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The leading independent newspaper covering dermatology news and commentary.
Natural, vaccine-induced, and hybrid immunity to COVID-19
Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.
Omicron’s immune evasion
Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.
Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
Natural immunity
Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.
Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.
There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
Vaccine-induced immunity
The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.
In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.
Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
Natural immunity vs. vaccine-induced immunity
Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.
Hybrid immunity
The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.
Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.
Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.
Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.
A version of this article first appeared on Medscape.com.
Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.
Omicron’s immune evasion
Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.
Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
Natural immunity
Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.
Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.
There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
Vaccine-induced immunity
The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.
In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.
Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
Natural immunity vs. vaccine-induced immunity
Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.
Hybrid immunity
The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.
Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.
Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.
Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.
A version of this article first appeared on Medscape.com.
Seroprevalence surveys suggest that, from the beginning of the pandemic to 2022, more than a third of the global population had been infected with SARS-CoV-2. As large numbers of people continue to be infected, the efficacy and duration of natural immunity, in terms of protection against SARS-CoV-2 reinfections and severe disease, are of crucial significance. The virus’s epidemiologic trajectory will be influenced by the trends in vaccine-induced and hybrid immunity.
Omicron’s immune evasion
Cases of SARS-CoV-2 reinfection are increasing around the world. According to data from the U.K. Health Security Agency, 650,000 people in England have been infected twice, and most of them were reinfected in the past 2 months. Before mid-November 2021, reinfections accounted for about 1% of reported cases, but the rate has now increased to around 10%. The reinfection risk was 16 times higher between mid-December 2021 and early January 2022. Experts believe that this spike in reinfections is related to the spread of Omicron, which overtook Delta as the dominant variant. Nonetheless, other aspects should also be considered.
Omicron’s greater propensity to spread is not unrelated to its ability to evade the body’s immune defenses. This aspect was raised in a letter recently published in the New England Journal of Medicine. The authors reported that the effectiveness of previous infection in preventing reinfection against the Alpha, Beta, and Delta variants was around 90%, but it was only 56% against Omicron.
Natural immunity
Natural immunity showed roughly similar effectiveness regarding protection against reinfection across different SARS-CoV-2 variants, with the exception of the Omicron variant. The risk of hospitalization and death was also reduced in SARS-CoV-2 reinfections versus primary infections. Observational studies indicate that natural immunity may offer equal or greater protection against SARS-CoV-2 infections, compared with immunization with two doses of an mRNA vaccine, but the data are not fully consistent.
Natural immunity seems to be relatively long-lasting. Data from Denmark and Austria show no evidence that protection against reinfections wanes after 6 months. Some investigations indicate that protection against reinfection is lowest 4-5 months after initial infection and increases thereafter, a finding that might hypothetically be explained by persistent viral shedding; that is, misclassification of prolonged SARS-CoV-2 infections as reinfections. While no comparison was made against information pertaining to unvaccinated, not previously-infected individuals, preliminary data from Israel suggest that protection from reinfection can decrease from 6 to more than 12 months after the first SARS-CoV-2 infection. Taken together, epidemiologic studies indicate that protection against reinfections by natural immunity lasts over 1 year with only moderate, if any, decline over this period. Among older individuals, immunocompromised patients, and those with certain comorbidities or exposure risk (for example, health care workers), rates of reinfection may be higher. It is plausible that reinfection risk may be a function of exposure risk.
There is accumulating evidence that reinfections may be significantly less severe than primary infections with SARS-CoV-2. Reduced clinical severity of SARS-CoV-2 reinfections naturally also makes sense from a biologic point of view, inasmuch as a previously primed immune system should be better prepared for a rechallenge with this virus.
Vaccine-induced immunity
The short-term (<4 months) efficacy of mRNA vaccines against SARS-CoV-2 is high and varies from 94.1% (Moderna) to 95% (BioNTech/Pfizer). This has been confirmed by randomized controlled trials and was subsequently confirmed in effectiveness studies in real-world settings. Waning efficacy was observed with respect to protection against SARS-CoV-2 infections (for example, only approximately 20% after about half a year in Qatar), whereas protection against severe disease was either sustained or showed only a moderate decline.
In individuals who received two doses of the BioNTech/Pfizer vaccine at least 5 months earlier, an additional vaccine dose, a so-called booster, significantly lowered mortality and severe illness. These findings suggest that the booster restored and probably exceeded the initial short-term efficacy of the initial vaccination.
Data are still emerging regarding the efficacy of boosters against the Omicron variants. Preliminary data suggest a far lower ability to restore protection from infection and vaccination. However, fatalities and hospitalizations remain low.
