Cardiology News

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

A new draft consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes (EASD) addresses diagnosis and management of type 1 diabetes in adults.  

The impetus for the document comes from the “highly influential” EASD-ADA consensus report on the management of type 2 diabetes, which led to the realization that a comparable document was needed for adults with type 1 diabetes, said writing panel cochair Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles.

“In recent years, there have been rapid advances in the treatment of type 1 diabetes together with a growing recognition of the psychosocial burden of living with [it],” Dr. Peters said.

She noted that although there is already some guidance available for the management of type 1 diabetes in adults, “this gets admixed into broader guidelines, and many of those are mostly derived from data in people with type 2 diabetes.”  

The new draft document was coauthored by 14 content experts in type 1 diabetes, with equal numbers from the United States and Europe.
 

We want to be helpful to clinicians

Topics covered include diagnosis of type 1 diabetes, goals of therapy and glycemic targets, schedule of care, diabetes self-management education and additional behavioral considerations, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis, pancreas and islet cell transplantation, adjunctive therapies, special populations (including pregnant women, older adults, and inpatient management), and emergent/future perspectives, including beta-cell replacement and immunotherapy.

At the end of the document are tables of glycemic targets for adults with type 1 diabetes, schedule of care, nonglycemic factors that alter A1c levels, standardized continuous glucose meter (CGM) metrics for clinical care, examples of subcutaneous insulin regimens, and the various properties of approved and nonapproved adjunctive therapies for type 1 diabetes, including metformin, pramlintide, GLP-1 agonists, and SGLT2 inhibitors.  

Several colorful flowcharts are also provided, including algorithms for diagnosing and managing type 1 diabetes in adults.

Document coauthor M. Sue Kirkman, MD, of the Diabetes Care Center’s Clinical Trials Unit at the University of North Carolina, Chapel Hill, told this news organization: “We want it to be helpful to clinicians who are diagnosing type 1 diabetes in adults or caring for adults with type 1 diabetes, whether diagnosed in childhood or adulthood.”

The authors presented an overview of the document in a symposium on June 28 at the virtual ADA scientific sessions. The final version will be presented Oct. 1 at the EASD 2021 annual meeting.

The draft document and video of the ADA meeting presentation are both available on the ADA website.
 

New algorithm to reduce misdiagnosis of type 1 diabetes in adults

Misdiagnosis of adult-onset type 1 diabetes is common, occurring in up to 40% of those who develop the condition after age 30 years, said J. Hans de Vries, MD, PhD, medical director, Profil Institute for Metabolic Research, Neuss, Germany.

There are multiple reasons for this, including the fact that obesity and type 2 diabetes are becoming more prevalent at younger ages, C-peptide levels may still be relatively high at the time of clinical type 1 diabetes onset, and islet autoantibodies don’t have 100% positive predictive value.

“No single feature confirms type 1 diabetes in isolation,” Dr. de Vries noted.

The document provides a detailed diagnostic algorithm specifically for adults in whom type 1 diabetes is suspected, starting with autoantibody measurement. If the diagnosis isn’t confirmed that way, the algorithm advises investigating for monogenic diabetes, including use of a maturity-onset diabetes of the young (MODY) calculator and subsequent C-peptide measurement.

Measurement of C-peptide is also recommended if the diabetes type is still uncertain more than 3 years after diabetes onset in those treated with insulin, because by that point it is likely to be <200 pmol/L in people with type 1 diabetes.  
 

Clear statements on diabetes technology, preferred insulins

The draft document clearly states that physiologic insulin replacement using a pump or multiple daily injections, CGM, and analog rather than human insulin are standards of care for adults with type 1 diabetes. Use of hybrid closed-loop insulin delivery systems is advised when available, as they offer the “greatest benefits.”

However, the document also notes that in cases of cost barriers, subcutaneous regimens of human regular and NPH insulin may be used. It cautions, though, that these may result in higher glucose variability, higher risk of hypoglycemia, and less lifestyle flexibility.

Dr. Kirkman told this news organization: “Using human insulins such as NPH and Regular in type 1 diabetes is definitely not preferred, but sometimes due to people’s inability to afford analogs we have to use them. People need to know how to use them safely.”

As for the do-it-yourself insulin delivery systems, which many with type 1 diabetes now use with open-source software algorithms that reverse-engineer older pumps, the document advises that health care providers shouldn’t actively recommend them as they’re not approved by regulatory authorities, but should also “respect the individual’s right to make informed choices and continue to offer support,” Dr. Kirkman said when presenting the insulin therapy section.
 

