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How cannabis-based therapeutics could help fight COVID inflammation
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Survey finds European dermatologists unhappy with pandemic teledermatology experience
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
intensely, according to the findings of a survey presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“The results of our survey clearly show 7 out of 10 participating dermatologists declared that they were not happy with teledermatology, and most of them declared that they were not at all happy,” according to Mariano Suppa, MD, PhD, of the department of dermatology and venereology, Free University of Brussels.
“It was very interesting: it was not just about the lack of a good quality of consultation, but was also related to some extent to a lack of respect from some patients, and also a lack of empathy. The majority of survey respondents felt [attacked] by their own patients because they were proposing teledermatology. So, yes, we were forced to go to teledermatology, and I think we will be again to some extent, but clearly we’re not happy about it,” he elaborated in response to a question from session chair Brigitte Dreno, MD, professor of dermatology and vice dean of the faculty of medicine at the University of Nantes (France).
The survey, conducted by the EADV communication committee, assessed the pandemic’s impact on European dermatologists’ professional practices and personal lives through 30 brief questions, with space at the end for additional open-ended comments. In the comments section, many dermatologists vented about their income loss, the disorganized response to round one of the pandemic, and most of all about teledermatology. Common complaints were that teledermatology required a huge consumption of energy and constituted a major intrusion upon the physicians’ personal lives. And then there was the common theme of unkind treatment by some patients.
The survey was sent twice in June 2020 to more than 4,800 EADV members. It was completed by 490 dermatologists from 39 countries. Dr. Suppa attributed the low response rate to physician weariness of the topic due to saturation news media coverage of the pandemic.
Sixty-nine percent of responding dermatologists were women. Fifty-two percent of participants were over age 50, 81% lived in a city, and 53% worked in a university or public hospital or clinic. Twelve percent lived alone.
Impact on professional practice
Many European dermatologists were on the front lines in dealing with the first wave of COVID-19. Twenty-eight percent worked in a COVID-19 unit. Forty-eight percent of dermatologists performed COVID-19 tests, and those who didn’t either had no patient contact or couldn’t get test kits. Thirty-five percent of dermatologists saw patients who presented with skin signs of COVID-19. Four percent of survey respondents became infected.
Seventy percent rescheduled or canceled all or most patient appointments. Clinical care was prioritized: during the peak of the pandemic, 76% of dermatologists saw only urgent cases – mostly potentially serious rashes – and dermato-oncology patients. Seventy-six percent of dermatologists performed teledermatology, although by June 60% of respondents reported seeing at least three-quarters of their patients face-to-face.
Twenty-three percent of dermatologists reported having lost most or all of their income during March through June, and another 26% lost about half.
Impact on dermatologists’ personal lives
About half of survey respondents reported feeling stressed, and a similar percentage checked the box marked ‘anxiety.’ Nine percent reported depressive symptoms, 15% mentioned feeling anger, 17% uselessness, and 2% admitted suicidal ideation. But 30% of dermatologists reported experiencing no negative psychological effects whatsoever stemming from the pandemic.
Sixteen percent of dermatologists reported drinking more alcohol during sequestration.
But respondents cited positive effects as well: a renewed appreciation of the importance of time, and enjoyment of the additional time spent with family and alone. Many dermatologists relished the opportunity to spend more time cooking, reading literature, doing research, listening to or playing music, and practicing yoga or meditation. And dermatologists took solace and pride in being members of the vital medical community.
Dr. Dreno asked if the survey revealed evidence of underdiagnosis and undertreatment of dermatologic diseases during the pandemic. Dr. Suppa replied that the survey didn’t address that issue, but it’s his personal opinion that this was no doubt the case. Roughly one-quarter of dermatologists canceled all appointments, and when dermatology clinics became filled beginning in June, he and his colleagues saw a number of cases of delayed-diagnosis advanced skin cancer.
“I think that the diseases that were really penalized were the chronic inflammatory diseases, such as psoriasis, hidradenitis suppurativa, and also atopic dermatitis. We were doing a lot of telephone consultations for those patients at that time, and we saw in June that for those particular patients there was an unmet need in the pandemic because some of them really needed to have been seen. I think this is a lesson we should learn for the second wave that we’re unfortunately facing right now: We need to adopt restrictive measures to avoid spreading the pandemic, yes, for sure, but we need to keep in mind that there is not just COVID-19, but also other important diseases,” Dr. Suppa said.
A second EADV survey will be performed during the fall/winter wave of the pandemic.
Dr. Suppa reported having no financial conflicts regarding the EADV-funded survey.
SOURCE: Suppa M. EADV 2020. Presentation D3T03.4D
FROM THE EADV CONGRESS
COVID-19: U.S. sets new weekly high in children
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
HF an added risk in COVID-19, regardless of ejection fraction
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.
Biologics may protect psoriasis patients against severe COVID-19
presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.
This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.
He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.
Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.
Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.
Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.
The French experience
Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?
She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.
Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.
Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.
Proposed mechanism of benefit
The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.
He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.
“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.
The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.
Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.
This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.
He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.
Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.
Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.
Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.
The French experience
Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?
She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.
Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.
Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.
Proposed mechanism of benefit
The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.
He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.
“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.
The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.
Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
presented at the virtual annual congress of the European Academy of Dermatology and Venereology.
“Biologics seem to be very protective against severe, poor-prognosis COVID-19, but they do not prevent infection with the virus,” reported Giovanni Damiani, MD, a dermatologist at the University of Milan.
This apparent protective effect of biologic agents against severe and even fatal COVID-19 is all the more impressive because the psoriasis patients included in the Italian study – as is true of those elsewhere throughout the world – had relatively high rates of obesity, smoking, and chronic obstructive pulmonary disease, known risk factors for severe COVID-19, he added.
He presented a case-control study including 1,193 adult psoriasis patients on biologics or apremilast (Otezla) at Milan’s San Donato Hospital during the period from Feb. 21 to April 9, 2020. The control group comprised more than 10 million individuals, the entire adult population of the Lombardy region, of which Milan is the capital. This was the hardest-hit area in all of Italy during the first wave of COVID-19.
Twenty-two of the 1,193 psoriasis patients experienced confirmed COVID-19 during the study period. Seventeen were quarantined at home because their disease was mild. Five were hospitalized. But no psoriasis patients were placed in intensive care, and none died.
Psoriasis patients on biologics were significantly more likely than the general Lombardian population to test positive for COVID-19, with an unadjusted odds ratio of 3.43. They were at 9.05-fold increased risk of home quarantine for mild disease, and at 3.59-fold greater risk than controls for hospitalization for COVID-19. However, they were not at significantly increased risk of ICU admission. And while they actually had a 59% relative risk reduction for death, this didn’t achieve statistical significance.
Forty-five percent of the psoriasis patients were on an interleukin-17 (IL-17) inhibitor, 22% were on a tumor necrosis factor–alpha inhibitor, and 20% were taking an IL-12/23 inhibitor. Of note, none of 77 patients on apremilast developed COVID-19, even though it is widely considered a less potent psoriasis therapy than the injectable monoclonal antibody biologics.
The French experience
Anne-Claire Fougerousse, MD, and her French coinvestigators conducted a study designed to address a different question: Is it safe to start psoriasis patients on biologics or older conventional systemic agents such as methotrexate during the pandemic?
She presented a French national cross-sectional study of 1,418 adult psoriasis patients on a biologic or standard systemic therapy during a snapshot in time near the peak of the first wave of the pandemic in France: the period from April 27 to May 7, 2020. The group included 1,188 psoriasis patients on maintenance therapy and 230 who had initiated systemic treatment within the past 4 months. More than one-third of the patients had at least one risk factor for severe COVID-19.
Although testing wasn’t available to confirm all cases, 54 patients developed probable COVID-19 during the study period. Only five required hospitalization. None died. The two hospitalized psoriasis patients admitted to an ICU had obesity as a risk factor for severe COVID-19, as did another of the five hospitalized patients, reported Dr. Fougerousse, a dermatologist at the Bégin Military Teaching Hospital in Saint-Mandé, France. Hospitalization for COVID-19 was required in 0.43% of the French treatment initiators, not significantly different from the 0.34% rate in patients on maintenance systemic therapy. A study limitation was the lack of a control group.
