Feature

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

About 15 million doses of the Johnson & Johnson COVID-19 vaccine were ruined after workers at a manufacturing plant mixed up ingredients, The New York Times reported.

The Baltimore plant is operated by a company called Emergent BioSolutions, the Times said. The company works with both Johnson & Johnson and AstraZeneca.

The mistake has stopped shipments of the vaccine until the FDA investigates, the paper said. The mishap, however, does not affect doses of the J&J one-shot vaccine already delivered and being used.

The problem is that tens of millions of doses were supposed to come from the Baltimore plant.

The Associated Press reported that Emergent has had numerous problems with the FDA, with the agency citing the company for poorly trained employees, cracked vials and mold.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Meanwhile, in a statement, Johnson & Johnson said its own quality control process identified the problem in one batch of ingredients. The company said the Emergent plant in Baltimore is “not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.”

The company said it plans to still seek emergency use authorization for a different Emergent facility and will provide more experts on site at Emergent.

The Times reports that President Joe Biden’s team still believes the administration can meet its commitment to have enough vaccine doses to immunize every adult by the end of May.

Johnson & Johnson said it still plans to deliver an additional 24 million doses through April.

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

This article was updated 4/1/21.

About 15 million doses of the Johnson & Johnson COVID-19 vaccine were ruined after workers at a manufacturing plant mixed up ingredients, The New York Times reported.

The Baltimore plant is operated by a company called Emergent BioSolutions, the Times said. The company works with both Johnson & Johnson and AstraZeneca.

The mistake has stopped shipments of the vaccine until the FDA investigates, the paper said. The mishap, however, does not affect doses of the J&J one-shot vaccine already delivered and being used.

The problem is that tens of millions of doses were supposed to come from the Baltimore plant.

The Associated Press reported that Emergent has had numerous problems with the FDA, with the agency citing the company for poorly trained employees, cracked vials and mold.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Meanwhile, in a statement, Johnson & Johnson said its own quality control process identified the problem in one batch of ingredients. The company said the Emergent plant in Baltimore is “not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.”

The company said it plans to still seek emergency use authorization for a different Emergent facility and will provide more experts on site at Emergent.

The Times reports that President Joe Biden’s team still believes the administration can meet its commitment to have enough vaccine doses to immunize every adult by the end of May.

Johnson & Johnson said it still plans to deliver an additional 24 million doses through April.

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

This article was updated 4/1/21.

About 15 million doses of the Johnson & Johnson COVID-19 vaccine were ruined after workers at a manufacturing plant mixed up ingredients, The New York Times reported.

The Baltimore plant is operated by a company called Emergent BioSolutions, the Times said. The company works with both Johnson & Johnson and AstraZeneca.

The mistake has stopped shipments of the vaccine until the FDA investigates, the paper said. The mishap, however, does not affect doses of the J&J one-shot vaccine already delivered and being used.

The problem is that tens of millions of doses were supposed to come from the Baltimore plant.

The Associated Press reported that Emergent has had numerous problems with the FDA, with the agency citing the company for poorly trained employees, cracked vials and mold.

The records cover inspections at Emergent facilities, including Bayview, since 2017. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Meanwhile, in a statement, Johnson & Johnson said its own quality control process identified the problem in one batch of ingredients. The company said the Emergent plant in Baltimore is “not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.”

The company said it plans to still seek emergency use authorization for a different Emergent facility and will provide more experts on site at Emergent.

The Times reports that President Joe Biden’s team still believes the administration can meet its commitment to have enough vaccine doses to immunize every adult by the end of May.

Johnson & Johnson said it still plans to deliver an additional 24 million doses through April.

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

This article was updated 4/1/21.

Ob.Gyn. News acknowledges the passing of Charles B. Hammond, MD, a longtime editorial board member, who died on Feb. 1, 2021.

Courtesy Dr. Charles B. Hammond

Dr. Hammond served on the Ob.Gyn. News Advisory Board for 33 years. His service as a board member was one of many leadership roles to which he dedicated his time and expertise. Dr. Hammond served as president of the American College of Obstetrics & Gynecology (ACOG) from 2002 to 2003, and received a Lifetime Achievement Award from ACOG in 2015. He also served as president of the American Society of Reproductive Medicine, president of the American Gynecological and Obstetrical Society, and president of the North Carolina Obstetrical and Gynecological Society.

Dr. Hammond was honored by Duke University, Durham, N.C., as E.C. Hamblen Professor Emeritus in 2010, after more than 40 years in academia. He held the title of Edwin Crowell Hamblen Distinguished Professor of Reproductive Biology and Family Planning and Chair of the Department of Obstetrics & Gynecology from 1980 to 2002. During this time, he distinguished himself for his work in pioneering treatments for gestational trophoblastic disease. As an extension of this research, he was a founder of the Southeast Regional Trophoblastic Disease Center. In addition, Dr. Hammond was often consulted for his expertise on issues related to menopause and hormone replacement therapy.

Dr. Hammond began his medical career at Duke University after graduating from The Citadel with a bachelor of science degree in 1958. After earning his medical degree in 1961, he remained at Duke as a resident in obstetrics and gynecology, followed by completion of a fellowship in reproductive endocrinology in 1964. From 1964 to 1966, he served at the National Institutes of Health as a fellow in the National Cancer Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

A few years later, in 1969, Dr. Hammond launched his long and distinguished academic career with an assistant professor position in the department of obstetrics & gynecology at Duke.

Dr. Hammond’s many honors include a National Association for Women’s Health Lifetime Achievement Award and membership in the Institute of Medicine, now the National Academy of Medicine. He also was named a fellow of the Royal College of Obstetricians and Gynaecologists, and an honorary member of the Canadian Society of Obstetrics and Gynecology. Dr. Hammond will be remembered not only as a physician, researcher, educator, and mentor, but also an advocate for women’s health.

Ob.Gyn. News acknowledges the passing of Charles B. Hammond, MD, a longtime editorial board member, who died on Feb. 1, 2021.

Courtesy Dr. Charles B. Hammond

Dr. Hammond served on the Ob.Gyn. News Advisory Board for 33 years. His service as a board member was one of many leadership roles to which he dedicated his time and expertise. Dr. Hammond served as president of the American College of Obstetrics & Gynecology (ACOG) from 2002 to 2003, and received a Lifetime Achievement Award from ACOG in 2015. He also served as president of the American Society of Reproductive Medicine, president of the American Gynecological and Obstetrical Society, and president of the North Carolina Obstetrical and Gynecological Society.

Dr. Hammond was honored by Duke University, Durham, N.C., as E.C. Hamblen Professor Emeritus in 2010, after more than 40 years in academia. He held the title of Edwin Crowell Hamblen Distinguished Professor of Reproductive Biology and Family Planning and Chair of the Department of Obstetrics & Gynecology from 1980 to 2002. During this time, he distinguished himself for his work in pioneering treatments for gestational trophoblastic disease. As an extension of this research, he was a founder of the Southeast Regional Trophoblastic Disease Center. In addition, Dr. Hammond was often consulted for his expertise on issues related to menopause and hormone replacement therapy.

Dr. Hammond began his medical career at Duke University after graduating from The Citadel with a bachelor of science degree in 1958. After earning his medical degree in 1961, he remained at Duke as a resident in obstetrics and gynecology, followed by completion of a fellowship in reproductive endocrinology in 1964. From 1964 to 1966, he served at the National Institutes of Health as a fellow in the National Cancer Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

A few years later, in 1969, Dr. Hammond launched his long and distinguished academic career with an assistant professor position in the department of obstetrics & gynecology at Duke.

Dr. Hammond’s many honors include a National Association for Women’s Health Lifetime Achievement Award and membership in the Institute of Medicine, now the National Academy of Medicine. He also was named a fellow of the Royal College of Obstetricians and Gynaecologists, and an honorary member of the Canadian Society of Obstetrics and Gynecology. Dr. Hammond will be remembered not only as a physician, researcher, educator, and mentor, but also an advocate for women’s health.

