MDedge Endocrinology

The Food and Drug Administration has cleared the Tandem Mobi insulin pump for people with diabetes aged 6 years or older.

The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.

Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.

The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.

The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.

Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
 

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

The Food and Drug Administration has cleared the Tandem Mobi insulin pump for people with diabetes aged 6 years or older.

The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.

Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.

The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.

The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.

Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
 

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

The Food and Drug Administration has cleared the Tandem Mobi insulin pump for people with diabetes aged 6 years or older.

The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.

Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.

The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.

The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.

Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
 

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

Findings from a recent study indicate that the less U.S. patients pay out of pocket for drugs that often have high co-pays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagonlike peptide-1 (GLP-1) agonists, the more they adhere to taking these medications.

The study, led by Utibe R. Essien, MD, from University of California, Los Angeles, and Balvindar Singh, MD, PhD, from University of Pittsburgh, was published online in JAMA Cardiology.

Patient data from Clinformatics Data Mart, a health insurance claims database, was analyzed for the study. The information for 90,041 adults from the United States who had commercial and Medicare health insurance, and who started taking a GLP-1 agonist or SGLT2 inhibitor between 2014 and 2020 was reviewed. Participants had type 2 diabetes, heart failure, or both.

The primary outcome showed patients with a lower drug co-pay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher co-pay. These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.

After full adjustments were made and after the 12 months, patients with a high co-pay of $50 per month or more were 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a co-pay of less than $10 per month for these agents.

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” the authors conclude.

The authors acknowledge the study’s limitations, including the inability to exclude residual confounding, uncertain generalizability for those without health insurance or with public insurance and possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities. Additionally, this study did not have information on patients’ preferences associated with medication use, including specific reasons for poor adherence, and could not assess how co-payments influenced initial prescription receipt or abandonment at the pharmacy, or other factors including possible price inflation.

The study received no commercial funding. One author (not a lead author) is an adviser to several drug companies including ones that market SGLT2 inhibitors or GLP-1 agonists.

Findings from a recent study indicate that the less U.S. patients pay out of pocket for drugs that often have high co-pays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagonlike peptide-1 (GLP-1) agonists, the more they adhere to taking these medications.

The study, led by Utibe R. Essien, MD, from University of California, Los Angeles, and Balvindar Singh, MD, PhD, from University of Pittsburgh, was published online in JAMA Cardiology.

Patient data from Clinformatics Data Mart, a health insurance claims database, was analyzed for the study. The information for 90,041 adults from the United States who had commercial and Medicare health insurance, and who started taking a GLP-1 agonist or SGLT2 inhibitor between 2014 and 2020 was reviewed. Participants had type 2 diabetes, heart failure, or both.

The primary outcome showed patients with a lower drug co-pay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher co-pay. These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.

After full adjustments were made and after the 12 months, patients with a high co-pay of $50 per month or more were 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a co-pay of less than $10 per month for these agents.

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” the authors conclude.

The authors acknowledge the study’s limitations, including the inability to exclude residual confounding, uncertain generalizability for those without health insurance or with public insurance and possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities. Additionally, this study did not have information on patients’ preferences associated with medication use, including specific reasons for poor adherence, and could not assess how co-payments influenced initial prescription receipt or abandonment at the pharmacy, or other factors including possible price inflation.

The study received no commercial funding. One author (not a lead author) is an adviser to several drug companies including ones that market SGLT2 inhibitors or GLP-1 agonists.

Findings from a recent study indicate that the less U.S. patients pay out of pocket for drugs that often have high co-pays, such as sodium-glucose cotransporter 2 (SGLT2) inhibitors or glucagonlike peptide-1 (GLP-1) agonists, the more they adhere to taking these medications.

The study, led by Utibe R. Essien, MD, from University of California, Los Angeles, and Balvindar Singh, MD, PhD, from University of Pittsburgh, was published online in JAMA Cardiology.

Patient data from Clinformatics Data Mart, a health insurance claims database, was analyzed for the study. The information for 90,041 adults from the United States who had commercial and Medicare health insurance, and who started taking a GLP-1 agonist or SGLT2 inhibitor between 2014 and 2020 was reviewed. Participants had type 2 diabetes, heart failure, or both.

The primary outcome showed patients with a lower drug co-pay had significantly higher odds of 12-month adherence to GLP-1 agonists and SGLT2 inhibitors, compared with those with a higher co-pay. These differences persisted after controlling for patient demographic, clinical, and socioeconomic covariates.

After full adjustments were made and after the 12 months, patients with a high co-pay of $50 per month or more were 53% less likely to adhere to an SGLT2 inhibitor and 32% less likely to adhere to a GLP-1 agonist, compared with patients with a co-pay of less than $10 per month for these agents.

“Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in patients with type 2 diabetes and heart failure,” the authors conclude.

The authors acknowledge the study’s limitations, including the inability to exclude residual confounding, uncertain generalizability for those without health insurance or with public insurance and possible misclassifications of type 2 diabetes and heart failure diagnoses or medical comorbidities. Additionally, this study did not have information on patients’ preferences associated with medication use, including specific reasons for poor adherence, and could not assess how co-payments influenced initial prescription receipt or abandonment at the pharmacy, or other factors including possible price inflation.

The study received no commercial funding. One author (not a lead author) is an adviser to several drug companies including ones that market SGLT2 inhibitors or GLP-1 agonists.

A smartphone-based app designed to deliver cognitive-behavioral therapy (CBT) to adults with type 2 diabetes received marketing approval as a class II medical device from the Food and Drug Administration on July 10, becoming the first digital behavioral therapeutic device for people with diabetes to receive this designation for U.S. patients.
 

Better Therapeutics representatives said that the app, formerly known as BT-001, will be called AspyreRX, with U.S. sales planned to launch in October-December 2023.

The app will be available to patients exclusively by prescription, with a planned 90-day use duration and an option for a second 90-day prescription. A company official said the price per prescription will be about $500-800, although this is not yet finalized. The app is intended for use in concert with the conventional pillars of glycemic control in people with type 2 diabetes: lifestyle modification and treatment with antidiabetes medications.

Senior staff members of Better Therapeutics acknowledged the critical need for an education program, which they will now launch for clinicians, payers, and patients to get across the message of the potential benefit and safety associated with using the CBT app. Their initial marketing will target patients with type 2 diabetes and poorly controlled hemoglobin A1c levels in five to six U.S. regions with high numbers of these patients. The company will also attempt to make the app available through the Department of Veterans Affairs health system and try to secure coverage by Medicare and commercial health-insurance providers.
 

Approval based on pivotal trial results

The FDA approval focused on data collected in the BT-001 randomized, controlled trial, which included 669 U.S. adults with poorly controlled type 2 diabetes. Results, published in 2022 in Diabetes Care, showed that after 90 days, people using the app had an average incremental reduction in A1c of 0.39 percentage points, compared with control patients who didn’t use the app, the primary endpoint. Use of the app also appeared safe.