Nonetheless, the data did answer the investigators’ main question: “This is the first data showing no increased incidence of severe COVID-19 in psoriasis patients receiving systemic therapy in the treatment initiation period compared to those on maintenance therapy. This may now allow physicians to initiate conventional systemic or biologic therapy in patients with severe psoriasis on a case-by-case basis in the context of the persistent COVID-19 pandemic,” Dr. Fougerousse concluded.
Proposed mechanism of benefit
The Italian study findings that biologics boost the risk of infection with the SARS-CoV-2 virus in psoriasis patients while potentially protecting them against ICU admission and death are backed by a biologically plausible albeit as yet unproven mechanism of action, Dr. Damiani asserted.
He elaborated: A vast body of high-quality clinical trials data demonstrates that these targeted immunosuppressive agents are associated with modestly increased risk of viral infections, including both skin and respiratory tract infections. So there is no reason to suppose these agents would offer protection against the first phase of COVID-19, involving SARS-CoV-2 infection, nor protect against the second (pulmonary phase), whose hallmarks are dyspnea with or without hypoxia. But progression to the third phase, involving hyperinflammation and hypercoagulation – dubbed the cytokine storm – could be a different matter.
“Of particular interest was that our patients on IL-17 inhibitors displayed a really great outcome. Interleukin-17 has procoagulant and prothrombotic effects, organizes bronchoalveolar remodeling, has a profibrotic effect, induces mitochondrial dysfunction, and encourages dendritic cell migration in peribronchial lymph nodes. Therefore, by antagonizing this interleukin, we may have a better prognosis, although further studies are needed to be certain,” Dr. Damiani commented.
Publication of his preliminary findings drew the attention of a group of highly respected thought leaders in psoriasis, including James G. Krueger, MD, head of the laboratory for investigative dermatology and codirector of the center for clinical and investigative science at Rockefeller University, New York.
The Italian report prompted them to analyze data from the phase 4, double-blind, randomized ObePso-S study investigating the effects of the IL-17 inhibitor secukinumab (Cosentyx) on systemic inflammatory markers and gene expression in psoriasis patients. The investigators demonstrated that IL-17–mediated inflammation in psoriasis patients was associated with increased expression of the angiotensin-converting enzyme 2 (ACE2) receptor in lesional skin, and that treatment with secukinumab dropped ACE2 expression to levels seen in nonlesional skin. Given that ACE2 is the chief portal of entry for SARS-CoV-2 and that IL-17 exerts systemic proinflammatory effects, it’s plausible that inhibition of IL-17–mediated inflammation via dampening of ACE2 expression in noncutaneous epithelia “could prove to be advantageous in patients with psoriasis who are at risk for SARS-CoV-2 infection,” according to Dr. Krueger and his coinvestigators in the Journal of Allergy and Clinical Immunology.
Dr. Damiani and Dr. Fougerousse reported having no financial conflicts regarding their studies. The secukinumab/ACE2 receptor study was funded by Novartis.
FROM THE EADV CONGRESS
Med student’s cardiac crisis a COVID-era medical mystery
Within minutes of her arrival at Community North Hospital in Indianapolis, Ramya Yeleti’s vital signs plummeted; her pulse was at 45 beats per minute and her ejection fraction was hovering near 10%. “I definitely thought there was a chance I would close my eyes and never open them again, but I only had a few seconds to process that,” she recalled. Then everything went black. Ramya fell unconscious as shock pads were positioned and a swarm of clinicians prepared to insert an Impella heart pump through a catheter into her aorta.
The third-year medical student and aspiring psychiatrist had been doing in-person neurology rotations in July when she began to experience fever and uncontrolled vomiting. Her initial thought was that she must have caught the flu from a patient.
After all, Ramya, along with her father Ram Yeleti, MD, mother Indira, and twin sister Divya, had all weathered COVID-19 in previous months and later tested positive for SARS-CoV-2 antibodies. The only family member who had been spared was her younger brother Rohith.
Indira suffered a severe case, requiring ICU care for 2 days but no ventilator; the others experienced mostly mild symptoms. Ramya — who was studying for her third-year board exams after classes at Marian University College of Osteopathic Medicine in Indianapolis went virtual in March — was left with lingering fatigue; however, her cough and muscle aches abated and her sense of taste and smell returned. When she started rotations, she thought her life was getting back to normal.
Ramya’s flu symptoms did not improve. A university-mandated rapid COVID test came back negative, but 2 more days of vomiting started to worry both her and her father, who is a cardiologist and chief physician executive at Community Health Network in Indianapolis. After Ramya felt some chest pain, she asked her father to listen to her heart. All sounded normal, and Ram prescribed ondansetron for her nausea.
But the antiemetic didn’t work, and by the next morning both father and daughter were convinced that they needed to head to the emergency department.
“I wanted to double-check if I was missing something about her being dehydrated,” Ram told Medscape Medical News. “Several things can cause protracted nausea, like hepatitis, appendicitis, or another infection. I feel terribly guilty I didn’t realize she had a heart condition.”
A surprising turn for the worst
Ramya’s subtle symptoms quickly gave way to the dramatic cardiac crisis that unfolded just after her arrival at Community North. “Her EKG looked absolutely horrendous, like a 75-year-old having a heart attack,” Ram said.
As a cardiologist, he knew his daughter’s situation was growing dire when he heard physicians shouting that the Impella wasn’t working and she needed extracorporeal membrane oxygenation (ECMO).
“At that point, I didn’t think she’d survive,” her father recalled. “We had 10 physicians in the room who worked on her for 5 hours to get her stabilized.”
“It was especially traumatic because, obviously, I knew exactly what was happening,” he added. “You can’t sugarcoat anything.”
After being connected to the heart–lung equipment, Ramya was transferred to IU Health Methodist Hospital, also in Indianapolis, where she was tested again for COVID-19. Unlike the rapid test administered just days earlier, the PCR assay came back positive.
“I knew she had acute myocarditis, but coronavirus never crossed my mind,” said Ram.
“As we were dealing with her heart, we were also dealing with this challenge: she was coming back positive for COVID-19 again,” said Roopa Rao, MD, the heart failure transplant cardiologist at IU Health who treated Ramya.
“We weren’t sure whether we were dealing with an active infection or dead virus” from her previous infection, Rao said, “so we started treating her like she had active COVID-19 and gave her remdesivir, convalescent plasma, and steroids, which was the protocol in our hospital.”
A biopsy of Ramya’s heart tissue, along with blood tests, indicated a past parvovirus infection. It’s possible that Ramya’s previous coronavirus infection made her susceptible to heart damage from a newer parvovirus infection, said Rao. Either virus, or both together, could have been responsible for the calamity.
Although it was unheard of during Ramya’s cardiac crisis in early August, evolving evidence now raises the possibility that she is one of a handful of people in the world to be reinfected with SARS-CoV-2. Also emerging are cases of COVID-related myocarditis and other extreme heart complications, particularly in young people.
“At the time, it wasn’t really clear if people could have another infection so quickly,” Rao told Medscape Medical News. “It is possible she is one of these rare individuals to have COVID-19 twice. I’m hoping at some point we will have some clarity.”
“I would favor a coinfection as probably the triggering factor for her sickness,” she said. “It may take some time, but like any other disease — and it doesn’t look like COVID will go away magically — I hope we’ll have some answers down the road.”
Another wrinkle
The next 48 hours brought astonishing news: Ramya’s heart function had rebounded to nearly normal, and her ejection fraction increased to about 45%. Heart transplantation wouldn’t be necessary, although Rao stood poised to follow through if ECMO only sustained, rather than improved, Ramya’s prognosis.
“Ramya was so sick that if she didn’t recover, the only option would be a heart transplant,” said Rao. “But we wanted to do everything to keep that heart.”