Psychosocial aspects of type 1 diabetes ‘underappreciated’

Special emphasis is placed on psychosocial support, which may be overlooked in adults, Dr. Kirkman noted.

“Clinicians probably underappreciate what people with type 1 diabetes go through on a daily basis. A lot of the evidence out there regarding psychosocial issues is in children and families of children with type 1 diabetes, or in adults with type 2 diabetes ... Maximizing quality of life needs to be at the forefront of care, not just focusing on glycemic goals.”

Indeed, between 20% and 40% of people with type 1 diabetes experience diabetes-related emotional distress – including 15% with depression – particularly at the time of diagnosis and when complications develop, noted Frank J. Snoek, PhD, professor of medical psychology at Amsterdam University Medical Center, the Netherlands.

To address this, the draft advises that “self-management difficulties, psychological, and social problems” be screened periodically and monitored using validated screening tools.

“Health care providers should be proficient at asking questions about and discussing emotional health, psychological needs, and social challenges as part of the consultation,” Dr. Snoek said.

Dr. Peters disclosed ties with Abbott Diabetes Care, AstraZeneca, Lilly, Medscape, Novo Nordisk, Vertex, and Zealand, Omada, and Teladoc. Dr. Kirkman has received research support from Novo Nordisk and Bayer. Dr. de Vries disclosed ties with Adocia, Novo Nordisk, Zealand, Eli Lilly, and Afon Technology. Dr. Snoek reported ties with Roche Diabetes, Novo Nordisk, Sanofi, and Eli Lilly.

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

A new draft consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes (EASD) addresses diagnosis and management of type 1 diabetes in adults.  

The impetus for the document comes from the “highly influential” EASD-ADA consensus report on the management of type 2 diabetes, which led to the realization that a comparable document was needed for adults with type 1 diabetes, said writing panel cochair Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles.

“In recent years, there have been rapid advances in the treatment of type 1 diabetes together with a growing recognition of the psychosocial burden of living with [it],” Dr. Peters said.

She noted that although there is already some guidance available for the management of type 1 diabetes in adults, “this gets admixed into broader guidelines, and many of those are mostly derived from data in people with type 2 diabetes.”  

The new draft document was coauthored by 14 content experts in type 1 diabetes, with equal numbers from the United States and Europe.
 

We want to be helpful to clinicians

Topics covered include diagnosis of type 1 diabetes, goals of therapy and glycemic targets, schedule of care, diabetes self-management education and additional behavioral considerations, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis, pancreas and islet cell transplantation, adjunctive therapies, special populations (including pregnant women, older adults, and inpatient management), and emergent/future perspectives, including beta-cell replacement and immunotherapy.

At the end of the document are tables of glycemic targets for adults with type 1 diabetes, schedule of care, nonglycemic factors that alter A1c levels, standardized continuous glucose meter (CGM) metrics for clinical care, examples of subcutaneous insulin regimens, and the various properties of approved and nonapproved adjunctive therapies for type 1 diabetes, including metformin, pramlintide, GLP-1 agonists, and SGLT2 inhibitors.  

Several colorful flowcharts are also provided, including algorithms for diagnosing and managing type 1 diabetes in adults.

Document coauthor M. Sue Kirkman, MD, of the Diabetes Care Center’s Clinical Trials Unit at the University of North Carolina, Chapel Hill, told this news organization: “We want it to be helpful to clinicians who are diagnosing type 1 diabetes in adults or caring for adults with type 1 diabetes, whether diagnosed in childhood or adulthood.”

The authors presented an overview of the document in a symposium on June 28 at the virtual ADA scientific sessions. The final version will be presented Oct. 1 at the EASD 2021 annual meeting.

The draft document and video of the ADA meeting presentation are both available on the ADA website.
 

New algorithm to reduce misdiagnosis of type 1 diabetes in adults

Misdiagnosis of adult-onset type 1 diabetes is common, occurring in up to 40% of those who develop the condition after age 30 years, said J. Hans de Vries, MD, PhD, medical director, Profil Institute for Metabolic Research, Neuss, Germany.

There are multiple reasons for this, including the fact that obesity and type 2 diabetes are becoming more prevalent at younger ages, C-peptide levels may still be relatively high at the time of clinical type 1 diabetes onset, and islet autoantibodies don’t have 100% positive predictive value.

“No single feature confirms type 1 diabetes in isolation,” Dr. de Vries noted.

The document provides a detailed diagnostic algorithm specifically for adults in whom type 1 diabetes is suspected, starting with autoantibody measurement. If the diagnosis isn’t confirmed that way, the algorithm advises investigating for monogenic diabetes, including use of a maturity-onset diabetes of the young (MODY) calculator and subsequent C-peptide measurement.