Subsequent meeting presentations of study findings showed that A1c-lowering linked with app use was durable during continued use for a total of 180 days, that the effectiveness of the app in helping to lower A1c levels was “dose dependent” relative to the number of lessons a person completed, and that using the app significantly linked with a reduced need for intensified glycemic control through added medications.

Another finding of the extended-use phase of the study was that 81% of patients assigned to the app-using group continued to regularly use the app after 180 days, a level of durable engagement by patients that “exceeded our expectations,” said Diane Gomez-Thinnes, chief commercial officer of Better Therapeutics, during a press conference.

The company plans to tweak the app prior to its launch based on additional analyses of results from the pivotal study to further improve patient engagement and app ease of use. The company is also planning to expand the range of smartphones that can support the app, although about 90%-95% of U.S. smartphones have this capability.

Better Therapeutics is also actively developing and testing other modifications to the basic CBT app to make it usable by people with other cardiometabolic disorders such as hypertension, obesity, and fatty liver disease.

The BT-001 study was funded by Better Therapeutics.

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

A smartphone-based app designed to deliver cognitive-behavioral therapy (CBT) to adults with type 2 diabetes received marketing approval as a class II medical device from the Food and Drug Administration on July 10, becoming the first digital behavioral therapeutic device for people with diabetes to receive this designation for U.S. patients.
 

Better Therapeutics representatives said that the app, formerly known as BT-001, will be called AspyreRX, with U.S. sales planned to launch in October-December 2023.

The app will be available to patients exclusively by prescription, with a planned 90-day use duration and an option for a second 90-day prescription. A company official said the price per prescription will be about $500-800, although this is not yet finalized. The app is intended for use in concert with the conventional pillars of glycemic control in people with type 2 diabetes: lifestyle modification and treatment with antidiabetes medications.

Senior staff members of Better Therapeutics acknowledged the critical need for an education program, which they will now launch for clinicians, payers, and patients to get across the message of the potential benefit and safety associated with using the CBT app. Their initial marketing will target patients with type 2 diabetes and poorly controlled hemoglobin A1c levels in five to six U.S. regions with high numbers of these patients. The company will also attempt to make the app available through the Department of Veterans Affairs health system and try to secure coverage by Medicare and commercial health-insurance providers.
 

Approval based on pivotal trial results

The FDA approval focused on data collected in the BT-001 randomized, controlled trial, which included 669 U.S. adults with poorly controlled type 2 diabetes. Results, published in 2022 in Diabetes Care, showed that after 90 days, people using the app had an average incremental reduction in A1c of 0.39 percentage points, compared with control patients who didn’t use the app, the primary endpoint. Use of the app also appeared safe.

Subsequent meeting presentations of study findings showed that A1c-lowering linked with app use was durable during continued use for a total of 180 days, that the effectiveness of the app in helping to lower A1c levels was “dose dependent” relative to the number of lessons a person completed, and that using the app significantly linked with a reduced need for intensified glycemic control through added medications.

Another finding of the extended-use phase of the study was that 81% of patients assigned to the app-using group continued to regularly use the app after 180 days, a level of durable engagement by patients that “exceeded our expectations,” said Diane Gomez-Thinnes, chief commercial officer of Better Therapeutics, during a press conference.

The company plans to tweak the app prior to its launch based on additional analyses of results from the pivotal study to further improve patient engagement and app ease of use. The company is also planning to expand the range of smartphones that can support the app, although about 90%-95% of U.S. smartphones have this capability.

Better Therapeutics is also actively developing and testing other modifications to the basic CBT app to make it usable by people with other cardiometabolic disorders such as hypertension, obesity, and fatty liver disease.

The BT-001 study was funded by Better Therapeutics.

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

A smartphone-based app designed to deliver cognitive-behavioral therapy (CBT) to adults with type 2 diabetes received marketing approval as a class II medical device from the Food and Drug Administration on July 10, becoming the first digital behavioral therapeutic device for people with diabetes to receive this designation for U.S. patients.
 

Better Therapeutics representatives said that the app, formerly known as BT-001, will be called AspyreRX, with U.S. sales planned to launch in October-December 2023.

The app will be available to patients exclusively by prescription, with a planned 90-day use duration and an option for a second 90-day prescription. A company official said the price per prescription will be about $500-800, although this is not yet finalized. The app is intended for use in concert with the conventional pillars of glycemic control in people with type 2 diabetes: lifestyle modification and treatment with antidiabetes medications.

Senior staff members of Better Therapeutics acknowledged the critical need for an education program, which they will now launch for clinicians, payers, and patients to get across the message of the potential benefit and safety associated with using the CBT app. Their initial marketing will target patients with type 2 diabetes and poorly controlled hemoglobin A1c levels in five to six U.S. regions with high numbers of these patients. The company will also attempt to make the app available through the Department of Veterans Affairs health system and try to secure coverage by Medicare and commercial health-insurance providers.
 

Approval based on pivotal trial results

The FDA approval focused on data collected in the BT-001 randomized, controlled trial, which included 669 U.S. adults with poorly controlled type 2 diabetes. Results, published in 2022 in Diabetes Care, showed that after 90 days, people using the app had an average incremental reduction in A1c of 0.39 percentage points, compared with control patients who didn’t use the app, the primary endpoint. Use of the app also appeared safe.

Subsequent meeting presentations of study findings showed that A1c-lowering linked with app use was durable during continued use for a total of 180 days, that the effectiveness of the app in helping to lower A1c levels was “dose dependent” relative to the number of lessons a person completed, and that using the app significantly linked with a reduced need for intensified glycemic control through added medications.

Another finding of the extended-use phase of the study was that 81% of patients assigned to the app-using group continued to regularly use the app after 180 days, a level of durable engagement by patients that “exceeded our expectations,” said Diane Gomez-Thinnes, chief commercial officer of Better Therapeutics, during a press conference.

The company plans to tweak the app prior to its launch based on additional analyses of results from the pivotal study to further improve patient engagement and app ease of use. The company is also planning to expand the range of smartphones that can support the app, although about 90%-95% of U.S. smartphones have this capability.

Better Therapeutics is also actively developing and testing other modifications to the basic CBT app to make it usable by people with other cardiometabolic disorders such as hypertension, obesity, and fatty liver disease.

The BT-001 study was funded by Better Therapeutics.

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

SAN DIEGO – The landmark Diabetes Control and Complications Trial (DCCT) follow-up study has entered a new phase, focusing on a relatively recent phenomenon: aging in type 1 diabetes.

New funding for 2022-2027 for the DCCT long-term observational follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC) will go toward investigating aspects of type 1 diabetes that are associated with aging and are also common in type 2 diabetes, including cardiovascular disease, fatty liver disease, and sleep apnea.

The original randomized DCCT clinical trial results, published in 1993 in the New England Journal of Medicine, proved that early intensive glycemic control was the key to preventing or slowing the progression of long-term eye, kidney, and nerve complications of type 1 diabetes. Subsequently, EDIC has yielded many more major findings including that early tight glycemic control also reduces cardiovascular risk and prolongs survival in type 1 diabetes.

