Clinical Endocrinology News

This transcript has been edited for clarity. 

I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service? 

You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement. 

There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot. 

The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that. 

It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.

I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right? 

In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.

Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.

In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.

This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.

These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.

They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it. 

I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States. 

I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area. 

For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.

It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.

When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
 

Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service? 

You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement. 

There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot. 

The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that. 

It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.

I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right? 

In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.

Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.

In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.

This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.

These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.

They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it. 

I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States. 

I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area. 

For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.

It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.

When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
 

Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I’d like to pose a question: When should doctors retire? When, as practicing physicians or surgeons, do we become too old to deliver competent service? 

You will be amazed to hear, those of you who have listened to my videos before — and although it is a matter of public knowledge — that I’m 68. I know it’s impossible to imagine, due to this youthful appearance, visage, and so on, but I am. I’ve been a cancer doctor for 40 years; therefore, I need to think a little about retirement. 

There are two elements of this for me. I’m a university professor, and in Oxford we did vote, as a democracy of scholars, to have a mandatory retirement age around 68. This is so that we can bring new blood forward so that we can create the space to promote new professors, to bring youngsters in to make new ideas, and to get rid of us fusty old lot. 

The other argument would be, of course, that we are wise, we’re experienced, we are world-weary, and we’re successful — otherwise, we wouldn’t have lasted as academics as long. Nevertheless, we voted to do that. 

It’s possible to have a discussion with the university to extend this, and for those of us who are clinical academics, I have an honorary appointment as a consultant cancer physician in the hospital and my university professorial appointment, too.

I can extend it probably until I’m about 70. It feels like a nice, round number at which to retire — somewhat arbitrarily, one would admit. But does that feel right? 

In the United States, more than 25% of the physician workforce is over the age of 65. There are many studies showing that there is a 20% cognitive decline for most individuals between the ages of 45 and 65.

Are we as capable as an elderly workforce as once we were? Clearly, it’s hardly individualistic. It depends on each of our own health status, where we started from, and so on, but are there any general rules that we can apply? I think these are starting to creep in around the sense of revalidation.

In the United Kingdom, we have a General Medical Council (GMC). I need to have a license to practice from the GMC and a sense of fitness to practice. I have annual appraisals within the hospital system, in which I explore delivery of care, how I’m doing as a mentor, am I reaching the milestones I’ve set in terms of academic achievements, and so on.

This is a peer-to-peer process. We have senior physicians — people like myself — who act as appraisers to support our colleagues and to maintain that sense of fitness to practice. Every 5 years, I’m revalidated by the GMC. They take account of the annual appraisals and a report made by the senior physician within my hospital network who’s a so-called designated person.

These two elements come together with patient feedback, with 360-degree feedback from colleagues, and so on. This is quite a firmly regulated system that I think works. Our mandatory retirement age of 65 has gone. That was phased out by the government. In fact, our NHS is making an effort to retain older elders in the workforce.

They see the benefits of mentorship, experience, leadership, and networks. At a time when the majority of NHS are actively seeking to retire when 65, the NHS is trying to retain and pull back those of us who have been around for that wee bit longer and who still feel committed to doing it. 

I’d be really interested to see what you think. There’s variation from country to country. I know that, in Australia, they’re talking about annual appraisals of doctors over the age of 70. I’d be very interested to hear what you think is likely to happen in the United States. 

I think our system works pretty well, as long as you’re within the NHS and hospital system. If you wanted to still practice, but practice privately, you would still have to find somebody who’d be prepared to conduct appraisals and so on outside of the NHS. It’s an interesting area. 

For myself, I still feel competent. Patients seem to like me. That’s an objective assessment by this 360-degree thing in which patients reflected very positively, indeed, in my approach to the delivery of the care and so on, as did colleagues. I’m still publishing, I go to meetings, I cheer things, bits and bobs. I’d say I’m a wee bit unusual in terms of still having a strong academic profile in doing stuff.

It’s an interesting question. Richard Doll, one of the world’s great epidemiologists who, of course, was the dominant discoverer of the link between smoking and lung cancer, was attending seminars, sitting in the front row, and coming into university 3 days a week at age 90, continuing to be contributory with his extraordinarily sharp intellect and vast, vast experience.

When I think of experience, all young cancer doctors are now immunologists. When I was a young doctor, I was a clinical pharmacologist. There are many lessons and tricks that I learned which I do need to pass on to the younger generation of today. What do you think? Should there be a mandatory retirement age? How do we best measure, assess, and revalidate elderly physicians and surgeons? How can we continue to contribute to those who choose to do so? For the time being, as always, thanks for listening.
 

Dr. Kerr is professor, Nuffield Department of Clinical Laboratory Science, University of Oxford, and professor of cancer medicine, Oxford Cancer Centre, Oxford, United Kingdom. He has disclosed ties with Celleron Therapeutics, Oxford Cancer Biomarkers (Board of Directors); Afrox (charity; Trustee); GlaxoSmithKline and Bayer HealthCare Pharmaceuticals (Consultant), Genomic Health; Merck Serono, and Roche.

A version of this article appeared on Medscape.com.

Over the past few decades, researchers have developed a compelling case against ultraprocessed foods and beverages, linking them to several chronic diseases and adverse health conditions. Yet, even as this evidence mounted, these food items have become increasingly prominent in diets globally. 

Now, recent studies are unlocking why cutting back on ultraprocessed foods can be so challenging. In their ability to fuel intense cravings, loss of control, and even withdrawal symptoms, ultraprocessed foods appear as capable of triggering addiction as traditional culprits like tobacco and alcohol. 

This has driven efforts to better understand the addictive nature of these foods and identify strategies for combating it. 
 

The Key Role of the Food Industry

Some foods are more likely to trigger addictions than others. For instance, in our studies, participants frequently mention chocolate, pizza, French fries, potato chips, and soda as some of the most addictive foods. What these foods all share is an ability to deliver high doses of refined carbohydrates, fat, or salt at levels exceeding those found in natural foods (eg, fruits, vegetables, beans).

Furthermore, ultraprocessed foods are industrially mass-produced in a process that relies on the heavy use of flavor enhancers and additives, as well as preservatives and packaging that make them shelf-stable. This has flooded our food supply with cheap, accessible, hyperrewarding foods that our brains are not well equipped to resist.

To add to these already substantial effects, the food industry often employs strategies reminiscent of Big Tobacco. They engineer foods to hit our “bliss points,” maximizing craving and fostering brand loyalty from a young age. This product engineering, coupled with aggressive marketing, makes these foods both attractive and seemingly ubiquitous. 
 

How Many People Are Affected?

Addiction to ultraprocessed food is more common than you might think. According to the Yale Food Addiction Scale — a tool that uses the same criteria for diagnosing substance use disorders to assess ultraprocessed food addiction (UPFA) — about 14% of adults and 12% of children show clinically significant signs of addiction to such foods. This is quite similar to addiction rates among adults for legal substances like alcohol and tobacco. 

