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When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

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

When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

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

When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

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

For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

• Loss of energy
• Hypersomnia
• A craving for carbohydrates
• Overeating
• Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

• Loss of energy
• Hypersomnia
• A craving for carbohydrates
• Overeating
• Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

• Loss of energy
• Hypersomnia
• A craving for carbohydrates
• Overeating
• Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

TOPLINE:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

• Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
• Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
• The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
• The secondary exposure examined was the use of medications indicated for AUD.
• The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

• About 59% of participants experienced AUD-related hospitalization.
• Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
• Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
• The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
• Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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

TOPLINE:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

• Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
• Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
• The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
• The secondary exposure examined was the use of medications indicated for AUD.
• The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

• About 59% of participants experienced AUD-related hospitalization.
• Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
• Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
• The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
• Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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

TOPLINE:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

• Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
• Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
• The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
• The secondary exposure examined was the use of medications indicated for AUD.
• The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

• About 59% of participants experienced AUD-related hospitalization.
• Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
• Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
• The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
• Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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

WASHINGTON — Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR). 

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR). 

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR). 

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

In older postmenopausal women with type 2 diabetes (T2D), pyridoxamine treatment has potential to prevent fractures and protect bone tissue by targeting advanced glycation end products and also lowers levels of A1c, an early glycation product.

METHODOLOGY:

• Despite greater bone density and low bone turnover, people with T2D have increased fractures risk and higher associated mortality, but previous research linking advanced glycation end products (AGEs) to bone fragility suggests an AGE inhibitor could be a novel therapeutic strategy to prevent the accumulation of AGE in bone tissue.
• This randomized clinical trial, conducted at the Metabolic Bone Disease Unit of Columbia University Irving Medical Center, New York City, from December 2017 to February 2021, assessed the efficacy of the vitamin B6 metabolite pyridoxamine, an AGE inhibitor, in promoting bone formation in 55 older postmenopausal women with T2D.
• The participants received either 200 mg of oral pyridoxamine dihydrochloride (n = 27; mean age, 75.6 years) or matching placebo tablets (n = 28; mean age, 73.1 years) twice daily for 1 year.
• The primary outcome was the change in the levels of the bone formation marker Procollagen Type I Intact N-terminal Propeptide (P1NP) from baseline to after 12 months of treatment.
• Other outcomes included changes in bone mineral density measured at the lumbar spine, total hip, femoral neck, and 1/3 radius using dual energy x-ray absorptiometry; A1c levels; and skin autofluorescence at 12 months, a surrogate for bone AGEs. The safety of pyridoxamine was evaluated by monitoring neurologic findings and adverse events because high doses of the parent vitamin B6 have been reported to cause neurotoxicity.

TAKEAWAY:

• At 12 months, pyridoxamine treatment increased P1NP levels by 23% (P = .028) compared with 4.1% with placebo (P = .576), a “nearly significant difference.”
• Bone mineral density at the femoral neck increased by 2.64% with pyridoxamine but decreased by 0.91% with placebo (P = .007), with no changes at the lumbar spine, total hip, or 1/3 radius. The levels of bone resorption markers or skin autofluorescence were not significantly different between the groups.
• A1c levels decreased by 0.38% in the pyridoxamine group and correlated with increased P1NP levels, compared with a 0.05% increase in the placebo group (P = .04).
• Pyridoxamine was well tolerated. Four serious adverse events were reported in the pyridoxamine group and seven in the placebo group; none of these were related to the trial treatment.

IN PRACTICE:

“[The study] findings suggest that AGE inhibition might clinically improve the low bone formation state of T2D, and that PM [pyridoxamine] might warrant further investigation as a potential disease mechanism-directed approach for the therapy of T2D bone fragility,” the authors wrote.

SOURCE:

The study was led by Aiden V. Brossfield, Metabolic Bone Disease Unit, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study findings were preliminary. The study’s small sample size and individual variability led to a lack of statistical significance. The exclusion of men may have limited the generalizability of the findings. The short duration of 1 year may have been insufficient for detecting changes in skin AGEs. The levels of circulating AGEs or pyridoxamine were not measured, which could have provided additional insights.

DISCLOSURES:

The study was supported by a grant from the US National Institute on Aging. The authors declared no conflicts of interest.

