“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.

There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”

In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”

“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”

Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said. 

It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
 

Removing the stigma

If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.

“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity. 

“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
 

More cost-effective treatment?

Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.

“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.

“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.” 
 

How they created four obesity types

Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes. 

“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said. 

The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA. 

The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
 

Moving forward

After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.  

Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said. 

An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030. 

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

It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.

The goal of creating the obesity types and test is to increase chances of losing weight and improving health and well-being versus a one-strategy-fits-all approach. It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity. 

Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.

This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).

“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. 

Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website. 

A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023. 

The other obesity categories are:

• “Hungry brain,” where the brain does not recognize signals that the stomach is full
• “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
• “Slow burn,” where people have a slow metabolism and low energy level

People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
 

Some things to consider

While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted. 

University of Texas Southwestern Medical Center

“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.

“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.

There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”

In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”

“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”

Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said. 

It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
 

Removing the stigma

If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.

“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity. 

“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
 

More cost-effective treatment?

Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.

“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.

“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.” 
 

How they created four obesity types

Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes. 

“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said. 

The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA. 

The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
 

Moving forward

After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.  

Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said. 

An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030. 

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

It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.

The goal of creating the obesity types and test is to increase chances of losing weight and improving health and well-being versus a one-strategy-fits-all approach. It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity. 

Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.

This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).

“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn. 

Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website. 

A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023. 

The other obesity categories are:

• “Hungry brain,” where the brain does not recognize signals that the stomach is full
• “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
• “Slow burn,” where people have a slow metabolism and low energy level

People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
 

Some things to consider

While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted. 

University of Texas Southwestern Medical Center

“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.

“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.

There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”

In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”

“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”

Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said. 

It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
 

Removing the stigma

If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.

“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity. 

“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
 

More cost-effective treatment?

Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.

“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.

“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.” 
 

How they created four obesity types

Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes. 

“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said. 

The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA. 

The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
 

Moving forward

After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.  

Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said. 

An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030. 

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

Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter 1 as well as SGLT2, has received marketing approval from the Food and Drug Administration for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.

This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.

Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect U.S. sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.

Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

They base this niche target for sotagliflozin on results from the SOLOIST-WHF trial, which randomized 1,222 patients with type 2 diabetes recently hospitalized for worsening heart failure and showed a significant 33% reduction in the rate of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure, compared with control patients during a median 9 months of follow-up. Nearly half of the enrolled patients received their first dose while still hospitalized, while the other half received their first dose a median of 2 days after hospital discharge. The drug appeared safe.
 

Cutting heart failure rehospitalizations in half

An exploratory post hoc analysis of SOLOIST-WHF showed that treatment with sotagliflozin cut the rate of rehospitalizations roughly in half after both 30 and 90 days compared with control patients, according to an abstract presented at the 2022 annual scientific sessions of the AHA that has not yet been published in a peer-reviewed journal.

The only SGLT2 inhibitor tested so far when initiated in patients during hospitalization for heart failure is empagliflozin, in the EMPULSE trial, which randomized 530 patients. EMPULSE also showed that starting an SGLT2 inhibitor in this setting was safe and resulted in significant clinical benefit, the study’s primary endpoint, defined as a composite of death from any cause, number of heart failure events, and time to first heart failure event, or a 5-point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days.

In the DELIVER trial, which tested dapagliflozin in patients with heart failure with preserved ejection fraction, roughly 10% of patients started study treatment during or within 30 days of heart failure hospitalization, and in this subgroup, dapagliflozin appeared as effective as it was in the other 90% of patients who did not start the drug during an acute or subacute phase.

Despite the SOLOIST-WHF evidence for sotagliflozin’s safety and efficacy in this economically important clinical setting, some experts say the drug faces an uphill path as it contends for market share against two solidly established, albeit dramatically underused, SGLT2 inhibitors. (Recent data document that 20% or fewer of U.S. patients eligible for treatment with an SGLT2 inhibitor receive it, such as a review of 49,000 patients hospitalized during 2021-2022 with heart failure with reduced ejection fraction.)