Measurement of C-peptide is also recommended if the diabetes type is still uncertain more than 3 years after diabetes onset in those treated with insulin, because by that point it is likely to be <200 pmol/L in people with type 1 diabetes.  
 

Clear statements on diabetes technology, preferred insulins

The draft document clearly states that physiologic insulin replacement using a pump or multiple daily injections, CGM, and analog rather than human insulin are standards of care for adults with type 1 diabetes. Use of hybrid closed-loop insulin delivery systems is advised when available, as they offer the “greatest benefits.”

However, the document also notes that in cases of cost barriers, subcutaneous regimens of human regular and NPH insulin may be used. It cautions, though, that these may result in higher glucose variability, higher risk of hypoglycemia, and less lifestyle flexibility.

Dr. Kirkman told this news organization: “Using human insulins such as NPH and Regular in type 1 diabetes is definitely not preferred, but sometimes due to people’s inability to afford analogs we have to use them. People need to know how to use them safely.”

As for the do-it-yourself insulin delivery systems, which many with type 1 diabetes now use with open-source software algorithms that reverse-engineer older pumps, the document advises that health care providers shouldn’t actively recommend them as they’re not approved by regulatory authorities, but should also “respect the individual’s right to make informed choices and continue to offer support,” Dr. Kirkman said when presenting the insulin therapy section.
 

Psychosocial aspects of type 1 diabetes ‘underappreciated’

Special emphasis is placed on psychosocial support, which may be overlooked in adults, Dr. Kirkman noted.

“Clinicians probably underappreciate what people with type 1 diabetes go through on a daily basis. A lot of the evidence out there regarding psychosocial issues is in children and families of children with type 1 diabetes, or in adults with type 2 diabetes ... Maximizing quality of life needs to be at the forefront of care, not just focusing on glycemic goals.”

Indeed, between 20% and 40% of people with type 1 diabetes experience diabetes-related emotional distress – including 15% with depression – particularly at the time of diagnosis and when complications develop, noted Frank J. Snoek, PhD, professor of medical psychology at Amsterdam University Medical Center, the Netherlands.

To address this, the draft advises that “self-management difficulties, psychological, and social problems” be screened periodically and monitored using validated screening tools.

“Health care providers should be proficient at asking questions about and discussing emotional health, psychological needs, and social challenges as part of the consultation,” Dr. Snoek said.

Dr. Peters disclosed ties with Abbott Diabetes Care, AstraZeneca, Lilly, Medscape, Novo Nordisk, Vertex, and Zealand, Omada, and Teladoc. Dr. Kirkman has received research support from Novo Nordisk and Bayer. Dr. de Vries disclosed ties with Adocia, Novo Nordisk, Zealand, Eli Lilly, and Afon Technology. Dr. Snoek reported ties with Roche Diabetes, Novo Nordisk, Sanofi, and Eli Lilly.

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

A new draft consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes (EASD) addresses diagnosis and management of type 1 diabetes in adults.  

The impetus for the document comes from the “highly influential” EASD-ADA consensus report on the management of type 2 diabetes, which led to the realization that a comparable document was needed for adults with type 1 diabetes, said writing panel cochair Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles.

“In recent years, there have been rapid advances in the treatment of type 1 diabetes together with a growing recognition of the psychosocial burden of living with [it],” Dr. Peters said.

She noted that although there is already some guidance available for the management of type 1 diabetes in adults, “this gets admixed into broader guidelines, and many of those are mostly derived from data in people with type 2 diabetes.”  

The new draft document was coauthored by 14 content experts in type 1 diabetes, with equal numbers from the United States and Europe.
 

We want to be helpful to clinicians

Topics covered include diagnosis of type 1 diabetes, goals of therapy and glycemic targets, schedule of care, diabetes self-management education and additional behavioral considerations, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis, pancreas and islet cell transplantation, adjunctive therapies, special populations (including pregnant women, older adults, and inpatient management), and emergent/future perspectives, including beta-cell replacement and immunotherapy.

At the end of the document are tables of glycemic targets for adults with type 1 diabetes, schedule of care, nonglycemic factors that alter A1c levels, standardized continuous glucose meter (CGM) metrics for clinical care, examples of subcutaneous insulin regimens, and the various properties of approved and nonapproved adjunctive therapies for type 1 diabetes, including metformin, pramlintide, GLP-1 agonists, and SGLT2 inhibitors.  

