A novel T-cell engineered product, Orca-T (Orca Bio), was associated with lower incidence of both acute and chronic graft-versus-host disease (GVHD) and more than double the rate of GVHD-free and relapse-free survival, compared with the current standard of care for patients undergoing hematopoietic stem cell transplants (HSCT), investigators said.

In both a multicenter phase 1 trial (NCT04013685) and single-center phase 1/2 trial (NCT01660607) with a total of 50 patients, those who received Orca-T with single-agent GVHD prophylaxis had a 1-year GVHD-free and relapse-free survival rate of 75%, compared with 31% for patients who received standard of care with two-agent prophylaxis, reported Everett H. Meyer, MD, PhD, from the Stanford (Calif.) University.

“Orca-T has good evidence for reduced acute graft-versus-host disease, reduced chromic graft-versus-host disease, and a low nonrelapse mortality,” he said at the Transplant & Cellular Therapies Meetings.

The product can be quickly manufactured and delivered to treatment centers across the continental United States, with “vein-to-vein” time of less than 72 hours, he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Orca-T consists of highly purified, donor-derived T-regulatory (Treg) cells that are sorted and delivered on day 0 with hematopoietic stem cells, without immunosuppressants, followed 2 days later with infusion of a matching dose of conventional T cells.

“The Treg cells are allowed to expand to create the right microenvironment for the [conventional T cells],” he explained.

In preclinical studies, donor-derived, high-purity Tregs delivered prior to adoptive transfer of conventional T cells prevented GVHD while maintaining graft-versus-tumor immunity, he said.
 

Two T-cell infusions

He reported updated results from current studies on a total of 50 adults, with a cohort of 144 patients treated concurrently with standard of care as controls.

The Orca-T–treated patients had a median age of 47 and 52% were male. Indications for transplant included acute myeloid and acute lymphoblastic leukemia, chronic myeloid leukemia, B-cell lymphoma, myelodysplastic syndrome/myelofibrosis, and other unspecified indications.

In both the Orca-T and control cohorts, patients underwent myeloablative conditioning from 10 to 2 days prior to stem cell infusion.

As noted patients in the experimental arm received infusion of hematopoietic stem/progenitor cells and Tregs, followed 2 days later by conventional T-cell infusion, and, on the day after that, tacrolimus at a target dose of 4.6 ng/mL. The conventional T cells were reserved from donor apheresis and were otherwise unmanipulated prior to infusion into the recipient, Dr. Meyer noted.

Patients in the standard-of-care arm received tacrolimus on the day before standard infusion of the apheresis product, followed by methotrexate prophylaxis on days 1, 3, 6 and 11.

Time to neutrophil engraftment, platelet engraftment, and from day 0 to hospital discharge were all significantly shorter in the Orca-T group, at 12 versus 14 days (P < .0001), 11 vs. 17 days (P < .0001), and 15 vs. 17 days (P = .01) respectively.

At 100 days of follow-up, the rate of grade 2 or greater acute GVHD was 30% among standard-of-care patients versus 10% among Orca-T–treated patients. At 1-year follow-up, respective rates of chronic GVHD were 46% vs. 3%.
 

Safety

“In general, the protocol is extremely well tolerated by our patients. We’ve seen no exceptional infectious disease complications, and we’ve seen no other major complications,” Dr. Meyer said.

Cytomegalovirus prophylaxis was used variably, depending on the center and on the attending physician. Epstein-Barr virus reactivation occurred in eight patients, with one requiring therapy, but there was no biopsy or radiographic evidence of posttransplant lymphoproliferative disorder.

In all, 18% of patients had serious adverse events during the reporting period, all of which resolved. There were no treatment-related deaths in the Orca-T arm, compared with 11% of controls.
 

Engraftment differences explored

In the question-and-answer session following the presentation, Christopher J. Gamper, MD, PhD, from the Johns Hopkins Hospital in Baltimore, told Dr. Meyer that “your outcomes from Orca-T look excellent,” and asked about the cost differential, compared with similar, unmanipulated transplants performed with standard GVHD prophylaxis.

“Is this recovered by lower costs for treatment of GVHD?” he asked.

“I have not done an economic cost analysis of course, and I think others may be looking into this,” Dr. Meyer replied. “Graft engineering can be expensive, although it’s an engineering proposition and one could imagine that the costs will go down substantially over time.”

Session moderator Alan Hanash, MD, PhD, from Memorial Sloan Kettering Cancer Center in New York, commented on the differences in engraftment between the experimental controls arms, and asked Dr. Meyer: “Do you think this is due to the difference in prophylaxis? Absence of methotrexate? Do you think that it could be a direct impact of regulatory T cells on hematopoietic engraftment?”

“Certainly not having methotrexate is beneficial for engraftment, and may account for the differences we see, Dr. Meyer said. “However, it is possible that Tregs could be playing a facilitative role. There certainly is good preclinical literature that Tregs, particularly in the bone marrow space, can facilitate bone marrow engraftment.”

The Orca-T trials are sponsored by Orca Bio and Stanford, with support from the National Institutes of Health. Dr. Meyer receives research support from Orca and is a scientific adviser to GigaGen, Triursus, Incyte, and Indee Labs. Dr. Hanash and Dr. Gamper had no relevant disclosures.

A novel T-cell engineered product, Orca-T (Orca Bio), was associated with lower incidence of both acute and chronic graft-versus-host disease (GVHD) and more than double the rate of GVHD-free and relapse-free survival, compared with the current standard of care for patients undergoing hematopoietic stem cell transplants (HSCT), investigators said.

In both a multicenter phase 1 trial (NCT04013685) and single-center phase 1/2 trial (NCT01660607) with a total of 50 patients, those who received Orca-T with single-agent GVHD prophylaxis had a 1-year GVHD-free and relapse-free survival rate of 75%, compared with 31% for patients who received standard of care with two-agent prophylaxis, reported Everett H. Meyer, MD, PhD, from the Stanford (Calif.) University.

“Orca-T has good evidence for reduced acute graft-versus-host disease, reduced chromic graft-versus-host disease, and a low nonrelapse mortality,” he said at the Transplant & Cellular Therapies Meetings.

The product can be quickly manufactured and delivered to treatment centers across the continental United States, with “vein-to-vein” time of less than 72 hours, he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Orca-T consists of highly purified, donor-derived T-regulatory (Treg) cells that are sorted and delivered on day 0 with hematopoietic stem cells, without immunosuppressants, followed 2 days later with infusion of a matching dose of conventional T cells.

“The Treg cells are allowed to expand to create the right microenvironment for the [conventional T cells],” he explained.

In preclinical studies, donor-derived, high-purity Tregs delivered prior to adoptive transfer of conventional T cells prevented GVHD while maintaining graft-versus-tumor immunity, he said.
 

Two T-cell infusions

He reported updated results from current studies on a total of 50 adults, with a cohort of 144 patients treated concurrently with standard of care as controls.

The Orca-T–treated patients had a median age of 47 and 52% were male. Indications for transplant included acute myeloid and acute lymphoblastic leukemia, chronic myeloid leukemia, B-cell lymphoma, myelodysplastic syndrome/myelofibrosis, and other unspecified indications.

In both the Orca-T and control cohorts, patients underwent myeloablative conditioning from 10 to 2 days prior to stem cell infusion.

As noted patients in the experimental arm received infusion of hematopoietic stem/progenitor cells and Tregs, followed 2 days later by conventional T-cell infusion, and, on the day after that, tacrolimus at a target dose of 4.6 ng/mL. The conventional T cells were reserved from donor apheresis and were otherwise unmanipulated prior to infusion into the recipient, Dr. Meyer noted.

Patients in the standard-of-care arm received tacrolimus on the day before standard infusion of the apheresis product, followed by methotrexate prophylaxis on days 1, 3, 6 and 11.

Time to neutrophil engraftment, platelet engraftment, and from day 0 to hospital discharge were all significantly shorter in the Orca-T group, at 12 versus 14 days (P < .0001), 11 vs. 17 days (P < .0001), and 15 vs. 17 days (P = .01) respectively.

At 100 days of follow-up, the rate of grade 2 or greater acute GVHD was 30% among standard-of-care patients versus 10% among Orca-T–treated patients. At 1-year follow-up, respective rates of chronic GVHD were 46% vs. 3%.
 

Safety

“In general, the protocol is extremely well tolerated by our patients. We’ve seen no exceptional infectious disease complications, and we’ve seen no other major complications,” Dr. Meyer said.

Cytomegalovirus prophylaxis was used variably, depending on the center and on the attending physician. Epstein-Barr virus reactivation occurred in eight patients, with one requiring therapy, but there was no biopsy or radiographic evidence of posttransplant lymphoproliferative disorder.

In all, 18% of patients had serious adverse events during the reporting period, all of which resolved. There were no treatment-related deaths in the Orca-T arm, compared with 11% of controls.
 

Engraftment differences explored

In the question-and-answer session following the presentation, Christopher J. Gamper, MD, PhD, from the Johns Hopkins Hospital in Baltimore, told Dr. Meyer that “your outcomes from Orca-T look excellent,” and asked about the cost differential, compared with similar, unmanipulated transplants performed with standard GVHD prophylaxis.

“Is this recovered by lower costs for treatment of GVHD?” he asked.

“I have not done an economic cost analysis of course, and I think others may be looking into this,” Dr. Meyer replied. “Graft engineering can be expensive, although it’s an engineering proposition and one could imagine that the costs will go down substantially over time.”

Session moderator Alan Hanash, MD, PhD, from Memorial Sloan Kettering Cancer Center in New York, commented on the differences in engraftment between the experimental controls arms, and asked Dr. Meyer: “Do you think this is due to the difference in prophylaxis? Absence of methotrexate? Do you think that it could be a direct impact of regulatory T cells on hematopoietic engraftment?”

“Certainly not having methotrexate is beneficial for engraftment, and may account for the differences we see, Dr. Meyer said. “However, it is possible that Tregs could be playing a facilitative role. There certainly is good preclinical literature that Tregs, particularly in the bone marrow space, can facilitate bone marrow engraftment.”

The Orca-T trials are sponsored by Orca Bio and Stanford, with support from the National Institutes of Health. Dr. Meyer receives research support from Orca and is a scientific adviser to GigaGen, Triursus, Incyte, and Indee Labs. Dr. Hanash and Dr. Gamper had no relevant disclosures.

A novel T-cell engineered product, Orca-T (Orca Bio), was associated with lower incidence of both acute and chronic graft-versus-host disease (GVHD) and more than double the rate of GVHD-free and relapse-free survival, compared with the current standard of care for patients undergoing hematopoietic stem cell transplants (HSCT), investigators said.

In both a multicenter phase 1 trial (NCT04013685) and single-center phase 1/2 trial (NCT01660607) with a total of 50 patients, those who received Orca-T with single-agent GVHD prophylaxis had a 1-year GVHD-free and relapse-free survival rate of 75%, compared with 31% for patients who received standard of care with two-agent prophylaxis, reported Everett H. Meyer, MD, PhD, from the Stanford (Calif.) University.

“Orca-T has good evidence for reduced acute graft-versus-host disease, reduced chromic graft-versus-host disease, and a low nonrelapse mortality,” he said at the Transplant & Cellular Therapies Meetings.

The product can be quickly manufactured and delivered to treatment centers across the continental United States, with “vein-to-vein” time of less than 72 hours, he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Orca-T consists of highly purified, donor-derived T-regulatory (Treg) cells that are sorted and delivered on day 0 with hematopoietic stem cells, without immunosuppressants, followed 2 days later with infusion of a matching dose of conventional T cells.

“The Treg cells are allowed to expand to create the right microenvironment for the [conventional T cells],” he explained.

In preclinical studies, donor-derived, high-purity Tregs delivered prior to adoptive transfer of conventional T cells prevented GVHD while maintaining graft-versus-tumor immunity, he said.
 