Others foresee a clear role for sotagliflozin, particularly because of additional facets of the drug’s performance in trials that they perceive give it an edge over dapagliflozin and empagliflozin. This includes evidence that sotagliflozin treatment uniquely (within the SGLT2 inhibitor class) cuts the rate of strokes and myocardial infarctions, as well as evidence of its apparent ability to lower hemoglobin A1c levels in patients with type 2 diabetes and with an estimated glomerular filtration rate below 30 mL/min per 1.73 m², a property likely linked to inhibition of SGLT1 in the gut that dampens intestinal glucose absorption.
 

Sotagliflozin uptake ‘will be a challenge’

“It will be a challenge” for sotagliflozin uptake, given the head start that both dapagliflozin and empagliflozin have had as well-documented agents for patients with heart failure, commented Javed Butler, MD, a heart failure clinician and trialist who is president of the Baylor Scott & White Research Institute in Dallas.

Given the position dapagliflozin and empagliflozin currently have in U.S. heart failure management – with the SGLT2 inhibitor class called out in guidelines as foundational for treating patients with heart failure with reduced ejection fraction and likely soon for heart failure with preserved ejection fraction as well – “I can’t imagine [sotagliflozin] will be considered a preferred option,” Dr. Butler said in an interview.

Another expert was even more dismissive of sotagliflozin’s role.

“There is no persuasive evidence that sotagliflozin has any advantages, compared with the SGLT2 inhibitors, for the treatment of heart failure,” said Milton Packer, MD, a heart failure specialist and trialist at Baylor University Medical Center, Dallas. “I do not see why U.S. physicians might pivot from established SGLT2 inhibitors to sotagliflozin,” unless it was priced “at a very meaningful discount to available SGLT2 inhibitors.”

At the time it announced the FDA’s approval, Lexicon did not provide details on how it would price sotagliflozin. Existing retail prices for dapagliflozin and empagliflozin run about $550-$600/month, a price point that has contributed to slow U.S. uptake of the drug class. But experts anticipate a dramatic shake-up of the U.S. market for SGLT2 inhibitors with expected introduction of a generic SGLT2 inhibitor formulation by 2025, a development that could further dampen sotagliflozin’s prospects.

Other experts are more optimistic about the new agent’s uptake, perhaps none more than Deepak L. Bhatt, MD, MPH, who led both pivotal trials that provide the bulk of sotagliflozin’s evidence package.

copyright CYIM

In addition to SOLOIST-WHF, Dr. Bhatt also headed the SCORED trial, with 10,584 patients with type 2 diabetes, CKD, and risks for cardiovascular disease randomized to sotagliflozin or placebo and followed for a median of 16 months. The primary result showed that sotagliflozin treatment cut the combined rate of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure by a significant 26% relative to control patients.
 

A clear MACE benefit

“The data from SOLOIST-WHF and SCORED look at least as good as the data for the SGLT2 inhibitors for heart failure, and what appears to be different are the rates for MI and stroke in SCORED,” said Dr. Bhatt, director of Mount Sinai Heart, New York.

“I believe the rate of major adverse cardiovascular events [MACE] were reduced [in SCORED], and this is different from the SGLT2 inhibitors,” he said in an interview.

In 2022, Dr. Bhatt reported results from a prespecified secondary analysis of SCORED that showed that treatment with sotagliflozin cut the rate of MACE by a significant 21%-26%, compared with placebo. This finding was, in part, driven by the first data to show a substantial benefit from an SGLT inhibitor on stroke rates.

And while SCORED did not report a significant benefit for slowing progression of CKD, subsequent post hoc analyses have suggested this advantage also in as-yet-unpublished findings, Dr. Bhatt added.