Several colorful flowcharts are also provided, including algorithms for diagnosing and managing type 1 diabetes in adults.

Document coauthor M. Sue Kirkman, MD, of the Diabetes Care Center’s Clinical Trials Unit at the University of North Carolina, Chapel Hill, told this news organization: “We want it to be helpful to clinicians who are diagnosing type 1 diabetes in adults or caring for adults with type 1 diabetes, whether diagnosed in childhood or adulthood.”

The authors presented an overview of the document in a symposium on June 28 at the virtual ADA scientific sessions. The final version will be presented Oct. 1 at the EASD 2021 annual meeting.

The draft document and video of the ADA meeting presentation are both available on the ADA website.
 

New algorithm to reduce misdiagnosis of type 1 diabetes in adults

Misdiagnosis of adult-onset type 1 diabetes is common, occurring in up to 40% of those who develop the condition after age 30 years, said J. Hans de Vries, MD, PhD, medical director, Profil Institute for Metabolic Research, Neuss, Germany.

There are multiple reasons for this, including the fact that obesity and type 2 diabetes are becoming more prevalent at younger ages, C-peptide levels may still be relatively high at the time of clinical type 1 diabetes onset, and islet autoantibodies don’t have 100% positive predictive value.

“No single feature confirms type 1 diabetes in isolation,” Dr. de Vries noted.

The document provides a detailed diagnostic algorithm specifically for adults in whom type 1 diabetes is suspected, starting with autoantibody measurement. If the diagnosis isn’t confirmed that way, the algorithm advises investigating for monogenic diabetes, including use of a maturity-onset diabetes of the young (MODY) calculator and subsequent C-peptide measurement.

Measurement of C-peptide is also recommended if the diabetes type is still uncertain more than 3 years after diabetes onset in those treated with insulin, because by that point it is likely to be <200 pmol/L in people with type 1 diabetes.  
 

Clear statements on diabetes technology, preferred insulins

The draft document clearly states that physiologic insulin replacement using a pump or multiple daily injections, CGM, and analog rather than human insulin are standards of care for adults with type 1 diabetes. Use of hybrid closed-loop insulin delivery systems is advised when available, as they offer the “greatest benefits.”

However, the document also notes that in cases of cost barriers, subcutaneous regimens of human regular and NPH insulin may be used. It cautions, though, that these may result in higher glucose variability, higher risk of hypoglycemia, and less lifestyle flexibility.

Dr. Kirkman told this news organization: “Using human insulins such as NPH and Regular in type 1 diabetes is definitely not preferred, but sometimes due to people’s inability to afford analogs we have to use them. People need to know how to use them safely.”

As for the do-it-yourself insulin delivery systems, which many with type 1 diabetes now use with open-source software algorithms that reverse-engineer older pumps, the document advises that health care providers shouldn’t actively recommend them as they’re not approved by regulatory authorities, but should also “respect the individual’s right to make informed choices and continue to offer support,” Dr. Kirkman said when presenting the insulin therapy section.
 

Psychosocial aspects of type 1 diabetes ‘underappreciated’

Special emphasis is placed on psychosocial support, which may be overlooked in adults, Dr. Kirkman noted.

“Clinicians probably underappreciate what people with type 1 diabetes go through on a daily basis. A lot of the evidence out there regarding psychosocial issues is in children and families of children with type 1 diabetes, or in adults with type 2 diabetes ... Maximizing quality of life needs to be at the forefront of care, not just focusing on glycemic goals.”

Indeed, between 20% and 40% of people with type 1 diabetes experience diabetes-related emotional distress – including 15% with depression – particularly at the time of diagnosis and when complications develop, noted Frank J. Snoek, PhD, professor of medical psychology at Amsterdam University Medical Center, the Netherlands.

To address this, the draft advises that “self-management difficulties, psychological, and social problems” be screened periodically and monitored using validated screening tools.

“Health care providers should be proficient at asking questions about and discussing emotional health, psychological needs, and social challenges as part of the consultation,” Dr. Snoek said.

Dr. Peters disclosed ties with Abbott Diabetes Care, AstraZeneca, Lilly, Medscape, Novo Nordisk, Vertex, and Zealand, Omada, and Teladoc. Dr. Kirkman has received research support from Novo Nordisk and Bayer. Dr. de Vries disclosed ties with Adocia, Novo Nordisk, Zealand, Eli Lilly, and Afon Technology. Dr. Snoek reported ties with Roche Diabetes, Novo Nordisk, Sanofi, and Eli Lilly.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

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The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.

“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.

To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.

They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.

Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.

The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.

The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.

Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.

Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.

The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.