Ob.Gyn. News acknowledges the passing of Charles B. Hammond, MD, a longtime editorial board member, who died on Feb. 1, 2021.

Courtesy Dr. Charles B. Hammond

Dr. Hammond served on the Ob.Gyn. News Advisory Board for 33 years. His service as a board member was one of many leadership roles to which he dedicated his time and expertise. Dr. Hammond served as president of the American College of Obstetrics & Gynecology (ACOG) from 2002 to 2003, and received a Lifetime Achievement Award from ACOG in 2015. He also served as president of the American Society of Reproductive Medicine, president of the American Gynecological and Obstetrical Society, and president of the North Carolina Obstetrical and Gynecological Society.

Dr. Hammond was honored by Duke University, Durham, N.C., as E.C. Hamblen Professor Emeritus in 2010, after more than 40 years in academia. He held the title of Edwin Crowell Hamblen Distinguished Professor of Reproductive Biology and Family Planning and Chair of the Department of Obstetrics & Gynecology from 1980 to 2002. During this time, he distinguished himself for his work in pioneering treatments for gestational trophoblastic disease. As an extension of this research, he was a founder of the Southeast Regional Trophoblastic Disease Center. In addition, Dr. Hammond was often consulted for his expertise on issues related to menopause and hormone replacement therapy.

Dr. Hammond began his medical career at Duke University after graduating from The Citadel with a bachelor of science degree in 1958. After earning his medical degree in 1961, he remained at Duke as a resident in obstetrics and gynecology, followed by completion of a fellowship in reproductive endocrinology in 1964. From 1964 to 1966, he served at the National Institutes of Health as a fellow in the National Cancer Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

A few years later, in 1969, Dr. Hammond launched his long and distinguished academic career with an assistant professor position in the department of obstetrics & gynecology at Duke.

Dr. Hammond’s many honors include a National Association for Women’s Health Lifetime Achievement Award and membership in the Institute of Medicine, now the National Academy of Medicine. He also was named a fellow of the Royal College of Obstetricians and Gynaecologists, and an honorary member of the Canadian Society of Obstetrics and Gynecology. Dr. Hammond will be remembered not only as a physician, researcher, educator, and mentor, but also an advocate for women’s health.

After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.

The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.

belchonock/Thinkstock

From respected to reviled

Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.

Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.

Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.

The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.

At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.

Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.

They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
 

Cardiologists push back

Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.

But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.

Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.

Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.

Tenet successfully argued that the case should go to arbitration.

Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.

For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.

In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”

The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
 

“Wholesale retrial”

To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.

In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.

“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.

Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.

Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.

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

After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.

The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.

belchonock/Thinkstock

From respected to reviled

Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.

Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.

Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.

The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.

At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.

Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.

They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
 

Cardiologists push back

Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.

But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.

Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.

Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.

Tenet successfully argued that the case should go to arbitration.

Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.

For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.

In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”

The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
 

“Wholesale retrial”

To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.

In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.

“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.

Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.

Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.

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

After losing at arbitration, as well as in federal court and partially on appeal, Tenet Healthcare is refusing to comment on whether it will continue to battle two Detroit-area cardiologists whom the hospital corporation fired from leadership positions in 2018.

The cardiologists were awarded $10.6 million from an arbitrator, who found that Detroit Medical Center (DMC) and its parent, Tenet, retaliated against Amir Kaki, MD, and Mahir Elder, MD, when the doctors repeatedly reported concerns about patient safety and potential fraud.

belchonock/Thinkstock

From respected to reviled

Both Dr. Kaki and Dr. Elder were respected at DMC, according to court filings.

Dr. Kaki was recruited from Weill Cornell Medical College by a Detroit mayor because of his expertise in interventional cardiology. He had staff privileges at DMC beginning in 2012 and was a clinical associate professor and assistant program director of the interventional cardiology fellowship program at Wayne State University in Detroit. He became director of the cardiac catheterization services unit at the new DMC Heart Hospital at Harper-Hutzel Hospital in Detroit in 2014, and 4 years later was appointed director of the facility’s anticoagulation clinic. Dr. Kaki was nominated for and completed Tenet’s Leadership Academy.

Dr. Elder was a clinical professor and assistant fellowship director at Wayne State and was a clinical professor of medicine at Michigan State University. Beginning in 2008, he held directorships at DMC’s cardiac care unit, ambulatory services program, cardiac CT angiogram program, PERT program, and carotid stenting program. Dr. Elder was voted Teacher of the Year for 10 consecutive years by DMC cardiology fellows.

The two doctors aimed high when it came to quality of care and ethics, according to legal filings. Over the years, Dr. Kaki and Dr. Elder repeatedly reported what they considered to be egregious violations of patient safety and of Medicare and Medicaid fraud laws. The clinicians complained about unsterile surgical instruments and the removal of a stat laboratory from the cardiac catheterization unit, noting that the removal would cause delays that would endanger lives.

At peer review meetings, as well as with administrators, they flagged colleagues who they said were performing unnecessary or dangerous procedures solely to generate revenue. At least one doctor falsified records of such a procedure after a patient died, alleged Dr. Kaki and Dr. Elder.

Tenet hired outside attorneys in the fall of 2018, telling Dr. Kaki and Dr. Elder that the legal team would investigate their complaints. However, the investigation was a sham: Filings allege that the investigation was used instead to build a case against Dr. Kaki and Dr. Elder and that Tenet leadership used the inquiry to pressure the cardiologists to resign.

They refused, and in October 2018, they were fired from their leadership positions. DMC and Tenet then held a press conference in which they said that Dr. Kaki and Dr. Elder had been dismissed for “violations” of the “Tenet Standards of Conduct.”
 

Cardiologists push back

Dr. Kaki and Dr. Elder, however, were not willing to just walk away. They sought reinstatement through an internal DMC appeals panel of their peers. The clinicians who participated on that panel ruled that neither firing was justified.

But DMC’s governing board voted in April 2020 to deny privileges to both cardiologists.

Tenet continued a campaign of retaliation, according to legal filings, by not paying the clinicians for being on call, by removing them from peer review committees, and by prohibiting them from teaching or giving lectures. DMC refused to give Dr. Kaki his personnel record, stating that he was never an employee when he was in the leadership position. Dr. Kaki sued, and a Wayne County Circuit Court judge granted his motion to get his file. DMC and Tenet appealed that ruling but lost.

Eventually, Ms. Gordon sued DMC and Tenet in federal court, alleging the hospital retaliated against the cardiologists, interfered with their ability to earn a living by disparaging them, refused to renew their privileges in 2019, and committed violations under multiple federal and state statutes, including the False Claims Act and the Fair Labor Standards Act.

Tenet successfully argued that the case should go to arbitration.

Arbitrator Mary Beth Kelly, though, ruled in December 2020 that the vast majority of the complaints compiled against the two physicians in the external investigation were not verified or supported and that Tenet and DMC had retaliated against Dr. Kaki and Dr. Elder.

For that harm, Ms. Kelly awarded each clinician $1 million, according to the final ruling shared in an interview.

In addition, she awarded Dr. Kaki $2.3 million in back pay and 2 years of front pay (slightly more than $1 million). She awarded Dr. Elder $2.3 million in back pay and $2.1 million in front pay for 4 years, noting that “his strong association with DMC may make it more difficult for him to successfully transition into the situation he enjoyed prior to termination and nonrenewal.”

The clinicians also were awarded legal fees of $623,816 and court costs of $110,673.
 

“Wholesale retrial”

To secure the award, Ms. Gordon had to seek a ruling from the U.S. District Court for Eastern Michigan. Tenet asked that court to overturn the arbitrator’s award and to keep it sealed from public view.

In his February ruling, Judge Arthur J. Tarnow wrote that Tenet and DMC “not only attempt to relitigate the legal issues, but also endeavor to introduce a factual counternarrative unmoored from the findings of the Arbitrator and including evidence which the Arbitrator specifically found inadmissible.