Natural immunity vs. vaccine-induced immunity
Comparisons of natural immunity with vaccine-induced immunity are complicated by a series of biases and by combinations of biases – for example, the biases of comparisons between infected and uninfected, plus the biases of comparisons between vaccinated and nonvaccinated, with strong potential selection biases and confounding. Of particular note, the proportion of people previously infected and/or vaccinated may influence estimates of effectiveness. Regarding this point, one study compared unvaccinated patients with a prior SARS-CoV-2 infection and vaccinated individuals followed up from a week after the second vaccine dose onward versus a group of unvaccinated, not previously infected individuals. The findings showed that, compared with unvaccinated, not previously infected individuals, the natural immunity group and the vaccinated group had similar protection of 94.8% and 92.8% against infection, of 94.1% and 94.2% against hospitalization, and of 96.4% and 94.4% against severe illness, respectively.
Hybrid immunity
The combination of a previous SARS-CoV-2 infection and a respective vaccination is called hybrid immunity. This combination seems to confer the greatest protection against SARS-CoV-2 infections, but several knowledge gaps remain regarding this issue.
Data from Israel showed that, when the time since the last immunity-conferring event (either primary infection or vaccination) was the same, the rates of SARS-CoV-2 infections were similar in the following groups: individuals who had a previous infection and no vaccination, individuals who had an infection and were then vaccinated with a single dose after at least 3 months, and individuals who were vaccinated (two doses) and then infected. Severe disease was relatively rare overall.
Data on the efficacy of hybrid immunity point in the direction of hybrid immunity being superior, as compared with either vaccine-induced (without a booster) immunity or natural immunity alone. Timing and mode of vaccination of previously infected individuals to achieve optimal hybrid immunity are central questions that remain to be addressed in future studies.
Given that vaccination rates are continuously increasing and that, by the beginning of 2022, perhaps half or more of the global population had already been infected with SARS-CoV-2, with the vast majority of this group not being officially detected, it would appear logical that future infection waves, even with highly transmissible variants of SARS-CoV-2, may be limited with respect to their maximum potential health burden. The advent of Omicron suggests that massive surges can occur even in populations with extremely high rates of previous vaccination and variable rates of prior infections. However, even then, the accompanying burden of hospitalizations and deaths is far less than what was seen in 2020 and 2021. One may argue that the pandemic has already transitioned to the endemic phase and that Omicron is an endemic wave occurring in the setting of already widespread population immunity.
A version of this article first appeared on Medscape.com.
‘Profound implications’: COVID ups diabetes risk 40% a year later
COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.
“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.
“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.
The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.
There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.
The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.
The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.
Millions more with new diabetes as late manifestation of COVID-19
“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.
“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.
“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.
Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”
Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.
However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
Diabetes risk significantly increased after COVID-19 in all analyses
The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.
Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.
Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.
Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.
The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.
Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.
They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”
Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.”
Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.
“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.
“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.
The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.
There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.
The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.
The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.
Millions more with new diabetes as late manifestation of COVID-19
“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.
“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.
“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.
Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”
Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.
However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
Diabetes risk significantly increased after COVID-19 in all analyses
The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.
Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.
Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.
Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.
The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.
Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.
They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”
Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.”
Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
COVID-19 infection appears to significantly raise the risk for diabetes by about 40% at 1 year, indicate new data from a very large Veterans Administration population.
“If patients have a prior history of COVID-19, that’s a risk factor for diabetes and they should certainly be screened for diabetes,” study coauthor Ziyad Al-Aly, MD, a nephrologist and chief of research and development at VA St. Louis Health Care, told this news organization.
“It’s still premature to make guidelines. I think we have to process the data landscape to understand what this all really means, but it’s really, really clear that all these roads are pointing in one direction, that COVID-19 increases the risk of diabetes up to a year later. The risk is small but not negligible,” he said.
The database includes over 8 million people and 180,000 with a prior COVID-19 diagnosis. Significantly increased diabetes risks compared to those not infected ranging from 31% to more than double were found in an analysis of subgroups based on diabetes risk score, body mass index, age, race, prediabetes status, and deprivation level, even after adjustment for confounding factors.
There was a gradient of diabetes risk by COVID-19 severity – i.e., whether patients had not been hospitalized, had been hospitalized, or stayed in intensive care – but a significant excess diabetes burden was seen even among those with “mild” COVID-19. The diabetes risk was also elevated compared to both contemporary and historical controls.
The study was published March 21 in The Lancet Diabetes & Endocrinology, by Yan Xie, MPH, also of VA St Louis Health Care, along with Dr. Al-Aly.
The data align with those from another study just published from a nationwide German primary care database. That study was smaller and of shorter duration than the new VA study but consistent, said Dr. Al-Aly, a clinical epidemiologist at Washington University, St. Louis.