“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.

The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.

Procedures versus evaluation and management

Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.

Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.

The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”

“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”

The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.

In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.

“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”

Institutions can also assist women faculty in preparing promotion dossiers.

“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”

The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.

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

Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.

“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.

To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.

They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.

Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.

The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.

The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.

Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.

Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.

The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.

“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.

The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.

Procedures versus evaluation and management

Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.

Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.

The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”

“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”

The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.

In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.

“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”

Institutions can also assist women faculty in preparing promotion dossiers.

“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”

The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.

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

Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.

“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.

To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.

They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.

Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.

The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.

The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.

Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.

Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.

The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.

“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.

The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.

Procedures versus evaluation and management

Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.

Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.

The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”

“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”

The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.

In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.

“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”

Institutions can also assist women faculty in preparing promotion dossiers.

“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”

The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.

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

Data from a long-term study suggest that testosterone replacement therapy (TRT) for men with hypogonadism may reduce the risk for major adverse cardiovascular events. Previous studies have yielded conflicting results on whether there is a benefit.

The latest results come from a study of 805 men with hypogonadism from Germany and Qatar who were followed for nearly a decade. For those who received parenteral testosterone 1,000 mg every 12 weeks, there were improvements in classical cardiovascular risk factors, such as obesity, lipid level, and inflammatory markers, whereas among those who chose not to take testosterone (control patients), all of these factors worsened.

In addition, there were only 16 deaths among patients in the TRT group, and none of the deaths were from myocardial infarction or stroke. In contrast, there were 74 deaths among the control patients, as well as 70 cases of MI and 59 strokes.

The men in the study were all at relatively high risk for cardiovascular adverse events. In the TRT group, the mean Framingham Risk score was 15.5; in the control group, it was 15.8. This translates into mean 10-year risks of 22.7% and 23.5%, respectively.

“Given that all these men would normally have been expected to suffer a heart attack or stroke in the next 5-10 years with no other intervention, it was a real surprise to see no cardiovascular events at all in the group on testosterone therapy. It’s clear that this treatment can significantly reduce the risks in this particular group,” commented lead investigator Omar Aboumarzouk, MD, from Hamad Medical in Doha, Qatar.

He presented the new data at the 2021 annual congress of the European Association of Urology.

Dr. Aboumarzouk emphasized, however, that, “while men need testosterone for certain psychological and biological functions, only those with low levels who display other symptoms are likely to benefit from testosterone therapy.”

Maarten Albersen, MD, a urologist at the University of Leuven (Belgium), who was not involved in the study, noted that, although the study showed a reduction in major adverse cardiovascular events and mortality among the men who received TRT, the risk scores were in the intermediate range, and the men in the TRT group were slightly younger and were at slightly lower risk at baseline.

“The study was long enough to see differences in the rate of cardiovascular events. However, the numbers involved and the fact that the trial was not randomized mean it’s still difficult to draw any hard conclusions,” he said.
 

Registry study

The data came from a cumulative registry study begun in 2004 to assess the long-term efficacy and safety of TRT every 3 months in men with hypogonadism. The study, conducted in Bremen, Dresden, and Muenster in Germany, as well as in Doha, Qatar, is ongoing.

At total of 805 men were enrolled; 412 received TRT, and 393 declined testosterone replacement and served as control patients.

The investigators reported 10-year data. Statistical models controlled for age, body mass index, smoking, alcohol, total and HDL cholesterol level, systolic blood pressure, and type 2 diabetes.

The median age at baseline was lower among those in the TRT arm, at 57.7 years versus 63.7 years for control patients (P < .001).

All classical cardiovascular risk factors, including obesity, glycemic control, lipid pattern, and C-reactive protein, improved in the TRT group and worsened in the control group.

Dr. Albersen noted that “a new trial is now underway, aiming to recruit 6,000 participants, and this should provide definitive answers on the cardiovascular risks or even benefits of hormone therapy in men with low testosterone.”

No funding source for the study was reported. Dr. Aboumarzouk and Dr. Albersen have disclosed no relevant financial relationships.

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

Data from a long-term study suggest that testosterone replacement therapy (TRT) for men with hypogonadism may reduce the risk for major adverse cardiovascular events. Previous studies have yielded conflicting results on whether there is a benefit.

The latest results come from a study of 805 men with hypogonadism from Germany and Qatar who were followed for nearly a decade. For those who received parenteral testosterone 1,000 mg every 12 weeks, there were improvements in classical cardiovascular risk factors, such as obesity, lipid level, and inflammatory markers, whereas among those who chose not to take testosterone (control patients), all of these factors worsened.