And although the phenomenon of metabolic memory initially seen in EDIC means that early glycemic control is important, subsequent EDIC data also have suggested that it is never too late to initiate intensive glycemic control, speakers emphasized during a special symposium commemorating 40 years since the start of DCCT, held during the annual scientific sessions of the American Diabetes Association. As with the 30-year DCCT/EDIC commemorative symposium held in 2013, local study participants were in the audience and were acknowledged with long applause.

Together, DCCT and EDIC – both funded by the National Institutes of Health at 27 sites in the United States and Canada – have changed the standard of care for people with type 1 diabetes and continue to inform clinical practice. Prior to the DCCT, between 1930 and 1970, about a third of people with type 1 diabetes developed vision loss and one in five experienced kidney failure and/or myocardial infarction. Stroke and amputation were also common, DCCT/EDIC chair David M. Nathan, MD, said while introducing the symposium.

“All of the advances in care of type 1 diabetes have developed because this study demonstrated that it was important – continuous glucose monitoring (CGM), new insulins, better [insulin] pumps. ... I think the most profound finding is that mortality in our intensively treated cohort is the same as in the general population. That says it all,” Dr. Nathan said in an interview.

And now, “what we still have yet to contribute is what happens to type 1 diabetes as people get older,” added Dr. Nathan, a professor of medicine at Harvard Medical School and director of the Diabetes Center at Massachusetts General Hospital, both in Boston.
 

‘Something that heretofore none of us could have imagined’

The 1,441 DCCT participants had a mean age of 27 years at baseline in 1983, when they were randomized to intensive insulin therapy or usual care. The 1,375 participants (96%) who continued into EDIC in 1994 were an average of 35 years old at that point, when the usual care group was taught intensive glycemic management and all participants returned to their personal health care teams. The 1,075 participants in EDIC today are an average age of 63 years.

Only 11 participants had died at the start of EDIC, and just 250 (17%) have died as of 2023, said study coordinator cochair Gayle Lorenzi, RN, who is a certified diabetes care and education specialist at the University of California, San Diego.

“DCCT/EDIC because of its longevity represents a unique opportunity to explore aging in long duration of type 1 diabetes, something that heretofore none of us could have imagined, especially for those of you in the audience who started your careers in the 70s and 80s,” Ms. Lorenzi commented.

About 36% of the cohort now has overweight and 40% have obesity, mirroring the general population. And they now have a mean hemoglobin A1c of 7.3%.

According to Barbara H. Braffett, PhD, co–principal investigator at the DCCT/EDIC data coordinating center: “The EDIC study is now shifting its focus during the next 5 years to understand the clinical course of type 1 diabetes in the setting of advancing duration and age, as well as increasing adiposity, which has progressively affected individuals with type 1 diabetes and has potential long-term adverse consequences.”

Dr. Braffett outlined the new study approaches added in 2022-2027. Cardiopulmonary exercise testing, two-dimensional Doppler echocardiography, and carotid-femoral pulse wave velocity will be used to quantify functional and structural changes central to heart failure.

Dr. Nathan commented that, although enough cardiovascular events were available in EDIC by 2006 to demonstrate a significant 58% reduction in the intensive therapy group, “now we can start looking at the aging heart. We have a bunch of great cardiologists working with us who will be guiding us on measuring everything.”

Fatty liver disease in the setting of increasing adiposity will also be investigated using transient elastography (FibroScan) and the Fibrosis-4 index, a quantification of liver enzymes and platelet count.

Dr. Nathan noted that the study participants have had “this kind of funny metabolic milieu in their liver for decades. They don’t make insulin in their pancreas, and therefore, the insulin they get is peripheral and then it goes to their liver. Well, what does that do to them?”

Participants will also complete three symptom questionnaires assessing obstructive sleep apnea, aimed at guiding future sleep studies in those found to be at high risk, Dr. Braffett said.
 

DCCT/EDIC over 40 years: ‘Incredibly complete picture’

As of 2023, the DCCT/EDIC participants have been studied for longer than 60% of their lifespans and for over 80% of their diabetes duration, Dr. Braffett noted.

During the EDIC 2017-2022 cycle, Dr. Braffett and other speakers summarized, prior EDIC efforts had focused on aspects of cognitive function, physical function, and cheiroarthropathy.

Other DCCT/EDIC studies examined the relationship of A1c and diabetes duration in cardiovascular disease risk, the association of microvascular complications with the risk of cardiovascular disease beyond traditional risk factors, and the risk of severe hypoglycemia over the first 30 years of DCCT/EDIC follow-up.

Moreover, the longitudinal eye and kidney assessments over the 40 years have informed screening guidelines for retinopathy and urinary albumin.

Dr. Nathan said: “Today, the number with horrible complications is very few, but we haven’t erased complications entirely. ... We have this incredibly complete picture of type 1 diabetes that allows us to explore everything. We welcome people to come to us with ideas. That’s the value of this research.”

Dr. Nathan, Ms. Lorenzi, and Dr. Braffett reported no relevant financial relationships.

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

SAN DIEGO – The landmark Diabetes Control and Complications Trial (DCCT) follow-up study has entered a new phase, focusing on a relatively recent phenomenon: aging in type 1 diabetes.

New funding for 2022-2027 for the DCCT long-term observational follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC) will go toward investigating aspects of type 1 diabetes that are associated with aging and are also common in type 2 diabetes, including cardiovascular disease, fatty liver disease, and sleep apnea.

The original randomized DCCT clinical trial results, published in 1993 in the New England Journal of Medicine, proved that early intensive glycemic control was the key to preventing or slowing the progression of long-term eye, kidney, and nerve complications of type 1 diabetes. Subsequently, EDIC has yielded many more major findings including that early tight glycemic control also reduces cardiovascular risk and prolongs survival in type 1 diabetes.

And although the phenomenon of metabolic memory initially seen in EDIC means that early glycemic control is important, subsequent EDIC data also have suggested that it is never too late to initiate intensive glycemic control, speakers emphasized during a special symposium commemorating 40 years since the start of DCCT, held during the annual scientific sessions of the American Diabetes Association. As with the 30-year DCCT/EDIC commemorative symposium held in 2013, local study participants were in the audience and were acknowledged with long applause.

Together, DCCT and EDIC – both funded by the National Institutes of Health at 27 sites in the United States and Canada – have changed the standard of care for people with type 1 diabetes and continue to inform clinical practice. Prior to the DCCT, between 1930 and 1970, about a third of people with type 1 diabetes developed vision loss and one in five experienced kidney failure and/or myocardial infarction. Stroke and amputation were also common, DCCT/EDIC chair David M. Nathan, MD, said while introducing the symposium.

“All of the advances in care of type 1 diabetes have developed because this study demonstrated that it was important – continuous glucose monitoring (CGM), new insulins, better [insulin] pumps. ... I think the most profound finding is that mortality in our intensively treated cohort is the same as in the general population. That says it all,” Dr. Nathan said in an interview.

And now, “what we still have yet to contribute is what happens to type 1 diabetes as people get older,” added Dr. Nathan, a professor of medicine at Harvard Medical School and director of the Diabetes Center at Massachusetts General Hospital, both in Boston.
 