Millions more with new diabetes as late manifestation of COVID-19
“Millions of people in the U.S. have had COVID-19, so this is going to translate to literally millions more people with new-onset diabetes. Better to identify them early so they can be adequately treated,” Dr. Al-Aly said in an interview.
“The long-term implications of SARS-CoV-2 infection increasing diabetes risk are profound,” Venkat Narayan, MD, and Lisa R. Staimez, PhD, both of the Rollins School of Public Health and Emory Global Diabetes Research Center at Emory University, Atlanta, said in an accompanying editorial.
“With large and growing numbers of people worldwide infected with SARS-CoV-2 (434,154,739 cumulative cases by Feb. 28, 2022), any COVID-19-related increases in diabetes incidence could lead to unprecedented cases of diabetes worldwide – wreaking havoc on already over-stretched and under-resourced clinical and public health systems globally, with devastating tolls in terms of deaths and suffering,” they added.
Medscape Medical News contributor Eric Topol MD, of Scripps Research Institute, La Jolla, Calif., agrees. He said these new data “are most profound. The researchers found a 40% increase in diabetes that wasn’t present at 1 month after COVID-19 but at 1 year, it was. Some kind of late manifestation is happening here.”
Dr. Al-Aly told this news organization that the mechanisms for the association are unknown and likely to be heterogeneous. Among the people who already had risk factors for type 2 diabetes, such as obesity or metabolic syndrome, SARS-CoV-2 could simply accelerate that process and “put them over the edge” to overt diabetes.
However, for those without diabetes risk factors, “COVID-19 with all the inflammation it provokes in the body could be leading to de novo disease.” (Diabetes status was ascertained by ICD-10 codes and only about 0.70% of the total were recorded as type 1 diabetes. But, since autoantibody testing wasn’t routinely conducted, it’s unknown how many of the cases may have been type 1 misclassified as type 2, Dr. Al-Aly acknowledged.)
Diabetes risk significantly increased after COVID-19 in all analyses
The analysis included 181,280 patients in the U.S. Department of Veterans Affairs health care database with a COVID-19 diagnosis who survived for at least 30 days afterward during March 2020 through Sept. 30, 2021, with 4,118,441 contemporary controls without COVID-19 seen during 2019, and a historical control group of 4,286,911 people seen at the VA in 2017. Average follow-up was about a year.
Compared with the contemporary controls, the COVID-19 group had an excess diabetes burden of 13.46 per 1,000 person-years with a hazard ratio of 1.40. They had an increased 12.35 per 1,000 person-year risk for incident use of glucose-lowering medications, with a hazard ratio of 1.85. Similar results were seen with the historical controls.
Subgroup analyses showed an increased risk for diabetes following COVID-19 infection by age (≤ 65 years and > 65 years), race (White and Black), sex (male and female), BMI categories (> 18.5 to ≤ 25 kg/m², > 25 to ≤ 30 kg/m², and > 30 kg/m²), and area deprivation index quartiles. The increased risk was also seen across diabetes risk score quartiles.
Notably, COVID-19 significantly elevated the diabetes risk by 59% even for the subgroup with BMI between 18 and 25 kg/m², and by 38% among those with the lowest diabetes risk score quartile.
The COVID-19 population included 162,096 who were not hospitalized, 15,078 hospitalized, and 4,106 admitted to intensive care. Here, the hazard ratios for diabetes compared to the contemporary controls were 1.25, 2.73, and 3.76, respectively, all significant.
Dr. Al-Aly said that his group is now further analyzing the VA data for other outcomes including cardiovascular disease and kidney disease, as well as the now well-documented long COVID symptoms including fatigue, pain, and neurocognitive dysfunction.
They’re also investigating the impact of the COVID-19 vaccine to see whether the risks are mitigated in the case of breakthrough infections: “We’re doing a broad systematic assessment. The next paper will be more comprehensive.”
Dr. Narayan and Dr. Staimez wrote: “The potential connection between COVID-19 and diabetes highlights that infectious diseases (eg, SARS-CoV-2) and chronic diseases (eg, diabetes) cannot be viewed in siloes. When we emerge out of the pandemic, the much-neglected non-communicable diseases, such as type 2 diabetes, will continue their relentless trajectory, possibly in an accelerated manner, as the leading burdens of global health.”
Dr. Al-Aly declared support from the U.S. Department of Veterans Affairs for the submitted work. He has received consultation fees from Gilead Sciences and funding (unrelated to this work) from Tonix Pharmaceuticals. He is a member of the board of directors for Veterans Research and Education Foundation of Saint Louis, associate editor for the Journal of the American Society of Nephrology, and a member of multiple editorial boards. Dr. Narayan and Dr. Staimez have received support from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
FROM THE LANCET DIABETES & ENDOCRINOLOGY
FDA approves new immunotherapy combo for metastatic melanoma
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
Yes, Russian docs should be shut out of medical associations, says ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
‘It’s about transparency’: Indiana law prohibits misleading medical titles
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
U.S. health officials tracking COVID-19 increase in U.K.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
Trial gives new guidance for choosing initial PsA treatment
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.