Research has shown that behaviors and brain mechanisms contributing to addictive disorders, such as cravings and impulsivity, also apply to UPFA. 

Many more people outside of those who meet the criteria for UPFA are influenced by their addictive properties. Picture a teenager craving a sugary drink after school, a child needing the morning cereal fix, or adults reaching for candy and fast food; these scenarios illustrate how addictive ultraprocessed foods permeate our daily lives. 

From a public health standpoint, this comes at a significant cost. Even experiencing one or two symptoms of UPFA, such as intense cravings or a feeling of loss of control over intake, can lead to consuming too many calories, sugar, fat, and sodium in a way that puts health at risk.
 

Clinical Implications

Numerous studies have found that individuals who exhibit UPFA have more severe mental and physical health challenges. For example, UPFA is associated with higher rates of diet-related diseases (like type 2 diabetes), greater overall mental health issues, and generally poorer outcomes in weight loss treatments.

Despite the growing understanding of UPFA’s relevance in clinical settings, research is still limited on how to best treat, manage, or prevent it. Most of the existing work has focused on investigating whether UPFA is indeed a real condition, with efforts to create clinical guidelines only just beginning.

Of note, UPFA isn’t officially recognized as a diagnosis — yet. If it were, it could spark much more research into how to handle it clinically.

There is some debate about whether we really need this new diagnosis, given that eating disorders are already recognized. However, the statistics tell a different story: Around 14% of people might have UPFA compared with about 1% for binge-type eating disorders. This suggests that many individuals with problematic eating habits are currently flying under the radar with our existing diagnostic categories. 

What’s even more concerning is that these individuals often suffer significant problems and exhibit distinct brain differences, even if they do not neatly fit into an existing eating disorder diagnosis. Officially recognizing UPFA could open up new avenues for support and lead to better treatments aimed at reducing compulsive eating patterns.
 

Treatment Options

Treatment options for UPFA are still being explored. Initial evidence suggests that medications used for treating substance addiction, such as naltrexone and bupropion, might help with highly processed food addiction as well. Newer drugs, like glucagon-like peptide-1 receptor agonists, which appear to curb food cravings and manage addictive behaviors, also look promising.

Psychosocial approaches can also be used to address UPFA. Strategies include:

• Helping individuals become more aware of their triggers for addictive patterns of intake. This often involves identifying certain types of food (eg, potato chips, candy), specific places or times of day (eg, sitting on the couch at night while watching TV), and particular emotional states (eg, anger, loneliness, boredom, sadness). Increasing awareness of personal triggers can help people minimize their exposure to these and develop coping strategies when they do arise.
• Many people use ultraprocessed foods to cope with challenging emotions. Helping individuals develop healthier strategies to regulate their emotions can be key. This may include seeking out social support, journaling, going for a walk, or practicing mindfulness.
• UPFA can be associated with erratic and inconsistent eating patterns. Stabilizing eating habits by consuming regular meals composed of more minimally processed foods (eg, vegetables, fruits, high-quality protein, beans) can help heal the body and reduce vulnerability to ultraprocessed food triggers.
• Many people with UPFA have other existing mental health conditions, including mood disorders, anxiety, substance use disorders, or trauma-related disorders. Addressing these co-occurring mental health conditions can help reduce reliance on ultraprocessed foods.

Public-policy interventions may also help safeguard vulnerable populations from developing UPFA. For instance, support exists for policies to protect children from cigarette marketing and to put clear addiction warning labels on cigarette packages. A similar approach could be applied to reduce the harms associated with ultraprocessed foods, particularly for children.

Combating this growing problem requires treating ultraprocessed foods like other addictive substances. By identifying the threat posed by these common food items, we can not only help patients with UPFA, but also potentially stave off the development of several diet-related conditions.
 

Dr. Gearhardt, professor of psychology, University of Michigan, Ann Arbor, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Over the past few decades, researchers have developed a compelling case against ultraprocessed foods and beverages, linking them to several chronic diseases and adverse health conditions. Yet, even as this evidence mounted, these food items have become increasingly prominent in diets globally. 

Now, recent studies are unlocking why cutting back on ultraprocessed foods can be so challenging. In their ability to fuel intense cravings, loss of control, and even withdrawal symptoms, ultraprocessed foods appear as capable of triggering addiction as traditional culprits like tobacco and alcohol. 

This has driven efforts to better understand the addictive nature of these foods and identify strategies for combating it. 
 

The Key Role of the Food Industry

Some foods are more likely to trigger addictions than others. For instance, in our studies, participants frequently mention chocolate, pizza, French fries, potato chips, and soda as some of the most addictive foods. What these foods all share is an ability to deliver high doses of refined carbohydrates, fat, or salt at levels exceeding those found in natural foods (eg, fruits, vegetables, beans).

Furthermore, ultraprocessed foods are industrially mass-produced in a process that relies on the heavy use of flavor enhancers and additives, as well as preservatives and packaging that make them shelf-stable. This has flooded our food supply with cheap, accessible, hyperrewarding foods that our brains are not well equipped to resist.

To add to these already substantial effects, the food industry often employs strategies reminiscent of Big Tobacco. They engineer foods to hit our “bliss points,” maximizing craving and fostering brand loyalty from a young age. This product engineering, coupled with aggressive marketing, makes these foods both attractive and seemingly ubiquitous. 
 

How Many People Are Affected?

Addiction to ultraprocessed food is more common than you might think. According to the Yale Food Addiction Scale — a tool that uses the same criteria for diagnosing substance use disorders to assess ultraprocessed food addiction (UPFA) — about 14% of adults and 12% of children show clinically significant signs of addiction to such foods. This is quite similar to addiction rates among adults for legal substances like alcohol and tobacco. 

Research has shown that behaviors and brain mechanisms contributing to addictive disorders, such as cravings and impulsivity, also apply to UPFA. 

Many more people outside of those who meet the criteria for UPFA are influenced by their addictive properties. Picture a teenager craving a sugary drink after school, a child needing the morning cereal fix, or adults reaching for candy and fast food; these scenarios illustrate how addictive ultraprocessed foods permeate our daily lives. 

From a public health standpoint, this comes at a significant cost. Even experiencing one or two symptoms of UPFA, such as intense cravings or a feeling of loss of control over intake, can lead to consuming too many calories, sugar, fat, and sodium in a way that puts health at risk.
 

Clinical Implications

Numerous studies have found that individuals who exhibit UPFA have more severe mental and physical health challenges. For example, UPFA is associated with higher rates of diet-related diseases (like type 2 diabetes), greater overall mental health issues, and generally poorer outcomes in weight loss treatments.

Despite the growing understanding of UPFA’s relevance in clinical settings, research is still limited on how to best treat, manage, or prevent it. Most of the existing work has focused on investigating whether UPFA is indeed a real condition, with efforts to create clinical guidelines only just beginning.