In addition, there were only 16 deaths among patients in the TRT group, and none of the deaths were from myocardial infarction or stroke. In contrast, there were 74 deaths among the control patients, as well as 70 cases of MI and 59 strokes.

The men in the study were all at relatively high risk for cardiovascular adverse events. In the TRT group, the mean Framingham Risk score was 15.5; in the control group, it was 15.8. This translates into mean 10-year risks of 22.7% and 23.5%, respectively.

“Given that all these men would normally have been expected to suffer a heart attack or stroke in the next 5-10 years with no other intervention, it was a real surprise to see no cardiovascular events at all in the group on testosterone therapy. It’s clear that this treatment can significantly reduce the risks in this particular group,” commented lead investigator Omar Aboumarzouk, MD, from Hamad Medical in Doha, Qatar.

He presented the new data at the 2021 annual congress of the European Association of Urology.

Dr. Aboumarzouk emphasized, however, that, “while men need testosterone for certain psychological and biological functions, only those with low levels who display other symptoms are likely to benefit from testosterone therapy.”

Maarten Albersen, MD, a urologist at the University of Leuven (Belgium), who was not involved in the study, noted that, although the study showed a reduction in major adverse cardiovascular events and mortality among the men who received TRT, the risk scores were in the intermediate range, and the men in the TRT group were slightly younger and were at slightly lower risk at baseline.

“The study was long enough to see differences in the rate of cardiovascular events. However, the numbers involved and the fact that the trial was not randomized mean it’s still difficult to draw any hard conclusions,” he said.
 

Registry study

The data came from a cumulative registry study begun in 2004 to assess the long-term efficacy and safety of TRT every 3 months in men with hypogonadism. The study, conducted in Bremen, Dresden, and Muenster in Germany, as well as in Doha, Qatar, is ongoing.

At total of 805 men were enrolled; 412 received TRT, and 393 declined testosterone replacement and served as control patients.

The investigators reported 10-year data. Statistical models controlled for age, body mass index, smoking, alcohol, total and HDL cholesterol level, systolic blood pressure, and type 2 diabetes.

The median age at baseline was lower among those in the TRT arm, at 57.7 years versus 63.7 years for control patients (P < .001).

All classical cardiovascular risk factors, including obesity, glycemic control, lipid pattern, and C-reactive protein, improved in the TRT group and worsened in the control group.

Dr. Albersen noted that “a new trial is now underway, aiming to recruit 6,000 participants, and this should provide definitive answers on the cardiovascular risks or even benefits of hormone therapy in men with low testosterone.”

No funding source for the study was reported. Dr. Aboumarzouk and Dr. Albersen have disclosed no relevant financial relationships.

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

Data from a long-term study suggest that testosterone replacement therapy (TRT) for men with hypogonadism may reduce the risk for major adverse cardiovascular events. Previous studies have yielded conflicting results on whether there is a benefit.

The latest results come from a study of 805 men with hypogonadism from Germany and Qatar who were followed for nearly a decade. For those who received parenteral testosterone 1,000 mg every 12 weeks, there were improvements in classical cardiovascular risk factors, such as obesity, lipid level, and inflammatory markers, whereas among those who chose not to take testosterone (control patients), all of these factors worsened.

In addition, there were only 16 deaths among patients in the TRT group, and none of the deaths were from myocardial infarction or stroke. In contrast, there were 74 deaths among the control patients, as well as 70 cases of MI and 59 strokes.

The men in the study were all at relatively high risk for cardiovascular adverse events. In the TRT group, the mean Framingham Risk score was 15.5; in the control group, it was 15.8. This translates into mean 10-year risks of 22.7% and 23.5%, respectively.

“Given that all these men would normally have been expected to suffer a heart attack or stroke in the next 5-10 years with no other intervention, it was a real surprise to see no cardiovascular events at all in the group on testosterone therapy. It’s clear that this treatment can significantly reduce the risks in this particular group,” commented lead investigator Omar Aboumarzouk, MD, from Hamad Medical in Doha, Qatar.

He presented the new data at the 2021 annual congress of the European Association of Urology.

Dr. Aboumarzouk emphasized, however, that, “while men need testosterone for certain psychological and biological functions, only those with low levels who display other symptoms are likely to benefit from testosterone therapy.”

Maarten Albersen, MD, a urologist at the University of Leuven (Belgium), who was not involved in the study, noted that, although the study showed a reduction in major adverse cardiovascular events and mortality among the men who received TRT, the risk scores were in the intermediate range, and the men in the TRT group were slightly younger and were at slightly lower risk at baseline.