After steroid and COVID treatment, Ramya’s heart started to come back. “It didn’t make sense to me,” said Rao. “I don’t know what helped. If we hadn’t done ECMO, her heart probably wouldn’t have recovered, so I would say we have to support these patients and give them time for the heart to recover, even to the point of ECMO.”
Despite the good news, Ramya’s survival still hung in the balance. When she was disconnected from ECMO, clinicians discovered that the Impella device had caused a rare complication, damaging her mitral valve. The valve could be repaired surgically, but both Rao and Ram felt great trepidation at the prospect of cardiopulmonary bypass during the open-heart procedure.
“They would need to stop her heart and restart it, and I was concerned it would not restart,” Ram explained. “I didn’t like the idea of open-heart surgery, but my biggest fear was she was not going to survive it because of a really fresh, sick heart.”
The cardiologists’ fears did, in fact, come to pass: it took an hour to coax Ramya’s heart back at the end of surgery. But, just as the surgeon was preparing to reconnect Ramya to ECMO in desperation, “her heart recovered again,” Rao reported.
“Some things you never forget in life,” she said. “I can’t describe how everyone in the OR felt, all taking care of her. I told Ramya, ‘you are a fighter’.”
New strength
Six days would pass before Ramya woke up and learned of the astounding series of events that saved her. She knew “something was really wrong” because of the incision at the center of her chest, but learning she’d been on ECMO and the heart transplant list drove home how close to death she’d actually come.
“Most people don’t get off ECMO; they die on it,” she said. “And the chances of dying on the heart transplant list are very high. It was very strange to me that this was my story all of a sudden, when a week and a half earlier I was on rotation.”
Ongoing physical therapy over the past 3 months has transformed Ramya from a state of profound physical weakness to a place of relative strength. The now-fourth-year med student is turning 26 in November and is hungry to restart in-person rotations. Her downtime has been filled in part with researching myocarditis and collaborating with Rao on her own case study for journal publication.
But the mental trauma from her experience has girded her in ways she knows will make her stronger personally and professionally in the years ahead.
“It’s still very hard. I’m still recovering,” she acknowledged. “I described it to my therapist as an invisible wound on my brain.”
“When I came out of the hospital, I still had ECMO wounds, deep gashes on my legs that affected how fast and how long I could walk,” she said. “I felt like the same thing was going on my brain — a huge cut no one could see.”
Her intention to specialize in psychiatry has become more pressing now that Ramya has realized the impact of trauma on mental health.
“My body failing me was awful, but I could handle it,” she said. “Losing any part of my mind would have been way worse. I want to take care of that in my patients.”
This article first appeared on Medscape.com.
Within minutes of her arrival at Community North Hospital in Indianapolis, Ramya Yeleti’s vital signs plummeted; her pulse was at 45 beats per minute and her ejection fraction was hovering near 10%. “I definitely thought there was a chance I would close my eyes and never open them again, but I only had a few seconds to process that,” she recalled. Then everything went black. Ramya fell unconscious as shock pads were positioned and a swarm of clinicians prepared to insert an Impella heart pump through a catheter into her aorta.
The third-year medical student and aspiring psychiatrist had been doing in-person neurology rotations in July when she began to experience fever and uncontrolled vomiting. Her initial thought was that she must have caught the flu from a patient.
After all, Ramya, along with her father Ram Yeleti, MD, mother Indira, and twin sister Divya, had all weathered COVID-19 in previous months and later tested positive for SARS-CoV-2 antibodies. The only family member who had been spared was her younger brother Rohith.
Indira suffered a severe case, requiring ICU care for 2 days but no ventilator; the others experienced mostly mild symptoms. Ramya — who was studying for her third-year board exams after classes at Marian University College of Osteopathic Medicine in Indianapolis went virtual in March — was left with lingering fatigue; however, her cough and muscle aches abated and her sense of taste and smell returned. When she started rotations, she thought her life was getting back to normal.
Ramya’s flu symptoms did not improve. A university-mandated rapid COVID test came back negative, but 2 more days of vomiting started to worry both her and her father, who is a cardiologist and chief physician executive at Community Health Network in Indianapolis. After Ramya felt some chest pain, she asked her father to listen to her heart. All sounded normal, and Ram prescribed ondansetron for her nausea.
But the antiemetic didn’t work, and by the next morning both father and daughter were convinced that they needed to head to the emergency department.
“I wanted to double-check if I was missing something about her being dehydrated,” Ram told Medscape Medical News. “Several things can cause protracted nausea, like hepatitis, appendicitis, or another infection. I feel terribly guilty I didn’t realize she had a heart condition.”
A surprising turn for the worst
Ramya’s subtle symptoms quickly gave way to the dramatic cardiac crisis that unfolded just after her arrival at Community North. “Her EKG looked absolutely horrendous, like a 75-year-old having a heart attack,” Ram said.
As a cardiologist, he knew his daughter’s situation was growing dire when he heard physicians shouting that the Impella wasn’t working and she needed extracorporeal membrane oxygenation (ECMO).
“At that point, I didn’t think she’d survive,” her father recalled. “We had 10 physicians in the room who worked on her for 5 hours to get her stabilized.”
“It was especially traumatic because, obviously, I knew exactly what was happening,” he added. “You can’t sugarcoat anything.”
After being connected to the heart–lung equipment, Ramya was transferred to IU Health Methodist Hospital, also in Indianapolis, where she was tested again for COVID-19. Unlike the rapid test administered just days earlier, the PCR assay came back positive.
“I knew she had acute myocarditis, but coronavirus never crossed my mind,” said Ram.
“As we were dealing with her heart, we were also dealing with this challenge: she was coming back positive for COVID-19 again,” said Roopa Rao, MD, the heart failure transplant cardiologist at IU Health who treated Ramya.
“We weren’t sure whether we were dealing with an active infection or dead virus” from her previous infection, Rao said, “so we started treating her like she had active COVID-19 and gave her remdesivir, convalescent plasma, and steroids, which was the protocol in our hospital.”
A biopsy of Ramya’s heart tissue, along with blood tests, indicated a past parvovirus infection. It’s possible that Ramya’s previous coronavirus infection made her susceptible to heart damage from a newer parvovirus infection, said Rao. Either virus, or both together, could have been responsible for the calamity.
Although it was unheard of during Ramya’s cardiac crisis in early August, evolving evidence now raises the possibility that she is one of a handful of people in the world to be reinfected with SARS-CoV-2. Also emerging are cases of COVID-related myocarditis and other extreme heart complications, particularly in young people.
“At the time, it wasn’t really clear if people could have another infection so quickly,” Rao told Medscape Medical News. “It is possible she is one of these rare individuals to have COVID-19 twice. I’m hoping at some point we will have some clarity.”
“I would favor a coinfection as probably the triggering factor for her sickness,” she said. “It may take some time, but like any other disease — and it doesn’t look like COVID will go away magically — I hope we’ll have some answers down the road.”
Another wrinkle
The next 48 hours brought astonishing news: Ramya’s heart function had rebounded to nearly normal, and her ejection fraction increased to about 45%. Heart transplantation wouldn’t be necessary, although Rao stood poised to follow through if ECMO only sustained, rather than improved, Ramya’s prognosis.
“Ramya was so sick that if she didn’t recover, the only option would be a heart transplant,” said Rao. “But we wanted to do everything to keep that heart.”
After steroid and COVID treatment, Ramya’s heart started to come back. “It didn’t make sense to me,” said Rao. “I don’t know what helped. If we hadn’t done ECMO, her heart probably wouldn’t have recovered, so I would say we have to support these patients and give them time for the heart to recover, even to the point of ECMO.”
Despite the good news, Ramya’s survival still hung in the balance. When she was disconnected from ECMO, clinicians discovered that the Impella device had caused a rare complication, damaging her mitral valve. The valve could be repaired surgically, but both Rao and Ram felt great trepidation at the prospect of cardiopulmonary bypass during the open-heart procedure.
“They would need to stop her heart and restart it, and I was concerned it would not restart,” Ram explained. “I didn’t like the idea of open-heart surgery, but my biggest fear was she was not going to survive it because of a really fresh, sick heart.”