The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.
“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.
The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.
“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.
Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.
The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.
The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”
The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.
Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).
Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.
Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.
The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”
The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.
A version of this article first appeared on Medscape.com.
FROM THE LANCET RHEUMATOLOGY
Adverse skin effects of cancer immunotherapy reviewed
Immune checkpoint inhibitors (ICIs) have unquestionably revolutionized the care of patients with malignant melanoma, non-small cell lung cancer, and other types of cancer.
“The desirable, immune-mediated oncologic response is often achieved at the cost of immune-related adverse events (irAEs) that may potentially affect any organ system,” they write in a position statement on the management of ICI-derived dermatologic adverse events.
Recommendations from the EADV “Dermatology for Cancer Patients” task force have been published in the Journal of the European Academy of Dermatology and Venereology.
Task force members developed the recommendations based on clinical experience from published data and came up with specific recommendations for treating cutaneous toxicities associated with dermatologic immune-related adverse events (dirAEs) that occur in patients receiving immunotherapy with an ICI.
ICIs include the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab (Yervoy, Bristol Myers Squibb), and inhibitors of programmed death protein 1 (PD-1) and its ligand (PD-L1), including nivolumab (Opdivo, Bristol Myers Squibb), pembrolizumab (Keytruda, Merck), and other agents.
“The basic principle of management is that the interventions should be tailored to serve the equilibrium between patients’ relief from the symptoms and signs of skin toxicity and the preservation of an unimpeded oncologic treatment,” they write.
The recommendations are in line with those included in a 2021 update of the American Society of Clinical Oncology (ASCO) guidelines on the management of irAEs in patients treated with ICIs across the whole range of organ systems, said Milan J. Anadkat, MD, professor of dermatology and director of dermatology clinical trials at Washington University School of Medicine, St. Louis. Dr. Anadkat was a coauthor of the ASCO guideline update.
Although the European recommendations focus only on dermatologic side effects of ICIs in patients with cancer, “that doesn’t diminish their importance. They do a good job of summarizing how to approach and how to manage it depending on the severity of the toxicities and the various types of toxicities,” he told this news organization.
Having a paper focused exclusively on the dermatologic side effects of ICIs allows the inclusion of photographs that can help clinicians identify specific conditions that may require referral to a dermatologist, he said.
Both Dr. Anadkat and the authors of the European recommendations noted that dermatologic irAEs are more common with CTLA-4 inhibition than with PD-1/PD-L1 inhibition.
“It has to do with where the target is,” Dr. Anadkat said. “CTLA-4 inhibition works on a central aspect of the immune system, so it’s a much less specific site, whereas PD-1 affects an interaction at the site of the tumor cell itself, so it’s a little more specific.”
Pruritus
ICI-induced pruritus can occur without apparent skin changes, they write, noting that in a recent study of patients with dirAEs, about one-third had isolated pruritus.
The task force members cite a meta-analysis indicating a pruritus incidence of 13.2% for patients treated with nivolumab and 20.2% for patients treated with pembrolizumab but respective grade 3 pruritus rates of only 0.5% and 2.3%. The reported incidence of pruritus with ipilimumab was 47% in a different study.
Recommended treatments include topical moisturizers with or without medium-to-high potency corticosteroids for grade 1 reactions, non-sedating histamines and/or GABA agonists such as pregabalin, or gabapentin for grade 2 pruritus, and suspension of ICIs until pruritus improves in patients with grade 3 pruritus.
Maculopapular rash
Maculopapular or eczema-like rashes may occur in up to 68% of patients who receive a CTLA-4 inhibitor and up to 20% of those who receive a PD1/PD-L1 inhibitor, the authors note. Rashes commonly appear within 3-6 weeks of initiating therapy.
“The clinical presentation is nonspecific and consists of a rapid onset of multiple minimally scaly, erythematous macules and papules, congregating into plaques. Lesions are mostly located on trunk and extensor surfaces of the extremities and the face is generally spared,” they write.
Maculopapular rashes are typically accompanied by itching but could be asymptomatic, they noted.
Mild (grade 1) rashes may respond to moisturizers and topical potent or super-potent corticosteroids. Patients with grade 2 rash should also receive oral antihistamines. Systemic corticosteroids may be considered for patients with grade 3 rashes but only after other dirAEs that may require specific management, such as psoriasis, are ruled out.
Psoriasis-like rash
The most common form of psoriasis seen in patients treated with ICIs is psoriasis vulgaris with plaques, but other clinical variants are also seen, the authors note.