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

TOPLINE:

In older postmenopausal women with type 2 diabetes (T2D), pyridoxamine treatment has potential to prevent fractures and protect bone tissue by targeting advanced glycation end products and also lowers levels of A1c, an early glycation product.

METHODOLOGY:

• Despite greater bone density and low bone turnover, people with T2D have increased fractures risk and higher associated mortality, but previous research linking advanced glycation end products (AGEs) to bone fragility suggests an AGE inhibitor could be a novel therapeutic strategy to prevent the accumulation of AGE in bone tissue.
• This randomized clinical trial, conducted at the Metabolic Bone Disease Unit of Columbia University Irving Medical Center, New York City, from December 2017 to February 2021, assessed the efficacy of the vitamin B6 metabolite pyridoxamine, an AGE inhibitor, in promoting bone formation in 55 older postmenopausal women with T2D.
• The participants received either 200 mg of oral pyridoxamine dihydrochloride (n = 27; mean age, 75.6 years) or matching placebo tablets (n = 28; mean age, 73.1 years) twice daily for 1 year.
• The primary outcome was the change in the levels of the bone formation marker Procollagen Type I Intact N-terminal Propeptide (P1NP) from baseline to after 12 months of treatment.
• Other outcomes included changes in bone mineral density measured at the lumbar spine, total hip, femoral neck, and 1/3 radius using dual energy x-ray absorptiometry; A1c levels; and skin autofluorescence at 12 months, a surrogate for bone AGEs. The safety of pyridoxamine was evaluated by monitoring neurologic findings and adverse events because high doses of the parent vitamin B6 have been reported to cause neurotoxicity.

TAKEAWAY:

• At 12 months, pyridoxamine treatment increased P1NP levels by 23% (P = .028) compared with 4.1% with placebo (P = .576), a “nearly significant difference.”
• Bone mineral density at the femoral neck increased by 2.64% with pyridoxamine but decreased by 0.91% with placebo (P = .007), with no changes at the lumbar spine, total hip, or 1/3 radius. The levels of bone resorption markers or skin autofluorescence were not significantly different between the groups.
• A1c levels decreased by 0.38% in the pyridoxamine group and correlated with increased P1NP levels, compared with a 0.05% increase in the placebo group (P = .04).
• Pyridoxamine was well tolerated. Four serious adverse events were reported in the pyridoxamine group and seven in the placebo group; none of these were related to the trial treatment.

IN PRACTICE:

“[The study] findings suggest that AGE inhibition might clinically improve the low bone formation state of T2D, and that PM [pyridoxamine] might warrant further investigation as a potential disease mechanism-directed approach for the therapy of T2D bone fragility,” the authors wrote.

SOURCE:

The study was led by Aiden V. Brossfield, Metabolic Bone Disease Unit, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study findings were preliminary. The study’s small sample size and individual variability led to a lack of statistical significance. The exclusion of men may have limited the generalizability of the findings. The short duration of 1 year may have been insufficient for detecting changes in skin AGEs. The levels of circulating AGEs or pyridoxamine were not measured, which could have provided additional insights.

DISCLOSURES:

The study was supported by a grant from the US National Institute on Aging. The authors declared no conflicts of interest.

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

TOPLINE:

In older postmenopausal women with type 2 diabetes (T2D), pyridoxamine treatment has potential to prevent fractures and protect bone tissue by targeting advanced glycation end products and also lowers levels of A1c, an early glycation product.

METHODOLOGY:

• Despite greater bone density and low bone turnover, people with T2D have increased fractures risk and higher associated mortality, but previous research linking advanced glycation end products (AGEs) to bone fragility suggests an AGE inhibitor could be a novel therapeutic strategy to prevent the accumulation of AGE in bone tissue.
• This randomized clinical trial, conducted at the Metabolic Bone Disease Unit of Columbia University Irving Medical Center, New York City, from December 2017 to February 2021, assessed the efficacy of the vitamin B6 metabolite pyridoxamine, an AGE inhibitor, in promoting bone formation in 55 older postmenopausal women with T2D.
• The participants received either 200 mg of oral pyridoxamine dihydrochloride (n = 27; mean age, 75.6 years) or matching placebo tablets (n = 28; mean age, 73.1 years) twice daily for 1 year.
• The primary outcome was the change in the levels of the bone formation marker Procollagen Type I Intact N-terminal Propeptide (P1NP) from baseline to after 12 months of treatment.
• Other outcomes included changes in bone mineral density measured at the lumbar spine, total hip, femoral neck, and 1/3 radius using dual energy x-ray absorptiometry; A1c levels; and skin autofluorescence at 12 months, a surrogate for bone AGEs. The safety of pyridoxamine was evaluated by monitoring neurologic findings and adverse events because high doses of the parent vitamin B6 have been reported to cause neurotoxicity.

