COVID-19 Updates

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

Public spending on colchicine has grown exponentially over the past decade despite generics suggesting an uphill slog for patients seeking access to long-term therapy for gout or cardiac conditions.

Medicaid spending on single-ingredient colchicine jumped 2,833%, from $1.1 million in 2008 to $32.2 million in 2017, new findings show. Medicaid expansion likely played a role in the increase, but 58% was due to price hikes alone.

The centuries-old drug sold for pennies in the United States before increasing 50-fold to about $5 per pill in 2009 after the first FDA-approved colchicine product, Colcrys, was granted 3 years’ market exclusivity for the treatment of acute gout based on a 1-week trial.

If prices had remained at pre-Colcrys levels, Medicaid spending in 2017 would have totaled just $2.1 million rather than $32.2 million according to the analysis, published online Nov. 30 in JAMA Internal Medicine (doi: 10.1001/jamainternmed.2020.5017).

The study was motivated by difficulties gout patients have in accessing colchicine, but also last year’s COLCOT trial, which reported fewer ischemic cardiovascular events in patients receiving colchicine after MI, observed Natalie McCormick, PhD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.

“They were suggesting it could be a cost-effective way for secondary prevention and it is fairly inexpensive in most countries, but not the U.S.,” she said in an interview. “So there’s really a potential to increase public spending if more and more patients are then taking colchicine for prevention of cardiovascular events and the prices don’t change.”

The current pandemic could potentially further increase demand. Results initially slated for September are expected this month from the COLCORONA trial, which is testing whether the anti-inflammatory agent can prevent hospitalizations, lung complications, and death when given early in the course of COVID-19.

University of Oxford (England) researchers also announced last week that colchicine is being added to the massive RECOVERY trial, which is studying treatments for hospitalized COVID-19 patients.

Notably, the Canadian-based COLCOT trial did not use Colcrys, but rather a colchicine product that costs just $0.26 a pill in Canada, roughly the price of most generics available worldwide.

Authorized generics typically drive down drug prices when competing with independent generics, but this competition is missing in the United States, where Colcrys holds patents until 2029, Dr. McCormick and colleagues noted. More than a half-dozen independent generics have FDA approval to date, but only authorized generics with price points set by the brand-name companies are available to treat acute gout, pericarditis, and potentially millions with MI.

“One of the key takeaways is this difference between the brand names and the authorized generics and the independents,” she said. “The authorized [generics] have really not saved money. The list prices were just slightly lower and patients can also have more difficulty in getting those covered.”

For this analysis, the investigators used Medicaid and Medicare data to examine prices for all available forms of colchicine from 2008 to 2017, including unregulated/unapproved colchicine (2008-2010), generic combination probenecid-colchicine (2008-2017), Colcrys (2009-2017), brand-name single-ingredient colchicine Mitigare (approved in late 2014 but not marketed until 2015), and their authorized generics (2015-2017). Medicare trends from 2012 to 2017 were analyzed separately because pre-Colcrys Medicare data were not available.

Based on the results, combined spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million in 2017.

Inflation- and rebate-adjusted Medicaid unit prices rose from $0.24 a pill in 2008, when unapproved formulations were still available, to $4.20 a pill in 2011 (Colcrys only), and peaked at $4.66 a pill in 2015 (Colcrys plus authorized generics).

Prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout. Medicaid rebate-adjusted prices in 2017 were $3.99/pill for all single-ingredient colchicine products, $5.13/pill for Colcrys, $4.49/pill for Mitigare, and $3.88/pill for authorized generics.

Medicare rebate-adjusted 2017 per-pill prices were $5.81 for all single-ingredient colchicine products, $6.78 for Colcrys, $5.68 for Mitigare, $5.16 for authorized generics, and $0.70 for probenecid-colchicine.

“Authorized generics have still driven high spending,” Dr. McCormick said. “We really need to encourage more competition in order to improve access.”

In an accompanying commentary, B. Joseph Guglielmo, PharmD, University of California, San Francisco, pointed out that the estimated median research and development cost to bring a drug to market is between $985 million and $1,335 million, which inevitably translates into a high selling price for the drug. Such investment and its resultant cost, however, should be associated with potential worth to society.

“Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system,” he wrote. “The current study findings illustrate that we can never allow such an egregious case to take place again.”

Dr. McCormick reported grants from Canadian Institutes of Health Research during the conduct of the study. Dr. Guglielmo reported having no relevant conflicts of interest.

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at imnews@mdedge.com.

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at imnews@mdedge.com.

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at imnews@mdedge.com.

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.

Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

rfranki@mdedge.com

The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.

Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

rfranki@mdedge.com

The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.

Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

rfranki@mdedge.com

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.^1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 2020³) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million³) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States⁴). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.^5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,²² which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.²³ Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.²⁴ These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.^25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.

Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.^1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 2020³) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million³) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States⁴). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.^5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,²² which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.²³ Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.²⁴ These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.^25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.

Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.^1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 2020³) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million³) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States⁴). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.^5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,²² which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.²³ Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.²⁴ These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.^25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.