The cardiologists’ fears did, in fact, come to pass: it took an hour to coax Ramya’s heart back at the end of surgery. But, just as the surgeon was preparing to reconnect Ramya to ECMO in desperation, “her heart recovered again,” Rao reported.
“Some things you never forget in life,” she said. “I can’t describe how everyone in the OR felt, all taking care of her. I told Ramya, ‘you are a fighter’.”
New strength
Six days would pass before Ramya woke up and learned of the astounding series of events that saved her. She knew “something was really wrong” because of the incision at the center of her chest, but learning she’d been on ECMO and the heart transplant list drove home how close to death she’d actually come.
“Most people don’t get off ECMO; they die on it,” she said. “And the chances of dying on the heart transplant list are very high. It was very strange to me that this was my story all of a sudden, when a week and a half earlier I was on rotation.”
Ongoing physical therapy over the past 3 months has transformed Ramya from a state of profound physical weakness to a place of relative strength. The now-fourth-year med student is turning 26 in November and is hungry to restart in-person rotations. Her downtime has been filled in part with researching myocarditis and collaborating with Rao on her own case study for journal publication.
But the mental trauma from her experience has girded her in ways she knows will make her stronger personally and professionally in the years ahead.
“It’s still very hard. I’m still recovering,” she acknowledged. “I described it to my therapist as an invisible wound on my brain.”
“When I came out of the hospital, I still had ECMO wounds, deep gashes on my legs that affected how fast and how long I could walk,” she said. “I felt like the same thing was going on my brain — a huge cut no one could see.”
Her intention to specialize in psychiatry has become more pressing now that Ramya has realized the impact of trauma on mental health.
“My body failing me was awful, but I could handle it,” she said. “Losing any part of my mind would have been way worse. I want to take care of that in my patients.”
This article first appeared on Medscape.com.
Within minutes of her arrival at Community North Hospital in Indianapolis, Ramya Yeleti’s vital signs plummeted; her pulse was at 45 beats per minute and her ejection fraction was hovering near 10%. “I definitely thought there was a chance I would close my eyes and never open them again, but I only had a few seconds to process that,” she recalled. Then everything went black. Ramya fell unconscious as shock pads were positioned and a swarm of clinicians prepared to insert an Impella heart pump through a catheter into her aorta.
The third-year medical student and aspiring psychiatrist had been doing in-person neurology rotations in July when she began to experience fever and uncontrolled vomiting. Her initial thought was that she must have caught the flu from a patient.
After all, Ramya, along with her father Ram Yeleti, MD, mother Indira, and twin sister Divya, had all weathered COVID-19 in previous months and later tested positive for SARS-CoV-2 antibodies. The only family member who had been spared was her younger brother Rohith.
Indira suffered a severe case, requiring ICU care for 2 days but no ventilator; the others experienced mostly mild symptoms. Ramya — who was studying for her third-year board exams after classes at Marian University College of Osteopathic Medicine in Indianapolis went virtual in March — was left with lingering fatigue; however, her cough and muscle aches abated and her sense of taste and smell returned. When she started rotations, she thought her life was getting back to normal.
Ramya’s flu symptoms did not improve. A university-mandated rapid COVID test came back negative, but 2 more days of vomiting started to worry both her and her father, who is a cardiologist and chief physician executive at Community Health Network in Indianapolis. After Ramya felt some chest pain, she asked her father to listen to her heart. All sounded normal, and Ram prescribed ondansetron for her nausea.
But the antiemetic didn’t work, and by the next morning both father and daughter were convinced that they needed to head to the emergency department.
“I wanted to double-check if I was missing something about her being dehydrated,” Ram told Medscape Medical News. “Several things can cause protracted nausea, like hepatitis, appendicitis, or another infection. I feel terribly guilty I didn’t realize she had a heart condition.”
A surprising turn for the worst
Ramya’s subtle symptoms quickly gave way to the dramatic cardiac crisis that unfolded just after her arrival at Community North. “Her EKG looked absolutely horrendous, like a 75-year-old having a heart attack,” Ram said.
As a cardiologist, he knew his daughter’s situation was growing dire when he heard physicians shouting that the Impella wasn’t working and she needed extracorporeal membrane oxygenation (ECMO).
“At that point, I didn’t think she’d survive,” her father recalled. “We had 10 physicians in the room who worked on her for 5 hours to get her stabilized.”
“It was especially traumatic because, obviously, I knew exactly what was happening,” he added. “You can’t sugarcoat anything.”
After being connected to the heart–lung equipment, Ramya was transferred to IU Health Methodist Hospital, also in Indianapolis, where she was tested again for COVID-19. Unlike the rapid test administered just days earlier, the PCR assay came back positive.
“I knew she had acute myocarditis, but coronavirus never crossed my mind,” said Ram.
“As we were dealing with her heart, we were also dealing with this challenge: she was coming back positive for COVID-19 again,” said Roopa Rao, MD, the heart failure transplant cardiologist at IU Health who treated Ramya.
“We weren’t sure whether we were dealing with an active infection or dead virus” from her previous infection, Rao said, “so we started treating her like she had active COVID-19 and gave her remdesivir, convalescent plasma, and steroids, which was the protocol in our hospital.”
A biopsy of Ramya’s heart tissue, along with blood tests, indicated a past parvovirus infection. It’s possible that Ramya’s previous coronavirus infection made her susceptible to heart damage from a newer parvovirus infection, said Rao. Either virus, or both together, could have been responsible for the calamity.
Although it was unheard of during Ramya’s cardiac crisis in early August, evolving evidence now raises the possibility that she is one of a handful of people in the world to be reinfected with SARS-CoV-2. Also emerging are cases of COVID-related myocarditis and other extreme heart complications, particularly in young people.
“At the time, it wasn’t really clear if people could have another infection so quickly,” Rao told Medscape Medical News. “It is possible she is one of these rare individuals to have COVID-19 twice. I’m hoping at some point we will have some clarity.”
“I would favor a coinfection as probably the triggering factor for her sickness,” she said. “It may take some time, but like any other disease — and it doesn’t look like COVID will go away magically — I hope we’ll have some answers down the road.”
Another wrinkle
The next 48 hours brought astonishing news: Ramya’s heart function had rebounded to nearly normal, and her ejection fraction increased to about 45%. Heart transplantation wouldn’t be necessary, although Rao stood poised to follow through if ECMO only sustained, rather than improved, Ramya’s prognosis.
“Ramya was so sick that if she didn’t recover, the only option would be a heart transplant,” said Rao. “But we wanted to do everything to keep that heart.”
After steroid and COVID treatment, Ramya’s heart started to come back. “It didn’t make sense to me,” said Rao. “I don’t know what helped. If we hadn’t done ECMO, her heart probably wouldn’t have recovered, so I would say we have to support these patients and give them time for the heart to recover, even to the point of ECMO.”
Despite the good news, Ramya’s survival still hung in the balance. When she was disconnected from ECMO, clinicians discovered that the Impella device had caused a rare complication, damaging her mitral valve. The valve could be repaired surgically, but both Rao and Ram felt great trepidation at the prospect of cardiopulmonary bypass during the open-heart procedure.
“They would need to stop her heart and restart it, and I was concerned it would not restart,” Ram explained. “I didn’t like the idea of open-heart surgery, but my biggest fear was she was not going to survive it because of a really fresh, sick heart.”
The cardiologists’ fears did, in fact, come to pass: it took an hour to coax Ramya’s heart back at the end of surgery. But, just as the surgeon was preparing to reconnect Ramya to ECMO in desperation, “her heart recovered again,” Rao reported.
“Some things you never forget in life,” she said. “I can’t describe how everyone in the OR felt, all taking care of her. I told Ramya, ‘you are a fighter’.”
New strength
Six days would pass before Ramya woke up and learned of the astounding series of events that saved her. She knew “something was really wrong” because of the incision at the center of her chest, but learning she’d been on ECMO and the heart transplant list drove home how close to death she’d actually come.
