Cardiology News

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

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

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

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

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

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

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

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

In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.

This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case, encounters with a lack of knowledge about type 1 diabetes in healthcare settings are quite common, sometimes resulting in serious adverse consequences.

In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.

Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.

As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.

Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
 

We Need Insulin 24/7

Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.

This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.

On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.

The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
 

Fasting Is Fraught

I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.

Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.

“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.

If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.

But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.

But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.

When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.

Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
 

We Don’t React Well to Steroids

If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.

Procedures Can Be Pesky

People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.

Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.

In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.

Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.

Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
 

Duh, We Already Have Diabetes

I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.

But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.

I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.

In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.

Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.

In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.

This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case, encounters with a lack of knowledge about type 1 diabetes in healthcare settings are quite common, sometimes resulting in serious adverse consequences.

In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.

Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.

As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.

Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
 

We Need Insulin 24/7

Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.

This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.

On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.

The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
 

Fasting Is Fraught

I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.

Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.

“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.

If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.

But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.

But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.

When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.

Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
 

We Don’t React Well to Steroids

If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.

Procedures Can Be Pesky

People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.

Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.

In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.

Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.

Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
 

Duh, We Already Have Diabetes

I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.

But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.

I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.

In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.

Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.

In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.

This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case, encounters with a lack of knowledge about type 1 diabetes in healthcare settings are quite common, sometimes resulting in serious adverse consequences.

In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.

Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.

As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.

Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
 

We Need Insulin 24/7

Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.

This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.

On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.

The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
 

Fasting Is Fraught

I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.

Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.

“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.

If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.

But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.

But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.

When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.

Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
 

We Don’t React Well to Steroids

If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.

Procedures Can Be Pesky

People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.

Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.

In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.

Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.

Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
 

Duh, We Already Have Diabetes

I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.

But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.

I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.

In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.

Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
 

Safeguarding the Public

Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?

There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.

In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.

Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.

“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.

Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.

The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.

The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.

Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.

Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”

In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.

StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.

In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”

The FDA website explained what Medtronic was doing about it.

“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.

In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”

Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.

“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”

“That’s kind of a strange solution,” he said.

The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”

That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.

In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”

In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.

In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.

“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”

In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.

“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.

The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.

Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.

The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.

In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.

During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.

But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”

“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”

Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.

“There is no question that we would have liked to have solved these issues in full much earlier,” she said.

As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.

“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
 

‘Known Possible Complications’

Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.

Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.

The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”

In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.

Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”

Years later, something similar happened.

In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”

The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.

The patient “coded” the next day and died from an aortic bleed, the report said.

In the report to the FDA, the manufacturer blamed “case-specific circumstances.”

“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”

The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”

Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.

As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.

“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.

“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.

Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.

“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.

Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”

KFF Health News data editor Holly K. Hacker contributed to this report.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

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

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

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

People over age 60 who drink alcohol regularly are at an increased risk of early death, particularly from cancer or issues related to the heart and blood vessels.

That’s according to the findings of a new, large study that was published in JAMA Network Openand build upon numerous other recent studies concluding that any amount of alcohol consumption is linked to significant health risks. That’s a change from decades of public health messaging suggesting that moderate alcohol intake (one or two drinks per day) wasn’t dangerous. Recently, experts have uncovered flaws in how researchers came to those earlier conclusions.

In this latest study, researchers in Spain analyzed health data for more than 135,000 people, all of whom were at least 60 years old, lived in the United Kingdom, and provided their health information to the UK Biobank database. The average age of people at the start of the analysis period was 64.

The researchers compared 12 years of health outcomes for occasional drinkers with those who averaged drinking at least some alcohol on a daily basis. The greatest health risks were seen between occasional drinkers and those whom the researchers labeled “high risk.” Occasional drinkers had less than about two drinks per week. The high-risk group included men who averaged nearly three drinks per day or more, and women who averaged about a drink and a half per day or more. The analysis showed that, compared with occasional drinking, high-risk drinking was linked to a 33% increased risk of early death, a 39% increased risk of dying from cancer, and a 21% increased risk of dying from problems with the heart and blood vessels.

More moderate drinking habits were also linked to an increased risk of early death and dying from cancer, and even just averaging about one drink or less daily was associated with an 11% higher risk of dying from cancer. Low and moderate drinkers were most at risk if they also had health problems or experienced socioeconomic factors like living in less affluent neighborhoods.