“By seeking a wholesale retrial of their case after forcing plaintiffs to arbitrate in the first place,” Tenet and DMC basically ignored the goal of arbitration, which is to relieve judicial congestion and provide a faster and cheaper alternative to litigation, he wrote.

Judge Tarnow also warned Tenet and DMC against taking too long to reinstate privileges for Dr. Kaki and Dr. Elder. If they “continue to delay the restoration of plaintiffs’ privileges in the hopes of a different result on appeal, they will be in violation of this Order,” said the judge.

Tenet, however, tried one more avenue to block the cardiologists from getting privileges, appealing to the Sixth Circuit, which again ordered the company to grant the 1-year privileges.

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

Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.

After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.

But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.

So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.

It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.

For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.

Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”

In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.

On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.

Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.

But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.

Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.

And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
 

Mix only in ‘exceptional situations’

The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.

It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.

However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?

Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.

He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
 

Researcher says science backs mixing

A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.

“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”

In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.

For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.

In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.

For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.

But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.

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

Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.

After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.

But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.

So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.

It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.

For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.

Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”

In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.

On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.

Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.

But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.

Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.

And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
 

Mix only in ‘exceptional situations’

The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.

It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.

However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?

Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.

He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
 

Researcher says science backs mixing

A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.

“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”

In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.

For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.

In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.

For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.

But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.

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

Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.

After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.

But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.

So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.

It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.

For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.

Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”

In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.

On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.

Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.

But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.

Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.

And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
 

Mix only in ‘exceptional situations’

The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.

It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.

However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?

Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.

He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
 

Researcher says science backs mixing

A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.

“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”

In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.

For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.

In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.

For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.

But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.

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

Depression might be a disorder of the brain, but its harms aren’t confined to the cranium. Prolonged depression has been linked with a slew of health problems, from impaired immune function to gastrointestinal dysfunction. It’s also been linked with cardiovascular disease (CVD), even increasing the risk for heart attack and a disrupted heart rate. Now, researchers are exploring whether heart function could be a valuable biomarker in informing depression diagnosis and treatment.

Major depressive disorder has proved difficult to diagnose and treat, and biomarkers that indicate a depressive episode or suggest specific interventions would be an attractive solution to its clinically nebulous nature.

Currently, diagnosing depression relies on the patients effectively communicating their symptoms. If the patient does receive a diagnosis, treating it remains a matter of trial and error. It takes weeks to know whether a treatment is working, and in only one-third of cases does the condition go into remission after the patient is initially prescribed an antidepressant. Even after successful treatment, it’s challenging to identify who might be at risk for relapse, and when. Research now shows that cardiac biomarkers may be a way improve this picture. Clinicians could use changes in heart rate to both inform depression diagnosis and gauge a patient’s predicted response to treatment.

Given the increased risk for CVD among people with depression and the link between heart rate changes and CVD risk, these biomarkers could have implications for heart health, too. “We need more than just the current toolkit,” said Amit Shah, MD, a cardiologist and assistant professor of epidemiology at Emory University, Atlanta. “Ultimately, what we’re trying to do is develop interventions not only for depression but also for the associated physical health problems related to depression, in particular, cardiovascular disease,” he said. These overlapping interests – and the prospect of clinically considering both conditions in tandem – mean this research is “really worth its weight in gold,” added Dr. Shah.
 

The data on heart rate biomarkers

Patients with depression are often found to have lower heart rate variability (HRV) and higher heart rates. Scientists don’t know the mechanisms underpinning this relationship but think changes in the autonomic nervous system during depression, as well as stress generally, have a role.

Rébecca Robillard, PhD, is the head scientist of the Clinical Sleep Research Platform at the Royal’s Institute of Mental Health Research, Ottawa, Ont. In a 2019 study published in BMC Psychiatry, Dr. Robillard’s team used electrocardiogram recordings from sleep studies to see whether heart rate abnormalities were associated with depression. Using a profiling algorithm to analyze heart rate and HRV data, the team identified persons with depression with 80% accuracy among 174 people with sleep complaints.

“It’s still early days, but our work certainly suggests that [HRV and heart rate] could serve as potential biomarkers,” Dr. Robillard said.

In another study, Stephan Claes, MD, PhD, psychiatrist and professor of psychiatry at Katholieke Universiteit Leuven, Belgium, and his group tested the biomarker potential of heart rate and HRV data that were continuously recorded over several days. They too used an algorithm to distinguish 16 people with treatment-resistant depression from 16 without depression. Within the depression group, they used the algorithm to distinguish patients who had received ketamine treatment from those who had not.

The algorithm could differentiate between the depressed and nondepressed groups with 90% accuracy. Those with depression had higher overall heart rates, particularly at night, and lower HRV. Dr. Claes noted that, unlike in other studies, “the most reliable parameter that we had for this prediction was the heart rate, not the HRV.” After treatment, heart rates improved, but HRV remained the same.

Although their study has not yet been peer reviewed and more research is needed, Dr. Claes said that increased heart rate, especially during the night, could eventually serve as a warning sign of depression relapse. “That would allow a quicker referral to care and better care because of earlier intervention,” he said.
 

Finding a signal amid the noise

But heart rate and HRV aren’t foolproof biomarkers. Some studies have found that antidepressant use lowers HRV and that HRV changes aren’t unique to depression. There’s the added complication that depression often overlaps with other mental disorders.

“I think we’ve been very disappointed about the success of using particular biomarkers for particular disorders, because the majority of mental disorders are very heterogeneous,” said Andrew Kemp, PhD, psychology professor at Swansea University, Swansea, Wales. “A particular biomarker will, at the end of the day, be just one particular aspect of the overall profile that clinicians will have on particular individuals.”

The clinical utility of a heart rate–depression connection may go both ways.

For instance, depression could serve as a warning sign for atrial fibrillation, according to research from Parveen K. Garg, MD, associate professor of clinical medicine at the University of Southern California, Los Angeles. In a study involving more than 6,000 people, Dr. Garg showed that higher scores on depression scales correlated with a higher risk for the occurrence of atrial fibrillation over a follow-up period of about 13 years.

Depression is associated with other heart conditions as well. “A lot of data seem to suggest that just the presence of depression can increase risk for a whole range of cardiovascular problems,” said Dr. Garg. Epidemiologic studies have found associations between depression and the development of coronary heart disease and a modest increased risk for stroke.

“Things going on in your brain also have effects on the rest of your body,” said Dr. Garg. “Just recognizing this link, that maybe mental illness has an effect on other illnesses or diseases that can affect other parts of your body – I think that’s something we can share now.”

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

Depression might be a disorder of the brain, but its harms aren’t confined to the cranium. Prolonged depression has been linked with a slew of health problems, from impaired immune function to gastrointestinal dysfunction. It’s also been linked with cardiovascular disease (CVD), even increasing the risk for heart attack and a disrupted heart rate. Now, researchers are exploring whether heart function could be a valuable biomarker in informing depression diagnosis and treatment.

Major depressive disorder has proved difficult to diagnose and treat, and biomarkers that indicate a depressive episode or suggest specific interventions would be an attractive solution to its clinically nebulous nature.

Currently, diagnosing depression relies on the patients effectively communicating their symptoms. If the patient does receive a diagnosis, treating it remains a matter of trial and error. It takes weeks to know whether a treatment is working, and in only one-third of cases does the condition go into remission after the patient is initially prescribed an antidepressant. Even after successful treatment, it’s challenging to identify who might be at risk for relapse, and when. Research now shows that cardiac biomarkers may be a way improve this picture. Clinicians could use changes in heart rate to both inform depression diagnosis and gauge a patient’s predicted response to treatment.

Given the increased risk for CVD among people with depression and the link between heart rate changes and CVD risk, these biomarkers could have implications for heart health, too. “We need more than just the current toolkit,” said Amit Shah, MD, a cardiologist and assistant professor of epidemiology at Emory University, Atlanta. “Ultimately, what we’re trying to do is develop interventions not only for depression but also for the associated physical health problems related to depression, in particular, cardiovascular disease,” he said. These overlapping interests – and the prospect of clinically considering both conditions in tandem – mean this research is “really worth its weight in gold,” added Dr. Shah.
 