But he said he doubted nephrologists will see it as a first-line agent for slowing CKD progression – an indication already held by dapagliflozin, pending for empagliflozin, and also in place for a third SGLT2 inhibitor, canagliflozin (Invokana) – because sotagliflozin lacks clear significant and prespecified evidence for this effect.

Dr. Bhatt also acknowledged the limitation of sotagliflozin compared with the SGLT2 inhibitors as an agent for glucose control, again because of no evidence for this effect from a prospective analysis and no pending indication for type 2 diabetes treatment. But the SCORED data showed a clear A1c benefit, even in patients with severely reduced renal function.
 

Mostly for cardiologists? ‘Compelling’ reductions in MIs and strokes

That may mean sotagliflozin “won’t get much use by endocrinologists nor by primary care physicians,” commented Carol L. Wysham, MD, an endocrinologist with MultiCare in Spokane, Wash.

Sotagliflozin “will be a cardiology drug,” and will “have a hard time” competing with the SGLT2 inhibitors, she predicted.

Dr. Bhatt agreed that sotagliflozin “will be perceived as a drug for cardiologists to prescribe. I don’t see endocrinologists, nephrologists, and primary care physicians reaching for this drug if it has a heart failure label.” But, he added, “my hope is that the company files for additional indications. It deserves an indication for glycemic control.”

The evidence for a heart failure benefit from sotagliflozin is “valid and compelling,” and “having this option is great,” commented Mikhail N. Kosiborod, MD, a cardiologist, vice president of research at Saint Luke’s Health System, and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. But, he added, “it will be a reasonably tall task for sotagliflozin to come from behind and be disruptive in a space where there are already two well-established SGLT2 inhibitors” approved for preventing heart failure hospitalizations, “with a lot of data to back them up,”

The feature that sets sotagliflozin apart from the approved SGLT2 inhibitors is the “really compelling decrease” it produced in rates of MIs and strokes “that we simply do not see with SGLT2 inhibitors,” Dr. Kosiborod said in an interview.

He also cited results from SCORED that suggest “a meaningful reduction in A1c” when indirectly compared with SGLT2 inhibitors, especially in patients with more severe CKD. The lack of a dedicated A1c-lowering trial or an approved type 2 diabetes indication “will not be a problem for cardiologists,” he predicted, but also agreed that it is less likely to be used by primary care physicians in low-risk patients.

“I can see myself prescribing sotagliflozin,” said Dr. Kosiborod, a SCORED coinvestigator, especially for patients with coexisting type 2 diabetes, heart failure, CKD, and atherosclerotic cardiovascular disease. These patients may get “more bang for the buck” because of a reduced risk for MI and stroke, making sotagliflozin “a solid consideration in these patients if the economic factors align.”

Like others, Dr. Kosiborod cited the big impact pricing will have, especially if, as expected, a generic SGLT2 inhibitor soon comes onto the U.S. market. “Access and affordability are very important.”

SOLOIST-WHF and SCORED were sponsored initially by Sanofi and later by Lexicon after Sanofi pulled out of sotagliflozin development. Dr. Butler has been a consultant for Lexicon as well as for AstraZeneca (which markets Farxiga), Boehringer Ingelheim and Lilly (which jointly market Jardiance), and Janssen (which markets Invokana), as well as for numerous other companies. Dr. Packer has been a consultant for AstraZeneca, Boehringer Ingelheim, Lilly, and numerous other companies. Dr. Bhatt was lead investigator for SOLOIST-WHF and SCORED and has been an adviser for Boehringer Ingelheim and Janssen and numerous other companies. Dr. Wysham has been an adviser, speaker, and consultant for AstraZeneca, Boehringer Ingelheim, Lilly, Janssen, Novo Nordisk, and Sanofi, an adviser for Abbott, and a speaker for Insulet. Dr. Kosiborod was a member of the SCORED Steering Committee and has been a consultant for Lexicon, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk, and numerous other companies.

