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FDA Initiative Aims to Improve Diversity in Clinical Trials

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Changed
Mon, 09/23/2024 - 09:45

— Underrepresentation by gender and race in major clinical trials has been a cause for complaint for decades, but the Food and Drug Administration (FDA) has drafted a regulatory solution to this issue expected to be implemented sometime in 2025.

This initiative, known as the FDA’s Diversity Action Plan (DAP), will require plans for all pivotal and phase 3 trials to provide details in their design of how diversity will be achieved or, if there are no plans for diversity, the reason why, according to Valerie M. Harvey, MD, MPH, associate clinical professor, Edward Via College of Osteopathic Medicine, Blacksburg, Virginia. These rules will be codified, she said at the 2024 Skin of Color Update.

Once the DAP is enacted, “the sponsor must specify the rationale and goals for study enrollment by age, ethnicity, sex, and race,” she said. Furthermore, the submission to the FDA must “describe the methods to meet the diversity benchmarks.”
 

Lack of Trial Diversity Is Common Across Medicine

Although she focused on the relevance of this initiative to dermatology, Dr. Harvey said the lack of diversity in clinical trials is pervasive throughout medicine. In one survey of randomized controlled trials, less than 60% of trials even specified the race and ethnicity of the participants. In recent psoriasis trials, only 30% met a diversity definition of ≥ 20% of patients identifying as minority (Black, Hispanic, Asian, or other non-White group), said Dr. Harvey, who practices dermatology in Newport News, Virginia.

The FDA draft guidance for the DAP was released in June 2024 and is now available for submitting comments (until September 26). The plan is expected to be published in June 2025, according to Dr. Harvey. It will pertain to all pivotal and phase 3 trials enrolling 180 days after the publication date and will be relevant to all drugs and biologics as well as certain devices.

This initiative could be a critical step toward ensuring diversity in major clinical trials after years of stagnation, Dr. Harvey said, noting that despite repeated calls for more diversity in clinical trials, the literature suggests “little progress.”

However, she said that increasing diversity in clinical trials is just one step toward gathering data about the generalizability of efficacy and safety across racial and ethnic groups. A much more complex issue involves how race and ethnicity are defined in order to understand differences, if any, for efficacy and risk.

“Race is a dynamic social construct and a poor measure for biologic variation and skin color,” Dr. Harvey said. This means that work is needed to address the more complex issue of race and ethnicity stratification that will help clinicians understand the relative benefits and risks for the drugs in these trials.

Rather than differences based on genetic or other sources of biologic differences, she said, outcomes by race alone are often suspected of reflecting disparities in access to healthcare rather than a difference in therapeutic response.
 

Skin Color Is Inadequate to Define Race

When stratifying patients by race or ethnicity, Dr. Harvey said that “we have to be very, very careful in considering the study purpose and what the study question is.” A study attempting to compare benefits and risks among subgroups by race or ethnicity will require descriptors beyond skin color.

The recognized limitations of measuring skin tone as a surrogate of race are one reason for widespread interest in moving away from the Fitzpatrick skin type (FST) rating that has been widely considered a standard, according to Dr. Harvey. Several alternatives have been proposed, including the Monk Skin Tone Scale, the Individual Typology Angle, and the Eumelanin Human Skin Color Scale, but she cautioned that these are less well validated and generally have the limitations of the FST.

If skin color was ever useful for grouping individuals on the basis of shared physiology, growing rates of intermarriage and immigration have made skin color increasingly irrelevant to racial identity. If the goal is to evaluate the safety and efficacy of drugs across racial groups and ethnicities, the characterization of populations will almost certainly require multiple descriptors and biomarkers, she said.

“It is very important to have many tools for characterizing patients by skin type,” Susan Taylor, MD, professor of dermatology and vice chair for diversity, equity, and inclusion for the Department of Dermatology, University of Pennsylvania, Philadelphia, said in an interview at the meeting.

The reason is “there are limitations to all of them,” she said, noting also that the questions being asked about how and if skin color and race are relevant to therapeutic options differ by the question, such as innate response or access to care.

Dr. Taylor is part of a workshop that she said is evaluating a combination of instruments for characterizing skin color and race in ways relevant to the specific question being asked.

The solutions might differ. While simple clinical assessments involving skin color might be made with methods captured on a smartphone app, Dr. Taylor acknowledged that far more complex tools might be required to document the effect of racial or ethnic differences in drug efficacy and safety in a research setting.

Outside of a research setting, any tools that might be useful for assessing race as a variable must be practical, according to Dr. Harvey. She suggested that these must be time efficient, of reasonable cost, and most importantly, reliable.

Tools meeting these criteria do not currently exist, but Dr. Harvey said the work is underway. She expects a “top-down” collaborative approach to validate alternatives to the FST. If such tools can be developed with buy-in from the FDA, they might be particularly useful for translating trial data to patient care, she added.

Dr. Harvey reported financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Johnson & Johnson, L’Oréal, and SkinCeuticals. Dr. Taylor, president-elect of the American Academy of Dermatology, reported financial relationships with more than 25 pharmaceutical and cosmetic companies.

A version of this article appeared on Medscape.com.

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— Underrepresentation by gender and race in major clinical trials has been a cause for complaint for decades, but the Food and Drug Administration (FDA) has drafted a regulatory solution to this issue expected to be implemented sometime in 2025.

This initiative, known as the FDA’s Diversity Action Plan (DAP), will require plans for all pivotal and phase 3 trials to provide details in their design of how diversity will be achieved or, if there are no plans for diversity, the reason why, according to Valerie M. Harvey, MD, MPH, associate clinical professor, Edward Via College of Osteopathic Medicine, Blacksburg, Virginia. These rules will be codified, she said at the 2024 Skin of Color Update.

Once the DAP is enacted, “the sponsor must specify the rationale and goals for study enrollment by age, ethnicity, sex, and race,” she said. Furthermore, the submission to the FDA must “describe the methods to meet the diversity benchmarks.”
 

Lack of Trial Diversity Is Common Across Medicine

Although she focused on the relevance of this initiative to dermatology, Dr. Harvey said the lack of diversity in clinical trials is pervasive throughout medicine. In one survey of randomized controlled trials, less than 60% of trials even specified the race and ethnicity of the participants. In recent psoriasis trials, only 30% met a diversity definition of ≥ 20% of patients identifying as minority (Black, Hispanic, Asian, or other non-White group), said Dr. Harvey, who practices dermatology in Newport News, Virginia.

The FDA draft guidance for the DAP was released in June 2024 and is now available for submitting comments (until September 26). The plan is expected to be published in June 2025, according to Dr. Harvey. It will pertain to all pivotal and phase 3 trials enrolling 180 days after the publication date and will be relevant to all drugs and biologics as well as certain devices.

This initiative could be a critical step toward ensuring diversity in major clinical trials after years of stagnation, Dr. Harvey said, noting that despite repeated calls for more diversity in clinical trials, the literature suggests “little progress.”