The data on heart rate biomarkers

Patients with depression are often found to have lower heart rate variability (HRV) and higher heart rates. Scientists don’t know the mechanisms underpinning this relationship but think changes in the autonomic nervous system during depression, as well as stress generally, have a role.

Rébecca Robillard, PhD, is the head scientist of the Clinical Sleep Research Platform at the Royal’s Institute of Mental Health Research, Ottawa, Ont. In a 2019 study published in BMC Psychiatry, Dr. Robillard’s team used electrocardiogram recordings from sleep studies to see whether heart rate abnormalities were associated with depression. Using a profiling algorithm to analyze heart rate and HRV data, the team identified persons with depression with 80% accuracy among 174 people with sleep complaints.

“It’s still early days, but our work certainly suggests that [HRV and heart rate] could serve as potential biomarkers,” Dr. Robillard said.

In another study, Stephan Claes, MD, PhD, psychiatrist and professor of psychiatry at Katholieke Universiteit Leuven, Belgium, and his group tested the biomarker potential of heart rate and HRV data that were continuously recorded over several days. They too used an algorithm to distinguish 16 people with treatment-resistant depression from 16 without depression. Within the depression group, they used the algorithm to distinguish patients who had received ketamine treatment from those who had not.

The algorithm could differentiate between the depressed and nondepressed groups with 90% accuracy. Those with depression had higher overall heart rates, particularly at night, and lower HRV. Dr. Claes noted that, unlike in other studies, “the most reliable parameter that we had for this prediction was the heart rate, not the HRV.” After treatment, heart rates improved, but HRV remained the same.

Although their study has not yet been peer reviewed and more research is needed, Dr. Claes said that increased heart rate, especially during the night, could eventually serve as a warning sign of depression relapse. “That would allow a quicker referral to care and better care because of earlier intervention,” he said.
 

Finding a signal amid the noise

But heart rate and HRV aren’t foolproof biomarkers. Some studies have found that antidepressant use lowers HRV and that HRV changes aren’t unique to depression. There’s the added complication that depression often overlaps with other mental disorders.

“I think we’ve been very disappointed about the success of using particular biomarkers for particular disorders, because the majority of mental disorders are very heterogeneous,” said Andrew Kemp, PhD, psychology professor at Swansea University, Swansea, Wales. “A particular biomarker will, at the end of the day, be just one particular aspect of the overall profile that clinicians will have on particular individuals.”

The clinical utility of a heart rate–depression connection may go both ways.

For instance, depression could serve as a warning sign for atrial fibrillation, according to research from Parveen K. Garg, MD, associate professor of clinical medicine at the University of Southern California, Los Angeles. In a study involving more than 6,000 people, Dr. Garg showed that higher scores on depression scales correlated with a higher risk for the occurrence of atrial fibrillation over a follow-up period of about 13 years.

Depression is associated with other heart conditions as well. “A lot of data seem to suggest that just the presence of depression can increase risk for a whole range of cardiovascular problems,” said Dr. Garg. Epidemiologic studies have found associations between depression and the development of coronary heart disease and a modest increased risk for stroke.

“Things going on in your brain also have effects on the rest of your body,” said Dr. Garg. “Just recognizing this link, that maybe mental illness has an effect on other illnesses or diseases that can affect other parts of your body – I think that’s something we can share now.”

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

Depression might be a disorder of the brain, but its harms aren’t confined to the cranium. Prolonged depression has been linked with a slew of health problems, from impaired immune function to gastrointestinal dysfunction. It’s also been linked with cardiovascular disease (CVD), even increasing the risk for heart attack and a disrupted heart rate. Now, researchers are exploring whether heart function could be a valuable biomarker in informing depression diagnosis and treatment.

Major depressive disorder has proved difficult to diagnose and treat, and biomarkers that indicate a depressive episode or suggest specific interventions would be an attractive solution to its clinically nebulous nature.

Currently, diagnosing depression relies on the patients effectively communicating their symptoms. If the patient does receive a diagnosis, treating it remains a matter of trial and error. It takes weeks to know whether a treatment is working, and in only one-third of cases does the condition go into remission after the patient is initially prescribed an antidepressant. Even after successful treatment, it’s challenging to identify who might be at risk for relapse, and when. Research now shows that cardiac biomarkers may be a way improve this picture. Clinicians could use changes in heart rate to both inform depression diagnosis and gauge a patient’s predicted response to treatment.

Given the increased risk for CVD among people with depression and the link between heart rate changes and CVD risk, these biomarkers could have implications for heart health, too. “We need more than just the current toolkit,” said Amit Shah, MD, a cardiologist and assistant professor of epidemiology at Emory University, Atlanta. “Ultimately, what we’re trying to do is develop interventions not only for depression but also for the associated physical health problems related to depression, in particular, cardiovascular disease,” he said. These overlapping interests – and the prospect of clinically considering both conditions in tandem – mean this research is “really worth its weight in gold,” added Dr. Shah.
 

The data on heart rate biomarkers

Patients with depression are often found to have lower heart rate variability (HRV) and higher heart rates. Scientists don’t know the mechanisms underpinning this relationship but think changes in the autonomic nervous system during depression, as well as stress generally, have a role.

Rébecca Robillard, PhD, is the head scientist of the Clinical Sleep Research Platform at the Royal’s Institute of Mental Health Research, Ottawa, Ont. In a 2019 study published in BMC Psychiatry, Dr. Robillard’s team used electrocardiogram recordings from sleep studies to see whether heart rate abnormalities were associated with depression. Using a profiling algorithm to analyze heart rate and HRV data, the team identified persons with depression with 80% accuracy among 174 people with sleep complaints.

“It’s still early days, but our work certainly suggests that [HRV and heart rate] could serve as potential biomarkers,” Dr. Robillard said.

In another study, Stephan Claes, MD, PhD, psychiatrist and professor of psychiatry at Katholieke Universiteit Leuven, Belgium, and his group tested the biomarker potential of heart rate and HRV data that were continuously recorded over several days. They too used an algorithm to distinguish 16 people with treatment-resistant depression from 16 without depression. Within the depression group, they used the algorithm to distinguish patients who had received ketamine treatment from those who had not.

The algorithm could differentiate between the depressed and nondepressed groups with 90% accuracy. Those with depression had higher overall heart rates, particularly at night, and lower HRV. Dr. Claes noted that, unlike in other studies, “the most reliable parameter that we had for this prediction was the heart rate, not the HRV.” After treatment, heart rates improved, but HRV remained the same.

Although their study has not yet been peer reviewed and more research is needed, Dr. Claes said that increased heart rate, especially during the night, could eventually serve as a warning sign of depression relapse. “That would allow a quicker referral to care and better care because of earlier intervention,” he said.
 

Finding a signal amid the noise

But heart rate and HRV aren’t foolproof biomarkers. Some studies have found that antidepressant use lowers HRV and that HRV changes aren’t unique to depression. There’s the added complication that depression often overlaps with other mental disorders.

“I think we’ve been very disappointed about the success of using particular biomarkers for particular disorders, because the majority of mental disorders are very heterogeneous,” said Andrew Kemp, PhD, psychology professor at Swansea University, Swansea, Wales. “A particular biomarker will, at the end of the day, be just one particular aspect of the overall profile that clinicians will have on particular individuals.”

The clinical utility of a heart rate–depression connection may go both ways.

For instance, depression could serve as a warning sign for atrial fibrillation, according to research from Parveen K. Garg, MD, associate professor of clinical medicine at the University of Southern California, Los Angeles. In a study involving more than 6,000 people, Dr. Garg showed that higher scores on depression scales correlated with a higher risk for the occurrence of atrial fibrillation over a follow-up period of about 13 years.