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

Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter 1 as well as SGLT2, has received marketing approval from the Food and Drug Administration for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.

This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.

Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect U.S. sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.

Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

They base this niche target for sotagliflozin on results from the SOLOIST-WHF trial, which randomized 1,222 patients with type 2 diabetes recently hospitalized for worsening heart failure and showed a significant 33% reduction in the rate of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure, compared with control patients during a median 9 months of follow-up. Nearly half of the enrolled patients received their first dose while still hospitalized, while the other half received their first dose a median of 2 days after hospital discharge. The drug appeared safe.
 

Cutting heart failure rehospitalizations in half

An exploratory post hoc analysis of SOLOIST-WHF showed that treatment with sotagliflozin cut the rate of rehospitalizations roughly in half after both 30 and 90 days compared with control patients, according to an abstract presented at the 2022 annual scientific sessions of the AHA that has not yet been published in a peer-reviewed journal.

The only SGLT2 inhibitor tested so far when initiated in patients during hospitalization for heart failure is empagliflozin, in the EMPULSE trial, which randomized 530 patients. EMPULSE also showed that starting an SGLT2 inhibitor in this setting was safe and resulted in significant clinical benefit, the study’s primary endpoint, defined as a composite of death from any cause, number of heart failure events, and time to first heart failure event, or a 5-point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days.

In the DELIVER trial, which tested dapagliflozin in patients with heart failure with preserved ejection fraction, roughly 10% of patients started study treatment during or within 30 days of heart failure hospitalization, and in this subgroup, dapagliflozin appeared as effective as it was in the other 90% of patients who did not start the drug during an acute or subacute phase.

Despite the SOLOIST-WHF evidence for sotagliflozin’s safety and efficacy in this economically important clinical setting, some experts say the drug faces an uphill path as it contends for market share against two solidly established, albeit dramatically underused, SGLT2 inhibitors. (Recent data document that 20% or fewer of U.S. patients eligible for treatment with an SGLT2 inhibitor receive it, such as a review of 49,000 patients hospitalized during 2021-2022 with heart failure with reduced ejection fraction.)

Others foresee a clear role for sotagliflozin, particularly because of additional facets of the drug’s performance in trials that they perceive give it an edge over dapagliflozin and empagliflozin. This includes evidence that sotagliflozin treatment uniquely (within the SGLT2 inhibitor class) cuts the rate of strokes and myocardial infarctions, as well as evidence of its apparent ability to lower hemoglobin A1c levels in patients with type 2 diabetes and with an estimated glomerular filtration rate below 30 mL/min per 1.73 m², a property likely linked to inhibition of SGLT1 in the gut that dampens intestinal glucose absorption.
 

Sotagliflozin uptake ‘will be a challenge’

“It will be a challenge” for sotagliflozin uptake, given the head start that both dapagliflozin and empagliflozin have had as well-documented agents for patients with heart failure, commented Javed Butler, MD, a heart failure clinician and trialist who is president of the Baylor Scott & White Research Institute in Dallas.

Given the position dapagliflozin and empagliflozin currently have in U.S. heart failure management – with the SGLT2 inhibitor class called out in guidelines as foundational for treating patients with heart failure with reduced ejection fraction and likely soon for heart failure with preserved ejection fraction as well – “I can’t imagine [sotagliflozin] will be considered a preferred option,” Dr. Butler said in an interview.

Another expert was even more dismissive of sotagliflozin’s role.

“There is no persuasive evidence that sotagliflozin has any advantages, compared with the SGLT2 inhibitors, for the treatment of heart failure,” said Milton Packer, MD, a heart failure specialist and trialist at Baylor University Medical Center, Dallas. “I do not see why U.S. physicians might pivot from established SGLT2 inhibitors to sotagliflozin,” unless it was priced “at a very meaningful discount to available SGLT2 inhibitors.”