Of note, UPFA isn’t officially recognized as a diagnosis — yet. If it were, it could spark much more research into how to handle it clinically.

There is some debate about whether we really need this new diagnosis, given that eating disorders are already recognized. However, the statistics tell a different story: Around 14% of people might have UPFA compared with about 1% for binge-type eating disorders. This suggests that many individuals with problematic eating habits are currently flying under the radar with our existing diagnostic categories. 

What’s even more concerning is that these individuals often suffer significant problems and exhibit distinct brain differences, even if they do not neatly fit into an existing eating disorder diagnosis. Officially recognizing UPFA could open up new avenues for support and lead to better treatments aimed at reducing compulsive eating patterns.
 

Treatment Options

Treatment options for UPFA are still being explored. Initial evidence suggests that medications used for treating substance addiction, such as naltrexone and bupropion, might help with highly processed food addiction as well. Newer drugs, like glucagon-like peptide-1 receptor agonists, which appear to curb food cravings and manage addictive behaviors, also look promising.

Psychosocial approaches can also be used to address UPFA. Strategies include:

• Helping individuals become more aware of their triggers for addictive patterns of intake. This often involves identifying certain types of food (eg, potato chips, candy), specific places or times of day (eg, sitting on the couch at night while watching TV), and particular emotional states (eg, anger, loneliness, boredom, sadness). Increasing awareness of personal triggers can help people minimize their exposure to these and develop coping strategies when they do arise.
• Many people use ultraprocessed foods to cope with challenging emotions. Helping individuals develop healthier strategies to regulate their emotions can be key. This may include seeking out social support, journaling, going for a walk, or practicing mindfulness.
• UPFA can be associated with erratic and inconsistent eating patterns. Stabilizing eating habits by consuming regular meals composed of more minimally processed foods (eg, vegetables, fruits, high-quality protein, beans) can help heal the body and reduce vulnerability to ultraprocessed food triggers.
• Many people with UPFA have other existing mental health conditions, including mood disorders, anxiety, substance use disorders, or trauma-related disorders. Addressing these co-occurring mental health conditions can help reduce reliance on ultraprocessed foods.

Public-policy interventions may also help safeguard vulnerable populations from developing UPFA. For instance, support exists for policies to protect children from cigarette marketing and to put clear addiction warning labels on cigarette packages. A similar approach could be applied to reduce the harms associated with ultraprocessed foods, particularly for children.

Combating this growing problem requires treating ultraprocessed foods like other addictive substances. By identifying the threat posed by these common food items, we can not only help patients with UPFA, but also potentially stave off the development of several diet-related conditions.
 

Dr. Gearhardt, professor of psychology, University of Michigan, Ann Arbor, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Over the past few decades, researchers have developed a compelling case against ultraprocessed foods and beverages, linking them to several chronic diseases and adverse health conditions. Yet, even as this evidence mounted, these food items have become increasingly prominent in diets globally. 

Now, recent studies are unlocking why cutting back on ultraprocessed foods can be so challenging. In their ability to fuel intense cravings, loss of control, and even withdrawal symptoms, ultraprocessed foods appear as capable of triggering addiction as traditional culprits like tobacco and alcohol. 

This has driven efforts to better understand the addictive nature of these foods and identify strategies for combating it. 
 

The Key Role of the Food Industry

Some foods are more likely to trigger addictions than others. For instance, in our studies, participants frequently mention chocolate, pizza, French fries, potato chips, and soda as some of the most addictive foods. What these foods all share is an ability to deliver high doses of refined carbohydrates, fat, or salt at levels exceeding those found in natural foods (eg, fruits, vegetables, beans).

Furthermore, ultraprocessed foods are industrially mass-produced in a process that relies on the heavy use of flavor enhancers and additives, as well as preservatives and packaging that make them shelf-stable. This has flooded our food supply with cheap, accessible, hyperrewarding foods that our brains are not well equipped to resist.

To add to these already substantial effects, the food industry often employs strategies reminiscent of Big Tobacco. They engineer foods to hit our “bliss points,” maximizing craving and fostering brand loyalty from a young age. This product engineering, coupled with aggressive marketing, makes these foods both attractive and seemingly ubiquitous. 
 

How Many People Are Affected?

Addiction to ultraprocessed food is more common than you might think. According to the Yale Food Addiction Scale — a tool that uses the same criteria for diagnosing substance use disorders to assess ultraprocessed food addiction (UPFA) — about 14% of adults and 12% of children show clinically significant signs of addiction to such foods. This is quite similar to addiction rates among adults for legal substances like alcohol and tobacco. 

Research has shown that behaviors and brain mechanisms contributing to addictive disorders, such as cravings and impulsivity, also apply to UPFA. 

Many more people outside of those who meet the criteria for UPFA are influenced by their addictive properties. Picture a teenager craving a sugary drink after school, a child needing the morning cereal fix, or adults reaching for candy and fast food; these scenarios illustrate how addictive ultraprocessed foods permeate our daily lives. 

From a public health standpoint, this comes at a significant cost. Even experiencing one or two symptoms of UPFA, such as intense cravings or a feeling of loss of control over intake, can lead to consuming too many calories, sugar, fat, and sodium in a way that puts health at risk.
 

Clinical Implications

Numerous studies have found that individuals who exhibit UPFA have more severe mental and physical health challenges. For example, UPFA is associated with higher rates of diet-related diseases (like type 2 diabetes), greater overall mental health issues, and generally poorer outcomes in weight loss treatments.

Despite the growing understanding of UPFA’s relevance in clinical settings, research is still limited on how to best treat, manage, or prevent it. Most of the existing work has focused on investigating whether UPFA is indeed a real condition, with efforts to create clinical guidelines only just beginning.

Of note, UPFA isn’t officially recognized as a diagnosis — yet. If it were, it could spark much more research into how to handle it clinically.

There is some debate about whether we really need this new diagnosis, given that eating disorders are already recognized. However, the statistics tell a different story: Around 14% of people might have UPFA compared with about 1% for binge-type eating disorders. This suggests that many individuals with problematic eating habits are currently flying under the radar with our existing diagnostic categories. 

What’s even more concerning is that these individuals often suffer significant problems and exhibit distinct brain differences, even if they do not neatly fit into an existing eating disorder diagnosis. Officially recognizing UPFA could open up new avenues for support and lead to better treatments aimed at reducing compulsive eating patterns.
 

Treatment Options

Treatment options for UPFA are still being explored. Initial evidence suggests that medications used for treating substance addiction, such as naltrexone and bupropion, might help with highly processed food addiction as well. Newer drugs, like glucagon-like peptide-1 receptor agonists, which appear to curb food cravings and manage addictive behaviors, also look promising.