Depression is associated with other heart conditions as well. “A lot of data seem to suggest that just the presence of depression can increase risk for a whole range of cardiovascular problems,” said Dr. Garg. Epidemiologic studies have found associations between depression and the development of coronary heart disease and a modest increased risk for stroke.

“Things going on in your brain also have effects on the rest of your body,” said Dr. Garg. “Just recognizing this link, that maybe mental illness has an effect on other illnesses or diseases that can affect other parts of your body – I think that’s something we can share now.”

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

The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

rfranki@mdedge.com

The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

rfranki@mdedge.com

The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

rfranki@mdedge.com

Before COVID-19, postural orthostatic tachycardia syndrome (POTS) was one of those diseases that many people, including physicians, dismissed.

“They thought it was just anxious, crazy young women,” said Pam R. Taub, MD, who runs the cardiac rehabilitation program at the University of California, San Diego.

The cryptic autonomic condition was estimated to affect 1-3 million Americans before the pandemic hit. Now case reports confirm that it is a manifestation of postacute sequelae of SARS-CoV-2 infection (PASC), or so-called long-haul COVID-19.

“I’m excited that this condition that has been so often the ugly stepchild of both cardiology and neurology is getting some attention,” said Dr. Taub. She said she is hopeful that the National Institutes of Health’s commitment to PASC research will benefit patients affected by the cardiovascular dysautonomia characterized by orthostatic intolerance in the absence of orthostatic hypotension.

Postinfection POTS is not exclusive to SARS-CoV-2. It has been reported after Lyme disease and Epstein-Barr virus infections, for example. One theory is that some of the antibodies generated against the virus cross react and damage the autonomic nervous system, which regulates heart rate and blood pressure, Dr. Taub explained.

It is not known whether COVID-19 is more likely to trigger POTS than are other infections or whether the rise in cases merely reflects the fact that more than 115 million people worldwide have been infected with the novel coronavirus.

Medscape

Low blood volume, dysregulation of the autonomic nervous system, and autoimmunity may all play a role in POTS, perhaps leading to distinct subtypes, according to a State of the Science document from the NIH; the National Heart, Lung, and Blood Institute; and the National Institute of Neurological Disorders and Stroke.

In Dr. Taub’s experience, “The truth is that patients actually have a mix of the subtypes.”

Kamal Shouman, MD, an autonomic neurologist at Mayo Clinic, Rochester, Minn., said in an interview that he has seen patients present with post–COVID-19 POTS in “all flavors,” including “neuropathic POTS, which is thought of as the classic postinfectious phenomenon.”

Why does it mostly affect athletic women?

The condition, which can be the result of dehydration or prolonged bed rest, leading to deconditioning, affects women disproportionately.

According to Manesh Patel, MD, if a patient with POTS who is not a young woman is presented on medical rounds, the response is, “Tell me again why you think this patient has POTS.”

Mitchel L. Zoler/MDedge News

Poor (wo)man’s tilt test and treatment options

POTS is typically diagnosed with a tilt test and transcranial Doppler. Dr. Taub described her “poor man’s tilt test” of asking the patient to lie down for 5-10 minutes and then having the patient stand up.

She likes the fact that transcranial Doppler helps validate the brain fog that patients report, which can be dismissed as “just your excuse for not wanting to work.” If blood perfusion to the brain is cut by 40%-50%, “how are you going to think clearly?” she said.

Dr. Shouman noted that overall volume expansion with salt water, compression garments, and a graduated exercise program play a major role in the rehabilitation of all POTS patients.

He likes to tailor treatments to the most likely underlying cause. But patients should first undergo a medical assessment by their internists to make sure there isn’t a primary lung or heart problem.

“Once the decision is made for them to be evaluated in the autonomic practice and [a] POTS diagnosis is made, I think it is very useful to determine what type of POTS,” he said.

With hyperadrenergic POTS, “you are looking at a standing norepinephrine level of over 600 pg/mL or so.” For these patients, drugs such as ivabradine or beta-blockers can help, he noted.

Dr. Taub recently conducted a small study that showed a benefit with the selective I_f channel blocker ivabradine for patients with hyperadrenergic POTS unrelated to COVID-19. She tends to favor ivabradine over beta-blockers because it lowers heart rate but not blood pressure. In addition, beta-blockers can exacerbate fatigue and brain fog.

A small crossover study will compare propranolol and ivabradine in POTS. For someone who is very hypovolemic, “you might try a salt tablet or a prescription drug like fludrocortisone,” Dr. Taub explained.

Another problem that patients with POTS experience is an inability to exercise because of orthostatic intolerance. Recumbent exercise targets deconditioning and can tamp down the hyperadrenergic effect. Dr. Shouman’s approach is to start gradually with swimming or the use of a recumbent bike or a rowing machine.

Dr. Taub recommends wearables to patients because POTS is “a very dynamic condition” that is easy to overmedicate or undermedicate. If it’s a good day, the patients are well hydrated, and the standing heart rate is only 80 bpm, she tells them they could titrate down their second dose of ivabradine, for example. The feedback from wearables also helps patients manage their exercise response.

For Dr. Shouman, wearables are not always as accurate as he would like. He tells his patients that it’s okay to use one as long as it doesn’t become a source of anxiety such that they’re constantly checking it.
 

POTS hope: A COVID-19 silver lining?

With increasing attention being paid to long-haul COVID-19, are there any concerns that POTS will get lost among the myriad symptoms connected to PASC?

Dr. Shouman cautioned, “Not all long COVID is POTS,” and said that clinicians at long-haul clinics should be able to recognize the different conditions “when POTS is suspected. I think it is useful for those providers to make the appropriate referral for POTS clinic autonomic assessment.”

He and his colleagues at Mayo have seen quite a few patients who have post–COVID-19 autonomic dysfunction, such as vasodepressor syncope, not just POTS. They plan to write about this soon.

“Of all the things I treat in cardiology, this is the most complex, because there’s so many different systems involved,” said Dr. Taub, who has seen patients recover fully from POTS. “There’s a spectrum, and there’s people that are definitely on one end of the spectrum where they have very severe diseases.”

For her, the important message is, “No matter where you are on the spectrum, there are things we can do to make your symptoms better.” And with grant funding for PASC research, “hopefully we will address the mechanisms of disease, and we’ll be able to cure this,” she said.

Dr. Patel has served as a consultant for Bayer, Janssen, AstraZeneca, and Heartflow and has received research grants from Bayer, Janssen, AstraZeneca, and the National Heart, Lung, and Blood Institute. Dr. Shouman reports no relevant financial relationships. Dr. Taub has served as a consultant for Amgen, Bayer, Esperion, Boehringer Ingelheim, Novo Nordisk, and Sanofi; is a shareholder in Epirium Bio; and has received research grants from the National Institutes of Health, the American Heart Association, and the Department of Homeland Security/FEMA.

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

Before COVID-19, postural orthostatic tachycardia syndrome (POTS) was one of those diseases that many people, including physicians, dismissed.

“They thought it was just anxious, crazy young women,” said Pam R. Taub, MD, who runs the cardiac rehabilitation program at the University of California, San Diego.

The cryptic autonomic condition was estimated to affect 1-3 million Americans before the pandemic hit. Now case reports confirm that it is a manifestation of postacute sequelae of SARS-CoV-2 infection (PASC), or so-called long-haul COVID-19.

“I’m excited that this condition that has been so often the ugly stepchild of both cardiology and neurology is getting some attention,” said Dr. Taub. She said she is hopeful that the National Institutes of Health’s commitment to PASC research will benefit patients affected by the cardiovascular dysautonomia characterized by orthostatic intolerance in the absence of orthostatic hypotension.

Postinfection POTS is not exclusive to SARS-CoV-2. It has been reported after Lyme disease and Epstein-Barr virus infections, for example. One theory is that some of the antibodies generated against the virus cross react and damage the autonomic nervous system, which regulates heart rate and blood pressure, Dr. Taub explained.