“The study was long enough to see differences in the rate of cardiovascular events. However, the numbers involved and the fact that the trial was not randomized mean it’s still difficult to draw any hard conclusions,” he said.
 

Registry study

The data came from a cumulative registry study begun in 2004 to assess the long-term efficacy and safety of TRT every 3 months in men with hypogonadism. The study, conducted in Bremen, Dresden, and Muenster in Germany, as well as in Doha, Qatar, is ongoing.

At total of 805 men were enrolled; 412 received TRT, and 393 declined testosterone replacement and served as control patients.

The investigators reported 10-year data. Statistical models controlled for age, body mass index, smoking, alcohol, total and HDL cholesterol level, systolic blood pressure, and type 2 diabetes.

The median age at baseline was lower among those in the TRT arm, at 57.7 years versus 63.7 years for control patients (P < .001).

All classical cardiovascular risk factors, including obesity, glycemic control, lipid pattern, and C-reactive protein, improved in the TRT group and worsened in the control group.

Dr. Albersen noted that “a new trial is now underway, aiming to recruit 6,000 participants, and this should provide definitive answers on the cardiovascular risks or even benefits of hormone therapy in men with low testosterone.”

No funding source for the study was reported. Dr. Aboumarzouk and Dr. Albersen have disclosed no relevant financial relationships.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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

Simultaneous pancreas-kidney transplants are increasingly performed in the United States in people with type 2 diabetes who also have chronic kidney disease, with outcomes similar to those of people with type 1 diabetes.

Traditionally, recipients of pancreas transplants have been people with type 1 diabetes who also have either chronic kidney disease (CKD) or hypoglycemic unawareness. The former group could receive either a simultaneous pancreas-kidney or a pancreas after kidney transplant, while the latter – if they have normal kidney function – would be eligible for a pancreas transplant alone.

But increasingly in recent years, patients with type 2 diabetes and CKD have been receiving simultaneous pancreas-kidney transplants, with similar success rates to those of people with type 1 diabetes.

Such candidates are typically sufficiently fit, not morbidly obese, and taking insulin regardless of their C-peptide status, said Jon S. Odorico, MD, professor of surgery and director of pancreas and islet transplantation at the University of Wisconsin–Madison Transplant Program.

“One might ask: Is it a crazy idea to do a pancreas transplant for patients with type 2 diabetes? Based on the known mechanisms of hyperglycemia in these patients, it might seem so,” he said, noting that while individuals with type 2 diabetes usually have insulin resistance, many also have relative or absolute deficiency of insulin production.

“So by replacing beta-cell mass, pancreas transplantation addresses this beta-cell defect mechanism,” he explained when discussing the topic during a symposium held June 26 at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

Arguments in favor of simultaneous pancreas-kidney transplant in people with type 2 diabetes and CKD include the fact that type 2 diabetes is the leading cause of kidney disease in the United States – roughly 50-60% of candidates on the kidney transplant waiting list also have type 2 diabetes – and that kidney transplant alone tends to worsen diabetes control due to the required immunosuppression.

Moreover, due to a 2014 allocation policy change that separates simultaneous pancreas-kidney from kidney transplant–alone donor organs, waiting times are shorter for the former, and kidney quality is generally better than for kidney transplant alone, unless a living kidney donor is available.

And, Dr. Odorico added, “adding a pancreas to a kidney transplant does not appear to jeopardize patient survival or kidney graft survival in appropriately selected patients with diabetes.” However, he also noted that because type 2 diabetes is so heterogeneous, ideal candidates for simultaneous pancreas-kidney transplant are not yet clear.

Currently, people with type 2 diabetes account for about 20% of those receiving simultaneous pancreas-kidney transplants and about 50% of pancreas after kidney transplants. Few pancreas transplants alone are performed in type 2 diabetes because those individuals rarely experience severe life-threatening hypoglycemia, Dr. Odorico explained.
 

Criteria have shifted over time, C-peptide removed in 2019

In an interview, symposium moderator Peter G. Stock, MD, PhD, surgical director of the Kidney and Pancreas Transplant Program at the University of California, San Francisco, said he agreed that “it’s a surprising trend. It doesn’t make intuitive sense. In type 1 diabetes, it makes sense to replace the beta cells. But type 2 is due to a whole cluster of etiologies ... The view in the public domain is that it’s not due to the lack of insulin but problems with insulin resistance and obesity. So it doesn’t make a whole lot of sense to give you more insulin if it’s a receptor problem.”