However, she said that increasing diversity in clinical trials is just one step toward gathering data about the generalizability of efficacy and safety across racial and ethnic groups. A much more complex issue involves how race and ethnicity are defined in order to understand differences, if any, for efficacy and risk.

“Race is a dynamic social construct and a poor measure for biologic variation and skin color,” Dr. Harvey said. This means that work is needed to address the more complex issue of race and ethnicity stratification that will help clinicians understand the relative benefits and risks for the drugs in these trials.

Rather than differences based on genetic or other sources of biologic differences, she said, outcomes by race alone are often suspected of reflecting disparities in access to healthcare rather than a difference in therapeutic response.
 

Skin Color Is Inadequate to Define Race

When stratifying patients by race or ethnicity, Dr. Harvey said that “we have to be very, very careful in considering the study purpose and what the study question is.” A study attempting to compare benefits and risks among subgroups by race or ethnicity will require descriptors beyond skin color.

The recognized limitations of measuring skin tone as a surrogate of race are one reason for widespread interest in moving away from the Fitzpatrick skin type (FST) rating that has been widely considered a standard, according to Dr. Harvey. Several alternatives have been proposed, including the Monk Skin Tone Scale, the Individual Typology Angle, and the Eumelanin Human Skin Color Scale, but she cautioned that these are less well validated and generally have the limitations of the FST.

If skin color was ever useful for grouping individuals on the basis of shared physiology, growing rates of intermarriage and immigration have made skin color increasingly irrelevant to racial identity. If the goal is to evaluate the safety and efficacy of drugs across racial groups and ethnicities, the characterization of populations will almost certainly require multiple descriptors and biomarkers, she said.

“It is very important to have many tools for characterizing patients by skin type,” Susan Taylor, MD, professor of dermatology and vice chair for diversity, equity, and inclusion for the Department of Dermatology, University of Pennsylvania, Philadelphia, said in an interview at the meeting.

The reason is “there are limitations to all of them,” she said, noting also that the questions being asked about how and if skin color and race are relevant to therapeutic options differ by the question, such as innate response or access to care.

Dr. Taylor is part of a workshop that she said is evaluating a combination of instruments for characterizing skin color and race in ways relevant to the specific question being asked.

The solutions might differ. While simple clinical assessments involving skin color might be made with methods captured on a smartphone app, Dr. Taylor acknowledged that far more complex tools might be required to document the effect of racial or ethnic differences in drug efficacy and safety in a research setting.

Outside of a research setting, any tools that might be useful for assessing race as a variable must be practical, according to Dr. Harvey. She suggested that these must be time efficient, of reasonable cost, and most importantly, reliable.

Tools meeting these criteria do not currently exist, but Dr. Harvey said the work is underway. She expects a “top-down” collaborative approach to validate alternatives to the FST. If such tools can be developed with buy-in from the FDA, they might be particularly useful for translating trial data to patient care, she added.

Dr. Harvey reported financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Johnson & Johnson, L’Oréal, and SkinCeuticals. Dr. Taylor, president-elect of the American Academy of Dermatology, reported financial relationships with more than 25 pharmaceutical and cosmetic companies.

A version of this article appeared on Medscape.com.

— Underrepresentation by gender and race in major clinical trials has been a cause for complaint for decades, but the Food and Drug Administration (FDA) has drafted a regulatory solution to this issue expected to be implemented sometime in 2025.

This initiative, known as the FDA’s Diversity Action Plan (DAP), will require plans for all pivotal and phase 3 trials to provide details in their design of how diversity will be achieved or, if there are no plans for diversity, the reason why, according to Valerie M. Harvey, MD, MPH, associate clinical professor, Edward Via College of Osteopathic Medicine, Blacksburg, Virginia. These rules will be codified, she said at the 2024 Skin of Color Update.

Once the DAP is enacted, “the sponsor must specify the rationale and goals for study enrollment by age, ethnicity, sex, and race,” she said. Furthermore, the submission to the FDA must “describe the methods to meet the diversity benchmarks.”
 

Lack of Trial Diversity Is Common Across Medicine

Although she focused on the relevance of this initiative to dermatology, Dr. Harvey said the lack of diversity in clinical trials is pervasive throughout medicine. In one survey of randomized controlled trials, less than 60% of trials even specified the race and ethnicity of the participants. In recent psoriasis trials, only 30% met a diversity definition of ≥ 20% of patients identifying as minority (Black, Hispanic, Asian, or other non-White group), said Dr. Harvey, who practices dermatology in Newport News, Virginia.

The FDA draft guidance for the DAP was released in June 2024 and is now available for submitting comments (until September 26). The plan is expected to be published in June 2025, according to Dr. Harvey. It will pertain to all pivotal and phase 3 trials enrolling 180 days after the publication date and will be relevant to all drugs and biologics as well as certain devices.

This initiative could be a critical step toward ensuring diversity in major clinical trials after years of stagnation, Dr. Harvey said, noting that despite repeated calls for more diversity in clinical trials, the literature suggests “little progress.”

However, she said that increasing diversity in clinical trials is just one step toward gathering data about the generalizability of efficacy and safety across racial and ethnic groups. A much more complex issue involves how race and ethnicity are defined in order to understand differences, if any, for efficacy and risk.

“Race is a dynamic social construct and a poor measure for biologic variation and skin color,” Dr. Harvey said. This means that work is needed to address the more complex issue of race and ethnicity stratification that will help clinicians understand the relative benefits and risks for the drugs in these trials.

Rather than differences based on genetic or other sources of biologic differences, she said, outcomes by race alone are often suspected of reflecting disparities in access to healthcare rather than a difference in therapeutic response.
 

Skin Color Is Inadequate to Define Race

When stratifying patients by race or ethnicity, Dr. Harvey said that “we have to be very, very careful in considering the study purpose and what the study question is.” A study attempting to compare benefits and risks among subgroups by race or ethnicity will require descriptors beyond skin color.

The recognized limitations of measuring skin tone as a surrogate of race are one reason for widespread interest in moving away from the Fitzpatrick skin type (FST) rating that has been widely considered a standard, according to Dr. Harvey. Several alternatives have been proposed, including the Monk Skin Tone Scale, the Individual Typology Angle, and the Eumelanin Human Skin Color Scale, but she cautioned that these are less well validated and generally have the limitations of the FST.

If skin color was ever useful for grouping individuals on the basis of shared physiology, growing rates of intermarriage and immigration have made skin color increasingly irrelevant to racial identity. If the goal is to evaluate the safety and efficacy of drugs across racial groups and ethnicities, the characterization of populations will almost certainly require multiple descriptors and biomarkers, she said.

“It is very important to have many tools for characterizing patients by skin type,” Susan Taylor, MD, professor of dermatology and vice chair for diversity, equity, and inclusion for the Department of Dermatology, University of Pennsylvania, Philadelphia, said in an interview at the meeting.

The reason is “there are limitations to all of them,” she said, noting also that the questions being asked about how and if skin color and race are relevant to therapeutic options differ by the question, such as innate response or access to care.

Dr. Taylor is part of a workshop that she said is evaluating a combination of instruments for characterizing skin color and race in ways relevant to the specific question being asked.