It is not known whether COVID-19 is more likely to trigger POTS than are other infections or whether the rise in cases merely reflects the fact that more than 115 million people worldwide have been infected with the novel coronavirus.

Medscape

Low blood volume, dysregulation of the autonomic nervous system, and autoimmunity may all play a role in POTS, perhaps leading to distinct subtypes, according to a State of the Science document from the NIH; the National Heart, Lung, and Blood Institute; and the National Institute of Neurological Disorders and Stroke.

In Dr. Taub’s experience, “The truth is that patients actually have a mix of the subtypes.”

Kamal Shouman, MD, an autonomic neurologist at Mayo Clinic, Rochester, Minn., said in an interview that he has seen patients present with post–COVID-19 POTS in “all flavors,” including “neuropathic POTS, which is thought of as the classic postinfectious phenomenon.”

Why does it mostly affect athletic women?

The condition, which can be the result of dehydration or prolonged bed rest, leading to deconditioning, affects women disproportionately.

According to Manesh Patel, MD, if a patient with POTS who is not a young woman is presented on medical rounds, the response is, “Tell me again why you think this patient has POTS.”

Mitchel L. Zoler/MDedge News

Poor (wo)man’s tilt test and treatment options

POTS is typically diagnosed with a tilt test and transcranial Doppler. Dr. Taub described her “poor man’s tilt test” of asking the patient to lie down for 5-10 minutes and then having the patient stand up.

She likes the fact that transcranial Doppler helps validate the brain fog that patients report, which can be dismissed as “just your excuse for not wanting to work.” If blood perfusion to the brain is cut by 40%-50%, “how are you going to think clearly?” she said.

Dr. Shouman noted that overall volume expansion with salt water, compression garments, and a graduated exercise program play a major role in the rehabilitation of all POTS patients.

He likes to tailor treatments to the most likely underlying cause. But patients should first undergo a medical assessment by their internists to make sure there isn’t a primary lung or heart problem.

“Once the decision is made for them to be evaluated in the autonomic practice and [a] POTS diagnosis is made, I think it is very useful to determine what type of POTS,” he said.

With hyperadrenergic POTS, “you are looking at a standing norepinephrine level of over 600 pg/mL or so.” For these patients, drugs such as ivabradine or beta-blockers can help, he noted.

Dr. Taub recently conducted a small study that showed a benefit with the selective I_f channel blocker ivabradine for patients with hyperadrenergic POTS unrelated to COVID-19. She tends to favor ivabradine over beta-blockers because it lowers heart rate but not blood pressure. In addition, beta-blockers can exacerbate fatigue and brain fog.

A small crossover study will compare propranolol and ivabradine in POTS. For someone who is very hypovolemic, “you might try a salt tablet or a prescription drug like fludrocortisone,” Dr. Taub explained.

Another problem that patients with POTS experience is an inability to exercise because of orthostatic intolerance. Recumbent exercise targets deconditioning and can tamp down the hyperadrenergic effect. Dr. Shouman’s approach is to start gradually with swimming or the use of a recumbent bike or a rowing machine.

Dr. Taub recommends wearables to patients because POTS is “a very dynamic condition” that is easy to overmedicate or undermedicate. If it’s a good day, the patients are well hydrated, and the standing heart rate is only 80 bpm, she tells them they could titrate down their second dose of ivabradine, for example. The feedback from wearables also helps patients manage their exercise response.

For Dr. Shouman, wearables are not always as accurate as he would like. He tells his patients that it’s okay to use one as long as it doesn’t become a source of anxiety such that they’re constantly checking it.
 

POTS hope: A COVID-19 silver lining?

With increasing attention being paid to long-haul COVID-19, are there any concerns that POTS will get lost among the myriad symptoms connected to PASC?

Dr. Shouman cautioned, “Not all long COVID is POTS,” and said that clinicians at long-haul clinics should be able to recognize the different conditions “when POTS is suspected. I think it is useful for those providers to make the appropriate referral for POTS clinic autonomic assessment.”

He and his colleagues at Mayo have seen quite a few patients who have post–COVID-19 autonomic dysfunction, such as vasodepressor syncope, not just POTS. They plan to write about this soon.

“Of all the things I treat in cardiology, this is the most complex, because there’s so many different systems involved,” said Dr. Taub, who has seen patients recover fully from POTS. “There’s a spectrum, and there’s people that are definitely on one end of the spectrum where they have very severe diseases.”

For her, the important message is, “No matter where you are on the spectrum, there are things we can do to make your symptoms better.” And with grant funding for PASC research, “hopefully we will address the mechanisms of disease, and we’ll be able to cure this,” she said.

Dr. Patel has served as a consultant for Bayer, Janssen, AstraZeneca, and Heartflow and has received research grants from Bayer, Janssen, AstraZeneca, and the National Heart, Lung, and Blood Institute. Dr. Shouman reports no relevant financial relationships. Dr. Taub has served as a consultant for Amgen, Bayer, Esperion, Boehringer Ingelheim, Novo Nordisk, and Sanofi; is a shareholder in Epirium Bio; and has received research grants from the National Institutes of Health, the American Heart Association, and the Department of Homeland Security/FEMA.

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

Before COVID-19, postural orthostatic tachycardia syndrome (POTS) was one of those diseases that many people, including physicians, dismissed.

“They thought it was just anxious, crazy young women,” said Pam R. Taub, MD, who runs the cardiac rehabilitation program at the University of California, San Diego.

The cryptic autonomic condition was estimated to affect 1-3 million Americans before the pandemic hit. Now case reports confirm that it is a manifestation of postacute sequelae of SARS-CoV-2 infection (PASC), or so-called long-haul COVID-19.

“I’m excited that this condition that has been so often the ugly stepchild of both cardiology and neurology is getting some attention,” said Dr. Taub. She said she is hopeful that the National Institutes of Health’s commitment to PASC research will benefit patients affected by the cardiovascular dysautonomia characterized by orthostatic intolerance in the absence of orthostatic hypotension.

Postinfection POTS is not exclusive to SARS-CoV-2. It has been reported after Lyme disease and Epstein-Barr virus infections, for example. One theory is that some of the antibodies generated against the virus cross react and damage the autonomic nervous system, which regulates heart rate and blood pressure, Dr. Taub explained.

It is not known whether COVID-19 is more likely to trigger POTS than are other infections or whether the rise in cases merely reflects the fact that more than 115 million people worldwide have been infected with the novel coronavirus.

Medscape

Low blood volume, dysregulation of the autonomic nervous system, and autoimmunity may all play a role in POTS, perhaps leading to distinct subtypes, according to a State of the Science document from the NIH; the National Heart, Lung, and Blood Institute; and the National Institute of Neurological Disorders and Stroke.

In Dr. Taub’s experience, “The truth is that patients actually have a mix of the subtypes.”

Kamal Shouman, MD, an autonomic neurologist at Mayo Clinic, Rochester, Minn., said in an interview that he has seen patients present with post–COVID-19 POTS in “all flavors,” including “neuropathic POTS, which is thought of as the classic postinfectious phenomenon.”

Why does it mostly affect athletic women?

The condition, which can be the result of dehydration or prolonged bed rest, leading to deconditioning, affects women disproportionately.

According to Manesh Patel, MD, if a patient with POTS who is not a young woman is presented on medical rounds, the response is, “Tell me again why you think this patient has POTS.”

Mitchel L. Zoler/MDedge News

Poor (wo)man’s tilt test and treatment options

POTS is typically diagnosed with a tilt test and transcranial Doppler. Dr. Taub described her “poor man’s tilt test” of asking the patient to lie down for 5-10 minutes and then having the patient stand up.

She likes the fact that transcranial Doppler helps validate the brain fog that patients report, which can be dismissed as “just your excuse for not wanting to work.” If blood perfusion to the brain is cut by 40%-50%, “how are you going to think clearly?” she said.

Dr. Shouman noted that overall volume expansion with salt water, compression garments, and a graduated exercise program play a major role in the rehabilitation of all POTS patients.