Two T-cell infusions

He reported updated results from current studies on a total of 50 adults, with a cohort of 144 patients treated concurrently with standard of care as controls.

The Orca-T–treated patients had a median age of 47 and 52% were male. Indications for transplant included acute myeloid and acute lymphoblastic leukemia, chronic myeloid leukemia, B-cell lymphoma, myelodysplastic syndrome/myelofibrosis, and other unspecified indications.

In both the Orca-T and control cohorts, patients underwent myeloablative conditioning from 10 to 2 days prior to stem cell infusion.

As noted patients in the experimental arm received infusion of hematopoietic stem/progenitor cells and Tregs, followed 2 days later by conventional T-cell infusion, and, on the day after that, tacrolimus at a target dose of 4.6 ng/mL. The conventional T cells were reserved from donor apheresis and were otherwise unmanipulated prior to infusion into the recipient, Dr. Meyer noted.

Patients in the standard-of-care arm received tacrolimus on the day before standard infusion of the apheresis product, followed by methotrexate prophylaxis on days 1, 3, 6 and 11.

Time to neutrophil engraftment, platelet engraftment, and from day 0 to hospital discharge were all significantly shorter in the Orca-T group, at 12 versus 14 days (P < .0001), 11 vs. 17 days (P < .0001), and 15 vs. 17 days (P = .01) respectively.

At 100 days of follow-up, the rate of grade 2 or greater acute GVHD was 30% among standard-of-care patients versus 10% among Orca-T–treated patients. At 1-year follow-up, respective rates of chronic GVHD were 46% vs. 3%.
 

Safety

“In general, the protocol is extremely well tolerated by our patients. We’ve seen no exceptional infectious disease complications, and we’ve seen no other major complications,” Dr. Meyer said.

Cytomegalovirus prophylaxis was used variably, depending on the center and on the attending physician. Epstein-Barr virus reactivation occurred in eight patients, with one requiring therapy, but there was no biopsy or radiographic evidence of posttransplant lymphoproliferative disorder.

In all, 18% of patients had serious adverse events during the reporting period, all of which resolved. There were no treatment-related deaths in the Orca-T arm, compared with 11% of controls.
 

Engraftment differences explored

In the question-and-answer session following the presentation, Christopher J. Gamper, MD, PhD, from the Johns Hopkins Hospital in Baltimore, told Dr. Meyer that “your outcomes from Orca-T look excellent,” and asked about the cost differential, compared with similar, unmanipulated transplants performed with standard GVHD prophylaxis.

“Is this recovered by lower costs for treatment of GVHD?” he asked.

“I have not done an economic cost analysis of course, and I think others may be looking into this,” Dr. Meyer replied. “Graft engineering can be expensive, although it’s an engineering proposition and one could imagine that the costs will go down substantially over time.”

Session moderator Alan Hanash, MD, PhD, from Memorial Sloan Kettering Cancer Center in New York, commented on the differences in engraftment between the experimental controls arms, and asked Dr. Meyer: “Do you think this is due to the difference in prophylaxis? Absence of methotrexate? Do you think that it could be a direct impact of regulatory T cells on hematopoietic engraftment?”

“Certainly not having methotrexate is beneficial for engraftment, and may account for the differences we see, Dr. Meyer said. “However, it is possible that Tregs could be playing a facilitative role. There certainly is good preclinical literature that Tregs, particularly in the bone marrow space, can facilitate bone marrow engraftment.”

The Orca-T trials are sponsored by Orca Bio and Stanford, with support from the National Institutes of Health. Dr. Meyer receives research support from Orca and is a scientific adviser to GigaGen, Triursus, Incyte, and Indee Labs. Dr. Hanash and Dr. Gamper had no relevant disclosures.

Before the pandemic, a large majority of internists reported that they were generally happy with life outside of work, although by specialty, they were near the bottom in happiness.

But this year’s Medscape Internist Lifestyle, Happiness & Burnout Report 2021 shows a sharp drop, with just 55% of respondents saying they are somewhat or very happy in life outside work, compared with 78% last year.

Internists were not alone among the more than 12,000 physicians who responded to the survey. The contrast from last year’s report was clear for physicians in general and reflects COVID-19’s substantial toll on clinicians.

Burnout has ‘strong impact on lives’

The percentage of internists who reported burnout or depression, however, has stayed fairly consistent. This year, 46% reported being either burned out or burned out and depressed, as opposed to 44% last year.

More than half (52%) said that burnout had a strong or severe impact on their lives, and nearly 1 in 10 said it was severe enough that they are considering leaving medicine.

One percent of the internists who responded to the survey said they had attempted suicide, and 12% said they had thoughts of suicide but had not attempted it.

Most of those reporting burnout (82%) said it started before the COVID-19 pandemic, but 18% said it began with the pandemic.

Notably, though, physicians ranked problems related to stress from COVID-19 near the bottom among burnout drivers. The top factor, by far, again, was “too many bureaucratic tasks.”

 A large majority (78%) of internists work online for up to 10 hours a week, a number that could grow as telemedicine grows.
 

Exercise is top coping method

Responses gave a peek into how physicians are coping with burnout. Among internists, 49% put exercise at the top. Isolating themselves from others was the next most popular choice, at 45%. Eating junk food and drinking alcohol were further down the list, at 34% and 24%, respectively.

Few internists said they drink alcohol daily, a finding consistent with past years. In fact, 29% said they don’t drink at all, and 26% said they have fewer than one alcoholic drink per week. Only 7% said they had seven or more drinks per week.

The National Institute on Alcohol Abuse and Alcoholism advises that men not have more than 14 alcoholic drinks per week and that women not have more than 7.
 

Work-life balance topped list of concerns

By far, internists said work-life balance was their top workplace concern. Nearly half (48%) chose that answer, more than twice the percentage who said compensation was the biggest concern (21%).

Asked whether they would take a salary cut for more work-life balance, a similar proportion (46%) said yes.

Forty-three percent of internists manage to take 3-4 weeks of vacation, and 10% take at least 5 weeks, similar to reported vacation time in last year’s survey.

The vast majority are in committed relationships, with 79% reporting that they are married, and 5% reporting that they are living with a partner. Of those who are married, 48% described the marriage as very good; 32%, good; 16%, fair; 2%, poor; and 1%, very poor; 1% preferred not to answer.

One in five internists said their spouse was a physician, and 24% said their spouse worked in the health care field but not as a physician.

Pandemic has increased burnout

Douglas S. Paauw, MD, and Eileen Barrett, MD, two members of the Internal Medicine News editorial advisory board, said they were not surprised by the survey findings.

“There is more burnout since the pandemic,” said Dr. Paauw, professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and third-year medical student clerkship director at the University of Washington. “People may be working more hours, higher stress, but also, some may be working less hours, are socially isolated, taking on a new role of helping their kids in virtual education, andn living in cramped quarters with family that they may not be accustomed to spending so much time with.”

“Also, most physicians love travel, to detress, get back in balance, and that has by and large been taken away by the pandemic,” Dr. Paauw noted. “Unfortunately, bureaucracy did not go away during the pandemic!

Dr. Barrett, an internal medicine hospitalist, said, “It is most concerning to me today that 12% have had thoughts of suicide, and yet 39% are too busy to seek care for depression or burnout, and 17% aren’t seeking due to fear it will be disclosed,”

“Credentialing, medical license applications, and malpractice insurance applications can and must be changed posthaste to support physicians and stop stigmatizing mental health diagnoses and mental health care,” she said. “Removing application questions about physician mental health will be consistent with recommendations from the Federation of State Medical Boards, medical professional societies, and the Americans with Disabilities Act, and is something actionable and achievable for every organization to do in 2021.” “From a public policy perspective, I am deeply concerned about the physician workforce and how patients will be able to receive care from exhausted, burned out physicians who may be reducing their clinical hours to restore their personal happiness – understandably so,” added Dr. Barrett, who is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She pointed out that there are mental health resources available for physicians that don’t go through their employers or insurance such as www.emotionalppe.org/.

A version of this article first appeared on Medscape.com.
Katie Lennon contributed to this report.

Before the pandemic, a large majority of internists reported that they were generally happy with life outside of work, although by specialty, they were near the bottom in happiness.

But this year’s Medscape Internist Lifestyle, Happiness & Burnout Report 2021 shows a sharp drop, with just 55% of respondents saying they are somewhat or very happy in life outside work, compared with 78% last year.

Internists were not alone among the more than 12,000 physicians who responded to the survey. The contrast from last year’s report was clear for physicians in general and reflects COVID-19’s substantial toll on clinicians.

Burnout has ‘strong impact on lives’

The percentage of internists who reported burnout or depression, however, has stayed fairly consistent. This year, 46% reported being either burned out or burned out and depressed, as opposed to 44% last year.

More than half (52%) said that burnout had a strong or severe impact on their lives, and nearly 1 in 10 said it was severe enough that they are considering leaving medicine.

One percent of the internists who responded to the survey said they had attempted suicide, and 12% said they had thoughts of suicide but had not attempted it.

Most of those reporting burnout (82%) said it started before the COVID-19 pandemic, but 18% said it began with the pandemic.

Notably, though, physicians ranked problems related to stress from COVID-19 near the bottom among burnout drivers. The top factor, by far, again, was “too many bureaucratic tasks.”

 A large majority (78%) of internists work online for up to 10 hours a week, a number that could grow as telemedicine grows.
 

Exercise is top coping method

Responses gave a peek into how physicians are coping with burnout. Among internists, 49% put exercise at the top. Isolating themselves from others was the next most popular choice, at 45%. Eating junk food and drinking alcohol were further down the list, at 34% and 24%, respectively.

Few internists said they drink alcohol daily, a finding consistent with past years. In fact, 29% said they don’t drink at all, and 26% said they have fewer than one alcoholic drink per week. Only 7% said they had seven or more drinks per week.

The National Institute on Alcohol Abuse and Alcoholism advises that men not have more than 14 alcoholic drinks per week and that women not have more than 7.
 

Work-life balance topped list of concerns

By far, internists said work-life balance was their top workplace concern. Nearly half (48%) chose that answer, more than twice the percentage who said compensation was the biggest concern (21%).

Asked whether they would take a salary cut for more work-life balance, a similar proportion (46%) said yes.

Forty-three percent of internists manage to take 3-4 weeks of vacation, and 10% take at least 5 weeks, similar to reported vacation time in last year’s survey.

The vast majority are in committed relationships, with 79% reporting that they are married, and 5% reporting that they are living with a partner. Of those who are married, 48% described the marriage as very good; 32%, good; 16%, fair; 2%, poor; and 1%, very poor; 1% preferred not to answer.

One in five internists said their spouse was a physician, and 24% said their spouse worked in the health care field but not as a physician.

Pandemic has increased burnout

Douglas S. Paauw, MD, and Eileen Barrett, MD, two members of the Internal Medicine News editorial advisory board, said they were not surprised by the survey findings.

“There is more burnout since the pandemic,” said Dr. Paauw, professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and third-year medical student clerkship director at the University of Washington. “People may be working more hours, higher stress, but also, some may be working less hours, are socially isolated, taking on a new role of helping their kids in virtual education, andn living in cramped quarters with family that they may not be accustomed to spending so much time with.”

“Also, most physicians love travel, to detress, get back in balance, and that has by and large been taken away by the pandemic,” Dr. Paauw noted. “Unfortunately, bureaucracy did not go away during the pandemic!

Dr. Barrett, an internal medicine hospitalist, said, “It is most concerning to me today that 12% have had thoughts of suicide, and yet 39% are too busy to seek care for depression or burnout, and 17% aren’t seeking due to fear it will be disclosed,”

“Credentialing, medical license applications, and malpractice insurance applications can and must be changed posthaste to support physicians and stop stigmatizing mental health diagnoses and mental health care,” she said. “Removing application questions about physician mental health will be consistent with recommendations from the Federation of State Medical Boards, medical professional societies, and the Americans with Disabilities Act, and is something actionable and achievable for every organization to do in 2021.” “From a public policy perspective, I am deeply concerned about the physician workforce and how patients will be able to receive care from exhausted, burned out physicians who may be reducing their clinical hours to restore their personal happiness – understandably so,” added Dr. Barrett, who is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She pointed out that there are mental health resources available for physicians that don’t go through their employers or insurance such as www.emotionalppe.org/.