“Most people don’t get off ECMO; they die on it,” she said. “And the chances of dying on the heart transplant list are very high. It was very strange to me that this was my story all of a sudden, when a week and a half earlier I was on rotation.”
Ongoing physical therapy over the past 3 months has transformed Ramya from a state of profound physical weakness to a place of relative strength. The now-fourth-year med student is turning 26 in November and is hungry to restart in-person rotations. Her downtime has been filled in part with researching myocarditis and collaborating with Rao on her own case study for journal publication.
But the mental trauma from her experience has girded her in ways she knows will make her stronger personally and professionally in the years ahead.
“It’s still very hard. I’m still recovering,” she acknowledged. “I described it to my therapist as an invisible wound on my brain.”
“When I came out of the hospital, I still had ECMO wounds, deep gashes on my legs that affected how fast and how long I could walk,” she said. “I felt like the same thing was going on my brain — a huge cut no one could see.”
Her intention to specialize in psychiatry has become more pressing now that Ramya has realized the impact of trauma on mental health.
“My body failing me was awful, but I could handle it,” she said. “Losing any part of my mind would have been way worse. I want to take care of that in my patients.”
This article first appeared on Medscape.com.
About 17% of COVID-19 survivors retest positive in follow-up study
For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.
Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.
“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.
“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”
The study was published online Sept. 18 in the American Journal of Preventive Medicine.
The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.
“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.
“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
Official COVID-19 recovery
To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.
All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m2 in the positive group versus 25.9 in the negative group, was significant.
Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).
People returned for follow-up visits a mean 17 days after the second negative swab test.
Asymptomatic COVID-19 carriers
“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”
No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
Next steps
Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.
One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.
“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.
Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.
Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.
A version of this article originally appeared on Medscape.com.
For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.
Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.
“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.
“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”
The study was published online Sept. 18 in the American Journal of Preventive Medicine.
The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.
“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.
“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
Official COVID-19 recovery
To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.
All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m2 in the positive group versus 25.9 in the negative group, was significant.
Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).
People returned for follow-up visits a mean 17 days after the second negative swab test.
Asymptomatic COVID-19 carriers
“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”
No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
Next steps
Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.
One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.
“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.
Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.
Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.
A version of this article originally appeared on Medscape.com.
For reasons unknown, about one in six people who recovered from COVID-19 subsequently retested positive at least 2 weeks later, researchers reported in a study in Italy.
Sore throat and rhinitis were the only symptoms associated with a positive result. “Patients who continued to have respiratory symptoms, especially, were more likely to have a new positive test result,” lead author Francesco Landi, MD, PhD, said in an interview.
“This suggests the persistence of respiratory symptoms should not be underestimated and should be adequately assessed in all patients considered recovered from COVID-19,” he said.
“The study results are interesting,” Akiko Iwasaki, PhD, an immunobiologist at Yale University and the Howard Hughes Medical Institute, both in New Haven, Conn.,, said in an interview. “There are other reports of RNA detection postdischarge, but this study ... found that only two symptoms out of many – sore throat and rhinitis – were higher in those with PCR [polymerase chain reaction]-positive status.”
The study was published online Sept. 18 in the American Journal of Preventive Medicine.
The findings could carry important implications for people who continue to be symptomatic. “It is reasonable to be cautious and avoid close contact with others, wear a face mask, and possibly undergo an additional nasopharyngeal swab,” said Dr. Landi, associate professor of internal medicine at Catholic University of the Sacred Heart in Rome.
“One of most interesting findings is that persistent symptoms do not correlate with PCR positivity, suggesting that symptoms are in many cases not due to ongoing viral replication,” Jonathan Karn, PhD, professor and chair of the department of molecular biology and microbiology at Case Western Reserve University, Cleveland, said in an interview.
“The key technical problem, which they have discussed, is that a viral RNA signal in the PCR assay does not necessarily mean that infectious virus is present,” Dr. Karn said. He added that new comprehensive viral RNA analyses would be needed to answer this question.
Official COVID-19 recovery
To identify risk factors and COVID-19 survivors more likely to retest positive, Dr. Landi and members of the Gemelli Against COVID-19 Post-Acute Care Study Group evaluated 131 people after hospital discharge.
All participants met World Health Organization criteria for release from isolation, including two negative test results at least 24 hours apart, and were studied between April 21 and May 21. Mean age was 56 and 39% were women. Only a slightly higher mean body mass index of 27.6 kg/m2 in the positive group versus 25.9 in the negative group, was significant.
Although 51% of survivors reported fatigue, 44% had dyspnea, and 17% were coughing, the rates did not differ significantly between groups. In contrast, 18% of positive survivors and 4% of negative survivors had a sore throat (P = .04), and 27% versus 12%, respectively, reported rhinitis (P = .05).
People returned for follow-up visits a mean 17 days after the second negative swab test.
Asymptomatic COVID-19 carriers
“These findings indicate that a noteworthy rate of recovered patients with COVID-19 could still be asymptomatic carriers of the virus,” the researchers noted in the paper. “Even in the absence of specific guidelines, the 22 patients who tested positive for COVID-19 again were suggested to quarantine for a second time.”
No family member or close contact of the positive survivors reported SARS-CoV-2 infection. All patients continued to wear masks and observe social distancing recommendations, which makes it “very difficult to affirm whether these patients were really contagious,” the researchers noted.
Next steps
Evaluating all COVID-19 survivors to identify any who retest positive “will be a crucial contribution to a better understanding of both the natural history of COVID-19 as well as the public health implications of viral shedding,” the authors wrote.
One study limitation is that the reverse transcriptase–PCR test reveals genetic sequences specific to COVID-19. “It is important to underline that this is not a viral culture and cannot determine whether the virus is viable and transmissible,” the researchers noted.
“In this respect, we are trying to better understand if the persistence of long-time positive [reverse transcriptase]–PCR test for COVID-19 is really correlated to a potential contagiousness,” they added.
Dr. Landi and colleagues said their findings should be considered preliminary, and larger data samples are warranted to validate the results.
Dr. Landi and Dr. Karn disclosed no relevant financial relationships. Dr. Iwasaki disclosed a research grant from Condair, a 5% or greater equity interest in RIGImmune, and income of $250 or more from PureTec.
A version of this article originally appeared on Medscape.com.
CDC panel takes on COVID vaccine rollout, risks, and side effects
Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).
ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.
At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.
ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.
Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
Ethics and limited evidence
During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.
Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.
With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.
“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.
Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.
The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.
Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.
“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
Medical front line, then who?
There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.
A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.
Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.
Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.
The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”
Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.
The following are other findings of the CDC staff:
The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.
Differences were not substantial in some scenarios.
The need to continue efforts to slow the spread of COVID-19 should be emphasized.
Adverse effects
ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.
Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.
Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
Pregnancy and breastfeeding are special concerns
Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.
At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.
In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.
“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”
This article first appeared on Medscape.com.
Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).
ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.
At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.
ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.
Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
Ethics and limited evidence
During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.
Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.
With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.
“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.
Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.
The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.
Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.
“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
Medical front line, then who?
There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.
A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.
Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.
Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.
The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”
Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.
The following are other findings of the CDC staff:
The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.
Differences were not substantial in some scenarios.
The need to continue efforts to slow the spread of COVID-19 should be emphasized.
Adverse effects
ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.
Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.
Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
Pregnancy and breastfeeding are special concerns
Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.
At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.
In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.
“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”
This article first appeared on Medscape.com.
Federal advisers who will help determine which Americans get the first COVID vaccines took an in-depth look Oct. 30 at the challenges they face in selecting priority groups.
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will face two key decisions once a COVID vaccine wins clearance from the US Food and Drug Administration (FDA).
ACIP will need to decide whether to recommend its use in adults (the age group in which vaccines are currently being tested). The group will also need to offer direction on which groups should get priority in vaccine allocation, inasmuch as early supplies will not be sufficient to vaccinate everyone.
At the Oct. 30 meeting, CDC’s Kathleen Dooling, MD, MPH, suggested that ACIP plan on tackling these issues as two separate questions when it comes time to weigh in on an approved vaccine. Although there was no formal vote among ACIP members at the meeting, Dooling’s proposal for tackling a future recommendation in a two-part fashion drew positive feedback.