‘Something that heretofore none of us could have imagined’

The 1,441 DCCT participants had a mean age of 27 years at baseline in 1983, when they were randomized to intensive insulin therapy or usual care. The 1,375 participants (96%) who continued into EDIC in 1994 were an average of 35 years old at that point, when the usual care group was taught intensive glycemic management and all participants returned to their personal health care teams. The 1,075 participants in EDIC today are an average age of 63 years.

Only 11 participants had died at the start of EDIC, and just 250 (17%) have died as of 2023, said study coordinator cochair Gayle Lorenzi, RN, who is a certified diabetes care and education specialist at the University of California, San Diego.

“DCCT/EDIC because of its longevity represents a unique opportunity to explore aging in long duration of type 1 diabetes, something that heretofore none of us could have imagined, especially for those of you in the audience who started your careers in the 70s and 80s,” Ms. Lorenzi commented.

About 36% of the cohort now has overweight and 40% have obesity, mirroring the general population. And they now have a mean hemoglobin A1c of 7.3%.

According to Barbara H. Braffett, PhD, co–principal investigator at the DCCT/EDIC data coordinating center: “The EDIC study is now shifting its focus during the next 5 years to understand the clinical course of type 1 diabetes in the setting of advancing duration and age, as well as increasing adiposity, which has progressively affected individuals with type 1 diabetes and has potential long-term adverse consequences.”

Dr. Braffett outlined the new study approaches added in 2022-2027. Cardiopulmonary exercise testing, two-dimensional Doppler echocardiography, and carotid-femoral pulse wave velocity will be used to quantify functional and structural changes central to heart failure.

Dr. Nathan commented that, although enough cardiovascular events were available in EDIC by 2006 to demonstrate a significant 58% reduction in the intensive therapy group, “now we can start looking at the aging heart. We have a bunch of great cardiologists working with us who will be guiding us on measuring everything.”

Fatty liver disease in the setting of increasing adiposity will also be investigated using transient elastography (FibroScan) and the Fibrosis-4 index, a quantification of liver enzymes and platelet count.

Dr. Nathan noted that the study participants have had “this kind of funny metabolic milieu in their liver for decades. They don’t make insulin in their pancreas, and therefore, the insulin they get is peripheral and then it goes to their liver. Well, what does that do to them?”

Participants will also complete three symptom questionnaires assessing obstructive sleep apnea, aimed at guiding future sleep studies in those found to be at high risk, Dr. Braffett said.
 

DCCT/EDIC over 40 years: ‘Incredibly complete picture’

As of 2023, the DCCT/EDIC participants have been studied for longer than 60% of their lifespans and for over 80% of their diabetes duration, Dr. Braffett noted.

During the EDIC 2017-2022 cycle, Dr. Braffett and other speakers summarized, prior EDIC efforts had focused on aspects of cognitive function, physical function, and cheiroarthropathy.

Other DCCT/EDIC studies examined the relationship of A1c and diabetes duration in cardiovascular disease risk, the association of microvascular complications with the risk of cardiovascular disease beyond traditional risk factors, and the risk of severe hypoglycemia over the first 30 years of DCCT/EDIC follow-up.

Moreover, the longitudinal eye and kidney assessments over the 40 years have informed screening guidelines for retinopathy and urinary albumin.

Dr. Nathan said: “Today, the number with horrible complications is very few, but we haven’t erased complications entirely. ... We have this incredibly complete picture of type 1 diabetes that allows us to explore everything. We welcome people to come to us with ideas. That’s the value of this research.”

Dr. Nathan, Ms. Lorenzi, and Dr. Braffett reported no relevant financial relationships.

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

SAN DIEGO – The landmark Diabetes Control and Complications Trial (DCCT) follow-up study has entered a new phase, focusing on a relatively recent phenomenon: aging in type 1 diabetes.

New funding for 2022-2027 for the DCCT long-term observational follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC) will go toward investigating aspects of type 1 diabetes that are associated with aging and are also common in type 2 diabetes, including cardiovascular disease, fatty liver disease, and sleep apnea.

The original randomized DCCT clinical trial results, published in 1993 in the New England Journal of Medicine, proved that early intensive glycemic control was the key to preventing or slowing the progression of long-term eye, kidney, and nerve complications of type 1 diabetes. Subsequently, EDIC has yielded many more major findings including that early tight glycemic control also reduces cardiovascular risk and prolongs survival in type 1 diabetes.

And although the phenomenon of metabolic memory initially seen in EDIC means that early glycemic control is important, subsequent EDIC data also have suggested that it is never too late to initiate intensive glycemic control, speakers emphasized during a special symposium commemorating 40 years since the start of DCCT, held during the annual scientific sessions of the American Diabetes Association. As with the 30-year DCCT/EDIC commemorative symposium held in 2013, local study participants were in the audience and were acknowledged with long applause.

Together, DCCT and EDIC – both funded by the National Institutes of Health at 27 sites in the United States and Canada – have changed the standard of care for people with type 1 diabetes and continue to inform clinical practice. Prior to the DCCT, between 1930 and 1970, about a third of people with type 1 diabetes developed vision loss and one in five experienced kidney failure and/or myocardial infarction. Stroke and amputation were also common, DCCT/EDIC chair David M. Nathan, MD, said while introducing the symposium.

“All of the advances in care of type 1 diabetes have developed because this study demonstrated that it was important – continuous glucose monitoring (CGM), new insulins, better [insulin] pumps. ... I think the most profound finding is that mortality in our intensively treated cohort is the same as in the general population. That says it all,” Dr. Nathan said in an interview.

And now, “what we still have yet to contribute is what happens to type 1 diabetes as people get older,” added Dr. Nathan, a professor of medicine at Harvard Medical School and director of the Diabetes Center at Massachusetts General Hospital, both in Boston.
 

‘Something that heretofore none of us could have imagined’

The 1,441 DCCT participants had a mean age of 27 years at baseline in 1983, when they were randomized to intensive insulin therapy or usual care. The 1,375 participants (96%) who continued into EDIC in 1994 were an average of 35 years old at that point, when the usual care group was taught intensive glycemic management and all participants returned to their personal health care teams. The 1,075 participants in EDIC today are an average age of 63 years.

Only 11 participants had died at the start of EDIC, and just 250 (17%) have died as of 2023, said study coordinator cochair Gayle Lorenzi, RN, who is a certified diabetes care and education specialist at the University of California, San Diego.

“DCCT/EDIC because of its longevity represents a unique opportunity to explore aging in long duration of type 1 diabetes, something that heretofore none of us could have imagined, especially for those of you in the audience who started your careers in the 70s and 80s,” Ms. Lorenzi commented.

About 36% of the cohort now has overweight and 40% have obesity, mirroring the general population. And they now have a mean hemoglobin A1c of 7.3%.

According to Barbara H. Braffett, PhD, co–principal investigator at the DCCT/EDIC data coordinating center: “The EDIC study is now shifting its focus during the next 5 years to understand the clinical course of type 1 diabetes in the setting of advancing duration and age, as well as increasing adiposity, which has progressively affected individuals with type 1 diabetes and has potential long-term adverse consequences.”