A version of this article first appeared on Medscape.com.
Katie Lennon contributed to this report.

Before the pandemic, a large majority of internists reported that they were generally happy with life outside of work, although by specialty, they were near the bottom in happiness.

But this year’s Medscape Internist Lifestyle, Happiness & Burnout Report 2021 shows a sharp drop, with just 55% of respondents saying they are somewhat or very happy in life outside work, compared with 78% last year.

Internists were not alone among the more than 12,000 physicians who responded to the survey. The contrast from last year’s report was clear for physicians in general and reflects COVID-19’s substantial toll on clinicians.

Burnout has ‘strong impact on lives’

The percentage of internists who reported burnout or depression, however, has stayed fairly consistent. This year, 46% reported being either burned out or burned out and depressed, as opposed to 44% last year.

More than half (52%) said that burnout had a strong or severe impact on their lives, and nearly 1 in 10 said it was severe enough that they are considering leaving medicine.

One percent of the internists who responded to the survey said they had attempted suicide, and 12% said they had thoughts of suicide but had not attempted it.

Most of those reporting burnout (82%) said it started before the COVID-19 pandemic, but 18% said it began with the pandemic.

Notably, though, physicians ranked problems related to stress from COVID-19 near the bottom among burnout drivers. The top factor, by far, again, was “too many bureaucratic tasks.”

 A large majority (78%) of internists work online for up to 10 hours a week, a number that could grow as telemedicine grows.
 

Exercise is top coping method

Responses gave a peek into how physicians are coping with burnout. Among internists, 49% put exercise at the top. Isolating themselves from others was the next most popular choice, at 45%. Eating junk food and drinking alcohol were further down the list, at 34% and 24%, respectively.

Few internists said they drink alcohol daily, a finding consistent with past years. In fact, 29% said they don’t drink at all, and 26% said they have fewer than one alcoholic drink per week. Only 7% said they had seven or more drinks per week.

The National Institute on Alcohol Abuse and Alcoholism advises that men not have more than 14 alcoholic drinks per week and that women not have more than 7.
 

Work-life balance topped list of concerns

By far, internists said work-life balance was their top workplace concern. Nearly half (48%) chose that answer, more than twice the percentage who said compensation was the biggest concern (21%).

Asked whether they would take a salary cut for more work-life balance, a similar proportion (46%) said yes.

Forty-three percent of internists manage to take 3-4 weeks of vacation, and 10% take at least 5 weeks, similar to reported vacation time in last year’s survey.

The vast majority are in committed relationships, with 79% reporting that they are married, and 5% reporting that they are living with a partner. Of those who are married, 48% described the marriage as very good; 32%, good; 16%, fair; 2%, poor; and 1%, very poor; 1% preferred not to answer.

One in five internists said their spouse was a physician, and 24% said their spouse worked in the health care field but not as a physician.

Pandemic has increased burnout

Douglas S. Paauw, MD, and Eileen Barrett, MD, two members of the Internal Medicine News editorial advisory board, said they were not surprised by the survey findings.

“There is more burnout since the pandemic,” said Dr. Paauw, professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and third-year medical student clerkship director at the University of Washington. “People may be working more hours, higher stress, but also, some may be working less hours, are socially isolated, taking on a new role of helping their kids in virtual education, andn living in cramped quarters with family that they may not be accustomed to spending so much time with.”

“Also, most physicians love travel, to detress, get back in balance, and that has by and large been taken away by the pandemic,” Dr. Paauw noted. “Unfortunately, bureaucracy did not go away during the pandemic!

Dr. Barrett, an internal medicine hospitalist, said, “It is most concerning to me today that 12% have had thoughts of suicide, and yet 39% are too busy to seek care for depression or burnout, and 17% aren’t seeking due to fear it will be disclosed,”

“Credentialing, medical license applications, and malpractice insurance applications can and must be changed posthaste to support physicians and stop stigmatizing mental health diagnoses and mental health care,” she said. “Removing application questions about physician mental health will be consistent with recommendations from the Federation of State Medical Boards, medical professional societies, and the Americans with Disabilities Act, and is something actionable and achievable for every organization to do in 2021.” “From a public policy perspective, I am deeply concerned about the physician workforce and how patients will be able to receive care from exhausted, burned out physicians who may be reducing their clinical hours to restore their personal happiness – understandably so,” added Dr. Barrett, who is associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.

She pointed out that there are mental health resources available for physicians that don’t go through their employers or insurance such as www.emotionalppe.org/.

A version of this article first appeared on Medscape.com.
Katie Lennon contributed to this report.

When Frances R. Levin, MD, began her clinical psychiatry career in the mid-1990s, she spent a lot of time educating colleagues about the validity of an ADHD diagnosis in adults.

“That’s no longer an issue,” Dr. Levin, the Kennedy-Leavy Professor of Psychiatry at Columbia University, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “But at the time, we often thought, ‘ADHD is something that’s specific to people who are stimulant users.’ In fact, what we found over the years was that these rates are elevated in a range of substance use populations.”

According to National Comorbidity Survey, a nontreatment sample of more than 3,000 adults, individuals who have SUD have two to three times the risk of having ADHD, while individuals who have ADHD have about three times the rate of having an SUD, compared with those who don’t (Am J Psychiatry. 2006;163[4]:716-23). “When you move to treatment samples, the rates also remain quite high,” said Dr. Levin, who is also chief of the division of substance use disorders at the medical center.

“In the general population, the rates of ADHD are 2%-4%. When we look at people who are coming in specifically for treatment of their SUD, the rates are substantially higher, ranging from 10% to 24%.”

According to a 2014 review of medical literature, potential reasons for the association between ADHD and SUD vary and include underlying biologic deficits, such as parental SUDs and genetics; conduct disorder symptoms, such as defiance, rule breaking, and delinquency; poor performance in school, such as low grades, grade retention, or drop-out; and social difficulties, such as rejection from conventional groups or few quality friendships (Annu Rev Clin Psychol. 2014;10:607-39). Other potential pathways include neurocognitive deficits, stress-negative affect models, impulsive anger, and other underlying traits.

One key reason to treat ADHD in patients with SUDs is that they tend to develop the SUD earlier when the ADHD is present, Dr. Levin said. They’re also less likely to be retained in treatment and have a reduced likelihood of going into remission if dependence develops. “Even when they do achieve remission, it seems to take longer for people to reach remission,” she said. “They have more treatment exposure yet do less well in treatment. The other elephant in the room is that often people with ADHD and an SUD have other psychiatric comorbidities. This can make it more challenging to treat this population.”

One common assumption from clinicians regarding patients with ADHD and a concomitant SUD is that standard treatments for ADHD do not work in active substance users. Another is that, even if treatments work for ADHD, they do not affect the substance use disorder. “Understandably, there is also concern that active substance abusers will misuse and divert their medications,” she said. “Finally, there are often additional psychiatric comorbidities that may make it harder to effectively treat individuals with ADHD and SUD.”

Since 2002, 15 double-blind outpatient studies using stimulants/atomoxetine to treat substance abusers with ADHD have appeared in the medical literature, Dr. Levin said. Only three have included adolescents. “That’s surprising, because up to 40% of kids who come in for treatment, often for cannabis use disorder, will have ADHD, yet there is very little guidance from empirical studies as to how to best treat them,” she said. “There have been several studies looking at atomoxetine to treat substance abusers with ADHD, but results have been mixed. In the cannabis use populations, atomoxetine has not been shown to be effective in treating the substance use disorder, and results are mixed regarding superiority in reducing ADHD symptoms. There is one study showing that ADHD is more likely to be improved in adults with alcohol use disorders with mixed results regarding the alcohol use.”

Overall, most of the outpatient and inpatient studies conducted in this population have demonstrated some signal in terms of reducing ADHD, she said, while a minority of the outpatient studies suggest some benefit in terms of substance use. “What’s interesting is that when you see a response in terms of the ADHD, you often see an improvement in the substance use as well,” Dr. Levin said. “This potentially suggests that patients may be self-medicating their ADHD symptoms or that if the ADHD responds to treatment, then the patient may benefit from the psychosocial interventions that targets the SUD.”

A separate meta-analysis involving more than 1,000 patients found mixed results from pharmacologic interventions and concluded that, while they modestly improved ADHD symptoms, no beneficial effect was seen on drug abstinence or on treatment discontinuation (J Psychopharmacol. 2015 Jan;29[1]:15-23). “I would argue that you don’t need to be as nihilistic about this as the meta-analysis might suggest, because the devil’s in the details,” said Dr. Levin, whose own research was included in the work.

“First of all, many of the studies had high drop-out rates. The outcome measures were variable, and some of the studies used formulations with poor bioavailability. Also, trials that evaluated atomoxetine or stimulants were combined, which may be problematic given the different mechanisms of action. Further, the meta-analysis did not include two recent placebo-controlled trials in adults with stimulant-use disorders that both found that higher dosing of a long-acting stimulant resulted in greater improvements in ADHD symptoms and stimulant use” (Addict. 2014;109[3]:440-9 and JAMA Psychiatry. 2015;72[6]:593-602).

Dr. Levin went on to note that there are few empirical data to guide treatment for those who have multiple psychiatric disorders, let alone treatment for ADHD and SUDs without additional psychiatric disorders. The challenge is what to treat first and/or how to treat the concomitant conditions safely.

“Generally, if possible, treat what is most clinically impairing first,” she said. “Overall, both stimulants and atomoxetine may work for ADHD even in the presence of additional depression, anxiety disorders, and substance use disorders.”

She cautioned against treating a patient with ADHD medication if there is a preexisting psychosis or bipolar illness. “If you start a stimulant or atomoxetine and psychosis or mania occurs, you clearly want to stop the medication and reassess,” she said. Researchers found that the risk of precipitating mania with a stimulant is uncommon if you alleviate symptoms first with a mood stabilizer. “This is a situation where you probably want to treat the bipolar illness first, but it does not preclude the treatment of ADHD once the mood stabilization has occurred,” she said.

In patients with ADHD and anxiety, she often treats the ADHD first, “because oftentimes the anxiety is driven by the procrastination and the inability to get things done,” she explained. “It’s important to determine whether the anxiety is an independent disorder rather than symptoms of ADHD. Inner restlessness can be described as anxiety.”

When there are concerns that preclude the use of a controlled medication, there are medications, in addition to atomoxetine, that might be considered. While bupropion is not Food and Drug Administration approved for ADHD, it might be useful in comorbid mood disorders for nicotine dependence. Other off-label medications that may help include guanfacine, modafinil, and tricyclic antidepressants.

“To date, robust dosing of long-acting amphetamine or methylphenidate formulations have been shown to be effective for patients with stimulant-use disorder, but as mentioned earlier, the data only come from two studies,” she said.

In order to determine whether stimulant treatment is yielding a benefit in a patient with co-occurring ADHD and SUD, she recommends carrying out a structured assessment of ADHD symptoms. Monitoring for functional improvement is also key.

“If there is no improvement in social, occupational, or academic settings and the patient is still actively using drugs, then there is no reason to keep prescribing,” she said. Close monitoring for cardiovascular or other psychiatric symptoms are key as well. Further, for those individuals with both ADHD and a substance-use disorder, it is critical that both are targeted for treatment.

Dr. Levin reported that she has received research, training, or salary support from the National Institute on Drug Abuse, New York state, and the Substance Abuse and Mental Health Services Administration. She has also received or currently receives industry support from Indivior and U.S. World Meds and for medication and from Major League Baseball. In addition, Dr. Levin has been an unpaid scientific advisory board member for Alkermes, Indivior, and Novartis.