TAKEAWAY:

• At 12 months, pyridoxamine treatment increased P1NP levels by 23% (P = .028) compared with 4.1% with placebo (P = .576), a “nearly significant difference.”
• Bone mineral density at the femoral neck increased by 2.64% with pyridoxamine but decreased by 0.91% with placebo (P = .007), with no changes at the lumbar spine, total hip, or 1/3 radius. The levels of bone resorption markers or skin autofluorescence were not significantly different between the groups.
• A1c levels decreased by 0.38% in the pyridoxamine group and correlated with increased P1NP levels, compared with a 0.05% increase in the placebo group (P = .04).
• Pyridoxamine was well tolerated. Four serious adverse events were reported in the pyridoxamine group and seven in the placebo group; none of these were related to the trial treatment.

IN PRACTICE:

“[The study] findings suggest that AGE inhibition might clinically improve the low bone formation state of T2D, and that PM [pyridoxamine] might warrant further investigation as a potential disease mechanism-directed approach for the therapy of T2D bone fragility,” the authors wrote.

SOURCE:

The study was led by Aiden V. Brossfield, Metabolic Bone Disease Unit, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study findings were preliminary. The study’s small sample size and individual variability led to a lack of statistical significance. The exclusion of men may have limited the generalizability of the findings. The short duration of 1 year may have been insufficient for detecting changes in skin AGEs. The levels of circulating AGEs or pyridoxamine were not measured, which could have provided additional insights.

DISCLOSURES:

The study was supported by a grant from the US National Institute on Aging. The authors declared no conflicts of interest.

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

There was a recent Sermo post bemoaning the demise of fish tanks, and the calming they bring, in medical waiting rooms.

Aquariums, I agree, have a soporific effect on humans. I’m not immune myself on the rare occasions I encounter one. There’s something relaxing about watching the fish slowly glide back and forth while you admire their different colors, sizes, and patterns. This is why they persisted in a lot of places, such as videotapes (remember “Video Fish Tank”?), screen savers, and a key plot point in Finding Nemo.

 

Personally, I’d much rather watch a fish tank in a waiting room then have a TV blaring at me with news, doctor bios, and direct-to-consumer drug ads. I suspect my patients feel the same way. When I get the occasional offer for a free waiting room TV that will play some customized feed about my practice and “ask your doctor” treatments, I send it off to be recycled into kitchen towels.

I think the real reason fish tanks are gone is that eternal bugaboo of medicine: money.

Margins in most practices, including mine, are thin, and a real fish tank (I’m not talking about a guppy in a bowl) aren’t cheap. They take, well, fish, and the most colorful ones are saltwater. Then they take a pump, heater, chemicals, food, plants, and decorations. Then you have to throw in the cost of a service with expertise in maintaining them (let’s face it, none of us have time to do that ourselves) ...

You want to add that to your overhead? Me neither.

My waiting room, as a result, is pretty bland. A handful of magazines, some books of classic Far Side, Calvin & Hobbes, and Doonesbury cartoons. The magazines are older, but relatively timeless ones, like issues of the Smithsonian or National Geographic. I don’t put out news magazines of any kind. If I’m not going to read the news, my patients shouldn’t have to either. My lobby should be relaxing.

We also live in an era where patients bring their own entertainment, on phones or iPads, to read while waiting. There are often days when I straighten up the waiting room while closing and the magazines haven’t been touched.

Yes, I miss fish tanks. But, like so many other things, they’ve become a casualty of modern medicine. They simply don’t make financial sense.

I’d rather cut corners in the waiting room than with patient care.

 

Block has a solo neurology practice in Scottsdale, Arizona.

There was a recent Sermo post bemoaning the demise of fish tanks, and the calming they bring, in medical waiting rooms.