The solutions might differ. While simple clinical assessments involving skin color might be made with methods captured on a smartphone app, Dr. Taylor acknowledged that far more complex tools might be required to document the effect of racial or ethnic differences in drug efficacy and safety in a research setting.

Outside of a research setting, any tools that might be useful for assessing race as a variable must be practical, according to Dr. Harvey. She suggested that these must be time efficient, of reasonable cost, and most importantly, reliable.

Tools meeting these criteria do not currently exist, but Dr. Harvey said the work is underway. She expects a “top-down” collaborative approach to validate alternatives to the FST. If such tools can be developed with buy-in from the FDA, they might be particularly useful for translating trial data to patient care, she added.

Dr. Harvey reported financial relationships with AbbVie, Bristol-Myers Squibb, Janssen, Johnson & Johnson, L’Oréal, and SkinCeuticals. Dr. Taylor, president-elect of the American Academy of Dermatology, reported financial relationships with more than 25 pharmaceutical and cosmetic companies.

A version of this article appeared on Medscape.com.

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Should There Be a Mandatory Retirement Age for Physicians?

Article Type
Changed
Thu, 09/19/2024 - 15:47

This transcript has been edited for clarity

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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Hidden in Plain Sight: The Growing Epidemic of Ultraprocessed Food Addiction

Article Type
Changed
Thu, 09/19/2024 - 15:35

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

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

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

The Key Role of the Food Industry

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

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

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

How Many People Are Affected?

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

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

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

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

Clinical Implications

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

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

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

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

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

 

 

Treatment Options

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

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

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

The Key Role of the Food Industry

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

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

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

How Many People Are Affected?

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

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

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

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

Clinical Implications

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

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

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

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

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

 

 

Treatment Options

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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

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

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

The Key Role of the Food Industry

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

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

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

How Many People Are Affected?

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

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

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

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

Clinical Implications

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

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

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

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

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

 

 

Treatment Options

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

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

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

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

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

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

A version of this article appeared on Medscape.com.

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Bariatric Surgery and Weight Loss Make Brain Say Meh to Sweets

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Thu, 09/19/2024 - 14:17

 

TOPLINE:

A preference for less sweet beverages after bariatric surgery and weight loss appears to stem from a lower brain reward response to sweet taste without affecting the sensory regions.
 

METHODOLOGY:

  • Previous studies have suggested that individuals undergoing bariatric surgery show reduced preference for sweet-tasting food post-surgery, but the mechanisms behind these changes remain unclear.
  • This observational cohort study aimed to examine the neural processing of sweet taste in the reward regions of the brain before and after bariatric surgery in 24 women with obesity (mean body mass index [BMI], 47) who underwent bariatric surgery and 21 control participants with normal to overweight (mean BMI, 23.5).
  • Participants (mean age about 43 years; 75%-81% White) underwent sucrose taste testing and functional MRI (fMRI) to compare the responses of the brain with sucrose solutions of 0.10 M and 0.40 M (akin to sugar-sweetened beverages, such as Coca-Cola at ~0.32 M) and Mountain Dew at ~0.35 M) versus water.
  • In the bariatric surgery group, participants underwent fMRI 1-117 days before surgery, and 21 participants who lost about 20% of their weight after the surgery underwent a follow-up fMRI roughly 3-4 months later.
  • The researchers analyzed the brain’s reward response using a composite activation of several reward system regions (the ventral tegmental area, ventral striatum, and orbitofrontal cortex) and of sensory regions (the primary somatosensory cortex and primary insula taste cortex).
  •  

TAKEAWAY:

  • The perceived intensity of sweetness was comparable between the control group and the bariatric surgery group both before and after surgery.
  • In the bariatric surgery group, the average preferred sweet concentration decreased from 0.52 M before surgery to 0.29 M after surgery (P = .008).
  • The fMRI analysis indicated that women showed a trend toward a higher reward response to 0.4 M sucrose before bariatric surgery than the control participants.
  • The activation of the reward region in response to 0.4 M sucrose (but not 0.1 M) declined in the bariatric surgery group after surgery (P = .042).
  •  

IN PRACTICE:

“Our findings suggest that both the brain reward response to and subjective liking of an innately desirable taste decline following bariatric surgery,” the authors wrote.
 

SOURCE:

This study was led by Jonathan Alessi, Indiana University School of Medicine, Indianapolis, and published online in Obesity.
 

LIMITATIONS:

The study sample size was relatively small, and the duration of follow-up was short, with recruitment curtailed by the COVID-19 pandemic. This study did not assess the consumption of sugar or sweetened food, which could provide further insights into changes in the dietary behavior post-surgery. Participants included women only, and the findings could have been different if men were recruited.
 

DISCLOSURES:

This study was funded by the American Diabetes Association, Indiana Clinical and Translational Sciences Institute, and National Institute on Alcohol Abuse and Alcoholism. Three authors reported financial relationships with some pharmaceutical companies outside of this study.
 

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.

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TOPLINE:

A preference for less sweet beverages after bariatric surgery and weight loss appears to stem from a lower brain reward response to sweet taste without affecting the sensory regions.
 

METHODOLOGY:

  • Previous studies have suggested that individuals undergoing bariatric surgery show reduced preference for sweet-tasting food post-surgery, but the mechanisms behind these changes remain unclear.
  • This observational cohort study aimed to examine the neural processing of sweet taste in the reward regions of the brain before and after bariatric surgery in 24 women with obesity (mean body mass index [BMI], 47) who underwent bariatric surgery and 21 control participants with normal to overweight (mean BMI, 23.5).
  • Participants (mean age about 43 years; 75%-81% White) underwent sucrose taste testing and functional MRI (fMRI) to compare the responses of the brain with sucrose solutions of 0.10 M and 0.40 M (akin to sugar-sweetened beverages, such as Coca-Cola at ~0.32 M) and Mountain Dew at ~0.35 M) versus water.
  • In the bariatric surgery group, participants underwent fMRI 1-117 days before surgery, and 21 participants who lost about 20% of their weight after the surgery underwent a follow-up fMRI roughly 3-4 months later.
  • The researchers analyzed the brain’s reward response using a composite activation of several reward system regions (the ventral tegmental area, ventral striatum, and orbitofrontal cortex) and of sensory regions (the primary somatosensory cortex and primary insula taste cortex).
  •  

TAKEAWAY:

  • The perceived intensity of sweetness was comparable between the control group and the bariatric surgery group both before and after surgery.
  • In the bariatric surgery group, the average preferred sweet concentration decreased from 0.52 M before surgery to 0.29 M after surgery (P = .008).
  • The fMRI analysis indicated that women showed a trend toward a higher reward response to 0.4 M sucrose before bariatric surgery than the control participants.
  • The activation of the reward region in response to 0.4 M sucrose (but not 0.1 M) declined in the bariatric surgery group after surgery (P = .042).
  •  

IN PRACTICE:

“Our findings suggest that both the brain reward response to and subjective liking of an innately desirable taste decline following bariatric surgery,” the authors wrote.
 