“Topical agents (corticosteroids, Vitamin D analogues) are prescribed in Grades 1/2 and supplementary” to systemic treatment for patients with grade 3 or recalcitrant lesions, they write. “If skin-directed therapies fail to provide symptomatic control,” systemic treatment and narrow band UVB phototherapy “should be considered,” they add.
Evidence regarding the use of systemic therapies to treat psoriasis-like rash associated with ICIs is sparse. Acitretin can be safely used in patients with cancer. Low-dose methotrexate is also safe to use except in patients with non-melanoma skin cancers. Cyclosporine, however, should be avoided because of the potential for tumor-promoting effects, they emphasized.
The recommendations also cover treatment of lichen planus-like and vitiligo-like rashes, as well as hair and nail changes, autoimmune bullous disorders, and oral mucosal dirAEs.
In addition, the recommendations cover severe cutaneous adverse reactions as well as serious, potentially life-threatening dirAEs, including Stevens-Johnson syndrome/TEN, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome (DRESS/DIHS).
“The dose of corticosteroids may be adapted to the severity of DRESS. The therapeutic benefit of systemic corticosteroids in the management of SJS/TEN remains controversial, and some authors favor treatment with cyclosporine. However, the use of corticosteroids in this context of ICI treatment appears reasonable and should be proposed. Short courses of steroids seem also effective in AGEP,” the task force members write.
The recommendations did not have outside funding. Of the 19 authors, 6 disclosed relationships with various pharmaceutical companies, including AbbVie, Leo Pharma, Boehringer Ingelheim, Bristol Myers Squibb, and/or Janssen. Dr. Anadkat disclosed previous relationships with Merck, Bristol Myers Squibb, and current relationships with others.
A version of this article first appeared on Medscape.com.
Immune checkpoint inhibitors (ICIs) have unquestionably revolutionized the care of patients with malignant melanoma, non-small cell lung cancer, and other types of cancer.
“The desirable, immune-mediated oncologic response is often achieved at the cost of immune-related adverse events (irAEs) that may potentially affect any organ system,” they write in a position statement on the management of ICI-derived dermatologic adverse events.
Recommendations from the EADV “Dermatology for Cancer Patients” task force have been published in the Journal of the European Academy of Dermatology and Venereology.
Task force members developed the recommendations based on clinical experience from published data and came up with specific recommendations for treating cutaneous toxicities associated with dermatologic immune-related adverse events (dirAEs) that occur in patients receiving immunotherapy with an ICI.
ICIs include the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab (Yervoy, Bristol Myers Squibb), and inhibitors of programmed death protein 1 (PD-1) and its ligand (PD-L1), including nivolumab (Opdivo, Bristol Myers Squibb), pembrolizumab (Keytruda, Merck), and other agents.
“The basic principle of management is that the interventions should be tailored to serve the equilibrium between patients’ relief from the symptoms and signs of skin toxicity and the preservation of an unimpeded oncologic treatment,” they write.
The recommendations are in line with those included in a 2021 update of the American Society of Clinical Oncology (ASCO) guidelines on the management of irAEs in patients treated with ICIs across the whole range of organ systems, said Milan J. Anadkat, MD, professor of dermatology and director of dermatology clinical trials at Washington University School of Medicine, St. Louis. Dr. Anadkat was a coauthor of the ASCO guideline update.
Although the European recommendations focus only on dermatologic side effects of ICIs in patients with cancer, “that doesn’t diminish their importance. They do a good job of summarizing how to approach and how to manage it depending on the severity of the toxicities and the various types of toxicities,” he told this news organization.
Having a paper focused exclusively on the dermatologic side effects of ICIs allows the inclusion of photographs that can help clinicians identify specific conditions that may require referral to a dermatologist, he said.
Both Dr. Anadkat and the authors of the European recommendations noted that dermatologic irAEs are more common with CTLA-4 inhibition than with PD-1/PD-L1 inhibition.
“It has to do with where the target is,” Dr. Anadkat said. “CTLA-4 inhibition works on a central aspect of the immune system, so it’s a much less specific site, whereas PD-1 affects an interaction at the site of the tumor cell itself, so it’s a little more specific.”
Pruritus
ICI-induced pruritus can occur without apparent skin changes, they write, noting that in a recent study of patients with dirAEs, about one-third had isolated pruritus.
The task force members cite a meta-analysis indicating a pruritus incidence of 13.2% for patients treated with nivolumab and 20.2% for patients treated with pembrolizumab but respective grade 3 pruritus rates of only 0.5% and 2.3%. The reported incidence of pruritus with ipilimumab was 47% in a different study.