Aquariums, I agree, have a soporific effect on humans. I’m not immune myself on the rare occasions I encounter one. There’s something relaxing about watching the fish slowly glide back and forth while you admire their different colors, sizes, and patterns. This is why they persisted in a lot of places, such as videotapes (remember “Video Fish Tank”?), screen savers, and a key plot point in Finding Nemo.

 

Personally, I’d much rather watch a fish tank in a waiting room then have a TV blaring at me with news, doctor bios, and direct-to-consumer drug ads. I suspect my patients feel the same way. When I get the occasional offer for a free waiting room TV that will play some customized feed about my practice and “ask your doctor” treatments, I send it off to be recycled into kitchen towels.

I think the real reason fish tanks are gone is that eternal bugaboo of medicine: money.

Margins in most practices, including mine, are thin, and a real fish tank (I’m not talking about a guppy in a bowl) aren’t cheap. They take, well, fish, and the most colorful ones are saltwater. Then they take a pump, heater, chemicals, food, plants, and decorations. Then you have to throw in the cost of a service with expertise in maintaining them (let’s face it, none of us have time to do that ourselves) ...

You want to add that to your overhead? Me neither.

My waiting room, as a result, is pretty bland. A handful of magazines, some books of classic Far Side, Calvin & Hobbes, and Doonesbury cartoons. The magazines are older, but relatively timeless ones, like issues of the Smithsonian or National Geographic. I don’t put out news magazines of any kind. If I’m not going to read the news, my patients shouldn’t have to either. My lobby should be relaxing.

We also live in an era where patients bring their own entertainment, on phones or iPads, to read while waiting. There are often days when I straighten up the waiting room while closing and the magazines haven’t been touched.

Yes, I miss fish tanks. But, like so many other things, they’ve become a casualty of modern medicine. They simply don’t make financial sense.

I’d rather cut corners in the waiting room than with patient care.

 

Block has a solo neurology practice in Scottsdale, Arizona.

There was a recent Sermo post bemoaning the demise of fish tanks, and the calming they bring, in medical waiting rooms.

Aquariums, I agree, have a soporific effect on humans. I’m not immune myself on the rare occasions I encounter one. There’s something relaxing about watching the fish slowly glide back and forth while you admire their different colors, sizes, and patterns. This is why they persisted in a lot of places, such as videotapes (remember “Video Fish Tank”?), screen savers, and a key plot point in Finding Nemo.

 

Personally, I’d much rather watch a fish tank in a waiting room then have a TV blaring at me with news, doctor bios, and direct-to-consumer drug ads. I suspect my patients feel the same way. When I get the occasional offer for a free waiting room TV that will play some customized feed about my practice and “ask your doctor” treatments, I send it off to be recycled into kitchen towels.

I think the real reason fish tanks are gone is that eternal bugaboo of medicine: money.

Margins in most practices, including mine, are thin, and a real fish tank (I’m not talking about a guppy in a bowl) aren’t cheap. They take, well, fish, and the most colorful ones are saltwater. Then they take a pump, heater, chemicals, food, plants, and decorations. Then you have to throw in the cost of a service with expertise in maintaining them (let’s face it, none of us have time to do that ourselves) ...

You want to add that to your overhead? Me neither.

My waiting room, as a result, is pretty bland. A handful of magazines, some books of classic Far Side, Calvin & Hobbes, and Doonesbury cartoons. The magazines are older, but relatively timeless ones, like issues of the Smithsonian or National Geographic. I don’t put out news magazines of any kind. If I’m not going to read the news, my patients shouldn’t have to either. My lobby should be relaxing.

We also live in an era where patients bring their own entertainment, on phones or iPads, to read while waiting. There are often days when I straighten up the waiting room while closing and the magazines haven’t been touched.

Yes, I miss fish tanks. But, like so many other things, they’ve become a casualty of modern medicine. They simply don’t make financial sense.

I’d rather cut corners in the waiting room than with patient care.

 

Block has a solo neurology practice in Scottsdale, Arizona.

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

• Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
• Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
• Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

• Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
• Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
• All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
• Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

• Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
• There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
• The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
• In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
• The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

• Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
• Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
• All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
• Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

• Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
• There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
• The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
• In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
• The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

TOPLINE:

Up to one in seven young adults with obesity and type 2 diabetes (T2D) have clinically significant hepatic fibrosis, signaling the crucial need for screening in this population to aid early detection and intervention.