SOURCE:

This study was led by Jonathan Alessi, Indiana University School of Medicine, Indianapolis, and published online in Obesity.
 

LIMITATIONS:

The study sample size was relatively small, and the duration of follow-up was short, with recruitment curtailed by the COVID-19 pandemic. This study did not assess the consumption of sugar or sweetened food, which could provide further insights into changes in the dietary behavior post-surgery. Participants included women only, and the findings could have been different if men were recruited.
 

DISCLOSURES:

This study was funded by the American Diabetes Association, Indiana Clinical and Translational Sciences Institute, and National Institute on Alcohol Abuse and Alcoholism. Three authors reported financial relationships with some pharmaceutical companies outside of this study.
 

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:

A preference for less sweet beverages after bariatric surgery and weight loss appears to stem from a lower brain reward response to sweet taste without affecting the sensory regions.
 

METHODOLOGY:

  • Previous studies have suggested that individuals undergoing bariatric surgery show reduced preference for sweet-tasting food post-surgery, but the mechanisms behind these changes remain unclear.
  • This observational cohort study aimed to examine the neural processing of sweet taste in the reward regions of the brain before and after bariatric surgery in 24 women with obesity (mean body mass index [BMI], 47) who underwent bariatric surgery and 21 control participants with normal to overweight (mean BMI, 23.5).
  • Participants (mean age about 43 years; 75%-81% White) underwent sucrose taste testing and functional MRI (fMRI) to compare the responses of the brain with sucrose solutions of 0.10 M and 0.40 M (akin to sugar-sweetened beverages, such as Coca-Cola at ~0.32 M) and Mountain Dew at ~0.35 M) versus water.
  • In the bariatric surgery group, participants underwent fMRI 1-117 days before surgery, and 21 participants who lost about 20% of their weight after the surgery underwent a follow-up fMRI roughly 3-4 months later.
  • The researchers analyzed the brain’s reward response using a composite activation of several reward system regions (the ventral tegmental area, ventral striatum, and orbitofrontal cortex) and of sensory regions (the primary somatosensory cortex and primary insula taste cortex).
  •  

TAKEAWAY:

  • The perceived intensity of sweetness was comparable between the control group and the bariatric surgery group both before and after surgery.
  • In the bariatric surgery group, the average preferred sweet concentration decreased from 0.52 M before surgery to 0.29 M after surgery (P = .008).
  • The fMRI analysis indicated that women showed a trend toward a higher reward response to 0.4 M sucrose before bariatric surgery than the control participants.
  • The activation of the reward region in response to 0.4 M sucrose (but not 0.1 M) declined in the bariatric surgery group after surgery (P = .042).
  •  

IN PRACTICE:

“Our findings suggest that both the brain reward response to and subjective liking of an innately desirable taste decline following bariatric surgery,” the authors wrote.
 

SOURCE:

This study was led by Jonathan Alessi, Indiana University School of Medicine, Indianapolis, and published online in Obesity.
 

LIMITATIONS:

The study sample size was relatively small, and the duration of follow-up was short, with recruitment curtailed by the COVID-19 pandemic. This study did not assess the consumption of sugar or sweetened food, which could provide further insights into changes in the dietary behavior post-surgery. Participants included women only, and the findings could have been different if men were recruited.
 

DISCLOSURES:

This study was funded by the American Diabetes Association, Indiana Clinical and Translational Sciences Institute, and National Institute on Alcohol Abuse and Alcoholism. Three authors reported financial relationships with some pharmaceutical companies outside of this study.
 

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.

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‘Reform School’ for Pharmacy Benefit Managers: How Might Legislation Help Patients?

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Tue, 09/17/2024 - 11:38

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

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

Policy Categories of PBM Reform

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

Patient Access to Medications — Step Therapy Legislation

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

Dr. Madelaine A. Feldman

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

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

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

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

Patient Access to Medications — Prior Authorizations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Policy Categories of PBM Reform

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

Patient Access to Medications — Step Therapy Legislation

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

Dr. Madelaine A. Feldman

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

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

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

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

Patient Access to Medications — Prior Authorizations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Policy Categories of PBM Reform

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

Patient Access to Medications — Step Therapy Legislation

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

Dr. Madelaine A. Feldman

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

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

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

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

Patient Access to Medications — Prior Authorizations

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

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

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

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

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

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

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

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

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

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

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

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

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

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AI-Powered Clinical Documentation Tool Reduces EHR Time for Clinicians

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Wed, 09/18/2024 - 09:47

 

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

  • Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
  • Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
  • A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

  • The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
  • The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
  • Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

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

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TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

  • Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
  • Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
  • A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

  • The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
  • The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
  • Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

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

 

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

  • Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
  • Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
  • A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

  • The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
  • The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
  • Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

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

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Stress Management

Article Type
Changed
Mon, 09/16/2024 - 15:43

With the changing leaves and cooling temperatures, early autumn also brings the excitement of the new school year. While returning to sports, mastering new subjects, and spending time with old and new friends is exhilarating, this season can also be a time of intense stress.

For those high school students who are especially ambitious, the school year presents the challenge of a very high stakes performance, one whose success will be measured by admission to a prized college. Not only are there classes to study for, but schedules are packed with a maximum number of subjects, a maximum number of Advanced Placement courses and a maximum number of impressive extra-curricular activities. Varsity sports practice, SAT prep, Debate Club, volunteer hours, and on and on.

What is often missing is enough time for sleep, socializing, exploring new interests, and unwinding. When you hear your patients (or parents) describing the intense stress of their overloaded schedules compounded by a sense that “I have no choice,” you have an opportunity to complicate their thinking. Introduce the idea that there are smart approaches to performing your best under stress. Like professional athletes, those experiencing stress can think about their time as being their most precious resource and be intentional about how they can best balance preparation, performance, resting, and recharging. Pushing themselves relentlessly will inevitably lead to burnout and exhaustion. This approach will help them learn to make wise choices and will better serve their healthy development.

Dr. Susan D. Swick

Start by acknowledging the stress of high-stakes performance. Telling your patients that they need to lower the temperature by not putting so much pressure on themselves is likely to be experienced as a lack of confidence in them and is unlikely to get any traction. Instead, ask your patients what matters to them the most: Is it admission to the college of their choice? Achieving a certain score or GPA? Is it their competitiveness and drive to win? There is no wrong answer, but it is helpful for them to be able to reflect on what matters to them. Are they hoping to impress someone else? Are they worried about their future financial health and convinced that getting into a certain college will secure their financial success? Do they think this matters more to their parents than to themselves? Or have they discovered an intense interest in theoretical physics and want to be able to study at Caltech? If their ambition is meaningfully connected to an authentic interest or to their emerging identity, their sense of purpose will be much deeper and able to sustain them.