[email protected]

When Frances R. Levin, MD, began her clinical psychiatry career in the mid-1990s, she spent a lot of time educating colleagues about the validity of an ADHD diagnosis in adults.

“That’s no longer an issue,” Dr. Levin, the Kennedy-Leavy Professor of Psychiatry at Columbia University, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “But at the time, we often thought, ‘ADHD is something that’s specific to people who are stimulant users.’ In fact, what we found over the years was that these rates are elevated in a range of substance use populations.”

According to National Comorbidity Survey, a nontreatment sample of more than 3,000 adults, individuals who have SUD have two to three times the risk of having ADHD, while individuals who have ADHD have about three times the rate of having an SUD, compared with those who don’t (Am J Psychiatry. 2006;163[4]:716-23). “When you move to treatment samples, the rates also remain quite high,” said Dr. Levin, who is also chief of the division of substance use disorders at the medical center.

“In the general population, the rates of ADHD are 2%-4%. When we look at people who are coming in specifically for treatment of their SUD, the rates are substantially higher, ranging from 10% to 24%.”

According to a 2014 review of medical literature, potential reasons for the association between ADHD and SUD vary and include underlying biologic deficits, such as parental SUDs and genetics; conduct disorder symptoms, such as defiance, rule breaking, and delinquency; poor performance in school, such as low grades, grade retention, or drop-out; and social difficulties, such as rejection from conventional groups or few quality friendships (Annu Rev Clin Psychol. 2014;10:607-39). Other potential pathways include neurocognitive deficits, stress-negative affect models, impulsive anger, and other underlying traits.

One key reason to treat ADHD in patients with SUDs is that they tend to develop the SUD earlier when the ADHD is present, Dr. Levin said. They’re also less likely to be retained in treatment and have a reduced likelihood of going into remission if dependence develops. “Even when they do achieve remission, it seems to take longer for people to reach remission,” she said. “They have more treatment exposure yet do less well in treatment. The other elephant in the room is that often people with ADHD and an SUD have other psychiatric comorbidities. This can make it more challenging to treat this population.”

One common assumption from clinicians regarding patients with ADHD and a concomitant SUD is that standard treatments for ADHD do not work in active substance users. Another is that, even if treatments work for ADHD, they do not affect the substance use disorder. “Understandably, there is also concern that active substance abusers will misuse and divert their medications,” she said. “Finally, there are often additional psychiatric comorbidities that may make it harder to effectively treat individuals with ADHD and SUD.”

Since 2002, 15 double-blind outpatient studies using stimulants/atomoxetine to treat substance abusers with ADHD have appeared in the medical literature, Dr. Levin said. Only three have included adolescents. “That’s surprising, because up to 40% of kids who come in for treatment, often for cannabis use disorder, will have ADHD, yet there is very little guidance from empirical studies as to how to best treat them,” she said. “There have been several studies looking at atomoxetine to treat substance abusers with ADHD, but results have been mixed. In the cannabis use populations, atomoxetine has not been shown to be effective in treating the substance use disorder, and results are mixed regarding superiority in reducing ADHD symptoms. There is one study showing that ADHD is more likely to be improved in adults with alcohol use disorders with mixed results regarding the alcohol use.”

Overall, most of the outpatient and inpatient studies conducted in this population have demonstrated some signal in terms of reducing ADHD, she said, while a minority of the outpatient studies suggest some benefit in terms of substance use. “What’s interesting is that when you see a response in terms of the ADHD, you often see an improvement in the substance use as well,” Dr. Levin said. “This potentially suggests that patients may be self-medicating their ADHD symptoms or that if the ADHD responds to treatment, then the patient may benefit from the psychosocial interventions that targets the SUD.”

A separate meta-analysis involving more than 1,000 patients found mixed results from pharmacologic interventions and concluded that, while they modestly improved ADHD symptoms, no beneficial effect was seen on drug abstinence or on treatment discontinuation (J Psychopharmacol. 2015 Jan;29[1]:15-23). “I would argue that you don’t need to be as nihilistic about this as the meta-analysis might suggest, because the devil’s in the details,” said Dr. Levin, whose own research was included in the work.

“First of all, many of the studies had high drop-out rates. The outcome measures were variable, and some of the studies used formulations with poor bioavailability. Also, trials that evaluated atomoxetine or stimulants were combined, which may be problematic given the different mechanisms of action. Further, the meta-analysis did not include two recent placebo-controlled trials in adults with stimulant-use disorders that both found that higher dosing of a long-acting stimulant resulted in greater improvements in ADHD symptoms and stimulant use” (Addict. 2014;109[3]:440-9 and JAMA Psychiatry. 2015;72[6]:593-602).

Dr. Levin went on to note that there are few empirical data to guide treatment for those who have multiple psychiatric disorders, let alone treatment for ADHD and SUDs without additional psychiatric disorders. The challenge is what to treat first and/or how to treat the concomitant conditions safely.

“Generally, if possible, treat what is most clinically impairing first,” she said. “Overall, both stimulants and atomoxetine may work for ADHD even in the presence of additional depression, anxiety disorders, and substance use disorders.”

She cautioned against treating a patient with ADHD medication if there is a preexisting psychosis or bipolar illness. “If you start a stimulant or atomoxetine and psychosis or mania occurs, you clearly want to stop the medication and reassess,” she said. Researchers found that the risk of precipitating mania with a stimulant is uncommon if you alleviate symptoms first with a mood stabilizer. “This is a situation where you probably want to treat the bipolar illness first, but it does not preclude the treatment of ADHD once the mood stabilization has occurred,” she said.

In patients with ADHD and anxiety, she often treats the ADHD first, “because oftentimes the anxiety is driven by the procrastination and the inability to get things done,” she explained. “It’s important to determine whether the anxiety is an independent disorder rather than symptoms of ADHD. Inner restlessness can be described as anxiety.”

When there are concerns that preclude the use of a controlled medication, there are medications, in addition to atomoxetine, that might be considered. While bupropion is not Food and Drug Administration approved for ADHD, it might be useful in comorbid mood disorders for nicotine dependence. Other off-label medications that may help include guanfacine, modafinil, and tricyclic antidepressants.

“To date, robust dosing of long-acting amphetamine or methylphenidate formulations have been shown to be effective for patients with stimulant-use disorder, but as mentioned earlier, the data only come from two studies,” she said.

In order to determine whether stimulant treatment is yielding a benefit in a patient with co-occurring ADHD and SUD, she recommends carrying out a structured assessment of ADHD symptoms. Monitoring for functional improvement is also key.

“If there is no improvement in social, occupational, or academic settings and the patient is still actively using drugs, then there is no reason to keep prescribing,” she said. Close monitoring for cardiovascular or other psychiatric symptoms are key as well. Further, for those individuals with both ADHD and a substance-use disorder, it is critical that both are targeted for treatment.

Dr. Levin reported that she has received research, training, or salary support from the National Institute on Drug Abuse, New York state, and the Substance Abuse and Mental Health Services Administration. She has also received or currently receives industry support from Indivior and U.S. World Meds and for medication and from Major League Baseball. In addition, Dr. Levin has been an unpaid scientific advisory board member for Alkermes, Indivior, and Novartis.

[email protected]

When Frances R. Levin, MD, began her clinical psychiatry career in the mid-1990s, she spent a lot of time educating colleagues about the validity of an ADHD diagnosis in adults.

“That’s no longer an issue,” Dr. Levin, the Kennedy-Leavy Professor of Psychiatry at Columbia University, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “But at the time, we often thought, ‘ADHD is something that’s specific to people who are stimulant users.’ In fact, what we found over the years was that these rates are elevated in a range of substance use populations.”

According to National Comorbidity Survey, a nontreatment sample of more than 3,000 adults, individuals who have SUD have two to three times the risk of having ADHD, while individuals who have ADHD have about three times the rate of having an SUD, compared with those who don’t (Am J Psychiatry. 2006;163[4]:716-23). “When you move to treatment samples, the rates also remain quite high,” said Dr. Levin, who is also chief of the division of substance use disorders at the medical center.

“In the general population, the rates of ADHD are 2%-4%. When we look at people who are coming in specifically for treatment of their SUD, the rates are substantially higher, ranging from 10% to 24%.”

According to a 2014 review of medical literature, potential reasons for the association between ADHD and SUD vary and include underlying biologic deficits, such as parental SUDs and genetics; conduct disorder symptoms, such as defiance, rule breaking, and delinquency; poor performance in school, such as low grades, grade retention, or drop-out; and social difficulties, such as rejection from conventional groups or few quality friendships (Annu Rev Clin Psychol. 2014;10:607-39). Other potential pathways include neurocognitive deficits, stress-negative affect models, impulsive anger, and other underlying traits.

One key reason to treat ADHD in patients with SUDs is that they tend to develop the SUD earlier when the ADHD is present, Dr. Levin said. They’re also less likely to be retained in treatment and have a reduced likelihood of going into remission if dependence develops. “Even when they do achieve remission, it seems to take longer for people to reach remission,” she said. “They have more treatment exposure yet do less well in treatment. The other elephant in the room is that often people with ADHD and an SUD have other psychiatric comorbidities. This can make it more challenging to treat this population.”

One common assumption from clinicians regarding patients with ADHD and a concomitant SUD is that standard treatments for ADHD do not work in active substance users. Another is that, even if treatments work for ADHD, they do not affect the substance use disorder. “Understandably, there is also concern that active substance abusers will misuse and divert their medications,” she said. “Finally, there are often additional psychiatric comorbidities that may make it harder to effectively treat individuals with ADHD and SUD.”

Since 2002, 15 double-blind outpatient studies using stimulants/atomoxetine to treat substance abusers with ADHD have appeared in the medical literature, Dr. Levin said. Only three have included adolescents. “That’s surprising, because up to 40% of kids who come in for treatment, often for cannabis use disorder, will have ADHD, yet there is very little guidance from empirical studies as to how to best treat them,” she said. “There have been several studies looking at atomoxetine to treat substance abusers with ADHD, but results have been mixed. In the cannabis use populations, atomoxetine has not been shown to be effective in treating the substance use disorder, and results are mixed regarding superiority in reducing ADHD symptoms. There is one study showing that ADHD is more likely to be improved in adults with alcohol use disorders with mixed results regarding the alcohol use.”

Overall, most of the outpatient and inpatient studies conducted in this population have demonstrated some signal in terms of reducing ADHD, she said, while a minority of the outpatient studies suggest some benefit in terms of substance use. “What’s interesting is that when you see a response in terms of the ADHD, you often see an improvement in the substance use as well,” Dr. Levin said. “This potentially suggests that patients may be self-medicating their ADHD symptoms or that if the ADHD responds to treatment, then the patient may benefit from the psychosocial interventions that targets the SUD.”

A separate meta-analysis involving more than 1,000 patients found mixed results from pharmacologic interventions and concluded that, while they modestly improved ADHD symptoms, no beneficial effect was seen on drug abstinence or on treatment discontinuation (J Psychopharmacol. 2015 Jan;29[1]:15-23). “I would argue that you don’t need to be as nihilistic about this as the meta-analysis might suggest, because the devil’s in the details,” said Dr. Levin, whose own research was included in the work.

“First of all, many of the studies had high drop-out rates. The outcome measures were variable, and some of the studies used formulations with poor bioavailability. Also, trials that evaluated atomoxetine or stimulants were combined, which may be problematic given the different mechanisms of action. Further, the meta-analysis did not include two recent placebo-controlled trials in adults with stimulant-use disorders that both found that higher dosing of a long-acting stimulant resulted in greater improvements in ADHD symptoms and stimulant use” (Addict. 2014;109[3]:440-9 and JAMA Psychiatry. 2015;72[6]:593-602).