ACIP member Katherine A. Poehling, MD, MPH, suggested that the panel and CDC be ready to reexamine the situation frequently regarding COVID vaccination. “Perhaps we could think about reviewing data on a monthly basis and updating the recommendation, so that we can account for the concerns and balance both the benefits and the [potential] harm,” Poehling said.
Dooling agreed. “Both the vaccine recommendation and allocation will be revisited in what is a very dynamic situation,” Dooling replied to Poehling. “So all new evidence will be brought to ACIP, and certainly the allocation as vaccine distribution proceeds will need to be adjusted accordingly.”
Ethics and limited evidence
During the meeting, ACIP members repeatedly expressed discomfort with the prospect of having to weigh in on widespread use of COVID vaccines on the basis of limited evidence.
Within months, FDA may opt for a special clearance, known as an emergency use authorization (EUA), for one or more of the experimental COVID vaccines now in advanced testing. Many of FDA’s past EUA clearances were granted for test kits. For those EUA approvals, the agency considered risks of false results but not longer-term, direct harm to patients from these products.
With a COVID vaccine, there will be strong pressure to distribute doses as quickly as possible with the hope of curbing the pandemic, which has already led to more than 229,000 deaths in the United States alone and has disrupted lives and economies around the world. But questions will persist about the possibility of serious complications from these vaccines, ACIP members noted.
“My personal struggle is the ethical side and how to balance these two,” said ACIP member Robert L. Atmar, MD, of Baylor College of Medicine, Houston, Texas, who noted that he expects his fellow panelists to share this concern.
Currently, four experimental COVID vaccines likely to be used in the United States have advanced to phase 3 testing. Pfizer Inc and BioNtech have enrolled more than 42,000 participants in a test of their candidate, BNT162b2 vaccine, and rival Moderna has enrolled about 30,000 participants in a test of its mRNA-1273 vaccine, CDC staff said.
The other two advanced COVID vaccine candidates have overcome recent hurdles. AstraZeneca Plc on Oct. 23 announced that FDA had removed a hold on the testing of its AZD1222 vaccine candidate; the trial will enroll approximately 30,000 people. Johnson & Johnson’s Janssen unit also announced that day the lifting of a safety pause for its Ad26.COV2.S vaccine; the phase 3 trial for that vaccine will enroll approximately 60,000 volunteers. Federal agencies, states, and territories have developed plans for future distribution of COVID vaccines, CDC staff said in briefing materials for today’s ACIP meeting.
Several ACIP members raised many of the same concerns that members of an FDA advisory committee raised at a meeting earlier in October. ACIP and FDA advisers honed in on the FDA’s decision to set a median follow-up duration of 2 months in phase 3 trials in connection with expected EUA applications for COVID-19 vaccines.
“I struggle with following people for 2 months after their second vaccination as a time point to start making final decisions about safety,” said ACIP member Sharon E. Frey, MD, a professor at St. Louis University School of Medicine, St. Louis, Missouri. “I just want to put that out there.”
Medical front line, then who?
There is consensus that healthcare workers be in the first stage ― Phase 1 ― of distribution. That recommendation was made in a report from the National Academies of Sciences, Engineering, and Medicine (NASEM). Phase 1A would include first responders; Phase 1B might include people of all ages who have two or more comorbidities that put them at significantly higher risk for COVID-19 or death, as well as older adults living in congregate or overcrowded settings, the NASEM report said.
A presentation from the CDC’s Matthew Biggerstaff, ScD, MPH, underscored challenges in distributing what are expected to be limited initial supplies of COVID vaccines.
Biggerstaff showed several scenarios the CDC’s Data, Analytics, and Modeling Task Force had studied. The initial allocation of vaccines would be for healthcare workers, followed by what the CDC called Phase 1B.
Choices for a rollout may include next giving COVID vaccines to people at high risk, such as persons who have one or more chronic medical conditions, including heart disease, diabetes, kidney disease, or obesity. Other options for the rollout could be to vaccinate people aged 65 years and older or essential workers whose employment puts them in contact with the public, thus raising the risk of contracting the virus.
The CDC’s research found that the greatest impact in preventing death was to initially vaccinate adults aged 65 and older in Phase 1B. The agency staff described this approach as likely to result in an about “1 to 11% increase in averted deaths across the scenarios.”
Initially vaccinating essential workers or high-risk adults in Phase 1B would avert the most infections. The agency staff described this approach as yielding about “1 to 5% increase in averted infections across the scenarios,” Biggerstaff said during his presentation.
The following are other findings of the CDC staff:
The earlier the vaccine rollout relative to increasing transmission, the greater the averted percentage and differences between the strategies.
Differences were not substantial in some scenarios.
The need to continue efforts to slow the spread of COVID-19 should be emphasized.
Adverse effects
ACIP members also heard about strategies for tracking potential side effects of future vaccines. A presentation by Tom Shimabukuro, MD, MPH, MBA, from the CDC’s COVID-19 Vaccine Task Force/Vaccine Safety Team, included details about a new smartphone-based active surveillance program for COVID-19 vaccine safety.
Known as v-safe, this system would use Web-based survey monitoring and incorporate text messaging. It would conduct electronic health checks on vaccine recipients, which would occur daily during the first week post vaccination and weekly thereafter for 6 weeks from the time of vaccination.
Clinicians “can play an important role in helping CDC enroll patients in v-safe at the time of vaccination,” Shimabukuro noted in his presentation. This would add another task, though, for clinicians, the CDC staff noted.
Pregnancy and breastfeeding are special concerns
Of special concern with the rollout of a COVID vaccine are recommendations regarding pregnancy and breastfeeding. Women constitute about 75% of the healthcare workforce, CDC staff noted.
At the time the initial ACIP COVID vaccination recommendations are made, there could be approximately 330,000 healthcare personnel who are pregnant or who have recently given birth. Available data indicate potentially increased risks for severe maternal illness and preterm birth associated with SARS-CoV-2 infection, said CDC’s Megan Wallace, DrPH, MPH, in a presentation for the Friday meeting.
In an Oct. 27 letter to ACIP, Chair Jose Romero, the American College of Obstetricians and Gynecologists (ACOG), urged the panel to ensure that pregnant women and new mothers in the healthcare workforce have priority access to a COVID vaccine. Pregnant and lactating women were “noticeably and alarmingly absent from the NASEM vaccine allocation plan for COVID-19,” wrote Christopher M. Zahn, MD, vice president for practice activities at ACOG, in the letter to Romero.
“ACOG urges ACIP to incorporate pregnant and lactating women clearly and explicitly into its COVID-19 vaccine allocation and prioritization framework,” Zahn wrote. “Should an Emergency Use Authorization be executed for one or more COVID-19 vaccines and provide a permissive recommendation for pregnant and lactating women, pregnant health care workers, pregnant first responders, and pregnant individuals with underlying conditions should be prioritized for vaccination alongside their non-pregnant peers.”
This article first appeared on Medscape.com.
Hospitalists are natural leaders in the COVID-19 battle
Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.
“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.
Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.
“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”
Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
Where is hospital treatment for COVID-19 at today?
As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.
“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”
Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.
Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.
Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”
She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
The importance of teamwork
Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.
Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.
Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.
“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.
“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”
But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
A human fix in the hospital
Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.
One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
A version of this article originally appeared on Medscape.com.
Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.
“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.
Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.
“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”
Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
Where is hospital treatment for COVID-19 at today?
As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.
“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”
Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.
Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.
Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”
She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
The importance of teamwork
Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.
Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.
Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.
“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.
“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”
But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
A human fix in the hospital
Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.
One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
A version of this article originally appeared on Medscape.com.
Christopher Pribula, MD, a hospitalist at Sanford Broadway Medical Center in Fargo, N.D., didn’t anticipate becoming his hospital’s resident expert on COVID-19. Having just returned from vacation in March, he agreed to cover for a colleague on what would become the special care unit. “When our hospital medicine group decided that it would be the COVID unit, I just ran with it,” he said. Dr. Pribula spent the next 18 days doing 8- to 14-hour shifts and learning as much as he could as the hospital – and the nation – wrestled with the pandemic.