At the time it announced the FDA’s approval, Lexicon did not provide details on how it would price sotagliflozin. Existing retail prices for dapagliflozin and empagliflozin run about $550-$600/month, a price point that has contributed to slow U.S. uptake of the drug class. But experts anticipate a dramatic shake-up of the U.S. market for SGLT2 inhibitors with expected introduction of a generic SGLT2 inhibitor formulation by 2025, a development that could further dampen sotagliflozin’s prospects.

Other experts are more optimistic about the new agent’s uptake, perhaps none more than Deepak L. Bhatt, MD, MPH, who led both pivotal trials that provide the bulk of sotagliflozin’s evidence package.

copyright CYIM

In addition to SOLOIST-WHF, Dr. Bhatt also headed the SCORED trial, with 10,584 patients with type 2 diabetes, CKD, and risks for cardiovascular disease randomized to sotagliflozin or placebo and followed for a median of 16 months. The primary result showed that sotagliflozin treatment cut the combined rate of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure by a significant 26% relative to control patients.
 

A clear MACE benefit

“The data from SOLOIST-WHF and SCORED look at least as good as the data for the SGLT2 inhibitors for heart failure, and what appears to be different are the rates for MI and stroke in SCORED,” said Dr. Bhatt, director of Mount Sinai Heart, New York.

“I believe the rate of major adverse cardiovascular events [MACE] were reduced [in SCORED], and this is different from the SGLT2 inhibitors,” he said in an interview.

In 2022, Dr. Bhatt reported results from a prespecified secondary analysis of SCORED that showed that treatment with sotagliflozin cut the rate of MACE by a significant 21%-26%, compared with placebo. This finding was, in part, driven by the first data to show a substantial benefit from an SGLT inhibitor on stroke rates.

And while SCORED did not report a significant benefit for slowing progression of CKD, subsequent post hoc analyses have suggested this advantage also in as-yet-unpublished findings, Dr. Bhatt added.

But he said he doubted nephrologists will see it as a first-line agent for slowing CKD progression – an indication already held by dapagliflozin, pending for empagliflozin, and also in place for a third SGLT2 inhibitor, canagliflozin (Invokana) – because sotagliflozin lacks clear significant and prespecified evidence for this effect.

Dr. Bhatt also acknowledged the limitation of sotagliflozin compared with the SGLT2 inhibitors as an agent for glucose control, again because of no evidence for this effect from a prospective analysis and no pending indication for type 2 diabetes treatment. But the SCORED data showed a clear A1c benefit, even in patients with severely reduced renal function.
 

Mostly for cardiologists? ‘Compelling’ reductions in MIs and strokes

That may mean sotagliflozin “won’t get much use by endocrinologists nor by primary care physicians,” commented Carol L. Wysham, MD, an endocrinologist with MultiCare in Spokane, Wash.

Sotagliflozin “will be a cardiology drug,” and will “have a hard time” competing with the SGLT2 inhibitors, she predicted.

Dr. Bhatt agreed that sotagliflozin “will be perceived as a drug for cardiologists to prescribe. I don’t see endocrinologists, nephrologists, and primary care physicians reaching for this drug if it has a heart failure label.” But, he added, “my hope is that the company files for additional indications. It deserves an indication for glycemic control.”

The evidence for a heart failure benefit from sotagliflozin is “valid and compelling,” and “having this option is great,” commented Mikhail N. Kosiborod, MD, a cardiologist, vice president of research at Saint Luke’s Health System, and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. But, he added, “it will be a reasonably tall task for sotagliflozin to come from behind and be disruptive in a space where there are already two well-established SGLT2 inhibitors” approved for preventing heart failure hospitalizations, “with a lot of data to back them up,”

The feature that sets sotagliflozin apart from the approved SGLT2 inhibitors is the “really compelling decrease” it produced in rates of MIs and strokes “that we simply do not see with SGLT2 inhibitors,” Dr. Kosiborod said in an interview.