Psychosocial approaches can also be used to address UPFA. Strategies include:

• Helping individuals become more aware of their triggers for addictive patterns of intake. This often involves identifying certain types of food (eg, potato chips, candy), specific places or times of day (eg, sitting on the couch at night while watching TV), and particular emotional states (eg, anger, loneliness, boredom, sadness). Increasing awareness of personal triggers can help people minimize their exposure to these and develop coping strategies when they do arise.
• Many people use ultraprocessed foods to cope with challenging emotions. Helping individuals develop healthier strategies to regulate their emotions can be key. This may include seeking out social support, journaling, going for a walk, or practicing mindfulness.
• UPFA can be associated with erratic and inconsistent eating patterns. Stabilizing eating habits by consuming regular meals composed of more minimally processed foods (eg, vegetables, fruits, high-quality protein, beans) can help heal the body and reduce vulnerability to ultraprocessed food triggers.
• Many people with UPFA have other existing mental health conditions, including mood disorders, anxiety, substance use disorders, or trauma-related disorders. Addressing these co-occurring mental health conditions can help reduce reliance on ultraprocessed foods.

Public-policy interventions may also help safeguard vulnerable populations from developing UPFA. For instance, support exists for policies to protect children from cigarette marketing and to put clear addiction warning labels on cigarette packages. A similar approach could be applied to reduce the harms associated with ultraprocessed foods, particularly for children.

Combating this growing problem requires treating ultraprocessed foods like other addictive substances. By identifying the threat posed by these common food items, we can not only help patients with UPFA, but also potentially stave off the development of several diet-related conditions.
 

Dr. Gearhardt, professor of psychology, University of Michigan, Ann Arbor, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

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

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

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

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

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

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

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:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

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:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 up-regulated genes, which included up-regulated of 23 hair keratin–associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were down-regulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. Additionally, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

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.

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

CHICAGO — Use of CO₂ lasers and similar “energy-based” treatments result in little to no benefit for genitourinary syndrome of menopause (GSM) symptoms, according to research presented at the The Menopause Society 2024 Annual Meeting in Chicago on September 12.

“There was a concern that menopausal women are being targeted for treatments that may not have a lot of benefit and might have significant harms,” Elisheva Danan, MD, MPH, a physician at the Minneapolis VA Health Care System and an assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, told this news organization. While she was not surprised to find little evidence of benefit, “we were a little bit surprised that we also didn’t find significant evidence of harms.”

The study was unable to evaluate the potential for financial harms, but Dr. Danan noted that these therapies are often expensive and not typically covered by insurance. The treatments appear to be used primarily in private practice, she said, while “most academic clinicians were not familiar with these and do not use these lasers.”

The American Urological Association had requested the review, Dr. Danan said, “to inform clinical guidelines that they could put out for practitioners about treating genital urinary syndrome from menopause.” Yet the evidence available remains slim. “There’s a lot of outcomes that were not looked at by most of these [trials], or they were looked at in a way that we couldn’t separate out,” she said.

Kamalini Das, MD, a professor of ob.gyn. at the University of Minnesota who was not involved in the research, was surprised by the findings because studies to date have been variable, “but since this looks at multiple studies and they find no benefits, I would take these results as more significant than any of the small studies,” she told this news organization.

Dr. Das said she has patients who ask about using these therapies and have had them done. “So far, I’ve told them the jury is out on whether it will help or not, that there are some studies that say they’re beneficial and some studies that they’re not,” Dr. Das said.

But this new review changes what she will tell patients going forward, she said. “This is a good study because it consolidates lots of little studies, so I think I would use this to say, looking at all the studies together, this treatment is not beneficial.”

GSM occurs due to the body’s reduced production of estrogen and affects anywhere from 27% to 84% of postmenopausal women. It can involve a constellation of symptoms ranging from vaginal discomfort and irritation to painful urination or intercourse. Typical recommended treatments for GSM include systemic hormone therapy, localized hormonal treatments such as vaginal estrogen or dehydroepiandrosterone, nonhormonal creams and moisturizers, and the prescription drug ospemifene.

Most of these have been found effective, according to a recent systematic review  Dr. Danan published in the Annals of Internal Medicine that this news organization covered. But recent years have also seen a rapid increase in interest and the availability of energy-based treatments for GSM, such as CO₂ laser and radiofrequency interventions, particularly for those who cannot or do not want to use hormonal treatments. The idea behind these newer therapies is that they “heat tissue to cause a denaturation of collagen fibers and induce a wound-healing response,” with the aim of “enhancement of vaginal elasticity, restoration of premenopausal epithelial function, and symptom improvement,” the authors wrote.

Evidence has been scant and uneven for the safety and effectiveness of these treatments, and they have not been evaluated by the US Food and Drug Administration. The agency issued a warning in 2018 with remarks from then Commissioner Scott Gottlieb that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.”

Much of the evidence has focused on CO₂ lasers instead of other energy-based treatments, however, and a raft of new studies have been published on these interventions in the past 2 years. Dr. Danan and colleagues, therefore, assessed the most current state of the research with a systematic review of randomized controlled trials (RCTs) and prospective observational studies with control groups published through December 11, 2023.

Included studies needed to evaluate an energy-based treatment for at least 8 weeks in a minimum of 40 postmenopausal women (20 in each group) who had one or more GSM symptoms. The authors also included nonrandomized and uncontrolled studies with a follow-up of a year or more to assess possible adverse events. The studies also needed to assess at least one of eight core outcomes: Dyspareunia; vulvovaginal dryness; vulvovaginal discomfort/irritation; dysuria; change in most bothersome symptom; treatment satisfaction; adverse events; and distress, bother, or interference associated with genitourinary symptoms.

The authors identified 32 studies, including 16 RCTs, one quasi-RCT, and 15 nonrandomized studies. The researchers extracted and analyzed data from the 10 RCTs and one quasi-RCT that were rated as having low to moderate risk for bias.

Most of these studies assessed CO₂ lasers alone, while three assessed erbium:yttrium-aluminum-garnet (Er:YAG) laser, and one looked at CO₂ lasers vs radiofrequency treatments.

The average age of participants ranged from 56 to 64 years, and most trials were in the United States. Results showed that CO₂ lasers led to little or no difference in dysuria, dyspareunia, or quality of life when compared with sham lasers. The CO₂ laser therapy also showed little to no difference compared with vaginal estrogen creams for dyspareunia, dryness, discomfort/irritation, dysuria, or quality of life.

Most CO₂ laser studies reported on most outcomes, but the Er:YAG studies tended to report only on quality of life and/or one or two other outcomes. The radiofrequency study only assessed dyspareunia and quality of life.

“Treatment effects on other outcomes and effects of Er:YAG laser or radiofrequency on any outcomes are very uncertain,” the authors reported. Few adverse events and no serious adverse events were reported based on 15 studies, including the additional non-RCTs that had follow-up for at least a year.

“There are case reports and other types of studies that have shown some bad outcomes using laser therapies, and we really wanted to be expansive and include anything, especially because this is such a new treatment and all these trials were in the last couple of years,” Dr. Danan said. 