“Because I was the first hospitalist, along with our infectious disease specialist, Dr. Avish Nagpal, to really engage with the virus, people came to me with their questions,” Dr. Pribula said. Working to establish protocols for the care of COVID-19 patients involved a lot of planning, from nursing protocols to discharge planning.
Dr. Pribula was part of the hospital’s incident command structure, thought about how the system could scale up for a potential surge, and worked with the North Dakota Medical Association to reach out to outlying medical centers on safety and infection control. He even drew on his prior work experience as a medical technologist doing negative-pressure containment in a cell-processing facility to help create the hospital’s negative-pressure unit in an old ICU.
“We did a lot of communication from the start. To a certain extent we were making it up as we went along, but we sat down and huddled as a team every day at 9 and 4,” he explained. “We started out with observation and retrospective research, and learned piece by piece. But that’s how science works.”
Hospitalists across the country have played leading roles in their hospitals’ and health systems’ response to the pandemic, and not just because they are on the front lines providing patient care. Their job as doctors who work full-time in the hospital makes them natural leaders in improving clinical quality and hospital administrative protocols as well as studying the latest information and educating their colleagues. Responding to the pandemic has required lots of planning, careful attention to schedules and assignments and staff stress, and working with other departments in the hospital and groups in the community, including public health authorities.
Where is hospital treatment for COVID-19 at today?
As knowledge has grown, Dr. Pribula said, COVID-19 treatment in the hospital has come to incorporate remdesivir, a broad-spectrum antiviral; dexamethasone, a common steroid medication; and convalescent plasma, blood products from people who have recovered from the illness. “We went from no steroids to giving steroids. We went from putting patients on ventilators to avoid acute respiratory distress syndrome (ARDS) initially to now working to avoid intubation at all costs,” he said.
“What we found is that we need to pressure-support these patients. We do proning and CPAP while we let the lungs heal. By the time they arrive at the hospital, more often than not they’re on the backside of the viral load. But now we’re dealing with the body’s inflammatory response.”
Navneet Attri, MD, a hospitalist at Sutter Santa Rosa Regional Hospital in Santa Rosa, Calif., 50 miles north of San Francisco, experienced fears and uncertainties working at a hospital that treated early COVID patients from the Grand Princess cruise ship. Early on, she wrote a post describing her experience for The Hospitalist Leader, the Society of Hospital Medicine’s blog page.
Dr. Attri said she has gone through the gamut of emotions while caring for COVID-19 patients, addressing their fears and trying to support family members who aren’t allowed to enter the hospital to be at their loved one’s side. Sometimes, patient after patient with COVID-19 becomes almost too much. But seeing a lot of them in the intervening 6 months has increased her confidence level.
Understanding of how the disease is spread has continued to evolve, with a recent return to focusing on airborne transmission, she said. Frontline workers need N95 masks and eye shields, even if all of that PPE feels like a burden. Dr. Attri said she hardly notices the PPE anymore. “Putting it on is just a habit.”
She sits on Sonoma County’s COVID-19 surge planning group, which has representatives from the three local hospitals, the public health department, and other community agencies. “I report back to my hospitalist group about the situation in the community. Because our facilities were well prepared, our hospitals have not been overwhelmed,” she said.
The importance of teamwork
Sunil Shah, MD, a hospitalist with Northwell Health’s Southside Hospital in Bay Shore, N.Y., is part of the massive hospital medicine team, including reassigned specialists and volunteers from across the country, deployed at Northwell hospitals in Greater New York City and Long Island during the COVID-19 surge. Northwell probably has cared for more COVID-19 patients than any other health system in the country, and at the height of the surge the intensity of hospital care was like nothing he’s ever seen. But he also expressed gratitude that doctors from other parts of the country were willing to come and help out.
Southside Hospital went almost overnight from a 200-bed acute facility to a full, 350-bed, regional COVID-19–only hospital. “On busy days, our entire hospital was like a floating ICU,” he said. “You’d hear ‘rapid response’ or ‘code blue’ over the intercom every few seconds. Normally we’d have a designated rapid response person for the day, but with COVID, everybody stepped in to help – whoever was closest,” he said.
Majid Sheikh, MD, a hospitalist at Emory University Hospital in Atlanta, also became a go-to COVID-19 expert for his group. “I didn’t specifically volunteer, but my partner and I had the first cases, and the leadership group was happy to have us there,” he explained.
“One interesting thing I learned was the concept of the ‘happy’ hypoxemic patient, who is having a significant drop in oxygen saturation without developing any obvious signs of respiratory distress,” he said. “We’d be checking the accuracy of the reading and trying to figure out if it was real.” Emory was also one of the leaders in studying anticoagulant treatments for COVID-19 patients.
“Six months later I would say we’re definitely getting better outcomes on the floor, and our COVID patients aren’t landing in the ICU as easily,” Dr. Sheikh said. “It was scary at first, and doubly scary when doctors sometimes don’t feel they can say, ‘Hey, I’m scared too,’ or ‘By the way, I really don’t know what I’m doing.’ So, we’d be trying to reassure the patients when the information was coming to us in fragments.”
But he also believes that the pandemic has afforded hospitalists the opportunity to be the clinical detectives they were trained to be, sifting through clues. “I had to think more and really pay attention clinically in a much different way. You could say it was exciting and scary at the same time,” he said.
A human fix in the hospital
Dr. Pribula agreed that the pandemic has been both a difficult experience and a rewarding one. “I think of the people I first admitted. If they had shown up even a month later, would they still be with us?” He believes that his group and his field are going to get to a place where they have solid treatment plans for how to provide optimal care and how to protect providers from exposure.
One of the first COVID-19 patients in Fargo had dementia and was very distressed. “She had no idea why nobody was visiting or why we wouldn’t let her out of her room,” Dr. Pribula said. “Instead of reaching for sedatives, one of our nurses went into the room and talked with her, prayed a rosary, and played two hands of cards with her and didn’t have to sedate her. That’s what people need when they’re alone and scared. It wasn’t a medical fix but a human fix.”
A version of this article originally appeared on Medscape.com.
COVID and med ed cost: Are future docs paying more for less?
Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.
Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.
Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.
In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”
Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.
“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
COVID’s “hidden costs” for students
Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.
Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.
Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”
International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.
The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
Scaling back the price of med school?
Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.
Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.
Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.
He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.
“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
Pandemic as opportunity
Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.
This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”
As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.
Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.
Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.
Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”
Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”
Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.
Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.
Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.
Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.
This article first appeared on Medscape.com.
Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.
Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.
Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.
In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”
Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.
“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
COVID’s “hidden costs” for students
Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.
Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.
Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”
International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.
The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
Scaling back the price of med school?
Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.
Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.
Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.
He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.
“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
Pandemic as opportunity
Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.
This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”
As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.
Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.
Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.
Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”
Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”
Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.
Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.
Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.
Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.
This article first appeared on Medscape.com.
Like most medical students, Kaitlyn Thomas’s education was abruptly interrupted by the pandemic. Her school, an osteopathic medicine institution in the Midwest, followed guidelines issued by the American Association of Medical Colleges in March, shifting lectures online and suspending activities in which students interacted with patients. But even as Ms. Thomas’s learning opportunities dwindled for the sake of safety, the costs kept piling up.
Instead of going home to live with her family, she stayed in her apartment near school – and kept paying rent – so she could be nearby for the two licensing exams she was scheduled to take 3 months later. Both tests were canceled 9 days before she was scheduled to take them, one without any notification. This meant she had to travel to two different testing sites in two different states. All told, she said, the whole thing cost her around $2,000.
Ms. Thomas’s experience isn’t rare. Across the country, medical students find themselves paying substantial costs for a medical education now greatly altered by the pandemic. Despite restrictions on time spent in hospitals, hands-on learning, social events, and access to libraries, gyms, study spaces, and instructors, the price of tuition hasn’t dropped but has remained the same or has even risen.