Recommended treatments include topical moisturizers with or without medium-to-high potency corticosteroids for grade 1 reactions, non-sedating histamines and/or GABA agonists such as pregabalin, or gabapentin for grade 2 pruritus, and suspension of ICIs until pruritus improves in patients with grade 3 pruritus.
Maculopapular rash
Maculopapular or eczema-like rashes may occur in up to 68% of patients who receive a CTLA-4 inhibitor and up to 20% of those who receive a PD1/PD-L1 inhibitor, the authors note. Rashes commonly appear within 3-6 weeks of initiating therapy.
“The clinical presentation is nonspecific and consists of a rapid onset of multiple minimally scaly, erythematous macules and papules, congregating into plaques. Lesions are mostly located on trunk and extensor surfaces of the extremities and the face is generally spared,” they write.
Maculopapular rashes are typically accompanied by itching but could be asymptomatic, they noted.
Mild (grade 1) rashes may respond to moisturizers and topical potent or super-potent corticosteroids. Patients with grade 2 rash should also receive oral antihistamines. Systemic corticosteroids may be considered for patients with grade 3 rashes but only after other dirAEs that may require specific management, such as psoriasis, are ruled out.
Psoriasis-like rash
The most common form of psoriasis seen in patients treated with ICIs is psoriasis vulgaris with plaques, but other clinical variants are also seen, the authors note.
“Topical agents (corticosteroids, Vitamin D analogues) are prescribed in Grades 1/2 and supplementary” to systemic treatment for patients with grade 3 or recalcitrant lesions, they write. “If skin-directed therapies fail to provide symptomatic control,” systemic treatment and narrow band UVB phototherapy “should be considered,” they add.
Evidence regarding the use of systemic therapies to treat psoriasis-like rash associated with ICIs is sparse. Acitretin can be safely used in patients with cancer. Low-dose methotrexate is also safe to use except in patients with non-melanoma skin cancers. Cyclosporine, however, should be avoided because of the potential for tumor-promoting effects, they emphasized.
The recommendations also cover treatment of lichen planus-like and vitiligo-like rashes, as well as hair and nail changes, autoimmune bullous disorders, and oral mucosal dirAEs.
In addition, the recommendations cover severe cutaneous adverse reactions as well as serious, potentially life-threatening dirAEs, including Stevens-Johnson syndrome/TEN, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome (DRESS/DIHS).
“The dose of corticosteroids may be adapted to the severity of DRESS. The therapeutic benefit of systemic corticosteroids in the management of SJS/TEN remains controversial, and some authors favor treatment with cyclosporine. However, the use of corticosteroids in this context of ICI treatment appears reasonable and should be proposed. Short courses of steroids seem also effective in AGEP,” the task force members write.
The recommendations did not have outside funding. Of the 19 authors, 6 disclosed relationships with various pharmaceutical companies, including AbbVie, Leo Pharma, Boehringer Ingelheim, Bristol Myers Squibb, and/or Janssen. Dr. Anadkat disclosed previous relationships with Merck, Bristol Myers Squibb, and current relationships with others.
A version of this article first appeared on Medscape.com.
Immune checkpoint inhibitors (ICIs) have unquestionably revolutionized the care of patients with malignant melanoma, non-small cell lung cancer, and other types of cancer.
“The desirable, immune-mediated oncologic response is often achieved at the cost of immune-related adverse events (irAEs) that may potentially affect any organ system,” they write in a position statement on the management of ICI-derived dermatologic adverse events.
Recommendations from the EADV “Dermatology for Cancer Patients” task force have been published in the Journal of the European Academy of Dermatology and Venereology.
Task force members developed the recommendations based on clinical experience from published data and came up with specific recommendations for treating cutaneous toxicities associated with dermatologic immune-related adverse events (dirAEs) that occur in patients receiving immunotherapy with an ICI.
ICIs include the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab (Yervoy, Bristol Myers Squibb), and inhibitors of programmed death protein 1 (PD-1) and its ligand (PD-L1), including nivolumab (Opdivo, Bristol Myers Squibb), pembrolizumab (Keytruda, Merck), and other agents.
“The basic principle of management is that the interventions should be tailored to serve the equilibrium between patients’ relief from the symptoms and signs of skin toxicity and the preservation of an unimpeded oncologic treatment,” they write.
The recommendations are in line with those included in a 2021 update of the American Society of Clinical Oncology (ASCO) guidelines on the management of irAEs in patients treated with ICIs across the whole range of organ systems, said Milan J. Anadkat, MD, professor of dermatology and director of dermatology clinical trials at Washington University School of Medicine, St. Louis. Dr. Anadkat was a coauthor of the ASCO guideline update.
Although the European recommendations focus only on dermatologic side effects of ICIs in patients with cancer, “that doesn’t diminish their importance. They do a good job of summarizing how to approach and how to manage it depending on the severity of the toxicities and the various types of toxicities,” he told this news organization.