The review was limited by inconsistent or nonvalidated outcome reporting in the studies as well as small populations and short follow-up, typically less than 3 months.

The research was funded by the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. Dr. Danan and Dr. Das had no disclosures.
 

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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

People who received systemic glucocorticoids during short hospital stays were more than twice as likely to develop new onset diabetes than those who didn’t, reported the authors of a large study that analyzed more than a decade’s worth of patient records.

Rajna Golubic, MD, PhD, of the diabetes trials unit at the University of Oxford, United Kingdom, and colleagues did an observational cohort study, using data from electronic healthcare records of more than patients admitted between January 1, 2013, and October 1, 2023.

They looked for patients who didn’t have a diabetes diagnosis at the time of admission and who were not taking a steroid. Their research was presented this month at the 2024 annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain.

About 1.8%, of 316, of the 17,258 patients who received systemic glucocorticoids (tablets, injections, or infusions) during their hospital stay developed new-onset diabetes, while this happened to only 0.8%, or 3450, of the 434,348 who did not get these drugs, according to an abstract of the EASD presentation.

The median length of stay was 3 days (2-8) for the group of patients who took steroids, compared with 1 day (1-3) in those who did not. Further analysis showed that, when age and sex were factored in, patients receiving systemic glucocorticoids were more than twice as likely (2.6 times) to develop diabetes as those not receiving the treatment, Dr. Golubic said.

This research builds on previous studies that looked at smaller groups of patients and the diabetes risk in patients with specific conditions, including rheumatoid arthritis, Dr. Golubic said. It may prove helpful for clinicians considering when to employ steroids, which are useful medications for managing inflammation associated with many conditions.

“This gives them a very good estimate of how much more likely people treated with systemic glucocorticoids are to develop new-onset diabetes,” Dr. Golubic said.

Glucocorticoids have for decades been used for managing acute and chronic inflammatory diseases. The link to diabetes has been previously reported in smaller studies and in ones linked to specific conditions such as respiratory disease and rheumatoid arthritis.

Carolyn Cummins, PhD, an associate professor at the University of Toronto, Canada, who was not part of this study, told this news organization she was pleased to see a study of diabetes and steroids done with the scope that Dr. Golubic and colleagues undertook. Dr. Cummins in 2022 published an article titled “Fresh insights into glucocorticoid-induced diabetes mellitus and new therapeutic directions” in Nature Reviews Endocrinology. 

“We know that this is an issue, but we didn’t necessarily know numerically how significant it was,” Dr. Cummins said. “I would say it wasn’t a surprising finding, but it’s nice to actually have the numbers from a large study.”

Dr. Golubic and Dr. Cummins reported no relevant financial relationships.
 

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

Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.

This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.

So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.

I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM). This study may be the most comprehensive study yet to go beyond the simple associations between caffeine intake and outcomes, to try to answer the question of how this miraculous substance does what it does.

This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.

AHA/ASA Journals

Dr. F. Perry Wilson

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.

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

Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.

This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.

So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.

I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM). This study may be the most comprehensive study yet to go beyond the simple associations between caffeine intake and outcomes, to try to answer the question of how this miraculous substance does what it does.

This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.

AHA/ASA Journals

Dr. F. Perry Wilson

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.

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

Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.

This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.

So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.

I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM). This study may be the most comprehensive study yet to go beyond the simple associations between caffeine intake and outcomes, to try to answer the question of how this miraculous substance does what it does.

This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.

AHA/ASA Journals

Dr. F. Perry Wilson

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

The Journal of Clinical Endocrinology & Metabolism

Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.

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

MADRID — In spirited presentations at the annual meeting of the European Association for the Study of Diabetes, Louis J. Aronne, MD, of Weill Cornell Medicine in New York City, made a compelling case that the next generation of obesity medications will make bariatric surgery obsolete, and Francesco Rubino, MD, of King’s College London in England, made an equally compelling case that they will not.

In fact, Dr. Rubino predicted that “metabolic” surgery — new nomenclature reflecting the power of surgery to reduce not only obesity, but also other metabolic conditions, over the long term — will continue and could even increase in years to come.
 

‘Medical Treatment Will Dominate’

“Obesity treatment is the superhero of treating metabolic disease because it can defeat all of the bad guys at once, not just one, like the other treatments,” Dr. Aronne told meeting attendees. “If you treat somebody’s cholesterol, you’re just treating their cholesterol, and you may actually increase their risk of developing type 2 diabetes (T2D). You treat their blood pressure, you don’t treat their glucose and you don’t treat their lipids — the list goes on and on and on. But by treating obesity, if you can get enough weight loss, you can get all those things at once.”

He pointed to the SELECT trial, which showed that treating obesity with a glucagon-like peptide 1 receptor agonist reduced major adverse cardiovascular events as well as death from any cause, results in line with those from other modes of treatment for cardiovascular disease (CVD) or lipid lowering, he said. “But we get much more with these drugs, including positive effects on heart failure, chronic kidney disease, and a 73% reduction in T2D. So, we’re now on the verge of a major change in the way we manage metabolic disease.”

Dr. Aronne drew a parallel between treating obesity and the historic way of treating hypertension. Years ago, he said, “we waited too long to treat people. We waited until they had severe hypertension that in many cases was irreversible. What would you prefer to do now for obesity — have the patient lose weight with a medicine that is proven to reduce complications or wait until they develop diabetes, high blood pressure, heart disease and then have them undergo surgery to treat that?”

Looking ahead, “the trend could be to treat obesity before it gets out of hand,” he suggested. Treatment might start in people with a body mass index (BMI) of 27 kg/m², who would be treated to a target BMI of 25. “That’s only a 10% or so change, but our goal would be to keep them in the normal range so they never go above that target. In fact, I think we’re going to be looking at people with severe obesity in a few years and saying, ‘I can’t believe someone didn’t treat that guy earlier.’ What’s going to happen to bariatric surgery if no one gets to a higher weight?”

The plethora of current weight-loss drugs and the large group on the horizon mean that if someone doesn’t respond to one drug, there will be plenty of other choices, Dr. Aronne continued. People will be referred for surgery, but possibly only after they’ve not responded to medical treatment — or just the opposite. “In the United States, it’s much cheaper to have surgery, and I bet the insurance companies are going to make people have surgery before they can get the medicines,” he acknowledged.

A recent report from Morgan Stanley suggests that the global market for the newer weight-loss drugs could increase by 15-fold over the next 5 years as their benefits expand beyond weight loss and that as much as 9% of the US population will be taking the drugs by 2035, Dr. Aronne said, adding that he thinks 9% is an underestimate. By contrast, the number of patients treated by his team’s surgical program is down about 20%.

“I think it’s very clear that medical treatment is going to dominate,” he concluded. “But, it’s also possible that surgery could go up because so many people are going to be coming for medical therapy that we may wind up referring more for surgical therapy.”
 