Even with talent and a strong sense of purpose, performing well is very difficult and demanding. It is important to consider the cycle of performance as including preparation, performance itself, and effective rest and recovery, just as with athletic performance. Whether the performance is the SATs, an AP test, a debate or big game, there were probably hours of preparation for every hour of performance. Help them to consider the importance of this practice or preparation time, and how to use that time effectively. Are they able to work in environments where there are few distractions? Do they have the support or useful feedback they need? How are they able to know when it is time for a break or when they are ready? It can be helpful for them to appreciate whether preparation or performance is more challenging for them, as the former requires focus and patience, while the latter requires courage and tenacity. If they are aware of which is harder for them, they can be thoughtful about how to effectively handle those challenges.

Dr. Michael S. Jellinek

What can be most valuable for your patients is hearing from their pediatricians that they need to have time protected for rest and recharging, and not only for preparation and performance. Any athlete knows that failing to do so will lead to exhaustion and injury, and performance inevitably suffers. Rest is unwinding and slowing down, and a restful activity will leave them feeling calm, relaxed, and ready for sleep. A recharging activity is one that leaves them feeling refreshed and energized. Some common restful activities are a hot bath or shower, a distracting activity such as watching a show or surfing the web, playing a simple video game or puzzle or listening to music. Some recharging activities are creative ones (making art or music), engaging in hobbies, reading, or talking with a good friend. A few activities — sleep, exercise, and mindfulness meditation, are powerful in that they pack both rest and recharge into the same activity. Your patients should be discovering and learning which activities they find restful or recharging. The college application process or preparing for a varsity tryout will both add stress and give them an opportunity to learn what rests and recharges them. They should aim to have a list of at least five effective strategies that they can turn to when it’s time to rest or to recharge. Help them turn their work ethic to building a deeper well of self-knowledge that will serve them when they face challenges in high school or when they are on their own in college. This time of stress can be a time of growth, too.

Of course, remind your patients that this is a critical time to focus on basic self-care: They need consistently adequate, restful sleep, good nutrition, and physical activity. They will benefit from regular time in nature and time spent with friends that nourish them. They can find ways to compound these activities: Go for a walk with a friend, eat dinner with family, play a relaxing game while enjoying music. Lastly, ask your patients what is the last new thing they tried. It is easy to become so focused on an ambitious project that there is no time for exploration and play. Play is important throughout life, but adolescents are actively discovering their interests, talents, tastes, and values. To do this they need to be trying things that are new and maybe less purpose-driven. I call this type of activity “senseless fun.” Splashing in the pool is senseless fun, swimming laps is purposeful exercise that my contribute to recharging, and competing in a swim meet is often more on the stressful side. As they discover new talents, deeply engaging interests, what relaxes and recharges them, they will be learning who they are. Regardless of the outcome of a test, a big game, or where they go to college, it is this emerging knowledge about themselves that will carry them into adulthood. The pediatrician’s goal: Encouraging aspiration, exploration, and self-awareness in the context of giving permission for rest, recharging, and senseless fun.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

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With the changing leaves and cooling temperatures, early autumn also brings the excitement of the new school year. While returning to sports, mastering new subjects, and spending time with old and new friends is exhilarating, this season can also be a time of intense stress.

For those high school students who are especially ambitious, the school year presents the challenge of a very high stakes performance, one whose success will be measured by admission to a prized college. Not only are there classes to study for, but schedules are packed with a maximum number of subjects, a maximum number of Advanced Placement courses and a maximum number of impressive extra-curricular activities. Varsity sports practice, SAT prep, Debate Club, volunteer hours, and on and on.

What is often missing is enough time for sleep, socializing, exploring new interests, and unwinding. When you hear your patients (or parents) describing the intense stress of their overloaded schedules compounded by a sense that “I have no choice,” you have an opportunity to complicate their thinking. Introduce the idea that there are smart approaches to performing your best under stress. Like professional athletes, those experiencing stress can think about their time as being their most precious resource and be intentional about how they can best balance preparation, performance, resting, and recharging. Pushing themselves relentlessly will inevitably lead to burnout and exhaustion. This approach will help them learn to make wise choices and will better serve their healthy development.

Dr. Susan D. Swick

Start by acknowledging the stress of high-stakes performance. Telling your patients that they need to lower the temperature by not putting so much pressure on themselves is likely to be experienced as a lack of confidence in them and is unlikely to get any traction. Instead, ask your patients what matters to them the most: Is it admission to the college of their choice? Achieving a certain score or GPA? Is it their competitiveness and drive to win? There is no wrong answer, but it is helpful for them to be able to reflect on what matters to them. Are they hoping to impress someone else? Are they worried about their future financial health and convinced that getting into a certain college will secure their financial success? Do they think this matters more to their parents than to themselves? Or have they discovered an intense interest in theoretical physics and want to be able to study at Caltech? If their ambition is meaningfully connected to an authentic interest or to their emerging identity, their sense of purpose will be much deeper and able to sustain them.

Even with talent and a strong sense of purpose, performing well is very difficult and demanding. It is important to consider the cycle of performance as including preparation, performance itself, and effective rest and recovery, just as with athletic performance. Whether the performance is the SATs, an AP test, a debate or big game, there were probably hours of preparation for every hour of performance. Help them to consider the importance of this practice or preparation time, and how to use that time effectively. Are they able to work in environments where there are few distractions? Do they have the support or useful feedback they need? How are they able to know when it is time for a break or when they are ready? It can be helpful for them to appreciate whether preparation or performance is more challenging for them, as the former requires focus and patience, while the latter requires courage and tenacity. If they are aware of which is harder for them, they can be thoughtful about how to effectively handle those challenges.

Dr. Michael S. Jellinek

What can be most valuable for your patients is hearing from their pediatricians that they need to have time protected for rest and recharging, and not only for preparation and performance. Any athlete knows that failing to do so will lead to exhaustion and injury, and performance inevitably suffers. Rest is unwinding and slowing down, and a restful activity will leave them feeling calm, relaxed, and ready for sleep. A recharging activity is one that leaves them feeling refreshed and energized. Some common restful activities are a hot bath or shower, a distracting activity such as watching a show or surfing the web, playing a simple video game or puzzle or listening to music. Some recharging activities are creative ones (making art or music), engaging in hobbies, reading, or talking with a good friend. A few activities — sleep, exercise, and mindfulness meditation, are powerful in that they pack both rest and recharge into the same activity. Your patients should be discovering and learning which activities they find restful or recharging. The college application process or preparing for a varsity tryout will both add stress and give them an opportunity to learn what rests and recharges them. They should aim to have a list of at least five effective strategies that they can turn to when it’s time to rest or to recharge. Help them turn their work ethic to building a deeper well of self-knowledge that will serve them when they face challenges in high school or when they are on their own in college. This time of stress can be a time of growth, too.