The findings also suggested the potential that mostly drinking wine, or drinking mostly with meals, may be lower risk, but the researchers called for further study on those topics since “it may mostly reflect the effect of healthier lifestyles, slower alcohol absorption, or nonalcoholic components of beverages.”

A recent Gallup poll showed that overall, Americans’ attitudes toward the health impacts of alcohol are changing, with 65% of young adults (ages 18-34) saying that drinking can have negative health effects. But just 39% of adults age 55 or older agreed that drinking is bad for a person’s health. The gap in perspectives between younger and older adults about drinking is the largest on record, Gallup reported.

The study investigators reported no conflicts of interest.

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

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

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

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

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

At least 25% of unresponsive patients with a disorder of consciousness show signs of brain activity, an estimate that is higher than previous studies suggest.

“We found that at least 1 in 4 patients who are unresponsive to commands might actually be quite present and highly cognitive,” said study investigator Nicholas D. Schiff, MD, Feil Family Brain & Mind Research Institute and Department of Neurology, Weill Cornell Medicine, Rockefeller University Hospital, New York.

“In other words, if you go to the bedside and carefully examine someone with a severe brain injury and find no evidence of responsiveness, no one has been able to give you an a priori number to say how likely you are to be wrong in thinking this person is actually unaware, not processing language, and not capable of high-level cognitive work. And the answer to that now is at least 1 in 4 times.”

The findings were published online in The New England Journal of Medicine.
 

Clinical Implications? 

Cognitive motor dissociation (CMD) is a condition whereby patients with a severe brain injury who are unresponsive to commands at the bedside show brain activity on functional MRI (fMRI) or electroencephalography (EEG) when presented with selective motor imagery commands, such as “imagine playing tennis,” or “ imagine opening and closing your hand.”

Previous research shows that CMD is present in 10%-20% of people with a disorder of consciousness, a rate similar to that in patients with acute or chronic brain injury.

Understanding that a patient who appears unconscious has signs of cognitive processing could change the way clinicians and family interact with such individuals. Unresponsive patients who are aware may eventually be able to harness emerging communication technologies such as brain-computer interfaces.

In addition, knowing an individual’s CMD status could aid in prognosis. “We know from one study that there’s a four times increased likelihood that patients will be independent in a year in their function if they have cognitive motor dissociation,” said Dr. Schiff.

Unlike most previous studies of CMD, which were conducted at single sites and had relatively small cohorts, this new study included 353 adults with a disorder of consciousness (mean age, 37.9 years; 64% male) at six multinational sites.

Participants were recruited using a variety of methods, including consecutive enrollment of critically ill patients in the intensive care unit and enrollment of those with chronic illness or injury who were in the postacute phase of brain injury.
 

Response to Commands

Study participants were at different stages of recovery from an acute brain injury that had occurred an average of 8 months before the study started.

To determine the presence or absence of an observable response to commands among participants, trained staff used the Coma Recovery Scale–Revised (CRS-R); scores on this instrument range from 0 to 23, and higher scores indicate better neurobehavioral function.

About 40% of individuals were diagnosed with coma or vegetative state, 29% with minimally conscious state–minus, and 22% with minimally conscious state–plus. In all, 10% had emerged from a minimally conscious state.

Researchers assessed response to timed and repeated commands using fMRI or EEG in participants without an observable response to verbal commands, including those with a behavioral diagnosis of coma, vegetative state, or minimally conscious state–minus, and in participants with an observable response to verbal commands.

Of the 353 study participants, 61% underwent at least one fMRI assessment and 74% at least one EEG assessment. Both fMRI and EEG were performed in 35% of participants.

Dr. Schiff explained the two assessment types provide slightly different information, in that they measuring different types of brain signals. He also noted that although “every medical center in the world” has EEG, many do not have fMRI.

The brain imaging assessments captured brain activity within the motor area of the frontal cortex when tasked with motor imagery.

Of the 241 participants deemed to be in a coma or vegetative state or minimally conscious state–minus on the basis of CRS-R score, 60 (25%) had a response to commands on task-based fMRI, task-based EEG, or both.