Having a paper focused exclusively on the dermatologic side effects of ICIs allows the inclusion of photographs that can help clinicians identify specific conditions that may require referral to a dermatologist, he said.
Both Dr. Anadkat and the authors of the European recommendations noted that dermatologic irAEs are more common with CTLA-4 inhibition than with PD-1/PD-L1 inhibition.
“It has to do with where the target is,” Dr. Anadkat said. “CTLA-4 inhibition works on a central aspect of the immune system, so it’s a much less specific site, whereas PD-1 affects an interaction at the site of the tumor cell itself, so it’s a little more specific.”
Pruritus
ICI-induced pruritus can occur without apparent skin changes, they write, noting that in a recent study of patients with dirAEs, about one-third had isolated pruritus.
The task force members cite a meta-analysis indicating a pruritus incidence of 13.2% for patients treated with nivolumab and 20.2% for patients treated with pembrolizumab but respective grade 3 pruritus rates of only 0.5% and 2.3%. The reported incidence of pruritus with ipilimumab was 47% in a different study.
Recommended treatments include topical moisturizers with or without medium-to-high potency corticosteroids for grade 1 reactions, non-sedating histamines and/or GABA agonists such as pregabalin, or gabapentin for grade 2 pruritus, and suspension of ICIs until pruritus improves in patients with grade 3 pruritus.
Maculopapular rash
Maculopapular or eczema-like rashes may occur in up to 68% of patients who receive a CTLA-4 inhibitor and up to 20% of those who receive a PD1/PD-L1 inhibitor, the authors note. Rashes commonly appear within 3-6 weeks of initiating therapy.
“The clinical presentation is nonspecific and consists of a rapid onset of multiple minimally scaly, erythematous macules and papules, congregating into plaques. Lesions are mostly located on trunk and extensor surfaces of the extremities and the face is generally spared,” they write.
Maculopapular rashes are typically accompanied by itching but could be asymptomatic, they noted.
Mild (grade 1) rashes may respond to moisturizers and topical potent or super-potent corticosteroids. Patients with grade 2 rash should also receive oral antihistamines. Systemic corticosteroids may be considered for patients with grade 3 rashes but only after other dirAEs that may require specific management, such as psoriasis, are ruled out.
Psoriasis-like rash
The most common form of psoriasis seen in patients treated with ICIs is psoriasis vulgaris with plaques, but other clinical variants are also seen, the authors note.
“Topical agents (corticosteroids, Vitamin D analogues) are prescribed in Grades 1/2 and supplementary” to systemic treatment for patients with grade 3 or recalcitrant lesions, they write. “If skin-directed therapies fail to provide symptomatic control,” systemic treatment and narrow band UVB phototherapy “should be considered,” they add.
Evidence regarding the use of systemic therapies to treat psoriasis-like rash associated with ICIs is sparse. Acitretin can be safely used in patients with cancer. Low-dose methotrexate is also safe to use except in patients with non-melanoma skin cancers. Cyclosporine, however, should be avoided because of the potential for tumor-promoting effects, they emphasized.
The recommendations also cover treatment of lichen planus-like and vitiligo-like rashes, as well as hair and nail changes, autoimmune bullous disorders, and oral mucosal dirAEs.
In addition, the recommendations cover severe cutaneous adverse reactions as well as serious, potentially life-threatening dirAEs, including Stevens-Johnson syndrome/TEN, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome (DRESS/DIHS).
“The dose of corticosteroids may be adapted to the severity of DRESS. The therapeutic benefit of systemic corticosteroids in the management of SJS/TEN remains controversial, and some authors favor treatment with cyclosporine. However, the use of corticosteroids in this context of ICI treatment appears reasonable and should be proposed. Short courses of steroids seem also effective in AGEP,” the task force members write.
The recommendations did not have outside funding. Of the 19 authors, 6 disclosed relationships with various pharmaceutical companies, including AbbVie, Leo Pharma, Boehringer Ingelheim, Bristol Myers Squibb, and/or Janssen. Dr. Anadkat disclosed previous relationships with Merck, Bristol Myers Squibb, and current relationships with others.
A version of this article first appeared on Medscape.com.
COVID-19–alopecia areata link? Review doesn’t find much evidence
A new
If there is a connection, it’s likely not a strong one, said study author Rachel E. Christensen, a graduate student at Rutgers Robert Wood Johnson Medical School, in an interview. “Based on the reported number of cases following COVID-19, alopecia areata appears to be low on the list of common skin manifestations of COVID-19,” she said. Of 402 articles screened from three databases in the review, only 11 were identified as related to alopecia areata (AA) and COVID-19, and only 9 of those met the study inclusion criteria. “This number alone highlights the very low number of published articles investigating this connection.”