Dr. Levin went on to note that there are few empirical data to guide treatment for those who have multiple psychiatric disorders, let alone treatment for ADHD and SUDs without additional psychiatric disorders. The challenge is what to treat first and/or how to treat the concomitant conditions safely.

“Generally, if possible, treat what is most clinically impairing first,” she said. “Overall, both stimulants and atomoxetine may work for ADHD even in the presence of additional depression, anxiety disorders, and substance use disorders.”

She cautioned against treating a patient with ADHD medication if there is a preexisting psychosis or bipolar illness. “If you start a stimulant or atomoxetine and psychosis or mania occurs, you clearly want to stop the medication and reassess,” she said. Researchers found that the risk of precipitating mania with a stimulant is uncommon if you alleviate symptoms first with a mood stabilizer. “This is a situation where you probably want to treat the bipolar illness first, but it does not preclude the treatment of ADHD once the mood stabilization has occurred,” she said.

In patients with ADHD and anxiety, she often treats the ADHD first, “because oftentimes the anxiety is driven by the procrastination and the inability to get things done,” she explained. “It’s important to determine whether the anxiety is an independent disorder rather than symptoms of ADHD. Inner restlessness can be described as anxiety.”

When there are concerns that preclude the use of a controlled medication, there are medications, in addition to atomoxetine, that might be considered. While bupropion is not Food and Drug Administration approved for ADHD, it might be useful in comorbid mood disorders for nicotine dependence. Other off-label medications that may help include guanfacine, modafinil, and tricyclic antidepressants.

“To date, robust dosing of long-acting amphetamine or methylphenidate formulations have been shown to be effective for patients with stimulant-use disorder, but as mentioned earlier, the data only come from two studies,” she said.

In order to determine whether stimulant treatment is yielding a benefit in a patient with co-occurring ADHD and SUD, she recommends carrying out a structured assessment of ADHD symptoms. Monitoring for functional improvement is also key.

“If there is no improvement in social, occupational, or academic settings and the patient is still actively using drugs, then there is no reason to keep prescribing,” she said. Close monitoring for cardiovascular or other psychiatric symptoms are key as well. Further, for those individuals with both ADHD and a substance-use disorder, it is critical that both are targeted for treatment.

Dr. Levin reported that she has received research, training, or salary support from the National Institute on Drug Abuse, New York state, and the Substance Abuse and Mental Health Services Administration. She has also received or currently receives industry support from Indivior and U.S. World Meds and for medication and from Major League Baseball. In addition, Dr. Levin has been an unpaid scientific advisory board member for Alkermes, Indivior, and Novartis.

[email protected]

COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.

Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.

Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.

The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.

Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.

COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.

Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.

Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.

The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.

Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.

COVID-19 upended everything last year, including routine health care such as older people receiving their pneumonia, pertussis, and shingles shots. Weekly vaccinations for Medicare beneficiaries aged > 65 years dropped in the first half of 2020 by up to 89% when compared with the first half of 2019. Researchers from the Centers for Disease Control and Prevention (CDC) studied weekly receipt of 4 vaccines: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine, and recombinant zoster vaccine.

Before the national emergency was declared in March 2020, vaccination rates were consistently higher among Medicare beneficiaries than in the corresponding weeks in 2019. After the declaration, vaccination rates began dropping precipitously. In the first week alone, the rates were 25 to 62% lower than during the corresponding week in 2019.

Vaccination rates declined for all the vaccines studied, overall, and across all racial and ethnic groups. They began to recover gradually between late April and July, but were still lower in the last study week compared with 2019, except for PPSV23.

The emphasis naturally has been largely on COVID-19, but the other infections still present risks for older people. And now that states are beginning to lift restrictions, the researchers say, the likelihood of exposure to vaccine-preventable diseases is increasing. They urge health care providers to continue efforts to resolve disruptions in routine vaccinations, and to emphasize the safety of the vaccines.

Importantly, practitioners also need to explain to patients about expected reactions to some vaccines, and help them understand the potential overlap between vaccination reactions and symptoms of COVID-19.

A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.

According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.

Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.

The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.

The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.

Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day. 

But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.

Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”

Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”

A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”

That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.

Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.

Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”

A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.

According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.

Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.

The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.

The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.

Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day. 

But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.

Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”

Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”

A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”

That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.

Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.

Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”

A large portion of the general American public is still feeling wary of the COVID-19 vaccines. In a recent Pew Research survey, about 40% of respondents said they “would not get the vaccine” (although about half of that group allowed for flexibility and said they might when more information becomes available). In the Native American community, however, it’s a different story.

According to the Seattle-based Urban Indian Health Institute (UIHI), one of 12 Tribal Epidemiology Centers in the US, 75% of the 1,435 American Indian/Alaska Native participants in its National COVID-19 Vaccination Survey were willing to receive the vaccine. A big reason is that the emphasis in Native American communities has been on “we,” rather than “me.” Even though the respondents might feel reluctant due to “historical and current abuse from healthcare and government institutions,” the UIHI says, they ultimately felt the heavy cost of COVID-19 for them, their friends, families, and community outweighed potential risks.

Where there is hesitancy, it’s often due to concern about the exceptional speed of the clinical trials assessing the vaccines. Of those who were willing to get vaccinated, two-thirds were confident that the vaccines had been adequately tested for safety and effectiveness among Native people, in contrast to 31% of the “unwilling.” Seventy-five percent of the unwilling perceive the vaccine as dangerous to their health.

The willingness to receive a COVID-19 vaccine varied by Indian Health Services (IHS) region, with California Area having the lowest proportion (64%) and Albuquerque Area the highest (86%). The survey also asked about perceptions of COVID-19: 75% of those unwilling to get vaccinated felt they were at risk of being infected with COVID-19, compared with 85% of those willing to get a vaccine. Interestingly, though, the majority in the “unwilling” group takes the infection seriously and acknowledges the spread of COVID-19 in the state where they live.

The primary motivation for getting vaccinated, UIHI says, is a “strong sense of responsibility to protect the Native community and preserve cultural ways”—74% of all participants supported this concept. That’s a unique difference when compared with other communities of color, UIHI says. By comparison, only 36% of black communities and 53% of Latinx communities have been found to perceive vaccination as a community responsibility. The finding illustrates the importance of community in Native American culture—although that also differs within the 2 groups surveyed: Of those willing to get vaccinated, 87% believe it’s their communal responsibility, whereas 66% of the unwilling believe it’s an individual choice.

Tribal campaigns that emphasize the good individuals can do for the tribe appear to appeal. In an interview with NBC News, Abigail Echo-Hawk, director of UIHI, said the Seattle Indian Health Board, for example, went from about 7,000 calls a month about the vaccine to nearly 5,000 on 1 day. 

But it isn’t just the appeal to communal feeling that spurs participation—it’s also the knowledge that protecting people protects the culture. The Cherokee Tribe, for instance, has been mobilizing to get as many people vaccinated as possible, starting with some of the “most endangered members of the tribe”: those who still speak Cherokee. “We put Cherokee-fluent speakers, most of whom are elders, at the front of the line,” Principal Chief Chuck Hoskin Jr., leader of the Cherokee Nation, told NBC News. The tribe was able to put its roughly 22,000 Cherokee speakers at the top of the list because it answers to the IHS, not the state of Oklahoma, which has people aged < 65 years in Phase 4 of its vaccine rollout.

Appealing to the reverence for Native American culture and tradition is a wise move. Not only because it protects people, but also because vaccinating elders and fluent speakers may reassure others. “When fluent speakers got the vaccine, I think that helped people’s anxiety subside,” Hoskins said. “And I think people felt sort of a renewed obligation to try and protect the culture by being vaccinated.”

Many of the survey respondents viewed getting vaccinated as an act of love, protecting others. One participant planned to get the vaccine to “protect the knowledge keepers; ensuring knowledge is passed to our future generations.”

A majority of UIHI survey respondents who were unwilling to get vaccinated indicated they would be willing at some point in the future—often at least one year from now. This, UIHI says, “may suggest with proper messaging and education on the efficacy and safety of vaccine, hesitancy can be addressed.”

That could depend on who’s delivering the message. The greatest difference between the 2 groups, the UIHI says, was that those who were willing to take vaccines trusted government organizations (ie,Centers for Disease Control and prevention, Food and Drug Administration, and National Institutes of Health) and their regular doctor. Those unwilling to get vaccinated had the highest trust in Urban Indian health clinics, their regular doctor, and Tribal clinics, respectively. The biggest divide? Almost all of the willing group “mostly” or “completely” trusts Dr. Anthony Fauci and the scientists working on the vaccines. Most of the unwilling group does not.

Factors such as convenience, cost, and advice all entered into the respondents’ decision making. But one of the UIHI’s key recommendations is to continue to draw connections between getting vaccinated and the preservation of Native traditions, cultural pride, and love and respect for family, elders, and the broader Native community. Elders, Native community leaders, and Tribal leaders were among the top ambassadors for getting the message out, the UIHI survey found.

Ultimately, each individual decides who to trust. One of the survey respondents said, “Although the US government should have and could have done so much more for all people living here, if we turn down the vaccine, we not only risk our lives and the lives of others…we undermine all the struggles our tribes have gone through to keep our people safe. Even when the US government has directly worked against our tribal checkpoints and safety efforts. To not get vaccinated, is to say the US government’s failure to protect the people is right, and our tribal efforts, wisdom, and courage is wrong.”

The American Gastroenterological Association has announced the 2021 recipients of its annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA Recognition Prizes allow members to honor their contemporaries for their exceptional contributions to the field of gastroenterology and hepatology,” said Hashem B. El-Serag, MD, MPH, AGAF, chair of AGA. “The 2021 AGA Recognition Prize winners represent only a small group of our widely distinguished and exceptional members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”

This year the AGA Recognition Prizes will be presented virtually in May 2021.

• Michael Camilleri, MD, AGAF, Julius Friedenwald Medal
• Byron Cryer, MD, Distinguished Service Award in Diversity, Equity and Inclusion
• Sandra Quezada, MD, MS, Distinguished Service Award in Diversity, Equity and Inclusion
• Kim Barrett, Distinguished Achievement Award in Basic Science
• David Y. Graham, William Beaumont Prize
• Griffin Rodgers, MD, MACP, Research Service Award
• Lin Chang, Distinguished Educator Award
• Nimish Vakil, MD, AGAF, FASGE, Distinguished Clinician Award in Private Practice
• Peter H.R. Green, Distinguished Clinician Award in Academic Practice
• Vay Liang “Bill” Go, MD, AGAF, Distinguished Mentor Award
• Shahnaz Sultan, MD, MHSc, AGAF, Outstanding Service Award
• Osama Altayar, MD, Outstanding Service Award
• Perica Davitkov, MD, Outstanding Service Award
• Joseph D. Feuerstein, MD, Outstanding Service Award
• Shazia M. Siddique, MD, MSHP, Outstanding Service Award
• Yngve T. Falck-Ytter, MD, AGAF, Outstanding Service Award
• Joseph K. Lim, MD, AGAF, Outstanding Service Award

To learn more about our 2021 AGA recognition prize recipients, visit https://gastro.org/2021awards.
 

The American Gastroenterological Association has announced the 2021 recipients of its annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA Recognition Prizes allow members to honor their contemporaries for their exceptional contributions to the field of gastroenterology and hepatology,” said Hashem B. El-Serag, MD, MPH, AGAF, chair of AGA. “The 2021 AGA Recognition Prize winners represent only a small group of our widely distinguished and exceptional members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”

This year the AGA Recognition Prizes will be presented virtually in May 2021.