METHODOLOGY:

• Researchers aimed to assess the prevalence of hepatic steatosis and clinically significant fibrosis (stage ≥ 2) in young adults without a history of metabolic dysfunction–associated steatotic liver disease (MASLD), hypothesizing that the rates would be comparable with those in older adults, especially in the presence of cardiometabolic risk factors.
• Overall, 1420 participants aged 21-79 years with or without T2D (63% or 37%, respectively) were included from outpatient clinics at the University of Florida, Gainesville, Florida, and divided into two age groups: < 45 years (n = 243) and ≥ 45 years (n = 1177).
• All the participants underwent assessment of liver stiffness via transient elastography, with magnetic resonance elastography (MRE) or liver biopsy recommended when indicated.
• Participants also underwent a medical history review, physical examination, and fasting blood tests to rule out secondary causes of liver disease.

TAKEAWAY:

• Overall, 52% of participants had hepatic steatosis, and 9.5% had clinically significant fibrosis.
• There were no significant differences in the frequencies of hepatic steatosis (50.2% vs 52.7%; P = .6) or clinically significant hepatic fibrosis (7.5% vs 9.9%; P = .2) observed between young and older adults.
• The presence of either T2D or obesity was linked to an increased prevalence of both hepatic steatosis and fibrosis in both the age groups (P < .01).
• In young and older adults, the presence of both T2D and obesity led to the highest rates of both hepatic steatosis and clinically significant fibrosis, with the latter rate being statistically similar between the groups (15.7% vs 17.3%; P = .2).
• The presence of T2D and obesity was the strongest risk factors for hepatic fibrosis in young adults (odds ratios, 4.33 and 1.16, respectively; P < .05 for both).

IN PRACTICE:

“The clinical implication is that young adults with obesity and T2D carry a high risk of future cirrhosis, possibly as high as older adults, and must be aggressively screened at the first visit and carefully followed,” the authors wrote.

SOURCE:

This study, led by Anu Sharma, University of Florida College of Medicine, Gainesville, was published online in Obesity.

LIMITATIONS:

The diagnosis of clinically significant hepatic fibrosis was confirmed via MRE and/or liver biopsy in only 30% of all participants. The study population included a slightly higher proportion of young adults with obesity, T2D, and other cardiometabolic risk factors than that in national averages, which may have limited its generalizability. Genetic variants associated with MASLD were not included in this study.

DISCLOSURES:

This study was funded partly by grants from the National Institutes of Health and Echosens. One author disclosed receiving research support and serving as a consultant for various pharmaceutical companies.

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

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.

Two Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting access to a life-changing and life-saving medication for people with schizophrenia.

Members of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting on November 19 to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again. Clozapine — the only FDA-approved drug for treatment-resistant schizophrenia — can cause severe neutropenia, so is subject to a Risk Evaluation and Management Strategy (REMS).

Calling the current rules overly burdensome, a majority of committee members voted against continuing a requirement that pharmacies and physicians must provide documentation of a patient’s absolute neutrophil count (ANC) results through the REMS. Monitoring should continue, as directed in the labeling, said the panel.

Panelists also voted overwhelmingly that it is not necessary to mandate physician education about clozapine’s risk of neutropenia and the need for ANC monitoring.

The panel did not vote, however, on whether the REMS should be eliminated altogether. The FDA did not pose that as a voting question for the panels’ consideration.

Following intense lobbying by the American Psychiatric Association (APA), the National Alliance on Mental Illness, and others, the FDA announced in 2022 that the agency would exercise “enforcement discretion” by allowing prescribers and pharmacists to skirt the clozapine REMS rules. But the agency doesn’t know whether the program is meeting its goals, said Tiffany R. Farchione, MD, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research.

Among other things, the REMS requires that physicians and pharmacists be certified to prescribe and dispense the drug, that patients be enrolled, and that patient status forms be submitted monthly, showing ANC levels and appropriateness of continuing treatment. 

At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000–1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine.

“We know the drug is being underutilized,” said Farchione, adding that the agency wants to ensure that physicians and pharmacists “can use the drug, use it safely and help the patients who need it.” 