The percentage of participants with CMD varied across study sites, from 2% to 45%, but Dr. Schiff said the reason for this is unclear. 

The proportion of participants with CMD may have been even higher if all individuals had been assessed with both imaging techniques, he said.
 

Higher Rate of Awareness Than in Previous Research

The investigators noted that the percentage of participants with CMD in their study was up to 10 percentage points higher than in previous studies. This may be due to the multimodal approach that classified participants undergoing assessment with both fMRI and EEG on the basis of responses on either technique, they said. 

The median age was lower among participants with CMD than those without CMD (30.5 years vs 45.3 years).

Compared with participants without CMD, a higher percentage of those with such dissociation had brain trauma as an etiologic factor (65% vs 38%) and a diagnosis of minimally conscious state–minus on the CRS-R (53% vs 38%).

Among people with CMD, 18% were assessed with fMRI only, 22% with EEG only, and 60% with both fMRI and EEG.

Dr. Schiff noted that the use of both fMRI and EEG appears to be more sensitive in detecting brain activity during tasks compared with use of one of these techniques alone.

Of the 112 participants with a diagnosis of minimally conscious state–plus or who had emerged from the minimally conscious state, 38% had a response to commands on task-based fMRI, task-based EEG, or both. Among these participants, 23% were assessed with fMRI only, 19% with EEG only, and 58% with both fMRI and EEG.

Research shows “it’s very clear that people with severe brain injury continue to get better over time,” noted Dr. Schiff. “Every month and week matters, and so it probably is the case that a lot of these patients are picking up the level of recovery, and the later we go out to measure them, the more likely we are to find people who are CMD than not.”

These new results should prompt further study to explore whether detection of CMD can lead to improved outcomes, the investigators noted. “In addition, the standardization, validation, and simplification of task-based fMRI and EEG methods that are used to detect cognitive motor dissociation are needed to prompt widespread clinical integration of these techniques and investigation of the bioethical implications of the findings.”

All study participants with chronic brain injury had survived their initial illness or injury and had access to a research facility with advanced fMRI and EEG capabilities. “This survival bias may reflect greater cognitive reserve and resilience over time among the participants. As such, the results of our study may not be generalizable to the overall population of patients with cognitive motor dissociation,” the investigators wrote.

Another study limitation was that participating sites used heterogeneous strategies to acquire, analyze, and interpret data, which led to differences in the number, type, and ordering of the cognitive tasks assessed on fMRI and EEG.

“These differences, along with variations in recruitment strategies and participant characteristics, may have contributed to the unequal percentage of participants with cognitive motor dissociation observed at each site. Our findings may therefore not be generalizable across all centers,” the researchers wrote. 

Only a few academic medical centers have the specially trained personnel and techniques needed to assess patients for CMD — which, the researchers noted, limits the feasibility of performing these assessments in general practice.
 

Challenging Research

Commenting on the research, Aarti Sarwal, MD, professor of neurology and section chief, Neurocritical Care, Virginia Commonwealth University, Richmond, Virginia, noted that this was a “very challenging” study to perform, given that only a few academic centers are equipped to perform both fMRI and quantitative EEG analysis.

“In general, finding patients this far out, who have access to clinical, radiological, and electrophysiological testing and were provided good care enough to receive these, is a mammoth task in itself.” 

Dr. Sarwal said the study builds on efforts of the Curing Coma campaign , a clinical, scientific, and public health effort of the Neurocritical Care Society to tackle the concept of coma as a treatable medical entity.

“It continues to highlight the challenges of prognostication in acute brain injured patients by showing a higher presence of cognitive function than previously perceived,” she said.

Dr. Sarwal believes that the study’s largest impact is underscoring the need for more research into understanding the degree and quality of cognitive processing in patients with a disorder of consciousness. But it also underlines the need for a “healthy debate” on the cost/benefit analysis of pursuing such research, given the limited number of patients with access to resources. 

“This debate needs to include the caregivers and families outside the traditional realms of stakeholders overseeing the science.” 

Although communication with comatose patients is still “a ways away,” this research is “a step in the right direction,” said Dr. Sarwal. 