‘Surgery Is Saving Lives’

Dr. Rubino is convinced that anti-obesity drugs will not make surgery obsolete, “but it will not be business as usual,” he told meeting attendees. “In fact, I think these drugs will expedite a process that is already ongoing — a transformation of bariatric into metabolic surgery.”

“Bariatric surgery will go down in history as one of the biggest missed opportunities that we, as medical professionals, have seen over the past many years,” he said. “It has been shown beyond any doubt to reduce all-cause mortality — in other words, it saves lives,” and it’s also cost effective and improves quality of life. Yet, fewer than 1% of people globally who meet the criteria actually get the surgery.

Many clinicians don’t inform patients about the treatment and don’t refer them for it, he said. “That would be equivalent to having surgery for CVD [cardiovascular disease], cancer, or other important diseases available but not being accessed as they should be.”

A big reason for the dearth of procedures is that people have unrealistic expectations about diet and exercise interventions for weight loss, he said. His team’s survey, presented at the 26th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, showed that 43% of respondents believed diet and exercise was the best treatment for severe obesity (BMI > 35). A more recent survey asked which among several choices was the most effective weight-loss intervention, and again a large proportion “believed wrongly that diet and exercise is most effective — more so than drugs or surgery — despite plenty of evidence that this is not the case.”

In this context, he said, “any surgery, no matter how safe or effective, would never be very popular.” If obesity is viewed as a modifiable risk factor, patients may say they’ll think about it for 6 months. In contrast, “nobody will tell you ‘I will think about it’ if you tell them they need gallbladder surgery to get rid of gallstone pain.”

Although drugs are available to treat obesity, none of them are curative, and if they’re stopped, the weight comes back, Dr. Rubino pointed out. “Efficacy of drugs is measured in weeks or months, whereas efficacy of surgery is measured in decades of durability — in the case of bariatric surgery, 10-20 years. That’s why bariatric surgery will remain an option,” he said. “It’s not just preventing disease, it’s resolving ongoing disease.”

Furthermore, bariatric surgery is showing value for people with established T2D, whereas in the past, it was mainly considered to be a weight-loss intervention for younger, healthier patients, he said. “In my practice, we’re operating more often in people with T2D, even those at higher risk for anesthesia and surgery — eg, patients with heart failure, chronic kidney disease, on dialysis — and we’re still able to maintain the same safety with minimally invasive laparoscopic surgery that we had with healthier patients.”

A vote held at the end of the session revealed that the audience was split about half and half in favor of drugs making bariatric surgery obsolete or not.

“I think we may have to duke it out now,” Dr. Aronne quipped.

Dr. Aronne disclosed being a consultant, speaker, and adviser for and receiving research support from Altimmune, Amgen, AstraZeneca, Eli Lilly, Intellihealth, Janssen, Novo Nordisk, Pfizer, Senda, UnitedHealth Group, Versanis, and others; he has ownership interests in ERX, Intellihealth, Jamieson, Kallyope, Skye Bioscience, Veru, and others; and he is on the board of directors of ERX, Jamieson Wellness, and Intellihealth/FlyteHealth. Dr. Rubino disclosed receiving research and educational grants from Novo Nordisk, Ethicon, and Medtronic; he is on the scientific advisory board/data safety advisory board for Keyron, Morphic Medical, and GT Metabolic Solutions; he receives speaking honoraria from Medtronic, Ethicon, Novo Nordisk, and Eli Lilly; and he is president of the nonprofit Metabolic Health Institute.

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

MADRID — In spirited presentations at the annual meeting of the European Association for the Study of Diabetes, Louis J. Aronne, MD, of Weill Cornell Medicine in New York City, made a compelling case that the next generation of obesity medications will make bariatric surgery obsolete, and Francesco Rubino, MD, of King’s College London in England, made an equally compelling case that they will not.

In fact, Dr. Rubino predicted that “metabolic” surgery — new nomenclature reflecting the power of surgery to reduce not only obesity, but also other metabolic conditions, over the long term — will continue and could even increase in years to come.
 

‘Medical Treatment Will Dominate’

“Obesity treatment is the superhero of treating metabolic disease because it can defeat all of the bad guys at once, not just one, like the other treatments,” Dr. Aronne told meeting attendees. “If you treat somebody’s cholesterol, you’re just treating their cholesterol, and you may actually increase their risk of developing type 2 diabetes (T2D). You treat their blood pressure, you don’t treat their glucose and you don’t treat their lipids — the list goes on and on and on. But by treating obesity, if you can get enough weight loss, you can get all those things at once.”

He pointed to the SELECT trial, which showed that treating obesity with a glucagon-like peptide 1 receptor agonist reduced major adverse cardiovascular events as well as death from any cause, results in line with those from other modes of treatment for cardiovascular disease (CVD) or lipid lowering, he said. “But we get much more with these drugs, including positive effects on heart failure, chronic kidney disease, and a 73% reduction in T2D. So, we’re now on the verge of a major change in the way we manage metabolic disease.”

Dr. Aronne drew a parallel between treating obesity and the historic way of treating hypertension. Years ago, he said, “we waited too long to treat people. We waited until they had severe hypertension that in many cases was irreversible. What would you prefer to do now for obesity — have the patient lose weight with a medicine that is proven to reduce complications or wait until they develop diabetes, high blood pressure, heart disease and then have them undergo surgery to treat that?”

Looking ahead, “the trend could be to treat obesity before it gets out of hand,” he suggested. Treatment might start in people with a body mass index (BMI) of 27 kg/m², who would be treated to a target BMI of 25. “That’s only a 10% or so change, but our goal would be to keep them in the normal range so they never go above that target. In fact, I think we’re going to be looking at people with severe obesity in a few years and saying, ‘I can’t believe someone didn’t treat that guy earlier.’ What’s going to happen to bariatric surgery if no one gets to a higher weight?”

The plethora of current weight-loss drugs and the large group on the horizon mean that if someone doesn’t respond to one drug, there will be plenty of other choices, Dr. Aronne continued. People will be referred for surgery, but possibly only after they’ve not responded to medical treatment — or just the opposite. “In the United States, it’s much cheaper to have surgery, and I bet the insurance companies are going to make people have surgery before they can get the medicines,” he acknowledged.

A recent report from Morgan Stanley suggests that the global market for the newer weight-loss drugs could increase by 15-fold over the next 5 years as their benefits expand beyond weight loss and that as much as 9% of the US population will be taking the drugs by 2035, Dr. Aronne said, adding that he thinks 9% is an underestimate. By contrast, the number of patients treated by his team’s surgical program is down about 20%.

“I think it’s very clear that medical treatment is going to dominate,” he concluded. “But, it’s also possible that surgery could go up because so many people are going to be coming for medical therapy that we may wind up referring more for surgical therapy.”
 