He also cited results from SCORED that suggest “a meaningful reduction in A1c” when indirectly compared with SGLT2 inhibitors, especially in patients with more severe CKD. The lack of a dedicated A1c-lowering trial or an approved type 2 diabetes indication “will not be a problem for cardiologists,” he predicted, but also agreed that it is less likely to be used by primary care physicians in low-risk patients.

“I can see myself prescribing sotagliflozin,” said Dr. Kosiborod, a SCORED coinvestigator, especially for patients with coexisting type 2 diabetes, heart failure, CKD, and atherosclerotic cardiovascular disease. These patients may get “more bang for the buck” because of a reduced risk for MI and stroke, making sotagliflozin “a solid consideration in these patients if the economic factors align.”

Like others, Dr. Kosiborod cited the big impact pricing will have, especially if, as expected, a generic SGLT2 inhibitor soon comes onto the U.S. market. “Access and affordability are very important.”

SOLOIST-WHF and SCORED were sponsored initially by Sanofi and later by Lexicon after Sanofi pulled out of sotagliflozin development. Dr. Butler has been a consultant for Lexicon as well as for AstraZeneca (which markets Farxiga), Boehringer Ingelheim and Lilly (which jointly market Jardiance), and Janssen (which markets Invokana), as well as for numerous other companies. Dr. Packer has been a consultant for AstraZeneca, Boehringer Ingelheim, Lilly, and numerous other companies. Dr. Bhatt was lead investigator for SOLOIST-WHF and SCORED and has been an adviser for Boehringer Ingelheim and Janssen and numerous other companies. Dr. Wysham has been an adviser, speaker, and consultant for AstraZeneca, Boehringer Ingelheim, Lilly, Janssen, Novo Nordisk, and Sanofi, an adviser for Abbott, and a speaker for Insulet. Dr. Kosiborod was a member of the SCORED Steering Committee and has been a consultant for Lexicon, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk, and numerous other companies.

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

Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter 1 as well as SGLT2, has received marketing approval from the Food and Drug Administration for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.

This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.

Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect U.S. sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.

Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

They base this niche target for sotagliflozin on results from the SOLOIST-WHF trial, which randomized 1,222 patients with type 2 diabetes recently hospitalized for worsening heart failure and showed a significant 33% reduction in the rate of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure, compared with control patients during a median 9 months of follow-up. Nearly half of the enrolled patients received their first dose while still hospitalized, while the other half received their first dose a median of 2 days after hospital discharge. The drug appeared safe.
 

Cutting heart failure rehospitalizations in half

An exploratory post hoc analysis of SOLOIST-WHF showed that treatment with sotagliflozin cut the rate of rehospitalizations roughly in half after both 30 and 90 days compared with control patients, according to an abstract presented at the 2022 annual scientific sessions of the AHA that has not yet been published in a peer-reviewed journal.

The only SGLT2 inhibitor tested so far when initiated in patients during hospitalization for heart failure is empagliflozin, in the EMPULSE trial, which randomized 530 patients. EMPULSE also showed that starting an SGLT2 inhibitor in this setting was safe and resulted in significant clinical benefit, the study’s primary endpoint, defined as a composite of death from any cause, number of heart failure events, and time to first heart failure event, or a 5-point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days.

In the DELIVER trial, which tested dapagliflozin in patients with heart failure with preserved ejection fraction, roughly 10% of patients started study treatment during or within 30 days of heart failure hospitalization, and in this subgroup, dapagliflozin appeared as effective as it was in the other 90% of patients who did not start the drug during an acute or subacute phase.

Despite the SOLOIST-WHF evidence for sotagliflozin’s safety and efficacy in this economically important clinical setting, some experts say the drug faces an uphill path as it contends for market share against two solidly established, albeit dramatically underused, SGLT2 inhibitors. (Recent data document that 20% or fewer of U.S. patients eligible for treatment with an SGLT2 inhibitor receive it, such as a review of 49,000 patients hospitalized during 2021-2022 with heart failure with reduced ejection fraction.)