• Michael Camilleri, MD, AGAF, Julius Friedenwald Medal
• Byron Cryer, MD, Distinguished Service Award in Diversity, Equity and Inclusion
• Sandra Quezada, MD, MS, Distinguished Service Award in Diversity, Equity and Inclusion
• Kim Barrett, Distinguished Achievement Award in Basic Science
• David Y. Graham, William Beaumont Prize
• Griffin Rodgers, MD, MACP, Research Service Award
• Lin Chang, Distinguished Educator Award
• Nimish Vakil, MD, AGAF, FASGE, Distinguished Clinician Award in Private Practice
• Peter H.R. Green, Distinguished Clinician Award in Academic Practice
• Vay Liang “Bill” Go, MD, AGAF, Distinguished Mentor Award
• Shahnaz Sultan, MD, MHSc, AGAF, Outstanding Service Award
• Osama Altayar, MD, Outstanding Service Award
• Perica Davitkov, MD, Outstanding Service Award
• Joseph D. Feuerstein, MD, Outstanding Service Award
• Shazia M. Siddique, MD, MSHP, Outstanding Service Award
• Yngve T. Falck-Ytter, MD, AGAF, Outstanding Service Award
• Joseph K. Lim, MD, AGAF, Outstanding Service Award

To learn more about our 2021 AGA recognition prize recipients, visit https://gastro.org/2021awards.
 

The American Gastroenterological Association has announced the 2021 recipients of its annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology.

“AGA Recognition Prizes allow members to honor their contemporaries for their exceptional contributions to the field of gastroenterology and hepatology,” said Hashem B. El-Serag, MD, MPH, AGAF, chair of AGA. “The 2021 AGA Recognition Prize winners represent only a small group of our widely distinguished and exceptional members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representatives of AGA.”

This year the AGA Recognition Prizes will be presented virtually in May 2021.

• Michael Camilleri, MD, AGAF, Julius Friedenwald Medal
• Byron Cryer, MD, Distinguished Service Award in Diversity, Equity and Inclusion
• Sandra Quezada, MD, MS, Distinguished Service Award in Diversity, Equity and Inclusion
• Kim Barrett, Distinguished Achievement Award in Basic Science
• David Y. Graham, William Beaumont Prize
• Griffin Rodgers, MD, MACP, Research Service Award
• Lin Chang, Distinguished Educator Award
• Nimish Vakil, MD, AGAF, FASGE, Distinguished Clinician Award in Private Practice
• Peter H.R. Green, Distinguished Clinician Award in Academic Practice
• Vay Liang “Bill” Go, MD, AGAF, Distinguished Mentor Award
• Shahnaz Sultan, MD, MHSc, AGAF, Outstanding Service Award
• Osama Altayar, MD, Outstanding Service Award
• Perica Davitkov, MD, Outstanding Service Award
• Joseph D. Feuerstein, MD, Outstanding Service Award
• Shazia M. Siddique, MD, MSHP, Outstanding Service Award
• Yngve T. Falck-Ytter, MD, AGAF, Outstanding Service Award
• Joseph K. Lim, MD, AGAF, Outstanding Service Award

To learn more about our 2021 AGA recognition prize recipients, visit https://gastro.org/2021awards.
 

In a clinical trial comparing three graft-versus-host disease (GVHD)–prevention regimens in patients undergoing hematopoietic stem cell transplants, a calcineurin inhibitor (CNI)–free strategy using CD34-selected peripheral blood stem cells (PBSCs) was associated with a nearly twofold increase in transplant-related mortality, compared with either a different CNI-free regimen or tacrolimus plus methotrexate, investigators reported.

In the phase 3 Progress II trial, patients who received CD34-selected PBSCs without post-transplant immune suppression had a hazard ratio for death of 1.74 compared with patients who received T-cell depletion with posttransplant cyclophosphamide, and a HR of 1.78, compared with patients who received tacrolimus and methotrexate after a bone marrow graft, Miguel-Angel Perales , MD, from Memorial Sloan Kettering Cancer Center, New York, reported at the Transplant & Cellular Therapies Meetings.

“CD34 selection was associated with worse overall survival, which offset any benefit from lower rates of moderate to severe chronic GVHD,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Neither of the two CNI-free interventions were superior to tacrolimus/methotrexate with bone marrow–derived stem cells for preventing chronic GVHD, and there were no differences in the primary endpoint of chronic GVHD/relapse-free survival, Dr. Perales said.
 

T-cell depletion vs. CNI

The Progress II trial was designed to see whether either of two CNI-free, T-cell depletion approaches could improve chronic GVHD rates post transplant over a CNI-based regimen.

The investigators enrolled patients aged 65 years or younger with acute leukemia or myelodysplasia with fewer than 5% blasts and a HLA-matched related or unrelated donor.

The patients were randomly assigned to either bone marrow grafts with tacrolimus/methotrexate (118 patients), bone marrow with in vivo posttransplant cyclophosphamide (114), or PBSCs with ex vivo CD34-selected cells (114).

The primary endpoint of chronic GVHD/relapse-free survival (CRFS) was a time-to-event outcome defined as moderate to severe chronic GVHD according to National Institutes of Health consensus criteria, disease relapse or progression, or death from any cause.

As noted before, there were no between-arm differences in the primary CRFS endpoint, and in multivariate analysis controlling for donor type, patient characteristics, disease category and disease risk index, the only factor significantly predictive for CRFS was being aged 50 years or older.

The 2-year posttransplant survival rates were 61.6% in the CD34-selected arm, 76.7% in the posttransplant cyclophosphamide arm, and 74.2% in the tacrolimus/methotrexate arm.

As noted before, the HR for CRFS with CD34 versus tacrolimus/methotrexate was 1.74, and for CD34 versus cyclophosphamide was 1.78 (P = .02 for both comparisons). In contrast, there was no differe­nce in CRFS between posttransplant cyclophosphamide and tacrolimus/methotrexate.

Both relapse-free survival and transplant-related mortality were worse with the CD34-selected group, compared with the other two groups, but there were no significant differences among the arms in disease relapse.

Hematologic recovery was faster in the CD34 arm, but there were no significant differences in graft failure.

In addition, the incidence of grade II-IV acute GVHD was increased in the posttransplant cyclophosphamide group, compared with the other two, while chronic GVHD and moderate to severe chronic GVHD were reduced in the CD34 group.

There were no differences in quality of life measures among the groups, Dr. Perales said.
 

Practice changing?

In the question-and answer-session following the presentation, comoderator Sarah Nikiforow , MD, PhD, from the Dana-Farber Cancer Institute in Boston, who was not involved in the study, asked whether the trial results could be considered as practice changing for any centers that historically have done CD34 selection, or whether CD34 selection is still a viable approach to GVHD prophylaxis.

“That’s obviously a key question from the study, and a question that we’re asking ourselves,” Dr. Perales said. “I think the lesson that we took from this study as it pertains to CD34 selection is obviously the increased mortality, likely related to regimen toxicity, and I think the use of high-dose radiation is something that we have to reexamine.”

He said that his center is also considering whether to reduce antithymocyte globulin dosing, move it earlier in the process, and to use pharmokinetic-directed ATG as a possible means of decreasing nonrelapse mortality.

“I think it remains a useful platform for adoptive cell therapy, potentially targeting relapsed disease,” he added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Perales disclosed advisory board activities and consulting for multiple companies, and receiving research funding for clinical trials from several more. Dr. Nikiforow disclosed a consulting/advisory role for Kite Pharma, and travel accommodations and expense from Celyad Oncology.

In a clinical trial comparing three graft-versus-host disease (GVHD)–prevention regimens in patients undergoing hematopoietic stem cell transplants, a calcineurin inhibitor (CNI)–free strategy using CD34-selected peripheral blood stem cells (PBSCs) was associated with a nearly twofold increase in transplant-related mortality, compared with either a different CNI-free regimen or tacrolimus plus methotrexate, investigators reported.

In the phase 3 Progress II trial, patients who received CD34-selected PBSCs without post-transplant immune suppression had a hazard ratio for death of 1.74 compared with patients who received T-cell depletion with posttransplant cyclophosphamide, and a HR of 1.78, compared with patients who received tacrolimus and methotrexate after a bone marrow graft, Miguel-Angel Perales , MD, from Memorial Sloan Kettering Cancer Center, New York, reported at the Transplant & Cellular Therapies Meetings.

“CD34 selection was associated with worse overall survival, which offset any benefit from lower rates of moderate to severe chronic GVHD,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Neither of the two CNI-free interventions were superior to tacrolimus/methotrexate with bone marrow–derived stem cells for preventing chronic GVHD, and there were no differences in the primary endpoint of chronic GVHD/relapse-free survival, Dr. Perales said.
 

T-cell depletion vs. CNI

The Progress II trial was designed to see whether either of two CNI-free, T-cell depletion approaches could improve chronic GVHD rates post transplant over a CNI-based regimen.

The investigators enrolled patients aged 65 years or younger with acute leukemia or myelodysplasia with fewer than 5% blasts and a HLA-matched related or unrelated donor.

The patients were randomly assigned to either bone marrow grafts with tacrolimus/methotrexate (118 patients), bone marrow with in vivo posttransplant cyclophosphamide (114), or PBSCs with ex vivo CD34-selected cells (114).

The primary endpoint of chronic GVHD/relapse-free survival (CRFS) was a time-to-event outcome defined as moderate to severe chronic GVHD according to National Institutes of Health consensus criteria, disease relapse or progression, or death from any cause.

As noted before, there were no between-arm differences in the primary CRFS endpoint, and in multivariate analysis controlling for donor type, patient characteristics, disease category and disease risk index, the only factor significantly predictive for CRFS was being aged 50 years or older.

The 2-year posttransplant survival rates were 61.6% in the CD34-selected arm, 76.7% in the posttransplant cyclophosphamide arm, and 74.2% in the tacrolimus/methotrexate arm.

As noted before, the HR for CRFS with CD34 versus tacrolimus/methotrexate was 1.74, and for CD34 versus cyclophosphamide was 1.78 (P = .02 for both comparisons). In contrast, there was no differe­nce in CRFS between posttransplant cyclophosphamide and tacrolimus/methotrexate.

Both relapse-free survival and transplant-related mortality were worse with the CD34-selected group, compared with the other two groups, but there were no significant differences among the arms in disease relapse.

Hematologic recovery was faster in the CD34 arm, but there were no significant differences in graft failure.

In addition, the incidence of grade II-IV acute GVHD was increased in the posttransplant cyclophosphamide group, compared with the other two, while chronic GVHD and moderate to severe chronic GVHD were reduced in the CD34 group.

There were no differences in quality of life measures among the groups, Dr. Perales said.
 

Practice changing?

In the question-and answer-session following the presentation, comoderator Sarah Nikiforow , MD, PhD, from the Dana-Farber Cancer Institute in Boston, who was not involved in the study, asked whether the trial results could be considered as practice changing for any centers that historically have done CD34 selection, or whether CD34 selection is still a viable approach to GVHD prophylaxis.

“That’s obviously a key question from the study, and a question that we’re asking ourselves,” Dr. Perales said. “I think the lesson that we took from this study as it pertains to CD34 selection is obviously the increased mortality, likely related to regimen toxicity, and I think the use of high-dose radiation is something that we have to reexamine.”

He said that his center is also considering whether to reduce antithymocyte globulin dosing, move it earlier in the process, and to use pharmokinetic-directed ATG as a possible means of decreasing nonrelapse mortality.

“I think it remains a useful platform for adoptive cell therapy, potentially targeting relapsed disease,” he added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Perales disclosed advisory board activities and consulting for multiple companies, and receiving research funding for clinical trials from several more. Dr. Nikiforow disclosed a consulting/advisory role for Kite Pharma, and travel accommodations and expense from Celyad Oncology.

In a clinical trial comparing three graft-versus-host disease (GVHD)–prevention regimens in patients undergoing hematopoietic stem cell transplants, a calcineurin inhibitor (CNI)–free strategy using CD34-selected peripheral blood stem cells (PBSCs) was associated with a nearly twofold increase in transplant-related mortality, compared with either a different CNI-free regimen or tacrolimus plus methotrexate, investigators reported.