 

REMS a ‘Hindrance’

As reported by this news organization, research presented earlier this year at the APA annual meeting showed that the risk of moderate and severe neutropenia is low to minimal in people taking clozapine for treatment-resistant schizophrenia. Those findings prompted the study’s investigators to suggest clozapine REMS should be reconsidered.

In the November 19th committee meeting, many panelists said that clozapine was no more dangerous than many antipsychotics and that the administrative requirements were preventing clinicians from prescribing.

“I have fantasized for years about abolishing the clozapine REMS,” said Jacob S. Ballon, MD, MPH, a temporary panel member and associate professor of psychiatry at Stanford University in California.

Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine in Pennsylvania, agreed.

“I strongly feel that the REMS at this point is just a hindrance,” Narendran said. “I think you should get rid of the REMS.”

However, panelist Walter Dunn, MD, PhD, staff psychiatrist at the VA Greater Los Angeles Healthcare System, cautioned that modifying or eliminating the REMS might not necessarily increase prescribers. If monitoring ANC levels is still recommended in labeling, clinicians will still regard it as the standard of care, said Dunn. And “there are a whole host of other issues associated with clozapine,” that he said were “more concerning.” 

Many patients are accessing clozapine without going through the REMS, which is also of concern to the FDA and drug manufacturers. 

“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers.

Leah Hart, PharmD, a risk management analyst with the FDA, told the panel that the agency estimates that 25%-35% of patients taking clozapine may not be participating in the REMS. 

“Today, prescribers, pharmacies, and patients do not have to participate in the REMS in order patients to obtain clozapine,” Hart said.

 

Public Testimony Sways Panel

But psychiatrists, pharmacists, families, and patients who testified during the 90-minute open portion of the meeting disagreed with that assessment, saying the REMS program had a devastatingly chilling effect on clozapine access.

Patty Taggart of Las Vegas said her daughter had nine suicide attempts over the past 14 years, while having tried eight different antipsychotics. In August, after the most-recent attempt, Taggart begged the psychiatrist to prescribe clozapine to her daughter. The clinician refused, citing the REMS. After her daughter’s discharge, Taggart said she found another provider who would prescribe the medication.

Lisa Castellanos said her son Daniel had been treated with a variety of antipsychotics but denied clozapine until he was arrested in 2012 for assault during a psychotic break. The state used the medication to improve Daniel’s mental state so he could stand trial. But when he went to jail after accepting a plea deal, the prison stopped the clozapine. Daniel has since deteriorated and was recently ruled ineligible for parole.

Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements. 

Many panelists said they were moved by patients and family testimony. A dozen or more members of the public were wearing black t-shirts with white writing that declared: “Clozapine is the safest antipsychotic in the world.” 

 

‘Blood-for-Drug Program’

Brian Barnett, MD, director of the psychiatric treatment-resistance program at the Cleveland Clinic in Ohio, said during the public portion of the meeting that “many pharmacies simply refuse to dispense clozapine likely because of the administrative burden and lack of financial incentives.” 

Others want faxed lab results even when the results have been filed electronically, he said. “One of the most dangerous features of the current REMS system is its inflexibility, driven by the so-called ‘no blood, no drug’ ethos which has been baked into the minds of America’s pharmacists.”

“This is a blood-for-drug program,” agreed Rachel Strieff of Tempe, Arizona, who noted that her advocacy group, Angry Moms, and others had submitted 4,000 signatures calling for the end of the REMS. “The largest category of patients harmed by the clozapine REMS have never taken a single dose,” she said, noting that millions of eligible individuals are not getting the drug.

Panel chair James Floyd, MD, professor of medicine at the University of Washington, Seattle, said the public testimony was “very moving.” Families and patients had described “the intensity of suffering that people go through prior to getting to clozapine,” he added.

“We have to listen to that,” said Floyd.


“I want you to know that we hear you,” said Farchione. “We’re here today because of you and your loved ones. And your stories are important, and your experience is important, and what you’ve shared today will have an impact on regulatory decision making.”

While the FDA typically follows its panels’ advice, it’s unclear if the agency will do so for clozapine REMS or when it will release its final decision.

A version of this article appeared on Medscape.com.