He likes to tailor treatments to the most likely underlying cause. But patients should first undergo a medical assessment by their internists to make sure there isn’t a primary lung or heart problem.

“Once the decision is made for them to be evaluated in the autonomic practice and [a] POTS diagnosis is made, I think it is very useful to determine what type of POTS,” he said.

With hyperadrenergic POTS, “you are looking at a standing norepinephrine level of over 600 pg/mL or so.” For these patients, drugs such as ivabradine or beta-blockers can help, he noted.

Dr. Taub recently conducted a small study that showed a benefit with the selective I_f channel blocker ivabradine for patients with hyperadrenergic POTS unrelated to COVID-19. She tends to favor ivabradine over beta-blockers because it lowers heart rate but not blood pressure. In addition, beta-blockers can exacerbate fatigue and brain fog.

A small crossover study will compare propranolol and ivabradine in POTS. For someone who is very hypovolemic, “you might try a salt tablet or a prescription drug like fludrocortisone,” Dr. Taub explained.

Another problem that patients with POTS experience is an inability to exercise because of orthostatic intolerance. Recumbent exercise targets deconditioning and can tamp down the hyperadrenergic effect. Dr. Shouman’s approach is to start gradually with swimming or the use of a recumbent bike or a rowing machine.

Dr. Taub recommends wearables to patients because POTS is “a very dynamic condition” that is easy to overmedicate or undermedicate. If it’s a good day, the patients are well hydrated, and the standing heart rate is only 80 bpm, she tells them they could titrate down their second dose of ivabradine, for example. The feedback from wearables also helps patients manage their exercise response.

For Dr. Shouman, wearables are not always as accurate as he would like. He tells his patients that it’s okay to use one as long as it doesn’t become a source of anxiety such that they’re constantly checking it.
 

POTS hope: A COVID-19 silver lining?

With increasing attention being paid to long-haul COVID-19, are there any concerns that POTS will get lost among the myriad symptoms connected to PASC?

Dr. Shouman cautioned, “Not all long COVID is POTS,” and said that clinicians at long-haul clinics should be able to recognize the different conditions “when POTS is suspected. I think it is useful for those providers to make the appropriate referral for POTS clinic autonomic assessment.”

He and his colleagues at Mayo have seen quite a few patients who have post–COVID-19 autonomic dysfunction, such as vasodepressor syncope, not just POTS. They plan to write about this soon.

“Of all the things I treat in cardiology, this is the most complex, because there’s so many different systems involved,” said Dr. Taub, who has seen patients recover fully from POTS. “There’s a spectrum, and there’s people that are definitely on one end of the spectrum where they have very severe diseases.”

For her, the important message is, “No matter where you are on the spectrum, there are things we can do to make your symptoms better.” And with grant funding for PASC research, “hopefully we will address the mechanisms of disease, and we’ll be able to cure this,” she said.

Dr. Patel has served as a consultant for Bayer, Janssen, AstraZeneca, and Heartflow and has received research grants from Bayer, Janssen, AstraZeneca, and the National Heart, Lung, and Blood Institute. Dr. Shouman reports no relevant financial relationships. Dr. Taub has served as a consultant for Amgen, Bayer, Esperion, Boehringer Ingelheim, Novo Nordisk, and Sanofi; is a shareholder in Epirium Bio; and has received research grants from the National Institutes of Health, the American Heart Association, and the Department of Homeland Security/FEMA.

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

The American Academy of Pediatrics (AAP) released a statement condemning state legislation introduced across the country that would prohibit the medical treatment of children who identify as transgender.

“Politics has no place here. Transgender children, like all children, just want to belong. We will fight state by state, in the courts, and on the national stage to make sure they know they do,” said the American Academy of Pediatrics, an organization that recommends that youth who identify as transgender have access to comprehensive, gender-affirming and “developmentally appropriate” health care.

There has been a lot of controversy among physicians surrounding gender-affirming care for children. In 2019, three separate groups of physicians questioned the hormonal treatment of children and adolescents with gender dysphoria, saying more research is needed to support gender-affirming care recommendations from groups such as the AAP. In addition, California-based endocrinologist Michael K. Laidlaw, MD, called the use of puberty blockers – medication used to delay or prevent the onset of puberty – an “experiment” and “public health problem.”

Some of the bills circulating would prohibit gender-affirming care for children and penalize pediatricians and other physicians for providing such care. Other bills would prevent transgender youth from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Jason Rafferty, MD, a pediatrician who authored AAP’s 2018 policy statement encouraging pediatricians to provide gender-affirmative care to children and adolescents, said in an interview that these proposed state bills are targeting a vulnerable population at a vulnerable time.

“You have this marginalized group and right in the midst of a pandemic – and [social isolation] – and you have these policies coming out that are really targeting the most vulnerable,” said Dr. Rafferty, who practices at the Adolescent Healthcare Center at Hasbro Children’s Hospital, Providence, R.I. “Some of the proposed policies would ensure that some of these transgender kids wouldn’t have access to basic medical care [or access to areas] where pediatricians are affirming these kids and creating a safe environment for them.”

M. Brett Cooper, MD, of pediatrics at UT Southwestern Medical Center, Dallas, said in an interview that the proposed state legislations are based on personal beliefs, not evidence-based care.

He said the AAP is speaking out because many of these proposed state legislatures are advancing bills that would affect gender-diverse children.

“Many of these bills are making it close to passing both chambers of a state legislature and thus sent to the governor for approval,” Dr. Cooper said. “In past legislative sessions, bills such as these have never it made out of committee in either a state House or state Senate.”

Early in March, South Dakota Governor Kristi Noem tweeted that she was “excited to sign” a bill that would prevent children who are transgender from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Meanwhile, previous studies have shown that teens whose gender identity does not align with their sex assigned at birth were more likely to report a suicide attempt, compared with cisgender youth. A 2015 study has attributed this increased risk of suicide to marginalization, social exclusion, and trauma. The bills being proposed may exacerbate this, according to Dr. Rafferty.

These bills point in the direction of approaches and models that research shows may be harmful to transgender children, he said.

“Beyond that, policies that are out there affecting participation in sports and other activities really just draw attention to these youth in unnecessary ways and really puts their physical and mental health at risk in a school environment,” he added.

“Whether it’s health care, school, community, or home [these policies] just really create a very hostile and dangerous environment toward a population that already is at significant risk,” Dr. Rafferty said.

The AAP’s clinical care guidelines for children who identify as transgender state that pediatricians who provide gender-affirmative care and speak with children and their families about gender issues help foster an environment of nurturance and support.

“Many people think that the care provided to gender diverse young people is rogue,” Dr. Cooper said. “Pediatric gender clinics are often either multidisciplinary or have a readily accessible team, including social work, mental health, and the physician. Medical care for gender diverse youth follows well-established standards of care.”

Dr. Rafferty said it is important for care providers to support children and teenagers who identify as transgender by creating a safe space and helping them identify what they need.

“There’s a lot out there that really tries to unite gender and biological sex together, saying that gender can be reduced to your anatomy,” Dr. Rafferty said. “But I think what we’re coming to appreciate is that our sense of identity is much more complex than simply our genes or biology.”

Dr. Rafferty is a member of the American Academy of Pediatrics, the Society of Adolescent Health and Medicine, and the American Academy of Child and Adolescent Psychiatry. Dr. Cooper is a columnist for Pediatric News and is on the board of trustees for the Texas Medical Association.

The American Academy of Pediatrics (AAP) released a statement condemning state legislation introduced across the country that would prohibit the medical treatment of children who identify as transgender.

“Politics has no place here. Transgender children, like all children, just want to belong. We will fight state by state, in the courts, and on the national stage to make sure they know they do,” said the American Academy of Pediatrics, an organization that recommends that youth who identify as transgender have access to comprehensive, gender-affirming and “developmentally appropriate” health care.