Of course, remind your patients that this is a critical time to focus on basic self-care: They need consistently adequate, restful sleep, good nutrition, and physical activity. They will benefit from regular time in nature and time spent with friends that nourish them. They can find ways to compound these activities: Go for a walk with a friend, eat dinner with family, play a relaxing game while enjoying music. Lastly, ask your patients what is the last new thing they tried. It is easy to become so focused on an ambitious project that there is no time for exploration and play. Play is important throughout life, but adolescents are actively discovering their interests, talents, tastes, and values. To do this they need to be trying things that are new and maybe less purpose-driven. I call this type of activity “senseless fun.” Splashing in the pool is senseless fun, swimming laps is purposeful exercise that my contribute to recharging, and competing in a swim meet is often more on the stressful side. As they discover new talents, deeply engaging interests, what relaxes and recharges them, they will be learning who they are. Regardless of the outcome of a test, a big game, or where they go to college, it is this emerging knowledge about themselves that will carry them into adulthood. The pediatrician’s goal: Encouraging aspiration, exploration, and self-awareness in the context of giving permission for rest, recharging, and senseless fun.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

With the changing leaves and cooling temperatures, early autumn also brings the excitement of the new school year. While returning to sports, mastering new subjects, and spending time with old and new friends is exhilarating, this season can also be a time of intense stress.

For those high school students who are especially ambitious, the school year presents the challenge of a very high stakes performance, one whose success will be measured by admission to a prized college. Not only are there classes to study for, but schedules are packed with a maximum number of subjects, a maximum number of Advanced Placement courses and a maximum number of impressive extra-curricular activities. Varsity sports practice, SAT prep, Debate Club, volunteer hours, and on and on.

What is often missing is enough time for sleep, socializing, exploring new interests, and unwinding. When you hear your patients (or parents) describing the intense stress of their overloaded schedules compounded by a sense that “I have no choice,” you have an opportunity to complicate their thinking. Introduce the idea that there are smart approaches to performing your best under stress. Like professional athletes, those experiencing stress can think about their time as being their most precious resource and be intentional about how they can best balance preparation, performance, resting, and recharging. Pushing themselves relentlessly will inevitably lead to burnout and exhaustion. This approach will help them learn to make wise choices and will better serve their healthy development.

Dr. Susan D. Swick

Start by acknowledging the stress of high-stakes performance. Telling your patients that they need to lower the temperature by not putting so much pressure on themselves is likely to be experienced as a lack of confidence in them and is unlikely to get any traction. Instead, ask your patients what matters to them the most: Is it admission to the college of their choice? Achieving a certain score or GPA? Is it their competitiveness and drive to win? There is no wrong answer, but it is helpful for them to be able to reflect on what matters to them. Are they hoping to impress someone else? Are they worried about their future financial health and convinced that getting into a certain college will secure their financial success? Do they think this matters more to their parents than to themselves? Or have they discovered an intense interest in theoretical physics and want to be able to study at Caltech? If their ambition is meaningfully connected to an authentic interest or to their emerging identity, their sense of purpose will be much deeper and able to sustain them.

Even with talent and a strong sense of purpose, performing well is very difficult and demanding. It is important to consider the cycle of performance as including preparation, performance itself, and effective rest and recovery, just as with athletic performance. Whether the performance is the SATs, an AP test, a debate or big game, there were probably hours of preparation for every hour of performance. Help them to consider the importance of this practice or preparation time, and how to use that time effectively. Are they able to work in environments where there are few distractions? Do they have the support or useful feedback they need? How are they able to know when it is time for a break or when they are ready? It can be helpful for them to appreciate whether preparation or performance is more challenging for them, as the former requires focus and patience, while the latter requires courage and tenacity. If they are aware of which is harder for them, they can be thoughtful about how to effectively handle those challenges.

Dr. Michael S. Jellinek

What can be most valuable for your patients is hearing from their pediatricians that they need to have time protected for rest and recharging, and not only for preparation and performance. Any athlete knows that failing to do so will lead to exhaustion and injury, and performance inevitably suffers. Rest is unwinding and slowing down, and a restful activity will leave them feeling calm, relaxed, and ready for sleep. A recharging activity is one that leaves them feeling refreshed and energized. Some common restful activities are a hot bath or shower, a distracting activity such as watching a show or surfing the web, playing a simple video game or puzzle or listening to music. Some recharging activities are creative ones (making art or music), engaging in hobbies, reading, or talking with a good friend. A few activities — sleep, exercise, and mindfulness meditation, are powerful in that they pack both rest and recharge into the same activity. Your patients should be discovering and learning which activities they find restful or recharging. The college application process or preparing for a varsity tryout will both add stress and give them an opportunity to learn what rests and recharges them. They should aim to have a list of at least five effective strategies that they can turn to when it’s time to rest or to recharge. Help them turn their work ethic to building a deeper well of self-knowledge that will serve them when they face challenges in high school or when they are on their own in college. This time of stress can be a time of growth, too.

Of course, remind your patients that this is a critical time to focus on basic self-care: They need consistently adequate, restful sleep, good nutrition, and physical activity. They will benefit from regular time in nature and time spent with friends that nourish them. They can find ways to compound these activities: Go for a walk with a friend, eat dinner with family, play a relaxing game while enjoying music. Lastly, ask your patients what is the last new thing they tried. It is easy to become so focused on an ambitious project that there is no time for exploration and play. Play is important throughout life, but adolescents are actively discovering their interests, talents, tastes, and values. To do this they need to be trying things that are new and maybe less purpose-driven. I call this type of activity “senseless fun.” Splashing in the pool is senseless fun, swimming laps is purposeful exercise that my contribute to recharging, and competing in a swim meet is often more on the stressful side. As they discover new talents, deeply engaging interests, what relaxes and recharges them, they will be learning who they are. Regardless of the outcome of a test, a big game, or where they go to college, it is this emerging knowledge about themselves that will carry them into adulthood. The pediatrician’s goal: Encouraging aspiration, exploration, and self-awareness in the context of giving permission for rest, recharging, and senseless fun.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at pdnews@mdedge.com.

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Is It Time for Universal Suicide Screening?

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Wed, 09/18/2024 - 10:18

US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes. 

The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.

In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescentsand then in adults, the authors said there was insufficient evidence to support universal suicide screening. 

Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.

So, what is the case for — and against — universal screening?
 

Sounding an Alert

The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings. 

Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk. 

It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.

“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health. 

Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults. 

Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.

Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.

The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.

To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
 

 

 

Universal Screening Expands

Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.

There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States. 

Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett. 

Barriers may include adequate staffing, or a system in place to triage patients who screen positive. 

At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”

She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said. 
 

Pushback on Universal Screening

Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.

“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio. 

Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted. 

“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”

Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.

“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added. 

Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.

“Suicidal thoughts are very common, but suicide is a rare event,” he said. 

He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said. 
 

 

 

A Public Health Issue

If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said. 

“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”

Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.

Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others. 

“These have been shown to be very effective in saving lives,” Dr. Nestadt said.

Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt. 

In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well. 

Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way. 

The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.

“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”

Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes. 

The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.

In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescentsand then in adults, the authors said there was insufficient evidence to support universal suicide screening. 

Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.

So, what is the case for — and against — universal screening?
 

Sounding an Alert

The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings. 

Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk. 

It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.

“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health. 

Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults. 

Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.

Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.

The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.

To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
 

 

 

Universal Screening Expands

Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.

There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States. 

Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett. 

Barriers may include adequate staffing, or a system in place to triage patients who screen positive. 

At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”

She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said. 
 

Pushback on Universal Screening

Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.

“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio. 

Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted. 

“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”

Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.

“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added. 

Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.

“Suicidal thoughts are very common, but suicide is a rare event,” he said. 

He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said. 
 

 

 

A Public Health Issue

If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said. 

“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”

Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.

Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others. 

“These have been shown to be very effective in saving lives,” Dr. Nestadt said.

Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt. 

In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well. 

Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way. 

The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.

“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”

Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

US suicide rates have reached alarming levels, with data from Centers for Disease Control and Prevention (CDC) showing a 37% increase from 2000 to 2022. Nearly 49,000 people died by suicide in 2022 alone, translating to one death every 11 minutes. 

The increase in suicide rates has prompted calls for expansion of universal suicide screening, in which all individuals in medical or mental health care settings are screened for suicide risk, regardless of the purpose for their visit. But the psychiatric field is split on the issue, with some experts citing false positives and a lack of mental health care resources for those deemed at risk.

In 2022, when the US Preventative Services Task Force released its recommendations on suicide prevention, first in children and adolescentsand then in adults, the authors said there was insufficient evidence to support universal suicide screening. 

Proponents of the practice pushed back on that finding, arguing that universal suicide screening could help identify those at high risk who might otherwise go undiagnosed, leading to earlier, potentially lifesaving, intervention.

So, what is the case for — and against — universal screening?
 

Sounding an Alert

The introduction of universal screening was driven by a confluence of factors that began with a 1999 report by then-US Surgeon General David Satcher, MD. This was followed by a report in 2016 from the Joint Commission on Detecting and Treating Suicidal Ideation that called for healthcare organizations to improve detection and treatment of suicidal ideation in all healthcare care settings. 

Data from the alert showed that a significant number of people who died by suicide had a healthcare visit before their death. Half had seen a clinician a month before their death; nearly 30% had a medical visit just the week before — all with no detection of increased suicide risk. 

It was that sort of finding that led Parkland Health and Hospital System in Dallas to become the first US hospital to implement universal suicide screening. Since the program launched in 2015, the system has screened more than 4.3 million patients in its emergency department, inpatient units, and 20 primary care clinics.

“Since the program began, we’ve completed between 40,000 to 50,000 screenings per month,” said Kimberly Roaten, PhD, associate chief quality and safety officer for behavioral health at Parkland Health. 

Clinicians at Parkland use the five-item Ask Suicide-Screening Questions to assess suicidal intent, a commonly used tool that was originally developed for use in pediatric emergency rooms (ERs). The tool, which takes about 20 seconds to administer, has since been validated in both children and adults. 

Based on a patient’s response, a clinical decision support system integrated into the electronic health record classifies suicide risk as none, moderate, or high.

Patients identified as moderate risk are offered a more in-depth assessment with a mental health clinician, though participation is not mandatory, said Dr. Roaten. Those at high risk receive a more thorough evaluation.

The proportion of ER patients at Parkland who screen positive for any suicidal intent has consistently remained at about 7%, and at 2% in the primary care clinics, she said.

To better understand what the program may have had on suicide prevention, Dr. Roaten is leading a National Institute of Mental Health–funded study to link a decade of mortality data from the state of Texas to patient data from Parkland Health. Investigators will analyze information about patients identified at risk for suicide, those patients’ characteristics, and who dies by suicide.
 

 

 

Universal Screening Expands

Other health systems have adopted universal suicide screening including the Indian Health Service and the US Veterans Health Administration. Universal suicide screening is also in place in a growing number of primary care practices and hospitals throughout the United States and will be mandatory for patients aged 12 years and older in all acute care hospitals in California beginning in 2025.

There is also a push for universal screening to be coordinated through local, state, and federal government, nonprofit, and private sectors. The National Action Alliance for Suicide Prevention is charged with advancing the White House’s 2024 National Strategy for Suicide Prevention, a 10-year plan to address gaps in suicide prevention in the United States. 

Sarah Brummett, JD, director of the National Action Alliance for Suicide Prevention’s executive committee, said that universal suicide screening is part of the 2024 strategy. “We know there are barriers to universal screening, and so it’s important to recognize what they are so we can address them,” said Ms. Brummett. 

Barriers may include adequate staffing, or a system in place to triage patients who screen positive. 

At Parkland, cost and workload have been minimal, Dr. Roaten said. “We built a model that only dedicates our highest-value resources to the most at-risk patients.”

She also noted that relief may be on the horizon for health systems where cost is an obstacle to universal screening and subsequent intervention. “There are efforts at the federal level to increase funding for suicide assessment and crisis response,” she said. 
 

Pushback on Universal Screening

Universal suicide screening has its detractors, including critics who say expansion is unlikely to reduce suicide rates.

“The issue with suicidal ideation is that it is very dynamic. Suicidal ideation changes very quickly — sometimes within hours,” said Craig Bryan, PsyD, professor of psychiatry and behavioral health at Ohio State University in Columbus, Ohio. 

Universal screening can also lead to false positives, where a patient who screens positive for suicidal ideation has no actual intention of attempting suicide, potentially creating unnecessary concern and burden on health care resources, Dr. Bryan noted. 

“What do you do with everyone who screens positive?” Dr. Bryan said. “I’ve spoken with leaders of many health systems in the United States, and there is pushback against universal screening because they don’t have enough mental health resources to handle all of the referrals.”

Suicide screening also doesn’t predict who will die by suicide, Dr. Bryan added. It only identifies those willing to disclose suicidal thoughts. There is a significant number of people without mental illness who may never seek medical care, so “the warning signs we’re teaching people to recognize — depression, anxiety, and substance abuse — might not be evident in these individuals,” he said.

“Life sideswipes them suddenly, and they go from 0 to 60 ... and they may have access to a highly lethal method [of suicide] which weaponizes that moment of despair,” said Dr. Bryan. No amount of screening could possibly predict those types of suicides, he added. 

Paul Nestadt, MD, associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, agrees with Dr. Bryan and noted there isn’t a strong correlation between suicidal ideation and death by suicide.

“Suicidal thoughts are very common, but suicide is a rare event,” he said. 

He cited a study that showed that two thirds of individuals who died by suicide had denied experiencing suicidal thoughts when asked, and half of them died within 2 days of this denial. Other research suggests that as many as 98% of people who express suicidal ideation do not die by suicide, Dr. Nestadt said. 
 

 

 

A Public Health Issue

If universal screening is not the answer to predicting and preventing suicide, what is? One way would be to approach suicide as a public health issue, Dr. Nestadt said. 

“How did we reduce the rate of motor vehicle deaths? We didn’t test each driver’s reaction time behind the wheel,” he said. “Instead, we passed seatbelt and airbag legislation, implemented federal speed limits, and as a result, the number of motor vehicle fatalities decreased.”

Dr. Nestadt is an advocate for stronger gun safety legislation, which has proven effective in reducing suicide rates. A study published this year showed that states with child access prevention laws, negligent storage laws, and mandatory waiting periods for gun purchases reported fewer suicide deaths than those without that legislation.

Other measures might be applied in cases of extreme individual suicide risk, including extreme risk protection orders, also known as “red flag” laws, he added. This type of legislation provides a pathway for law enforcement to temporarily remove firearms from individuals who pose a risk to themselves or others. 