‘Surgery Is Saving Lives’

Dr. Rubino is convinced that anti-obesity drugs will not make surgery obsolete, “but it will not be business as usual,” he told meeting attendees. “In fact, I think these drugs will expedite a process that is already ongoing — a transformation of bariatric into metabolic surgery.”

“Bariatric surgery will go down in history as one of the biggest missed opportunities that we, as medical professionals, have seen over the past many years,” he said. “It has been shown beyond any doubt to reduce all-cause mortality — in other words, it saves lives,” and it’s also cost effective and improves quality of life. Yet, fewer than 1% of people globally who meet the criteria actually get the surgery.

Many clinicians don’t inform patients about the treatment and don’t refer them for it, he said. “That would be equivalent to having surgery for CVD [cardiovascular disease], cancer, or other important diseases available but not being accessed as they should be.”

A big reason for the dearth of procedures is that people have unrealistic expectations about diet and exercise interventions for weight loss, he said. His team’s survey, presented at the 26th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, showed that 43% of respondents believed diet and exercise was the best treatment for severe obesity (BMI > 35). A more recent survey asked which among several choices was the most effective weight-loss intervention, and again a large proportion “believed wrongly that diet and exercise is most effective — more so than drugs or surgery — despite plenty of evidence that this is not the case.”

In this context, he said, “any surgery, no matter how safe or effective, would never be very popular.” If obesity is viewed as a modifiable risk factor, patients may say they’ll think about it for 6 months. In contrast, “nobody will tell you ‘I will think about it’ if you tell them they need gallbladder surgery to get rid of gallstone pain.”

Although drugs are available to treat obesity, none of them are curative, and if they’re stopped, the weight comes back, Dr. Rubino pointed out. “Efficacy of drugs is measured in weeks or months, whereas efficacy of surgery is measured in decades of durability — in the case of bariatric surgery, 10-20 years. That’s why bariatric surgery will remain an option,” he said. “It’s not just preventing disease, it’s resolving ongoing disease.”

Furthermore, bariatric surgery is showing value for people with established T2D, whereas in the past, it was mainly considered to be a weight-loss intervention for younger, healthier patients, he said. “In my practice, we’re operating more often in people with T2D, even those at higher risk for anesthesia and surgery — eg, patients with heart failure, chronic kidney disease, on dialysis — and we’re still able to maintain the same safety with minimally invasive laparoscopic surgery that we had with healthier patients.”

A vote held at the end of the session revealed that the audience was split about half and half in favor of drugs making bariatric surgery obsolete or not.

“I think we may have to duke it out now,” Dr. Aronne quipped.

Dr. Aronne disclosed being a consultant, speaker, and adviser for and receiving research support from Altimmune, Amgen, AstraZeneca, Eli Lilly, Intellihealth, Janssen, Novo Nordisk, Pfizer, Senda, UnitedHealth Group, Versanis, and others; he has ownership interests in ERX, Intellihealth, Jamieson, Kallyope, Skye Bioscience, Veru, and others; and he is on the board of directors of ERX, Jamieson Wellness, and Intellihealth/FlyteHealth. Dr. Rubino disclosed receiving research and educational grants from Novo Nordisk, Ethicon, and Medtronic; he is on the scientific advisory board/data safety advisory board for Keyron, Morphic Medical, and GT Metabolic Solutions; he receives speaking honoraria from Medtronic, Ethicon, Novo Nordisk, and Eli Lilly; and he is president of the nonprofit Metabolic Health Institute.

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

MADRID — In spirited presentations at the annual meeting of the European Association for the Study of Diabetes, Louis J. Aronne, MD, of Weill Cornell Medicine in New York City, made a compelling case that the next generation of obesity medications will make bariatric surgery obsolete, and Francesco Rubino, MD, of King’s College London in England, made an equally compelling case that they will not.

In fact, Dr. Rubino predicted that “metabolic” surgery — new nomenclature reflecting the power of surgery to reduce not only obesity, but also other metabolic conditions, over the long term — will continue and could even increase in years to come.
 

‘Medical Treatment Will Dominate’

“Obesity treatment is the superhero of treating metabolic disease because it can defeat all of the bad guys at once, not just one, like the other treatments,” Dr. Aronne told meeting attendees. “If you treat somebody’s cholesterol, you’re just treating their cholesterol, and you may actually increase their risk of developing type 2 diabetes (T2D). You treat their blood pressure, you don’t treat their glucose and you don’t treat their lipids — the list goes on and on and on. But by treating obesity, if you can get enough weight loss, you can get all those things at once.”

He pointed to the SELECT trial, which showed that treating obesity with a glucagon-like peptide 1 receptor agonist reduced major adverse cardiovascular events as well as death from any cause, results in line with those from other modes of treatment for cardiovascular disease (CVD) or lipid lowering, he said. “But we get much more with these drugs, including positive effects on heart failure, chronic kidney disease, and a 73% reduction in T2D. So, we’re now on the verge of a major change in the way we manage metabolic disease.”

Dr. Aronne drew a parallel between treating obesity and the historic way of treating hypertension. Years ago, he said, “we waited too long to treat people. We waited until they had severe hypertension that in many cases was irreversible. What would you prefer to do now for obesity — have the patient lose weight with a medicine that is proven to reduce complications or wait until they develop diabetes, high blood pressure, heart disease and then have them undergo surgery to treat that?”

Looking ahead, “the trend could be to treat obesity before it gets out of hand,” he suggested. Treatment might start in people with a body mass index (BMI) of 27 kg/m², who would be treated to a target BMI of 25. “That’s only a 10% or so change, but our goal would be to keep them in the normal range so they never go above that target. In fact, I think we’re going to be looking at people with severe obesity in a few years and saying, ‘I can’t believe someone didn’t treat that guy earlier.’ What’s going to happen to bariatric surgery if no one gets to a higher weight?”

The plethora of current weight-loss drugs and the large group on the horizon mean that if someone doesn’t respond to one drug, there will be plenty of other choices, Dr. Aronne continued. People will be referred for surgery, but possibly only after they’ve not responded to medical treatment — or just the opposite. “In the United States, it’s much cheaper to have surgery, and I bet the insurance companies are going to make people have surgery before they can get the medicines,” he acknowledged.

A recent report from Morgan Stanley suggests that the global market for the newer weight-loss drugs could increase by 15-fold over the next 5 years as their benefits expand beyond weight loss and that as much as 9% of the US population will be taking the drugs by 2035, Dr. Aronne said, adding that he thinks 9% is an underestimate. By contrast, the number of patients treated by his team’s surgical program is down about 20%.

“I think it’s very clear that medical treatment is going to dominate,” he concluded. “But, it’s also possible that surgery could go up because so many people are going to be coming for medical therapy that we may wind up referring more for surgical therapy.”
 