Others foresee a clear role for sotagliflozin, particularly because of additional facets of the drug’s performance in trials that they perceive give it an edge over dapagliflozin and empagliflozin. This includes evidence that sotagliflozin treatment uniquely (within the SGLT2 inhibitor class) cuts the rate of strokes and myocardial infarctions, as well as evidence of its apparent ability to lower hemoglobin A1c levels in patients with type 2 diabetes and with an estimated glomerular filtration rate below 30 mL/min per 1.73 m², a property likely linked to inhibition of SGLT1 in the gut that dampens intestinal glucose absorption.
 

Sotagliflozin uptake ‘will be a challenge’

“It will be a challenge” for sotagliflozin uptake, given the head start that both dapagliflozin and empagliflozin have had as well-documented agents for patients with heart failure, commented Javed Butler, MD, a heart failure clinician and trialist who is president of the Baylor Scott & White Research Institute in Dallas.

Given the position dapagliflozin and empagliflozin currently have in U.S. heart failure management – with the SGLT2 inhibitor class called out in guidelines as foundational for treating patients with heart failure with reduced ejection fraction and likely soon for heart failure with preserved ejection fraction as well – “I can’t imagine [sotagliflozin] will be considered a preferred option,” Dr. Butler said in an interview.

Another expert was even more dismissive of sotagliflozin’s role.

“There is no persuasive evidence that sotagliflozin has any advantages, compared with the SGLT2 inhibitors, for the treatment of heart failure,” said Milton Packer, MD, a heart failure specialist and trialist at Baylor University Medical Center, Dallas. “I do not see why U.S. physicians might pivot from established SGLT2 inhibitors to sotagliflozin,” unless it was priced “at a very meaningful discount to available SGLT2 inhibitors.”

At the time it announced the FDA’s approval, Lexicon did not provide details on how it would price sotagliflozin. Existing retail prices for dapagliflozin and empagliflozin run about $550-$600/month, a price point that has contributed to slow U.S. uptake of the drug class. But experts anticipate a dramatic shake-up of the U.S. market for SGLT2 inhibitors with expected introduction of a generic SGLT2 inhibitor formulation by 2025, a development that could further dampen sotagliflozin’s prospects.

Other experts are more optimistic about the new agent’s uptake, perhaps none more than Deepak L. Bhatt, MD, MPH, who led both pivotal trials that provide the bulk of sotagliflozin’s evidence package.

copyright CYIM

In addition to SOLOIST-WHF, Dr. Bhatt also headed the SCORED trial, with 10,584 patients with type 2 diabetes, CKD, and risks for cardiovascular disease randomized to sotagliflozin or placebo and followed for a median of 16 months. The primary result showed that sotagliflozin treatment cut the combined rate of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure by a significant 26% relative to control patients.
 

A clear MACE benefit

“The data from SOLOIST-WHF and SCORED look at least as good as the data for the SGLT2 inhibitors for heart failure, and what appears to be different are the rates for MI and stroke in SCORED,” said Dr. Bhatt, director of Mount Sinai Heart, New York.

“I believe the rate of major adverse cardiovascular events [MACE] were reduced [in SCORED], and this is different from the SGLT2 inhibitors,” he said in an interview.

In 2022, Dr. Bhatt reported results from a prespecified secondary analysis of SCORED that showed that treatment with sotagliflozin cut the rate of MACE by a significant 21%-26%, compared with placebo. This finding was, in part, driven by the first data to show a substantial benefit from an SGLT inhibitor on stroke rates.

And while SCORED did not report a significant benefit for slowing progression of CKD, subsequent post hoc analyses have suggested this advantage also in as-yet-unpublished findings, Dr. Bhatt added.