There has been a lot of controversy among physicians surrounding gender-affirming care for children. In 2019, three separate groups of physicians questioned the hormonal treatment of children and adolescents with gender dysphoria, saying more research is needed to support gender-affirming care recommendations from groups such as the AAP. In addition, California-based endocrinologist Michael K. Laidlaw, MD, called the use of puberty blockers – medication used to delay or prevent the onset of puberty – an “experiment” and “public health problem.”

Some of the bills circulating would prohibit gender-affirming care for children and penalize pediatricians and other physicians for providing such care. Other bills would prevent transgender youth from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Jason Rafferty, MD, a pediatrician who authored AAP’s 2018 policy statement encouraging pediatricians to provide gender-affirmative care to children and adolescents, said in an interview that these proposed state bills are targeting a vulnerable population at a vulnerable time.

“You have this marginalized group and right in the midst of a pandemic – and [social isolation] – and you have these policies coming out that are really targeting the most vulnerable,” said Dr. Rafferty, who practices at the Adolescent Healthcare Center at Hasbro Children’s Hospital, Providence, R.I. “Some of the proposed policies would ensure that some of these transgender kids wouldn’t have access to basic medical care [or access to areas] where pediatricians are affirming these kids and creating a safe environment for them.”

M. Brett Cooper, MD, of pediatrics at UT Southwestern Medical Center, Dallas, said in an interview that the proposed state legislations are based on personal beliefs, not evidence-based care.

He said the AAP is speaking out because many of these proposed state legislatures are advancing bills that would affect gender-diverse children.

“Many of these bills are making it close to passing both chambers of a state legislature and thus sent to the governor for approval,” Dr. Cooper said. “In past legislative sessions, bills such as these have never it made out of committee in either a state House or state Senate.”

Early in March, South Dakota Governor Kristi Noem tweeted that she was “excited to sign” a bill that would prevent children who are transgender from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Meanwhile, previous studies have shown that teens whose gender identity does not align with their sex assigned at birth were more likely to report a suicide attempt, compared with cisgender youth. A 2015 study has attributed this increased risk of suicide to marginalization, social exclusion, and trauma. The bills being proposed may exacerbate this, according to Dr. Rafferty.

These bills point in the direction of approaches and models that research shows may be harmful to transgender children, he said.

“Beyond that, policies that are out there affecting participation in sports and other activities really just draw attention to these youth in unnecessary ways and really puts their physical and mental health at risk in a school environment,” he added.

“Whether it’s health care, school, community, or home [these policies] just really create a very hostile and dangerous environment toward a population that already is at significant risk,” Dr. Rafferty said.

The AAP’s clinical care guidelines for children who identify as transgender state that pediatricians who provide gender-affirmative care and speak with children and their families about gender issues help foster an environment of nurturance and support.

“Many people think that the care provided to gender diverse young people is rogue,” Dr. Cooper said. “Pediatric gender clinics are often either multidisciplinary or have a readily accessible team, including social work, mental health, and the physician. Medical care for gender diverse youth follows well-established standards of care.”

Dr. Rafferty said it is important for care providers to support children and teenagers who identify as transgender by creating a safe space and helping them identify what they need.

“There’s a lot out there that really tries to unite gender and biological sex together, saying that gender can be reduced to your anatomy,” Dr. Rafferty said. “But I think what we’re coming to appreciate is that our sense of identity is much more complex than simply our genes or biology.”

Dr. Rafferty is a member of the American Academy of Pediatrics, the Society of Adolescent Health and Medicine, and the American Academy of Child and Adolescent Psychiatry. Dr. Cooper is a columnist for Pediatric News and is on the board of trustees for the Texas Medical Association.

The American Academy of Pediatrics (AAP) released a statement condemning state legislation introduced across the country that would prohibit the medical treatment of children who identify as transgender.

“Politics has no place here. Transgender children, like all children, just want to belong. We will fight state by state, in the courts, and on the national stage to make sure they know they do,” said the American Academy of Pediatrics, an organization that recommends that youth who identify as transgender have access to comprehensive, gender-affirming and “developmentally appropriate” health care.

There has been a lot of controversy among physicians surrounding gender-affirming care for children. In 2019, three separate groups of physicians questioned the hormonal treatment of children and adolescents with gender dysphoria, saying more research is needed to support gender-affirming care recommendations from groups such as the AAP. In addition, California-based endocrinologist Michael K. Laidlaw, MD, called the use of puberty blockers – medication used to delay or prevent the onset of puberty – an “experiment” and “public health problem.”

Some of the bills circulating would prohibit gender-affirming care for children and penalize pediatricians and other physicians for providing such care. Other bills would prevent transgender youth from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Jason Rafferty, MD, a pediatrician who authored AAP’s 2018 policy statement encouraging pediatricians to provide gender-affirmative care to children and adolescents, said in an interview that these proposed state bills are targeting a vulnerable population at a vulnerable time.

“You have this marginalized group and right in the midst of a pandemic – and [social isolation] – and you have these policies coming out that are really targeting the most vulnerable,” said Dr. Rafferty, who practices at the Adolescent Healthcare Center at Hasbro Children’s Hospital, Providence, R.I. “Some of the proposed policies would ensure that some of these transgender kids wouldn’t have access to basic medical care [or access to areas] where pediatricians are affirming these kids and creating a safe environment for them.”

M. Brett Cooper, MD, of pediatrics at UT Southwestern Medical Center, Dallas, said in an interview that the proposed state legislations are based on personal beliefs, not evidence-based care.

He said the AAP is speaking out because many of these proposed state legislatures are advancing bills that would affect gender-diverse children.

“Many of these bills are making it close to passing both chambers of a state legislature and thus sent to the governor for approval,” Dr. Cooper said. “In past legislative sessions, bills such as these have never it made out of committee in either a state House or state Senate.”

Early in March, South Dakota Governor Kristi Noem tweeted that she was “excited to sign” a bill that would prevent children who are transgender from participating in sports or on athletic teams according to their gender identity, requiring them to join teams aligned with the sex they were assigned at birth.

Meanwhile, previous studies have shown that teens whose gender identity does not align with their sex assigned at birth were more likely to report a suicide attempt, compared with cisgender youth. A 2015 study has attributed this increased risk of suicide to marginalization, social exclusion, and trauma. The bills being proposed may exacerbate this, according to Dr. Rafferty.

These bills point in the direction of approaches and models that research shows may be harmful to transgender children, he said.

“Beyond that, policies that are out there affecting participation in sports and other activities really just draw attention to these youth in unnecessary ways and really puts their physical and mental health at risk in a school environment,” he added.

“Whether it’s health care, school, community, or home [these policies] just really create a very hostile and dangerous environment toward a population that already is at significant risk,” Dr. Rafferty said.

The AAP’s clinical care guidelines for children who identify as transgender state that pediatricians who provide gender-affirmative care and speak with children and their families about gender issues help foster an environment of nurturance and support.

“Many people think that the care provided to gender diverse young people is rogue,” Dr. Cooper said. “Pediatric gender clinics are often either multidisciplinary or have a readily accessible team, including social work, mental health, and the physician. Medical care for gender diverse youth follows well-established standards of care.”

Dr. Rafferty said it is important for care providers to support children and teenagers who identify as transgender by creating a safe space and helping them identify what they need.

“There’s a lot out there that really tries to unite gender and biological sex together, saying that gender can be reduced to your anatomy,” Dr. Rafferty said. “But I think what we’re coming to appreciate is that our sense of identity is much more complex than simply our genes or biology.”

Dr. Rafferty is a member of the American Academy of Pediatrics, the Society of Adolescent Health and Medicine, and the American Academy of Child and Adolescent Psychiatry. Dr. Cooper is a columnist for Pediatric News and is on the board of trustees for the Texas Medical Association.

Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.

The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.

The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.

“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”

In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.

There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.

The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.

Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.

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

Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.

The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.

The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.

“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”

In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.

There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.

The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.

Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.

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

Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.

The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.

The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.

“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”

In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.

There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.

The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.

Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.

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