Dr. Braffett outlined the new study approaches added in 2022-2027. Cardiopulmonary exercise testing, two-dimensional Doppler echocardiography, and carotid-femoral pulse wave velocity will be used to quantify functional and structural changes central to heart failure.

Dr. Nathan commented that, although enough cardiovascular events were available in EDIC by 2006 to demonstrate a significant 58% reduction in the intensive therapy group, “now we can start looking at the aging heart. We have a bunch of great cardiologists working with us who will be guiding us on measuring everything.”

Fatty liver disease in the setting of increasing adiposity will also be investigated using transient elastography (FibroScan) and the Fibrosis-4 index, a quantification of liver enzymes and platelet count.

Dr. Nathan noted that the study participants have had “this kind of funny metabolic milieu in their liver for decades. They don’t make insulin in their pancreas, and therefore, the insulin they get is peripheral and then it goes to their liver. Well, what does that do to them?”

Participants will also complete three symptom questionnaires assessing obstructive sleep apnea, aimed at guiding future sleep studies in those found to be at high risk, Dr. Braffett said.
 

DCCT/EDIC over 40 years: ‘Incredibly complete picture’

As of 2023, the DCCT/EDIC participants have been studied for longer than 60% of their lifespans and for over 80% of their diabetes duration, Dr. Braffett noted.

During the EDIC 2017-2022 cycle, Dr. Braffett and other speakers summarized, prior EDIC efforts had focused on aspects of cognitive function, physical function, and cheiroarthropathy.

Other DCCT/EDIC studies examined the relationship of A1c and diabetes duration in cardiovascular disease risk, the association of microvascular complications with the risk of cardiovascular disease beyond traditional risk factors, and the risk of severe hypoglycemia over the first 30 years of DCCT/EDIC follow-up.

Moreover, the longitudinal eye and kidney assessments over the 40 years have informed screening guidelines for retinopathy and urinary albumin.

Dr. Nathan said: “Today, the number with horrible complications is very few, but we haven’t erased complications entirely. ... We have this incredibly complete picture of type 1 diabetes that allows us to explore everything. We welcome people to come to us with ideas. That’s the value of this research.”

Dr. Nathan, Ms. Lorenzi, and Dr. Braffett reported no relevant financial relationships.

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

This transcript has been edited for clarity.

At ENDO 2023, I presented our systematic review and meta-analysis related to body image concerns in women and individuals with polycystic ovary syndrome (PCOS). PCOS is the most common endocrine condition affecting women worldwide. It’s as common as 10%-15%.

Previously thought to be a benign condition affecting a small proportion of women of reproductive age, it’s changed now. It affects women of all ages, all ethnicities, and throughout the world. Body image concern is an area where one feels uncomfortable with how they look and how they feel. Someone might wonder, why worry about body image concerns? When people have body image concerns, it leads to low self-esteem.

Low self-esteem can lead to depression and anxiety, eventually making you a not-so-productive member of society. Several studies have also shown that body image concerns can lead to eating disorders such as anorexia and bulimia, which can be life threatening. Several studies in the past have shown there is a link between PCOS and body image concerns, but what exactly is the link? We don’t know. How big is the problem? We didn’t know until now.

To answer this, we looked at everything published about PCOS and body image concerns together, be it a randomized study, a cluster study, or any kind of study. We put them all into one place and studied them for evidence. The second objective of our work was that we wanted to share any evidence with the international PCOS guidelines group, who are currently reviewing and revising the guidelines for 2023.

We looked at all the major scientific databases, such as PubMed, PubMed Central, and Medline, for any study that’s been published for polycystic ovary syndrome and body image concerns where they specifically used a validated questionnaire – that’s important, and I’ll come back to that later.

We found 6,221 articles on an initial search. After meticulously looking through all of them, we narrowed it down to 9 articles that were relevant to our work. That’s going from 6,221 articles to 9, which were reviewed by 2 independent researchers. If there was any conflict between them, a third independent researcher resolved the conflict.

We found some studies had used the same questionnaires and some had their own questionnaire. We combined the studies where they used the same questionnaire and we did what we call a meta-analysis. We used their data and combined them to find an additional analysis, which is a combination of the two.

The two most commonly used questionnaires were the Multidimensional Body-Self Relations Questionnaire (MBSRQ) survey and the Body-Esteem Scale for Adolescents and Adults (BESAA). I’m not going into detail, but in simplest terms, the MBSRQ has 69 questions, which breaks down into 5 subscales, and BESAA has 3 subscales, which has 23 questions.

When we combined the results in the MBSRQ questionnaire, women with PCOS fared worse in all the subscales, showing there is a concern about body image in women with PCOS when compared with their colleagues who are healthy and do not have PCOS.

With BESAA, we found a little bit of a mixed picture. There was still a significant difference about weight perception, but how they felt and how they attributed, there was no significant difference. Probably the main reason was that only two studies used it and there was a smaller number of people involved in the study.

Why is this important? This is the first systematic search on body image concerns in PCOS. We feel that by identifying or diagnosing body image concerns, we will be addressing patient concerns. That is important because we clinicians have our own thoughts of what we need to do to help women with PCOS to prevent long-term risk, but it’s also important to talk to the person sitting in front of you right now. What is their concern?

There’s also been a generational shift where women with PCOS used say, “Oh, I’m worried that I can’t have a kid,” to now say, “I’m worried that I don’t feel well about myself.” We need to address that.

When we shared these findings with the international PCOS guidelines, they said we should probably approach this on an individual case-by-case basis because it will mean that the length of consultation might increase if we spend time with body image concerns.

This is where questionnaires come into play. With a validated questionnaire, a person can complete that before they come into the consultation, thereby minimizing the amount of time spent. If they’re not scoring high on the questionnaire, we don’t need to address that. If they are scoring high, then it can be picked up as a topic to discuss.

As I mentioned, there are a couple of limitations, one being the fewer studies and lower numbers of people in the studies. We need to address this in the future.

Long story short, at the moment, there is evidence to say that body image concerns are quite significantly high in women and individuals with PCOS. This is something we need to address as soon as possible.

We are planning future work to understand how social media comes into play, how society influences body image, and how health care professionals across the world are addressing PCOS and body image concerns. Hopefully, we will be able to share these findings in the near future. Thank you.

Dr. Kempegowda is assistant professor in endocrinology, diabetes, and general medicine at the Institute of Applied Health Research, University of Birmingham, and a consultant in endocrinology, diabetes and acute medicine, Queen Elizabeth Hospital, Birmingham, England, and disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

At ENDO 2023, I presented our systematic review and meta-analysis related to body image concerns in women and individuals with polycystic ovary syndrome (PCOS). PCOS is the most common endocrine condition affecting women worldwide. It’s as common as 10%-15%.

Previously thought to be a benign condition affecting a small proportion of women of reproductive age, it’s changed now. It affects women of all ages, all ethnicities, and throughout the world. Body image concern is an area where one feels uncomfortable with how they look and how they feel. Someone might wonder, why worry about body image concerns? When people have body image concerns, it leads to low self-esteem.