In the phase 3 Progress II trial, patients who received CD34-selected PBSCs without post-transplant immune suppression had a hazard ratio for death of 1.74 compared with patients who received T-cell depletion with posttransplant cyclophosphamide, and a HR of 1.78, compared with patients who received tacrolimus and methotrexate after a bone marrow graft, Miguel-Angel Perales , MD, from Memorial Sloan Kettering Cancer Center, New York, reported at the Transplant & Cellular Therapies Meetings.

“CD34 selection was associated with worse overall survival, which offset any benefit from lower rates of moderate to severe chronic GVHD,” he said at the meeting held by the American Society for Blood and Marrow Transplantation and the Center for International Blood and Marrow Transplant Research.

Neither of the two CNI-free interventions were superior to tacrolimus/methotrexate with bone marrow–derived stem cells for preventing chronic GVHD, and there were no differences in the primary endpoint of chronic GVHD/relapse-free survival, Dr. Perales said.
 

T-cell depletion vs. CNI

The Progress II trial was designed to see whether either of two CNI-free, T-cell depletion approaches could improve chronic GVHD rates post transplant over a CNI-based regimen.

The investigators enrolled patients aged 65 years or younger with acute leukemia or myelodysplasia with fewer than 5% blasts and a HLA-matched related or unrelated donor.

The patients were randomly assigned to either bone marrow grafts with tacrolimus/methotrexate (118 patients), bone marrow with in vivo posttransplant cyclophosphamide (114), or PBSCs with ex vivo CD34-selected cells (114).

The primary endpoint of chronic GVHD/relapse-free survival (CRFS) was a time-to-event outcome defined as moderate to severe chronic GVHD according to National Institutes of Health consensus criteria, disease relapse or progression, or death from any cause.

As noted before, there were no between-arm differences in the primary CRFS endpoint, and in multivariate analysis controlling for donor type, patient characteristics, disease category and disease risk index, the only factor significantly predictive for CRFS was being aged 50 years or older.

The 2-year posttransplant survival rates were 61.6% in the CD34-selected arm, 76.7% in the posttransplant cyclophosphamide arm, and 74.2% in the tacrolimus/methotrexate arm.

As noted before, the HR for CRFS with CD34 versus tacrolimus/methotrexate was 1.74, and for CD34 versus cyclophosphamide was 1.78 (P = .02 for both comparisons). In contrast, there was no differe­nce in CRFS between posttransplant cyclophosphamide and tacrolimus/methotrexate.

Both relapse-free survival and transplant-related mortality were worse with the CD34-selected group, compared with the other two groups, but there were no significant differences among the arms in disease relapse.

Hematologic recovery was faster in the CD34 arm, but there were no significant differences in graft failure.

In addition, the incidence of grade II-IV acute GVHD was increased in the posttransplant cyclophosphamide group, compared with the other two, while chronic GVHD and moderate to severe chronic GVHD were reduced in the CD34 group.

There were no differences in quality of life measures among the groups, Dr. Perales said.
 

Practice changing?

In the question-and answer-session following the presentation, comoderator Sarah Nikiforow , MD, PhD, from the Dana-Farber Cancer Institute in Boston, who was not involved in the study, asked whether the trial results could be considered as practice changing for any centers that historically have done CD34 selection, or whether CD34 selection is still a viable approach to GVHD prophylaxis.

“That’s obviously a key question from the study, and a question that we’re asking ourselves,” Dr. Perales said. “I think the lesson that we took from this study as it pertains to CD34 selection is obviously the increased mortality, likely related to regimen toxicity, and I think the use of high-dose radiation is something that we have to reexamine.”

He said that his center is also considering whether to reduce antithymocyte globulin dosing, move it earlier in the process, and to use pharmokinetic-directed ATG as a possible means of decreasing nonrelapse mortality.

“I think it remains a useful platform for adoptive cell therapy, potentially targeting relapsed disease,” he added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Perales disclosed advisory board activities and consulting for multiple companies, and receiving research funding for clinical trials from several more. Dr. Nikiforow disclosed a consulting/advisory role for Kite Pharma, and travel accommodations and expense from Celyad Oncology.

An integrated analysis of data derived from 99 treatment-naive glioblastomas has identified characteristics that could help stratify patients for more effective treatment, according to the investigators.

The analysis provides a detailed map of genes, proteins, infiltrating cells, and signaling pathways that play key roles in driving glioblastoma, Liang-Bo Wang, MD, of Washington University in St. Louis, and colleagues reported in Cancer Cell.

For example, the team identified key phosphorylation events as potential mediators of oncogenic pathway activation and potential targets for EGFR-, TP53-, and RB1-altered tumors. Specifically, phosphorylated PTPN11 and PLCG1 represent a signaling hub in RTK-altered tumors, they found.

The investigators also identified four immune glioblastoma tumor subtypes characterized by distinct immune cell populations. Type 1 tumors have a high macrophage count and few T cells, type 2 tumors have a moderate macrophage count, type 3 tumors have a high T-cell count and few macrophages, and type 4 tumors have few or no immune cells of any type.

They also found that mesenchymal subtype EMT signature is specific to tumor cells but not to stroma, and histone H2B acetylation is enriched in classical glioblastomas with low macrophage content.

“To improve therapies for this deadly cancer, understanding the tumor cells themselves is important but not enough,” senior author Li Ding, PhD, a professor of medicine and genetics and director of computational biology in the division of oncology at Washington University stated in a press release. “We also must understand the tumor cells’ interactions with the surrounding environment, including immune cells and the connective tissues and blood vessels.”

The investigators, including researchers from Pacific Northwest National Laboratory, Case Western Reserve University, and the National Cancer Institute, performed high-resolution and high-depth analyses on 99 tumors.

“Harnessing new technologies, including proteomics, metabolomics, and single-cell sequencing, this study is an extremely deep dive into glioblastoma tumor biology, revealing new possibilities for therapy,” Dr. Ding said.

The study, which is part of the NCI’s Clinical Proteomic Tumor Analysis Consortium (CPTAC), is the largest and most detailed schematic of glioblastoma tumors to date, according to the press release.

The most immediate implication of the findings is better clinical trial design, study coauthor Milan G. Chheda, MD, stated in the press release.

Stratifying patients by tumor type, as identified in the current analysis, could allow researchers to test targeted therapies in the tumors most likely to respond to those therapies, explained Dr. Chheda, of Siteman Cancer Center at Barnes Jewish Hospital and Washington University.

The findings, particularly of multiple glioblastoma tumor subtypes, may explain the negative findings of trials looking at various immunotherapies for treating glioblastoma. Investigators for those trials haven’t considered the possibility of immune subgroups that may respond differently, the authors note, adding that research is underway to identify the best drugs to assess for the newly identified glioblastoma tumor types.

The study was supported by grants from the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium, the National Human Genome Research Institute, and the National Institutes of Health.

Dr. Wang and Dr. Ding reported having no disclosures. Dr. Chheda receives research support from NeoimmuneTech and Orbus Therapeutics, and royalties from UpToDate.

[email protected]

An integrated analysis of data derived from 99 treatment-naive glioblastomas has identified characteristics that could help stratify patients for more effective treatment, according to the investigators.

The analysis provides a detailed map of genes, proteins, infiltrating cells, and signaling pathways that play key roles in driving glioblastoma, Liang-Bo Wang, MD, of Washington University in St. Louis, and colleagues reported in Cancer Cell.

For example, the team identified key phosphorylation events as potential mediators of oncogenic pathway activation and potential targets for EGFR-, TP53-, and RB1-altered tumors. Specifically, phosphorylated PTPN11 and PLCG1 represent a signaling hub in RTK-altered tumors, they found.

The investigators also identified four immune glioblastoma tumor subtypes characterized by distinct immune cell populations. Type 1 tumors have a high macrophage count and few T cells, type 2 tumors have a moderate macrophage count, type 3 tumors have a high T-cell count and few macrophages, and type 4 tumors have few or no immune cells of any type.

They also found that mesenchymal subtype EMT signature is specific to tumor cells but not to stroma, and histone H2B acetylation is enriched in classical glioblastomas with low macrophage content.

“To improve therapies for this deadly cancer, understanding the tumor cells themselves is important but not enough,” senior author Li Ding, PhD, a professor of medicine and genetics and director of computational biology in the division of oncology at Washington University stated in a press release. “We also must understand the tumor cells’ interactions with the surrounding environment, including immune cells and the connective tissues and blood vessels.”

The investigators, including researchers from Pacific Northwest National Laboratory, Case Western Reserve University, and the National Cancer Institute, performed high-resolution and high-depth analyses on 99 tumors.

“Harnessing new technologies, including proteomics, metabolomics, and single-cell sequencing, this study is an extremely deep dive into glioblastoma tumor biology, revealing new possibilities for therapy,” Dr. Ding said.

The study, which is part of the NCI’s Clinical Proteomic Tumor Analysis Consortium (CPTAC), is the largest and most detailed schematic of glioblastoma tumors to date, according to the press release.

The most immediate implication of the findings is better clinical trial design, study coauthor Milan G. Chheda, MD, stated in the press release.

Stratifying patients by tumor type, as identified in the current analysis, could allow researchers to test targeted therapies in the tumors most likely to respond to those therapies, explained Dr. Chheda, of Siteman Cancer Center at Barnes Jewish Hospital and Washington University.

The findings, particularly of multiple glioblastoma tumor subtypes, may explain the negative findings of trials looking at various immunotherapies for treating glioblastoma. Investigators for those trials haven’t considered the possibility of immune subgroups that may respond differently, the authors note, adding that research is underway to identify the best drugs to assess for the newly identified glioblastoma tumor types.

The study was supported by grants from the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium, the National Human Genome Research Institute, and the National Institutes of Health.

Dr. Wang and Dr. Ding reported having no disclosures. Dr. Chheda receives research support from NeoimmuneTech and Orbus Therapeutics, and royalties from UpToDate.

[email protected]

An integrated analysis of data derived from 99 treatment-naive glioblastomas has identified characteristics that could help stratify patients for more effective treatment, according to the investigators.

The analysis provides a detailed map of genes, proteins, infiltrating cells, and signaling pathways that play key roles in driving glioblastoma, Liang-Bo Wang, MD, of Washington University in St. Louis, and colleagues reported in Cancer Cell.

For example, the team identified key phosphorylation events as potential mediators of oncogenic pathway activation and potential targets for EGFR-, TP53-, and RB1-altered tumors. Specifically, phosphorylated PTPN11 and PLCG1 represent a signaling hub in RTK-altered tumors, they found.

The investigators also identified four immune glioblastoma tumor subtypes characterized by distinct immune cell populations. Type 1 tumors have a high macrophage count and few T cells, type 2 tumors have a moderate macrophage count, type 3 tumors have a high T-cell count and few macrophages, and type 4 tumors have few or no immune cells of any type.

They also found that mesenchymal subtype EMT signature is specific to tumor cells but not to stroma, and histone H2B acetylation is enriched in classical glioblastomas with low macrophage content.

“To improve therapies for this deadly cancer, understanding the tumor cells themselves is important but not enough,” senior author Li Ding, PhD, a professor of medicine and genetics and director of computational biology in the division of oncology at Washington University stated in a press release. “We also must understand the tumor cells’ interactions with the surrounding environment, including immune cells and the connective tissues and blood vessels.”

The investigators, including researchers from Pacific Northwest National Laboratory, Case Western Reserve University, and the National Cancer Institute, performed high-resolution and high-depth analyses on 99 tumors.

“Harnessing new technologies, including proteomics, metabolomics, and single-cell sequencing, this study is an extremely deep dive into glioblastoma tumor biology, revealing new possibilities for therapy,” Dr. Ding said.

The study, which is part of the NCI’s Clinical Proteomic Tumor Analysis Consortium (CPTAC), is the largest and most detailed schematic of glioblastoma tumors to date, according to the press release.