‘Surgery Is Saving Lives’

Dr. Rubino is convinced that anti-obesity drugs will not make surgery obsolete, “but it will not be business as usual,” he told meeting attendees. “In fact, I think these drugs will expedite a process that is already ongoing — a transformation of bariatric into metabolic surgery.”

“Bariatric surgery will go down in history as one of the biggest missed opportunities that we, as medical professionals, have seen over the past many years,” he said. “It has been shown beyond any doubt to reduce all-cause mortality — in other words, it saves lives,” and it’s also cost effective and improves quality of life. Yet, fewer than 1% of people globally who meet the criteria actually get the surgery.

Many clinicians don’t inform patients about the treatment and don’t refer them for it, he said. “That would be equivalent to having surgery for CVD [cardiovascular disease], cancer, or other important diseases available but not being accessed as they should be.”

A big reason for the dearth of procedures is that people have unrealistic expectations about diet and exercise interventions for weight loss, he said. His team’s survey, presented at the 26th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, showed that 43% of respondents believed diet and exercise was the best treatment for severe obesity (BMI > 35). A more recent survey asked which among several choices was the most effective weight-loss intervention, and again a large proportion “believed wrongly that diet and exercise is most effective — more so than drugs or surgery — despite plenty of evidence that this is not the case.”

In this context, he said, “any surgery, no matter how safe or effective, would never be very popular.” If obesity is viewed as a modifiable risk factor, patients may say they’ll think about it for 6 months. In contrast, “nobody will tell you ‘I will think about it’ if you tell them they need gallbladder surgery to get rid of gallstone pain.”

Although drugs are available to treat obesity, none of them are curative, and if they’re stopped, the weight comes back, Dr. Rubino pointed out. “Efficacy of drugs is measured in weeks or months, whereas efficacy of surgery is measured in decades of durability — in the case of bariatric surgery, 10-20 years. That’s why bariatric surgery will remain an option,” he said. “It’s not just preventing disease, it’s resolving ongoing disease.”

Furthermore, bariatric surgery is showing value for people with established T2D, whereas in the past, it was mainly considered to be a weight-loss intervention for younger, healthier patients, he said. “In my practice, we’re operating more often in people with T2D, even those at higher risk for anesthesia and surgery — eg, patients with heart failure, chronic kidney disease, on dialysis — and we’re still able to maintain the same safety with minimally invasive laparoscopic surgery that we had with healthier patients.”

A vote held at the end of the session revealed that the audience was split about half and half in favor of drugs making bariatric surgery obsolete or not.

“I think we may have to duke it out now,” Dr. Aronne quipped.

Dr. Aronne disclosed being a consultant, speaker, and adviser for and receiving research support from Altimmune, Amgen, AstraZeneca, Eli Lilly, Intellihealth, Janssen, Novo Nordisk, Pfizer, Senda, UnitedHealth Group, Versanis, and others; he has ownership interests in ERX, Intellihealth, Jamieson, Kallyope, Skye Bioscience, Veru, and others; and he is on the board of directors of ERX, Jamieson Wellness, and Intellihealth/FlyteHealth. Dr. Rubino disclosed receiving research and educational grants from Novo Nordisk, Ethicon, and Medtronic; he is on the scientific advisory board/data safety advisory board for Keyron, Morphic Medical, and GT Metabolic Solutions; he receives speaking honoraria from Medtronic, Ethicon, Novo Nordisk, and Eli Lilly; and he is president of the nonprofit Metabolic Health Institute.

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

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

This transcript has been edited for clarity.

I’d like to talk about a recent report in the journal Menopause linking menopausal symptoms to increased risk for cognitive impairment. I’d also like to discuss some of the recent studies that have addressed whether hot flashes are linked to increased risk for heart disease and other forms of cardiovascular disease (CVD). 

Given that 75%-80% of perimenopausal and postmenopausal women have hot flashes and vasomotor symptoms, it’s undoubtedly a more complex relationship between hot flashes and these outcomes than a simple one-size-fits-all, yes-or-no question.

Increasing evidence shows that several additional factors are important, including the age at which the symptoms are occurring, the time since menopause, the severity of the symptoms, whether they co-occur with night sweats and sleep disruption, and the cardiovascular status of the woman.

Several studies suggest that women who have more severe hot flashes and vasomotor symptoms are more likely to have prevalent cardiovascular risk factors — hypertension, dyslipidemia, high body mass index, endothelial dysfunction — as measured by flow-mediated vasodilation and other measures.

It is quite plausible that hot flashes could be a marker for increased risk for cognitive impairment. But the question remains, are hot flashes associated with cognitive impairment independent of these other risk factors? It appears that the associations between hot flashes, vasomotor symptoms, and CVD, and other adverse outcomes, may be more likely when hot flashes persist after age 60 or are newly occurring in later menopause. In the Women’s Health Initiative observational study, the presence of hot flashes and vasomotor symptoms in early menopause was not linked to any increased risk for heart attack, stroke, total CVD, or all-cause mortality.

However, the onset of these symptoms, especially new onset of these symptoms after age 60 or in later menopause, was in fact linked to increased risk for CVD and all-cause mortality. With respect to cognitive impairment, if a woman is having hot flashes and night sweats with regular sleep disruption, performance on cognitive testing would not be as favorable as it would be in the absence of these symptoms.

This brings us to the new study in Menopause that included approximately 1300 Latino women in nine Latin American countries, with an average age of 55 years. Looking at the association between severe menopausal symptoms and cognitive impairment, researchers found that women with severe symptoms were more likely to have cognitive impairment.

Conversely, they found that the women who had a favorable CVD risk factor status (physically active, lower BMI, healthier) and were ever users of estrogen were less likely to have cognitive impairment.

Clearly, for estrogen therapy, we need randomized clinical trials of the presence or absence of vasomotor symptoms and cognitive and CVD outcomes. Such analyses are ongoing, and new randomized trials focused specifically on women in early menopause would be very beneficial.

At the present time, it’s important that we not alarm women about the associations seen in some of these studies because often they are not independent associations; they aren’t independent of other risk factors that are commonly linked to hot flashes and night sweats. There are many other complexities in the relationship between hot flashes and cognitive impairment.

We need to appreciate that women who have moderate to severe hot flashes (especially when associated with disrupted sleep) do have impaired quality of life. It’s important to treat these symptoms, especially in early menopause, and very effective hormonal and nonhormonal treatments are available.

For women with symptoms that persist into later menopause or who have new onset of symptoms in later menopause, it’s important to prioritize cardiovascular health. For example, be more vigilant about behavioral lifestyle counseling to lower risk, and be even more aggressive in treating dyslipidemia and diabetes.

JoAnn E. Manson, Professor of Medicine and the Michael and Lee Bell Professor of Women’s Health, Harvard Medical School; Chief, Division of Preventive Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and Past President, North American Menopause Society, 2011-2012, has disclosed the following relevant financial relationships: Received study pill donation and infrastructure support from Mars Symbioscience (for the COSMOS trial).

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

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.