But Dr. Stock noted that because in the past diabetes type wasn’t always rigorously assessed using C-peptide and antibody testing, which most centers measure today, “a number of transplants were done in people who turned out to have type 2. Our perception is that everybody who has type 2 is obese, but that’s not true anymore.”

Once it became apparent that some patients with type 2 diabetes who received pancreas transplants seemed to be doing well, the pancreas transplantation committee of the United Network for Organ Sharing (UNOS) established general criteria for the procedure in people with diabetes. They had to be taking insulin and have a C-peptide value of 2 ng/mL or below or taking insulin with a C-peptide greater than 2 ng/mL and a body mass index less than or equal to the maximum allowable BMI (28 kg/m² at the time).

Dr. Stock, who chaired that committee from 2005 to 2007, said: “We thought it was risky to offer a scarce pool of donor pancreases to people with type 2 when we had people with type 1 who we know will benefit from it. So initially, the committee decided to limit pancreas transplantation to those with type 2 who have fairly low insulin requirements and BMIs that are more in the range of people with type 1. And lo and behold the results were comparable.”

Subsequent to Dr. Stock’s tenure as chair, the UNOS committee decided that the BMI and C-peptide criteria for simultaneous pancreas-kidney were no longer scientifically justifiable and were potentially discriminatory both to minority populations with type 2 diabetes and people with type 1 diabetes who have a high BMI, so in 2019, they removed them.

Individual transplant centers must follow UNOS rules, but they can also add their own criteria. Some don’t perform simultaneous pancreas-kidney transplants in people with type 2 diabetes at all.

At Dr. Odorico’s center, which began doing so in 2012, patients with type 2 diabetes account for nearly 40% of all simultaneous pancreas-kidney transplants. Indications there include age 20-60 years, insulin dependent with requirements less than 1 unit/kg/day, CKD stage 3-5, predialysis or on dialysis, and BMI <33 kg/m².

“They are highly selected and a fairly fit group of patients,” Dr. Odorico noted.

Those who don’t meet all the requirements for simultaneous pancreas-kidney transplants may still be eligible for kidney transplant alone, from either a living or deceased donor, he said.

Dr. Stock’s criteria at UCSF are even more stringent for both BMI and insulin requirements.

SPK outcomes similar for type 1 and type 2 diabetes: Emerging data

Data to guide this area are accumulating slowly. Thus far, all studies have been retrospective and have used variable definitions for diabetes type and for graft failure. However, they’re fairly consistent in showing similar outcomes by diabetes type and little impact of C-peptide level on patient survival or survival of either kidney or pancreas graft, particularly after adjustment for confounding factors between the two types.

In a study from Dr. Odorico’s center of 284 type 1 and 39 type 2 diabetes patients undergoing simultaneous pancreas-kidney transplant between 2006 and 2017, pretransplant BMI and insulin requirements did not affect patient or graft survival in either type. There was a suggestion of greater risk for post-transplant diabetes with very high pretransplant insulin requirements (>75 units/day) but the numbers were too small to be definitive.  

“It’s clear we will be doing more pancreas transplants in the future in this group of patients, and it’s ripe for further investigation,” Dr. Odorico concluded.
 

Beta cells for all?

Dr. Stock added one more aspect. While of course whole-organ transplantation is limited by the shortage of human donors, stem cell–derived beta cells could potentially produce an unlimited supply. Both Dr. Stock and Dr. Odorico are working on different approaches to this.

“We’re really close,” he said, noting, “the data we get for people with type 2 diabetes undergoing solid organ pancreas transplant could also be applied to cellular therapy ... We need to get a better understanding of which patients will benefit. The data we have so far are very promising.”

Dr. Odorico is scientific founder, stock equity holder, scientific advisory board chair, and a prior grant support recipient from Regenerative Medical Solutions. He has reported receiving clinical trial support from Veloxis Pharmaceuticals, CareDx, Natera, and Vertex Pharmaceuticals. Dr. Stock has reported being on the scientific advisory board of Encellin and receives funding from the California Institute of Regenerative Medicine and National Institutes of Health.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.

“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.

“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.

Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.

“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
 

Premature battery depletion

The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.

The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.

And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.

However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.

Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.

In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.

After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.

In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.

“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.

“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.

The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.

The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.

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

St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.

“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.

“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.

Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.

“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
 

Premature battery depletion

The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.

The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.

And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.

However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.

Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.

In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.

After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.

In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.

“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.

“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.

The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.

The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.

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

St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.

“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.

“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.

Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.

“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
 

Premature battery depletion

The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.

The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.

And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.

However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.

Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.

In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.

After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.

In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.

“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.

“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.

The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.

The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.

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