The most immediate implication of the findings is better clinical trial design, study coauthor Milan G. Chheda, MD, stated in the press release.

Stratifying patients by tumor type, as identified in the current analysis, could allow researchers to test targeted therapies in the tumors most likely to respond to those therapies, explained Dr. Chheda, of Siteman Cancer Center at Barnes Jewish Hospital and Washington University.

The findings, particularly of multiple glioblastoma tumor subtypes, may explain the negative findings of trials looking at various immunotherapies for treating glioblastoma. Investigators for those trials haven’t considered the possibility of immune subgroups that may respond differently, the authors note, adding that research is underway to identify the best drugs to assess for the newly identified glioblastoma tumor types.

The study was supported by grants from the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium, the National Human Genome Research Institute, and the National Institutes of Health.

Dr. Wang and Dr. Ding reported having no disclosures. Dr. Chheda receives research support from NeoimmuneTech and Orbus Therapeutics, and royalties from UpToDate.

[email protected]

Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.

At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.

“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.

The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.

COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.

The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.

“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.

“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.

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

Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.

At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.

“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.

The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.

COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.

The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.

“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.

“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.

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

Oxford University is starting a COVID-19 vaccine study with children and young adults aged between 6 and 17 years.

At Oxford and three partner sites in London, Southampton, and Bristol, the phase 2 clinical trial will test whether kids and teens have a good immune response to the AstraZeneca vaccine. Previous trials have shown that the shot is safe in children.

“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” Andrew Pollard, PhD, the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.

The new trial will enroll 300 volunteers, with up to 240 receiving the vaccine. The control group will receive a meningitis vaccine, which is safe in children and produces similar side effects to the COVID-19 vaccine, such as a sore arm.

COVID-19 vaccine trials have included children over age 12, so this marks the youngest group to be tested so far. Pfizer, Moderna, and Janssen have announced plans to start trials in younger children this spring, according to the Washington Post. Widespread vaccination in children likely won’t occur until 2022, the newspaper reported.

The trial launched on Feb. 12, and the first vaccinations are expected by the end of the month. Parents can visit Oxford’s COVID-19 Vaccine Trial website to sign their children up for the study.

“This study will play an important role in helping to protect children in the future,” Grace Li, a pediatric clinical research fellow for the Oxford Vaccine Group, said in the statement.

“We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve,” she said.

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

Nearly half (47%) of family physicians who reported experiencing burnout in a Medscape survey said the burnout had had a strong or a severe impact on their lives, and 1 in 10 said it was serious enough to make them consider leaving medicine.

Yet, responses to the Medscape Family Medicine Physician Lifestyle, Happiness & Burnout Report 2021 also indicate that family physicians are in the middle of the pack again this year in rankings by specialty of physician happiness outside work. Overall, more than 12,000 physicians from more than 29 specialties responded to this year’s survey, conducted between Aug. 30 and Nov. 5, 2020.
 

Happiness levels sink for physicians

In light of the COVID-19 pandemic, happiness levels took a sharp drop among physicians across the board. Last year, for instance, the happiness level was highest for physicians practicing in diabetes and endocrinology, at 89%. They remain the happiest this year, but the proportion saying they were happy dropped to 73%. Infectious disease physicians were the least happy outside work both last year and this year, with the proportion reporting they were happy dropping from 69% to 45%.

For family physicians, happiness levels outside work plunged from 79% last year to 57% this year.

Burnout and depression levels, however, remained steady. The portion saying they were either burned out or burned out and depressed was up only 1 percentage point, rising to 47%.

Fifteen percent of family physicians have had thoughts of suicide, and 1% said they had attempted it, according to the survey responses.

The most common strategy for coping with burnout, reported by 48% of family physicians, is talking with family members and close friends, followed closely by exercise, reported by 46%.

Sixty-eight percent of family physicians say they exercise at least twice a week, and 12% exercise every day.

However, not all coping strategies were as positive: Forty-five percent said they cope by isolating themselves from others; 40% turned to junk food; and 23%-24% said they drank alcohol or were binge-eating to cope. Respondents could choose more than one answer.

Among family physicians, 75% expressed anxiety about their futures, given the pandemic, which is similar to the proportion among physicians overall (77%) who had the same worries.
 

Work-life balance biggest worry

The survey also asked what workplace issues concern family physicians the most. The biggest concern, by far, was work-life balance, chosen by 51%. Next highest was compensation, at 19%, followed by combining parenthood and work (9%) and relationships with colleagues/staff (6%).

More than half (52%) of family doctors said they would take a cut in pay to have better work-life balance.

A little more than a third (36%) of family physicians – about the same percentage as physicians overall – said they always or most of the time spend enough time on their own health and wellness. One in five said they rarely or never do.

Most in committed, satisfying relationships

Most family medicine physicians are juggling committed relationships with work life. In this survey, 78% said they were married, and another 5% said they were living with a partner.

A little more than half of married family doctors described their marriages as very good (51%). The rest were good (32%); fair (13%); poor (2%); and very poor (2%). Some (15%) had spouses who were also physicians, and 25% said their spouses worked in the health care field but were not physicians.

Almost all family physicians were able to take some vacation time during this reporting period – 43% took 3-4 weeks; 35% took 1-2 weeks; 10% took less than 1 week; 9% took 5-6 weeks; and 4% took more than 6 weeks.

If they drove to vacation destinations, they were likely to be in their favorite make of vehicle, which for family physicians were Toyotas (22%), Hondas (14%) and Fords (11%), according to the survey responses. Physicians overall favored Toyotas, Hondas, and BMWs.

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

Nearly half (47%) of family physicians who reported experiencing burnout in a Medscape survey said the burnout had had a strong or a severe impact on their lives, and 1 in 10 said it was serious enough to make them consider leaving medicine.

Yet, responses to the Medscape Family Medicine Physician Lifestyle, Happiness & Burnout Report 2021 also indicate that family physicians are in the middle of the pack again this year in rankings by specialty of physician happiness outside work. Overall, more than 12,000 physicians from more than 29 specialties responded to this year’s survey, conducted between Aug. 30 and Nov. 5, 2020.
 

Happiness levels sink for physicians

In light of the COVID-19 pandemic, happiness levels took a sharp drop among physicians across the board. Last year, for instance, the happiness level was highest for physicians practicing in diabetes and endocrinology, at 89%. They remain the happiest this year, but the proportion saying they were happy dropped to 73%. Infectious disease physicians were the least happy outside work both last year and this year, with the proportion reporting they were happy dropping from 69% to 45%.

For family physicians, happiness levels outside work plunged from 79% last year to 57% this year.

Burnout and depression levels, however, remained steady. The portion saying they were either burned out or burned out and depressed was up only 1 percentage point, rising to 47%.

Fifteen percent of family physicians have had thoughts of suicide, and 1% said they had attempted it, according to the survey responses.

The most common strategy for coping with burnout, reported by 48% of family physicians, is talking with family members and close friends, followed closely by exercise, reported by 46%.

Sixty-eight percent of family physicians say they exercise at least twice a week, and 12% exercise every day.

However, not all coping strategies were as positive: Forty-five percent said they cope by isolating themselves from others; 40% turned to junk food; and 23%-24% said they drank alcohol or were binge-eating to cope. Respondents could choose more than one answer.

Among family physicians, 75% expressed anxiety about their futures, given the pandemic, which is similar to the proportion among physicians overall (77%) who had the same worries.
 

Work-life balance biggest worry

The survey also asked what workplace issues concern family physicians the most. The biggest concern, by far, was work-life balance, chosen by 51%. Next highest was compensation, at 19%, followed by combining parenthood and work (9%) and relationships with colleagues/staff (6%).

More than half (52%) of family doctors said they would take a cut in pay to have better work-life balance.

A little more than a third (36%) of family physicians – about the same percentage as physicians overall – said they always or most of the time spend enough time on their own health and wellness. One in five said they rarely or never do.

Most in committed, satisfying relationships

Most family medicine physicians are juggling committed relationships with work life. In this survey, 78% said they were married, and another 5% said they were living with a partner.

A little more than half of married family doctors described their marriages as very good (51%). The rest were good (32%); fair (13%); poor (2%); and very poor (2%). Some (15%) had spouses who were also physicians, and 25% said their spouses worked in the health care field but were not physicians.

Almost all family physicians were able to take some vacation time during this reporting period – 43% took 3-4 weeks; 35% took 1-2 weeks; 10% took less than 1 week; 9% took 5-6 weeks; and 4% took more than 6 weeks.

If they drove to vacation destinations, they were likely to be in their favorite make of vehicle, which for family physicians were Toyotas (22%), Hondas (14%) and Fords (11%), according to the survey responses. Physicians overall favored Toyotas, Hondas, and BMWs.

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

Nearly half (47%) of family physicians who reported experiencing burnout in a Medscape survey said the burnout had had a strong or a severe impact on their lives, and 1 in 10 said it was serious enough to make them consider leaving medicine.

Yet, responses to the Medscape Family Medicine Physician Lifestyle, Happiness & Burnout Report 2021 also indicate that family physicians are in the middle of the pack again this year in rankings by specialty of physician happiness outside work. Overall, more than 12,000 physicians from more than 29 specialties responded to this year’s survey, conducted between Aug. 30 and Nov. 5, 2020.
 

Happiness levels sink for physicians

In light of the COVID-19 pandemic, happiness levels took a sharp drop among physicians across the board. Last year, for instance, the happiness level was highest for physicians practicing in diabetes and endocrinology, at 89%. They remain the happiest this year, but the proportion saying they were happy dropped to 73%. Infectious disease physicians were the least happy outside work both last year and this year, with the proportion reporting they were happy dropping from 69% to 45%.

For family physicians, happiness levels outside work plunged from 79% last year to 57% this year.

Burnout and depression levels, however, remained steady. The portion saying they were either burned out or burned out and depressed was up only 1 percentage point, rising to 47%.

Fifteen percent of family physicians have had thoughts of suicide, and 1% said they had attempted it, according to the survey responses.

The most common strategy for coping with burnout, reported by 48% of family physicians, is talking with family members and close friends, followed closely by exercise, reported by 46%.

Sixty-eight percent of family physicians say they exercise at least twice a week, and 12% exercise every day.

However, not all coping strategies were as positive: Forty-five percent said they cope by isolating themselves from others; 40% turned to junk food; and 23%-24% said they drank alcohol or were binge-eating to cope. Respondents could choose more than one answer.

Among family physicians, 75% expressed anxiety about their futures, given the pandemic, which is similar to the proportion among physicians overall (77%) who had the same worries.
 

Work-life balance biggest worry

The survey also asked what workplace issues concern family physicians the most. The biggest concern, by far, was work-life balance, chosen by 51%. Next highest was compensation, at 19%, followed by combining parenthood and work (9%) and relationships with colleagues/staff (6%).

More than half (52%) of family doctors said they would take a cut in pay to have better work-life balance.

A little more than a third (36%) of family physicians – about the same percentage as physicians overall – said they always or most of the time spend enough time on their own health and wellness. One in five said they rarely or never do.

Most in committed, satisfying relationships

Most family medicine physicians are juggling committed relationships with work life. In this survey, 78% said they were married, and another 5% said they were living with a partner.

A little more than half of married family doctors described their marriages as very good (51%). The rest were good (32%); fair (13%); poor (2%); and very poor (2%). Some (15%) had spouses who were also physicians, and 25% said their spouses worked in the health care field but were not physicians.

Almost all family physicians were able to take some vacation time during this reporting period – 43% took 3-4 weeks; 35% took 1-2 weeks; 10% took less than 1 week; 9% took 5-6 weeks; and 4% took more than 6 weeks.

If they drove to vacation destinations, they were likely to be in their favorite make of vehicle, which for family physicians were Toyotas (22%), Hondas (14%) and Fords (11%), according to the survey responses. Physicians overall favored Toyotas, Hondas, and BMWs.

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