In response, students have become vocal about the return on their pricey investment. “Am I just going to end up doing most of my year online, and what does that look like for my future patients?” Ms. Thomas asked. “It really doesn’t feel like a time to be limiting education.”
Medical schools and administrators are scrambling to find creative solutions for safely educating students. No matter what those solutions may be, experts say, the pandemic has drawn fresh attention to enduring questions about how the cost of medical education compares to its value. Although many are frustrated, some see the potential for COVID to open new opportunities for lasting innovation. At the very least, the pandemic has sparked conversations about what matters most in terms of producing qualified physicians.
“While this is a challenging time, we will get through it, and we will continue to educate doctors, and we will get them through to practice,” says Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine. Many in the midst of training still have one lingering question: Is the price future doctors are now paying still worth it?
COVID’s “hidden costs” for students
Tom is a third-year student at an allopathic medicine institution in the Caribbean. He asked not to be fully identified here, owing to concern about possible backlash. In March, Tom was doing clinical rotations in New York City when his training was put on hold. He returned home to Connecticut and resumed working 60-80 hours a week as a paramedic. As much as 75% of that income went to pay for the New York City apartment he was no longer living in – an apartment that cost more than $2,000 a month – and for student loans that suddenly came due when his enrollment status changed.
Tom has been able to take some online courses through his school. But he still doesn’t know whether state licensing boards will accept them, how residency programs will view them, or whether he will eventually have to retake those online classes in person. At the end of September, he was allowed to return to the hospital but was relocated to Chicago and was forced to move on short notice.
Like many students, Tom has worried that the pandemic may prevent him from acquiring crucial elements for his residency applications, things like letters of recommendation or key experiences. That could delay his next stage of training, which would mean lost future income, increasing student loan interest, and lost work experience. “This could also mean the difference between getting a residency and being able to practice medicine and not being able to practice my intended specialty,” he said. “This is the real hidden cost we may have to deal with.”
International medical students hoping to practice in the United States face additional costs. Michelle Warncke earned her bachelor’s degree in America but went to the United Kingdom for her master’s and her medical degree, which she completed in 2019. She then moved to North Carolina with her husband and saved money to take the exams she needed for residency in the states. But her scheduled Step 2 CS exam was canceled because of the pandemic. Now, like hundreds or even thousands of other students, she said she is unable to apply for residency, even as her student loans collect interest. An active Facebook group of international medical graduates includes about 1,500 people with comparable dilemmas.
The path to becoming a physician carries a well-known price tag, one that is already quite high. Now, for many, that price is substantially increasing. “The only way I can actually keep my medical credentials up to date and passable, to be able to ever get a shot at a residency in the following years,” she said, “is to move to another country and work for less pay, pay for a visa, pay for my exams, pay for my language test, and wait and hope that I might be able to as an older graduate then be able to apply for residency.”
Scaling back the price of med school?
Questions about the economics of medical education aren’t new, says David Asch, MD, MBA, an internal medicine physician and executive director of the Center for Health Care Innovation at the University of Pennsylvania, Philadelphia. But the changes forced by COVID could lead to innovations that may finally better balance the financial scales.
Such innovations are necessary, many say, given how medical education costs have skyrocketed over the past half century. In the 1960s, 4 years of medical school cost about $40,000 in today’s dollars, Dr. Asch and colleagues wrote in a 2020 analysis, which they conducted before the pandemic began. By 2018, the price of a medical education in the United States had ballooned to about $300,000. About 75% of students were taking out loans. Upon graduating, the average debt was $200,000.
Medical school is expensive for many tangible reasons, Dr. Asch said. Schools must pay for curriculum, faculty, technology, textbooks, lab materials, facilities, administrators, and more. But policy changes could decrease those costs.
He says one idea would be for medical schools to join forces and give students access to the same basic lectures in the early years, delivered online by top-notch instructors. Students could then participate in on-campus programs that might only require 3 years to complete instead of 4. By demonstrating what can be done via online platforms, he said, the pandemic might pave the way to permanent changes that could reduce costs.
“I’m not trying to pick on biochemistry professors and medical schools, but how many do we need in the country?” Dr. Asch asked. “We’re all watching the same episode of Seinfeld. Why can’t we all watch the same episode of the Krebs cycle?” If all 190 or so medical schools in the United States shared such preclinical courses, he says, each would require a fraction of the current cost to produce. “We could save 99.5% of the cost. So why don’t we do that?”
Pandemic as opportunity
Although the price of medical education has yet to decrease, schools are working to leverage the pandemic to provide increased educational value.
This generation of physicians will not only have to cope with the fallout of this pandemic, they will be the ones responsible for confronting the next pandemic as well, says Donald Brady, MD, senior associate dean for health sciences education at Vanderbilt University, Nashville, Tenn. “They will be the leaders in the future who will better be able to know how to handle it [a pandemic] because they were able to watch it and be part of it safely in the current circumstance.”
As much as possible, Vanderbilt is using the pandemic as an opportunity. As soon as it became clear that students couldn’t be involved in certain hands-on training, instructors developed a course about pandemics that included lectures on ethics, global health, systemic racism, and other topics. It also included experiential components of pandemic management, such as opportunities to work with patients through telehealth.
Students say they feel that they are getting less for their money and that they are paying for experiences that are no longer available, such as hands-on patient contact and community events. However, Dr. Brady said, schools have had to account for new expenses, including various now-required technologies and transitioning to courses online.
Some challenges can’t be solved with money alone. Medical schools across the country are working together to ensure that they are still adequately preparing students. Vanderbilt participates in an AAMC group that meets regularly and is also one of 37 institutions involved in an American Medical Association Consortium (AACOM). These groups discuss challenges, strategies, and opportunities for optimizing medical education during the pandemic.
Some institutions have come up with creative solutions. Ohio University’s Heritage College of Osteopathic Medicine, in Athens, Ohio, in collaboration with the Ohio Department of Health, launched a 4-week rotation for third-year students that focuses on public health. Harvard Medical School, Boston, was one of several schools that allowed students to graduate early in the spring. “We’re constantly talking to our colleagues and friends,” Dr. Brady said. “We learn from each other. There’s a lot of sharing going on.”
Other organizations are also working to make sure students ultimately get what they are paying for: a high-quality education. As soon as the pandemic began, the AACOM organized four working groups to address how schools could better use technology to deliver curricula and how students could participate in public health efforts, among other topics. “For the students, the part they don’t see and can’t really be aware of is all the things that happen behind the scenes,” Mr. Cain said. “People were working really hard to make sure that their education was still delivered, and delivered in a way that was going to assure a good product at the end.”
Ultimately, that product will be held to a rigid standard, said Geoffrey Young, the AAMC’s senior director for student affairs and programs. Medical schools must still meet standards of competency set by the liaison committee on medical education. Mr. Young says that even now those standards remain rigorous enough to ensure that medical students are learning what they need to know. “The core elements for competency may be slightly altered to address the realities that we’re experiencing because of COVID, but the core tenants of competencies will not change,” he said.
Even as conversations continue about what a medical education is worth, the pandemic is drawing new attention to the profession. No signs suggest that the value of tuition or a shift to more virtual offerings are scaring students away. Applications for medical schools were up 17% for the fall of 2021.
Brady expects the surge in interest to continue. “The increased focus and emphasis on public health, the increased focus and emphasis on health equity, the increased focus on the need for a more diverse physician workforce, the interest in basic science research around viruses, the interest in COVID itself – there are a lot of different elements that are setting us up for a potential boom in applications to medical school,” he said.
Beyond increasing interest, the pandemic may also finally force a reckoning on the disconnection between how schools think about costs and how students think about value, Dr. Asch said. “When students say: ‘I’m not getting as much from this,’ they’re saying, ‘you should price this according to its lower value.’ And when the medical schools are saying: ‘Oh, but it’s costing us so much more,’ they’re talking about pricing according to the cost. It’s like one group is speaking Latin and the other group is speaking Greek.” Perhaps, he said, COVID-related changes will finally get them speaking the same language.
This article first appeared on Medscape.com.