Low self-esteem can lead to depression and anxiety, eventually making you a not-so-productive member of society. Several studies have also shown that body image concerns can lead to eating disorders such as anorexia and bulimia, which can be life threatening. Several studies in the past have shown there is a link between PCOS and body image concerns, but what exactly is the link? We don’t know. How big is the problem? We didn’t know until now.

To answer this, we looked at everything published about PCOS and body image concerns together, be it a randomized study, a cluster study, or any kind of study. We put them all into one place and studied them for evidence. The second objective of our work was that we wanted to share any evidence with the international PCOS guidelines group, who are currently reviewing and revising the guidelines for 2023.

We looked at all the major scientific databases, such as PubMed, PubMed Central, and Medline, for any study that’s been published for polycystic ovary syndrome and body image concerns where they specifically used a validated questionnaire – that’s important, and I’ll come back to that later.

We found 6,221 articles on an initial search. After meticulously looking through all of them, we narrowed it down to 9 articles that were relevant to our work. That’s going from 6,221 articles to 9, which were reviewed by 2 independent researchers. If there was any conflict between them, a third independent researcher resolved the conflict.

We found some studies had used the same questionnaires and some had their own questionnaire. We combined the studies where they used the same questionnaire and we did what we call a meta-analysis. We used their data and combined them to find an additional analysis, which is a combination of the two.

The two most commonly used questionnaires were the Multidimensional Body-Self Relations Questionnaire (MBSRQ) survey and the Body-Esteem Scale for Adolescents and Adults (BESAA). I’m not going into detail, but in simplest terms, the MBSRQ has 69 questions, which breaks down into 5 subscales, and BESAA has 3 subscales, which has 23 questions.

When we combined the results in the MBSRQ questionnaire, women with PCOS fared worse in all the subscales, showing there is a concern about body image in women with PCOS when compared with their colleagues who are healthy and do not have PCOS.

With BESAA, we found a little bit of a mixed picture. There was still a significant difference about weight perception, but how they felt and how they attributed, there was no significant difference. Probably the main reason was that only two studies used it and there was a smaller number of people involved in the study.

Why is this important? This is the first systematic search on body image concerns in PCOS. We feel that by identifying or diagnosing body image concerns, we will be addressing patient concerns. That is important because we clinicians have our own thoughts of what we need to do to help women with PCOS to prevent long-term risk, but it’s also important to talk to the person sitting in front of you right now. What is their concern?

There’s also been a generational shift where women with PCOS used say, “Oh, I’m worried that I can’t have a kid,” to now say, “I’m worried that I don’t feel well about myself.” We need to address that.

When we shared these findings with the international PCOS guidelines, they said we should probably approach this on an individual case-by-case basis because it will mean that the length of consultation might increase if we spend time with body image concerns.

This is where questionnaires come into play. With a validated questionnaire, a person can complete that before they come into the consultation, thereby minimizing the amount of time spent. If they’re not scoring high on the questionnaire, we don’t need to address that. If they are scoring high, then it can be picked up as a topic to discuss.

As I mentioned, there are a couple of limitations, one being the fewer studies and lower numbers of people in the studies. We need to address this in the future.

Long story short, at the moment, there is evidence to say that body image concerns are quite significantly high in women and individuals with PCOS. This is something we need to address as soon as possible.

We are planning future work to understand how social media comes into play, how society influences body image, and how health care professionals across the world are addressing PCOS and body image concerns. Hopefully, we will be able to share these findings in the near future. Thank you.

Dr. Kempegowda is assistant professor in endocrinology, diabetes, and general medicine at the Institute of Applied Health Research, University of Birmingham, and a consultant in endocrinology, diabetes and acute medicine, Queen Elizabeth Hospital, Birmingham, England, and disclosed no relevant conflicts of interest.

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

This transcript has been edited for clarity.

At ENDO 2023, I presented our systematic review and meta-analysis related to body image concerns in women and individuals with polycystic ovary syndrome (PCOS). PCOS is the most common endocrine condition affecting women worldwide. It’s as common as 10%-15%.

Previously thought to be a benign condition affecting a small proportion of women of reproductive age, it’s changed now. It affects women of all ages, all ethnicities, and throughout the world. Body image concern is an area where one feels uncomfortable with how they look and how they feel. Someone might wonder, why worry about body image concerns? When people have body image concerns, it leads to low self-esteem.

Low self-esteem can lead to depression and anxiety, eventually making you a not-so-productive member of society. Several studies have also shown that body image concerns can lead to eating disorders such as anorexia and bulimia, which can be life threatening. Several studies in the past have shown there is a link between PCOS and body image concerns, but what exactly is the link? We don’t know. How big is the problem? We didn’t know until now.

To answer this, we looked at everything published about PCOS and body image concerns together, be it a randomized study, a cluster study, or any kind of study. We put them all into one place and studied them for evidence. The second objective of our work was that we wanted to share any evidence with the international PCOS guidelines group, who are currently reviewing and revising the guidelines for 2023.

We looked at all the major scientific databases, such as PubMed, PubMed Central, and Medline, for any study that’s been published for polycystic ovary syndrome and body image concerns where they specifically used a validated questionnaire – that’s important, and I’ll come back to that later.

We found 6,221 articles on an initial search. After meticulously looking through all of them, we narrowed it down to 9 articles that were relevant to our work. That’s going from 6,221 articles to 9, which were reviewed by 2 independent researchers. If there was any conflict between them, a third independent researcher resolved the conflict.

We found some studies had used the same questionnaires and some had their own questionnaire. We combined the studies where they used the same questionnaire and we did what we call a meta-analysis. We used their data and combined them to find an additional analysis, which is a combination of the two.

The two most commonly used questionnaires were the Multidimensional Body-Self Relations Questionnaire (MBSRQ) survey and the Body-Esteem Scale for Adolescents and Adults (BESAA). I’m not going into detail, but in simplest terms, the MBSRQ has 69 questions, which breaks down into 5 subscales, and BESAA has 3 subscales, which has 23 questions.

When we combined the results in the MBSRQ questionnaire, women with PCOS fared worse in all the subscales, showing there is a concern about body image in women with PCOS when compared with their colleagues who are healthy and do not have PCOS.

With BESAA, we found a little bit of a mixed picture. There was still a significant difference about weight perception, but how they felt and how they attributed, there was no significant difference. Probably the main reason was that only two studies used it and there was a smaller number of people involved in the study.

Why is this important? This is the first systematic search on body image concerns in PCOS. We feel that by identifying or diagnosing body image concerns, we will be addressing patient concerns. That is important because we clinicians have our own thoughts of what we need to do to help women with PCOS to prevent long-term risk, but it’s also important to talk to the person sitting in front of you right now. What is their concern?

There’s also been a generational shift where women with PCOS used say, “Oh, I’m worried that I can’t have a kid,” to now say, “I’m worried that I don’t feel well about myself.” We need to address that.

When we shared these findings with the international PCOS guidelines, they said we should probably approach this on an individual case-by-case basis because it will mean that the length of consultation might increase if we spend time with body image concerns.