“These have been shown to be very effective in saving lives,” Dr. Nestadt said.

Dr. Nestadt and others are also using machine learning models to predict suicide risk. Those identified as high-risk may be flagged on their electronic medical record. Ideally, when the algorithm becomes more accurate at predicting suicide, anyone treating this patient can then decide if action is needed, said Dr. Nestadt. 

In his work with suicidal military personnel, Dr. Bryan and his colleagues established a brief form of cognitive behavioral therapy (BCBT) to help participants challenge cognitive distortions and build coping strategies to deal with feel with intense feelings of distress. Data show that BCBT reduced suicide attempts among active-duty soldiers by 60% compared with standard mental health treatment. It has since been shown to work in civilians as well. 

Dr. Bryan is also researching fluctuations in the wish to live versus the wish to die relative to one another and mapping the trajectory of risk states along the way. 

The goal is that these and other suicide prevention strategies currently under study by his team and others will help stem the rise in suicide deaths.

“Overall, we need to train mental health providers to implement suicide prevention therapies and establish suicide risk programs,” Dr. Bryan said. “But until we build one of these suicide prevention interventions to scale, we’re putting the cart before the horse.”

Dr. Roaten, Ms. Brummett, Dr. Bryan, and Dr. Nestadt reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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One in Five Overdose Deaths in 2022 had an Unrelated Mental Illness

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Tue, 09/17/2024 - 11:08

 

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

  • The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
  • A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
  • MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
  • Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

  • In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
  • Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
  • Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
  • About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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

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TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

  • The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
  • A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
  • MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
  • Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

  • In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
  • Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
  • Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
  • About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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

 

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

  • The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
  • A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
  • MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
  • Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

  • In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
  • Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
  • Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
  • About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

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

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Ultra-Processed Doesn’t Always Mean Bad — Here’s How to Tell

Article Type
Changed
Thu, 09/12/2024 - 14:56

 

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

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You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

 

You may have been warned that ultra-processed foods can wreak havoc on your health. But not all of them are created equal. 

A new study out of The Lancet Regional Health – Americas looked at different types of ultra-processed foods and found that some were even linked with lower risks of cardiovascular diseasecoronary heart disease, and stroke

“Avoiding all ultra-processed foods is not practical for most people,” said Dariush Mozaffarian, MD, a cardiologist, public health scientist, and director of the Food is Medicine Institute at Tufts University in Boston, Massachusetts. “So, it is helpful to start to understand, within the category of all processing, what food might be more or less harmful.”

Researchers analyzed food questionnaires from three large groups of US adults, with most people in their review being White and female. The study found that sugary and artificially sweetened drinks, along with processed meats, were linked to a greater risk of cardiovascular disease and coronary heart disease. But cereals, savory snacks, and yogurt and dairy-based desserts were linked to a lower risk of these diseases. Ultra-processed cereals and breads were also linked to a lower stroke risk. 
 

The Truth About Processed Meat

Studies show that cured, salted, or smoked meats are linked to certain cancers.

“We know that sugar-sweetened beverages are associated with metabolic derangement for things like higher glucose levels, insulin resistance, visceral obesityprediabetesdiabetes, and higher triglycerides,” said Ashish Sarraju, MD, a cardiologist with the Cleveland Clinic in Ohio. “Added sugars associated with all of those things are in turn risk factors for heart disease.” Sugar-sweetened beverages are often very high in sugar, artificial colors, and other additives, and almost “nothing beneficial” in terms of ingredients, Dr. Mozaffarian said. “They’re also consumed in very high doses, very quickly.”

Processed meats have 400% higher levels of salt, compared with unprocessed meats, said Dr. Mozaffarian. They also contain high levels of added nitrates, which are a carcinogen that could also affect the heart and blood vessels. Certain ultra-processed foods, such as bacon, are often fried at sky-high temperatures, which can trigger inflammatory compounds. 

“If you put together the inflammatory effects, the salt, and the nitrates, this is a package of food that can really build to cause harm,” said Dr. Mozaffarian. The World Health Organization has also classified processed meats (bacon, ham, salami) as a group one carcinogen, he noted.

“Processed meats are typically high in saturated fats, sodium, and preservatives, which can increase blood pressure, promote inflammation, and negatively affect cholesterol levels, leading to a higher risk of coronary heart disease, said Joseph A. Daibes, DO, an interventional cardiologist at Lenox Hill Hospital, New York City. “The study underscores the importance of limiting these types of foods to reduce cardiovascular risk.”

But considering that breakfast cereals – albeit highly processed – are a top source of whole grains for Americans, it makes sense that they are linked with lower risk of heart disease, said Dr. Mozaffarian. 

“They have fiber, bran, whole grains, and they also have sugar, and additives,” he said. “But on average, putting all those things together, this study suggested that the net effect is beneficial. That doesn’t mean they couldn’t be more beneficial if we made them less processed, but they don’t seem to have harm.”

The active probiotics and fermentation in yogurt can make it a healthy snack of choice, as there has been more and more research showing that fermented foods with probiotics are good for heart health and work against metabolic disease, or a cluster of conditions that can increase the risk of stroke, heart disease, and type 2 diabetes, Dr. Mozaffarian said.

Savory snacks, cereals, and yogurt and dairy-based desserts may also be less calorie dense than sugary beverages and processed meats, said Dr. Daibes. 

“Additionally, the type of fat used in savory snacks and the presence of probiotics in yogurt may have neutral or even positive effects on heart health, as opposed to the harmful fats and additives found in many ultra-processed foods,” he said.
 

How Ultra-Processed Foods Can Harm Your Health 

There are “clear and concerning links” between eating ultra-processed foods and getting heart disease, according to Dr. Daibes. “In real-life clinical practice, it’s a rather clear and straightforward relationship – the patients who tend to have poorer diets, with more ultra-processed and nutrient-barren foods, tend to have worse health outcomes, both cardiovascular and otherwise.”

Processing foods is centered on breaking down the natural structures of foods, as well as the loss of their natural nutrients, Dr. Mozaffarian explained. When you include the word “ultra,” this refers to putting in industrial additives.

“I think refined starches (such as wheat, corn, and rice) and sugars are some of the biggest harms because it leads to a big spike in blood glucose,” Dr. Mozaffarian said. “But also, those refined starches and sugars are digested so quickly in the stomach and small intestine that you starve your gut bacteria in your large intestines.” 

Many “good-for-you ingredients,” such as fermentable fibers and bio-active compounds, are found in unprocessed, whole foods like fruits, vegetables, nuts, beans, and seeds, noted Dr. Mozaffarian. High levels of salt in ultra-processed foods are another cause for concern, as are other additives such as artificial flavorings, sweeteners, and thickeners. 
 

Opting for Whole Foods

There may be people looking to eat cleaner, unprocessed foods, but high cost and a lack of access to them could create challenges. Dr. Sarraju advises his patients to simply do their best to eat foods in their whole-ingredient form and avoid prepackaged foods as much as possible.

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

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