The study was funded by the James S. McDonnell Foundation and others. Dr. Schiff and Dr. Sarwal report no relevant financial disclosures.
 

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

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

What if a drug could help you live a longer, healthier life?

Scientists at the University of Connecticut are working on it. In a new study in Cell Metabolism, researchers described how to target specific cells to extend the lifespan and improve the health of mice late in life.

The study builds on a growing body of research, mostly in animals, testing interventions to slow aging and prolong health span, the length of time that one is not just alive but also healthy.

“Aging is the most important risk factor for every disease that we deal with in adult human beings,” said cardiologist Douglas Vaughan, MD, director of the Potocsnak Longevity Institute at Northwestern University’s Feinberg School of Medicine, Chicago. (Dr. Vaughan was not involved in the new study.) “So the big hypothesis is: If we could slow down aging just a little bit, we can push back the onset of disease.”

As we age, our cells wear out. It’s called cellular senescence — a state of irreversible cell cycle arrest — and it’s increasingly recognized as a key contributor to aging.

Senescent cells — or “zombie cells” — secrete harmful substances that disrupt tissue functioning. They’ve been linked to chronic inflammation, tissue damage, and the development of age-related diseases.

Senescence can be characterized by the accumulation of cells with high levels of specific markers like p21, or p21^high cells. Almost any cell can become a p21^high cell, and they accumulate with age, said Ming Xu, PhD, a professor at the UConn Center on Aging, UConn Health, Farmington, Connecticut, who led the study.

By targeting and eliminating p21^high senescent cells, Dr. Xu hopes to develop novel therapies that might help people live longer and enjoy more years in good health.

Such a treatment could be ready for human trials in 2-5 years, Dr. Xu said.
 

What the Researchers Did

Xu and colleagues used genetic engineering to eliminate p21^high cells in mice, introducing into their genome something they describe as an inducible “suicide gene.” Giving the mice a certain drug (a low dose of tamoxifen) activated the suicide gene in all p21^high cells, causing them to die. Administering this treatment once a month, from age 20 months (older age) until the end of life, significantly extended the rodents’ lifespan, reduced inflammation, and decreased gene activity linked to aging.

Treated mice lived, on average, for 33 months — 3 months longer than the untreated mice. The oldest treated mouse lived to 43 months — roughly 130 in human years.

But the treated mice didn’t just live longer; they were also healthier. In humans, walking speed and grip strength can be clues of overall health and vitality. The old, treated mice were able to walk faster and grip objects with greater strength than untreated mice of the same age.

Dr. Xu’s lab is now testing drugs that target p21^high cells in hopes of finding one that would work in humans. Leveraging immunotherapy technology to target these cells could be another option, Dr. Xu said.

The team also plans to test whether eliminating p21^high cells could prevent or alleviate diabetes or Alzheimer’s disease.
 

Challenges and Criticisms

The research provides “important evidence that targeting senescence and the molecular components of that pathway might provide some benefit in the long term,” Dr. Vaughan said.

But killing senescent cells could come with downsides.

“Senescence protects us from hyperproliferative responses,” potentially blocking cells from becoming malignant, Dr. Vaughan said. “There’s this effect on aging that is desirable, but at the same time, you may enhance your risk of cancer or malignancy or excessive proliferation in some cells.”

And of course, we don’t necessarily need drugs to prolong healthy life, Dr. Vaughan pointed out.

For many people, a long healthy life is already within reach. Humans live longer on average than they used to, and simple lifestyle choices — nourishing your body well, staying active, and maintaining a healthy weight — can increase one’s chances of good health.

The most consistently demonstrated intervention for extending lifespan “in almost every animal species is caloric restriction,” Dr. Vaughan said. (Dr. Xu’s team is also investigating whether fasting and exercise can lead to a decrease in p21^high cells.)

As for brain health, Dr. Vaughan and colleagues at Northwestern are studying “super agers,” people who are cognitively intact into their 90s.

“The one single thing that they found that contributes to that process, and contributes to that success, is really a social network and human bonds and interaction,” Dr. Vaughan said.

A version of this article appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

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 appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

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 appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

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 appeared on Medscape.com.