This is where questionnaires come into play. With a validated questionnaire, a person can complete that before they come into the consultation, thereby minimizing the amount of time spent. If they’re not scoring high on the questionnaire, we don’t need to address that. If they are scoring high, then it can be picked up as a topic to discuss.

As I mentioned, there are a couple of limitations, one being the fewer studies and lower numbers of people in the studies. We need to address this in the future.

Long story short, at the moment, there is evidence to say that body image concerns are quite significantly high in women and individuals with PCOS. This is something we need to address as soon as possible.

We are planning future work to understand how social media comes into play, how society influences body image, and how health care professionals across the world are addressing PCOS and body image concerns. Hopefully, we will be able to share these findings in the near future. Thank you.

Dr. Kempegowda is assistant professor in endocrinology, diabetes, and general medicine at the Institute of Applied Health Research, University of Birmingham, and a consultant in endocrinology, diabetes and acute medicine, Queen Elizabeth Hospital, Birmingham, England, and disclosed no relevant conflicts of interest.

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

The Food and Drug Administration has approved a labeling update for the injectable LDL cholesterol–lowering agent inclisiran (Leqvio) that expands its indications to include primary prevention for patients with elevated LDL cholesterol, Novartis has announced.

The first-in-class small interfering RNA (siRNA) agent was approved in 2021 as an adjunct to statins for patients with clinical cardiovascular disease or heterozygous familial hypercholesterolemia. The indications now include patients taking statins for primary dyslipidemia who have high-risk comorbidities such as diabetes but who do not have a history of cardiovascular events, the company said.

Inclisiran, with a mechanism of action unique among drugs for dyslipidemia, works by “silencing” RNA involved in the synthesis of proprotein convertase subtilisin/kexin type 9. The protein helps regulate the number of LDL cholesterol cell-surface receptors.

Novartis said it has “global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved a labeling update for the injectable LDL cholesterol–lowering agent inclisiran (Leqvio) that expands its indications to include primary prevention for patients with elevated LDL cholesterol, Novartis has announced.

The first-in-class small interfering RNA (siRNA) agent was approved in 2021 as an adjunct to statins for patients with clinical cardiovascular disease or heterozygous familial hypercholesterolemia. The indications now include patients taking statins for primary dyslipidemia who have high-risk comorbidities such as diabetes but who do not have a history of cardiovascular events, the company said.

Inclisiran, with a mechanism of action unique among drugs for dyslipidemia, works by “silencing” RNA involved in the synthesis of proprotein convertase subtilisin/kexin type 9. The protein helps regulate the number of LDL cholesterol cell-surface receptors.

Novartis said it has “global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved a labeling update for the injectable LDL cholesterol–lowering agent inclisiran (Leqvio) that expands its indications to include primary prevention for patients with elevated LDL cholesterol, Novartis has announced.

The first-in-class small interfering RNA (siRNA) agent was approved in 2021 as an adjunct to statins for patients with clinical cardiovascular disease or heterozygous familial hypercholesterolemia. The indications now include patients taking statins for primary dyslipidemia who have high-risk comorbidities such as diabetes but who do not have a history of cardiovascular events, the company said.

Inclisiran, with a mechanism of action unique among drugs for dyslipidemia, works by “silencing” RNA involved in the synthesis of proprotein convertase subtilisin/kexin type 9. The protein helps regulate the number of LDL cholesterol cell-surface receptors.

Novartis said it has “global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

A teenager who weighed 300 lb and was homeschooled because he was too big to fit in a classroom chair is among the patients Manal Habib, MD, has seen in her pediatric endocrinology practice.

The boy, a social butterfly who hated isolation and blamed himself for his “poor choices,” turned out to have an MC4R mutation that interfered with proper metabolism and satiation signals.

“People often blame obese and overweight people for not having enough willpower, but it’s often a physiological problem,” said Dr. Habib, who works at the University of California, Los Angeles.

She is among the clinicians offering more aggressive forms of weight management, prescribing medications, including metformin, semaglutide, and liraglutide – often off-label – to help children and teens with obesity who do not respond to lifestyle changes.

The results of intensive interventions can be life-changing: The teen Dr. Habib treated is back at school, playing sports, and no longer needs drugs to reduce cholesterol and blood pressure. He now takes a low maintenance dose of a weight-loss medication.

But the long-term effects of these new agents on children and teens are poorly understood, and both medication and surgery are associated with significant complications. Pediatricians treating kids pre- or post-intervention should be alert to a range of physical, psychological, and behavioral risks and complications.
 

Keeping bones healthy

Pediatricians should be aware of the risk to bone health in patients who undergo surgery, according to Misra Madhusmita, MD, chief of pediatric endocrinology at Massachusetts General Hospital in Boston. In a recent study, Dr. Madhusmita and her colleagues found that sleeve gastrectomy reduced vertebral bone strength in adolescents and young adults.

“This is a time of life when bone mass is typically accruing rapidly,” Dr. Madhusmita told this news organization. “A deleterious effect on bone accrual at this time of life raises concerns about suboptimal acquisition of peak bone mass, which is typically attained in early adult life and is a key factor determining bone health and fracture risk in later life.”

Reduced skeletal loading and muscle mass can weaken bones, as can malabsorption of nutrients. Fat loss can trigger lower levels of bioavailable androgens and their subsequent conversion to estrogen, negatively affecting bone density. And sleeve gastrectomy in particular lowers ghrelin, another hormone influencing skeletal health.

Clinicians should advise patients who have had surgery to follow a healthy diet and consume sufficient levels of calcium and vitamin D, said Dr. Madhusmita. Weight-bearing exercises, weight training, and resistance training are also imperative to build bone mass and muscle. Any preexisting conditions or lifestyle factors that weaken the bones should be taken into consideration.
 

Managing expectations

The long-term effects of weight loss medications on children are less documented than with surgery, according to Caren Mangarelli, MD, a former primary care physician who is now medical director of both the adolescent bariatric program and the children’s wellness and weight management clinic at Lurie Children’s Hospital in Chicago, Ill.

But one significant known risk is the potential for rebound weight gain and the complications like high blood pressure and high blood sugar that go with it if the patient stops medication. Dr. Mangarelli said that many clinicians lack the training required to safely facilitate weight loss medications for kids.

“We have to remember that obesity is a chronic disease, especially for those with more severe forms,” she said. “They’re not likely to outgrow it. It’s not like, ‘Oh, we’ll just put a patient on medication, they’ll lose weight, and we’ll take them off of it,’ because you could create a bad cycle of losing weight, followed by metabolism slowing down, hunger cues going up, and weight going back up.”

Making the risks of stopping medication clear and supporting compliance are essential, especially when it comes to injectables like semaglutide, which can be more burdensome than taking pills, requiring weekly subcutaneous injections. Pediatricians should ensure that families understand that medication is a long-term solution, Dr. Habib said.

Many families and patients “want a quick result. They’re focused on a specific size or weight, and they want to take the medication for a short period without changing anything else,” Dr. Habib said.