But he said he doubted nephrologists will see it as a first-line agent for slowing CKD progression – an indication already held by dapagliflozin, pending for empagliflozin, and also in place for a third SGLT2 inhibitor, canagliflozin (Invokana) – because sotagliflozin lacks clear significant and prespecified evidence for this effect.

Dr. Bhatt also acknowledged the limitation of sotagliflozin compared with the SGLT2 inhibitors as an agent for glucose control, again because of no evidence for this effect from a prospective analysis and no pending indication for type 2 diabetes treatment. But the SCORED data showed a clear A1c benefit, even in patients with severely reduced renal function.
 

Mostly for cardiologists? ‘Compelling’ reductions in MIs and strokes

That may mean sotagliflozin “won’t get much use by endocrinologists nor by primary care physicians,” commented Carol L. Wysham, MD, an endocrinologist with MultiCare in Spokane, Wash.

Sotagliflozin “will be a cardiology drug,” and will “have a hard time” competing with the SGLT2 inhibitors, she predicted.

Dr. Bhatt agreed that sotagliflozin “will be perceived as a drug for cardiologists to prescribe. I don’t see endocrinologists, nephrologists, and primary care physicians reaching for this drug if it has a heart failure label.” But, he added, “my hope is that the company files for additional indications. It deserves an indication for glycemic control.”

The evidence for a heart failure benefit from sotagliflozin is “valid and compelling,” and “having this option is great,” commented Mikhail N. Kosiborod, MD, a cardiologist, vice president of research at Saint Luke’s Health System, and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. But, he added, “it will be a reasonably tall task for sotagliflozin to come from behind and be disruptive in a space where there are already two well-established SGLT2 inhibitors” approved for preventing heart failure hospitalizations, “with a lot of data to back them up,”

The feature that sets sotagliflozin apart from the approved SGLT2 inhibitors is the “really compelling decrease” it produced in rates of MIs and strokes “that we simply do not see with SGLT2 inhibitors,” Dr. Kosiborod said in an interview.

He also cited results from SCORED that suggest “a meaningful reduction in A1c” when indirectly compared with SGLT2 inhibitors, especially in patients with more severe CKD. The lack of a dedicated A1c-lowering trial or an approved type 2 diabetes indication “will not be a problem for cardiologists,” he predicted, but also agreed that it is less likely to be used by primary care physicians in low-risk patients.

“I can see myself prescribing sotagliflozin,” said Dr. Kosiborod, a SCORED coinvestigator, especially for patients with coexisting type 2 diabetes, heart failure, CKD, and atherosclerotic cardiovascular disease. These patients may get “more bang for the buck” because of a reduced risk for MI and stroke, making sotagliflozin “a solid consideration in these patients if the economic factors align.”

Like others, Dr. Kosiborod cited the big impact pricing will have, especially if, as expected, a generic SGLT2 inhibitor soon comes onto the U.S. market. “Access and affordability are very important.”

SOLOIST-WHF and SCORED were sponsored initially by Sanofi and later by Lexicon after Sanofi pulled out of sotagliflozin development. Dr. Butler has been a consultant for Lexicon as well as for AstraZeneca (which markets Farxiga), Boehringer Ingelheim and Lilly (which jointly market Jardiance), and Janssen (which markets Invokana), as well as for numerous other companies. Dr. Packer has been a consultant for AstraZeneca, Boehringer Ingelheim, Lilly, and numerous other companies. Dr. Bhatt was lead investigator for SOLOIST-WHF and SCORED and has been an adviser for Boehringer Ingelheim and Janssen and numerous other companies. Dr. Wysham has been an adviser, speaker, and consultant for AstraZeneca, Boehringer Ingelheim, Lilly, Janssen, Novo Nordisk, and Sanofi, an adviser for Abbott, and a speaker for Insulet. Dr. Kosiborod was a member of the SCORED Steering Committee and has been a consultant for Lexicon, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk, and numerous other companies.

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