But children with genetic abnormalities or severe obesity could be on medication for their entire lives. Patients who make significant healthy lifestyle changes have a greater chance of weaning off drug therapy.

But “it’s hard with children because they’re dependent on their family,” Dr. Habib said. “One of the first things that I talk about with families is that it’s very important for everyone to be involved in making healthy changes, especially the parents, because the kids are going to follow their lifestyle and choices, not necessarily what they tell them to do.”
 

The behavioral and mental

One of Dr. Habib’s most striking cases was a 6-year-old patient with autism spectrum disorder experiencing early-onset puberty. Her condition made it difficult for her parents to enforce behavioral and lifestyle changes, making medication the best option to normalize the young girl’s body.

“The goal in this case is not necessarily to help her lose weight, but to prevent her from having severe health risks at such a young age,” said Habib.

Though medication may be the best solution when other options have failed, the ease of using medication may mean clinicians fail to address the complex emotional and psychosocial factors that can both cause and result from obesity.

“A lot of families think that if just this one thing were better, everything else would fall into place,” Habib said. “But there often are multiple layers to treating the patient.”

According to Cambria Garrell, MD, a pediatrician at the UCLA Fit for Healthy Weight Program in Los Angeles, pediatricians should be aware of the psychosocial and mental health factors such as undiagnosed mental illness or family dysfunction.

Dr. Garrell sometimes cares for children with undiagnosed mental health disorders. Children with conditions like attention-deficit/hyperactivity disorder and autism spectrum disorders may struggle with eating because of impulse control and sensory processing issues. Family functioning, issues at school, and lack of sleep are also major contributors to obesity to screen for.

“We really like to think about the environmental and psychosocial factors contributing to obesity instead of just pathologizing the weight,” Dr. Garrell said.
 

Risk for alcohol abuse

Bariatric and metabolic surgeries are associated with an increased risk for alcohol use disorder (AUD). Pediatricians treating children pre- or post-op should ensure that patients receive behavioral and mental health services to minimize the risk for alcohol abuse.

The risk for AUD is likely the result of changes to the way the body metabolizes alcohol, resulting in heightened sensitivity to it, although research is not conclusive, according to Dr. Mangarelli.

The risk for AUD is likely multifactorial, Dr. Mangarelli said.

“We don’t totally understand all of it, but if you’re experiencing a high more easily, that may lead to misuse,” Dr. Mangarelli said. “It’s also important to remember that this population of patients has experienced stigma for a very long time, and they often have associated mental health and body image issues.”

“Those problems don’t disappear on their own,” she added. “You want to make sure that patients are hooked into behavioral and mental health services before surgery so that they have somebody who’s following them after surgery.”

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Legislators in New York City recently approved a bill specifically prohibiting weight- and height-based discrimination, on par with existing protections for gender, race, sexual orientation, and other personal identities. Other U.S. cities, as well as New York state, are considering similar moves.

Weight-based discrimination in the United States has increased by an estimated 66% over the past decade, putting it on par with the prevalence of racial discrimination. More than 40% of adult Americans and 18% of children report experiencing weight discrimination in employment, school, and/or health care settings – as well as within interpersonal relationships – demonstrating a clear need to have legal protections in place.

For obesity advocates in Canada, the news from New York triggered a moment of reflection to consider how our own advocacy efforts have fared over the years, or not. Just like in the United States, body size and obesity (and appearance in general) are not specifically protected grounds under human rights legislation in Canada (for example, the Canadian Human Rights Act), unlike race, gender, sexual orientation, and religion.

Case law is uneven across the Canadian provinces when it comes to determining whether obesity is even a disease and/or a disability. And despite broad support for anti–weight discrimination policies in Canada (Front Public Health. 2023 Apr 17;11:1060794; Milbank Q. 2015 Dec;93[4]:691-731), years of advocacy at the national and provincial levels have not led to any legislative changes (Ramos Salas Obes Rev. 2017 Nov;18[11]:1323-35; Can J Diabetes. 2015 Apr. doi: 10.1016/j.jcjd.2015.01.009). A 2017 private members bill seeking to add protection for body size to Manitoba’s human rights code was defeated, with many members of the legislature citing enforcement difficulties as the reason for voting down the proposition.

Some obesity advocates have argued that people living with obesity can be protected under the grounds of disability in the Canadian Human Rights Act. To be protected, however, individuals must demonstrate that there is actual or perceived disability relating to their weight or size; yet, many people living with obesity and those who have a higher weight don’t perceive themselves as having a disability.

In our view, the disparate viewpoints on the worthiness of considering body size a human rights issue could be resolved, at least partially, by wider understanding and adoption of the relatively new clinical definition of obesity. This definition holds that obesity is not about size; an obesity diagnosis can be made only when objective clinical investigations identify that excess or abnormal adiposity (fat tissue) impairs health.

While obesity advocates use the clinical definition of obesity, weight and body size proponents disagree that obesity is a chronic disease, and in fact believe that treating it as such can be stigmatizing. In a sense, this can sometimes be true, as not all people with larger bodies have obesity per the new definition but risk being identified as “unhealthy” in the clinical world. Bias, it turns out, can be a two-way street.

Regardless of the advocacy strategy used, it’s clear that specific anti–weight discrimination laws are needed in Canada. One in four Canadian adults report experiencing discrimination in their day-to-day life, with race, gender, age, and weight being the most commonly reported forms. To refuse to protect them against some, but not all, forms of discrimination is itself unjust, and is surely rooted in the age-old misinformed concept that excess weight is the result of laziness, poor food choices, and lack of physical activity, among other moral failings.

Including body size in human rights codes may provide a mechanism to seek legal remedy from discriminatory acts, but it will do little to address rampant weight bias, in the same way that race-based legal protections don’t eradicate racism. And it’s not just the legal community that fails to understand that weight is, by and large, a product of our environment and our genes. Weight bias and stigma are well documented in media, workplaces, the home, and in health care systems.

The solution, in our minds, is meaningful education across all these domains, reinforcing that weight is not a behavior, just as health is not a size. If we truly understand and embrace these concepts, then as a society we may someday recognize that body size is not a choice, just like race, sexual orientation, gender identity, and other individual characteristics. And if it’s not a choice, if it’s not a behavior, then it deserves the same protections.

At the same time, people with obesity deserve to seek evidence-based treatment, just as those at higher weights who experience no weight or adiposity-related health issues deserve not to be identified as having a disease simply because of their size.

If we all follow the science, we might yet turn a common understanding into more equitable outcomes for all.

Dr. Ramos Salas and Mr. Hussey are research consultants for Replica Communications, Hamilton, Ont. She disclosed ties with the Canadian Institutes of Health Research, European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, The Obesity Society, World Obesity, and the World Health Organization. Mr. Hussey disclosed ties with the European Association for the Study of Obesity, Novo Nordisk, Obesity Canada, and the World Health Organization (Nutrition and Food Safety).

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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

In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.

The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.

APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.

The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.

Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.

The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.  

“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.

Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”

“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.

Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.

The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”

The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.

While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.

In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.

Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.

A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.

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