The review was published in JAAD International.
While COVID-19 has been linked to a variety of skin conditions, a 2021 South Korean study of 7,958 cases and 218,779 controls found no connection between infection and AA even after covariates such as age, gender, and income level were taken into account. In a letter to the editor published in 2020, dermatologists in Turkey reported that the percentage of patients with AA at the dermatology outpatient clinic jumped from 0.97% in May 2019 to 1.48% in May 2020. The number of patients in each group wasn’t reported.
Systematic review
The investigators launched the systematic review to gain a wider perspective, although there are still limitations. On the one hand, Ms. Christensen said, “we do know that COVID-19, like other viruses, has been linked to various dermatological disorders.”
However, “it is difficult to tease apart whether any worsening of alopecia areata we see following COVID-19 is due to the virus itself or the increased psychological burden related to the infection or to the pandemic in general,” she said. Indeed, the authors of the report in Turkey attributed the rise in cases to stress.
For the review, the researchers analyzed studies from Italy (four), Turkey (two), Brazil (one), the United States (one), and Poland (one).
Six of the studies reported cases of new-onset AA following COVID-19 infection (seven cases; average age, 37 years; females, three). Another study was a retrospective review of 32 patients with preexisting AA who developed COVID-19; none experienced significant worsening of AA within 6 months.
The review also included a study based on a survey of 389 patients with AA. The investigators found that, at a median 2.14 months after infection, 44% of those who had COVID-19 vs. 12% of those who were COVID negative had a relapse. Finally, a case report noted a patient with preexisting AA whose condition worsened following COVID infection.
The findings suggest that AA “could be a dermatological manifestation of COVID-19, with cases most often appearing 1-2 months following infection,” the authors wrote. “However, the heterogeneity of study designs and high proportion of case reports make it challenging to draw any conclusion.”
In an interview, dermatologist Brett King, MD, PhD, of the department of dermatology, Yale University, New Haven, Conn., said the review findings suggest that “there is little concern of alopecia areata following COVID infection.
Does new-onset AA happen, and are there exacerbations of preexisting disease related to COVID infection? Probably yes, but rarely.”
However, he noted that another form of alopecia, telogen effluvium (TE), is more common after COVID-19 infection. According to Dr. King, who was not involved with the systematic review, TE is typically time-limited, compared with AA’s more common chronic waxing-and-waning course.
“Distinguishing TE and AA is usually straightforward because AA typically presents with well-circumscribed patches of hair loss,” such as circular patches, “while TE manifests as diffuse hair loss,” he explained. “Rarely, however, AA does manifest diffuse hair loss without patches, similar to TE. In those cases, it may be difficult to distinguish them. A biopsy may be helpful if there is a question of the diagnosis.”
No study funding is reported. The review authors and Dr. King report no relevant disclosures.
A new
If there is a connection, it’s likely not a strong one, said study author Rachel E. Christensen, a graduate student at Rutgers Robert Wood Johnson Medical School, in an interview. “Based on the reported number of cases following COVID-19, alopecia areata appears to be low on the list of common skin manifestations of COVID-19,” she said. Of 402 articles screened from three databases in the review, only 11 were identified as related to alopecia areata (AA) and COVID-19, and only 9 of those met the study inclusion criteria. “This number alone highlights the very low number of published articles investigating this connection.”
The review was published in JAAD International.
While COVID-19 has been linked to a variety of skin conditions, a 2021 South Korean study of 7,958 cases and 218,779 controls found no connection between infection and AA even after covariates such as age, gender, and income level were taken into account. In a letter to the editor published in 2020, dermatologists in Turkey reported that the percentage of patients with AA at the dermatology outpatient clinic jumped from 0.97% in May 2019 to 1.48% in May 2020. The number of patients in each group wasn’t reported.
Systematic review
The investigators launched the systematic review to gain a wider perspective, although there are still limitations. On the one hand, Ms. Christensen said, “we do know that COVID-19, like other viruses, has been linked to various dermatological disorders.”
However, “it is difficult to tease apart whether any worsening of alopecia areata we see following COVID-19 is due to the virus itself or the increased psychological burden related to the infection or to the pandemic in general,” she said. Indeed, the authors of the report in Turkey attributed the rise in cases to stress.
For the review, the researchers analyzed studies from Italy (four), Turkey (two), Brazil (one), the United States (one), and Poland (one).
Six of the studies reported cases of new-onset AA following COVID-19 infection (seven cases; average age, 37 years; females, three). Another study was a retrospective review of 32 patients with preexisting AA who developed COVID-19; none experienced significant worsening of AA within 6 months.
The review also included a study based on a survey of 389 patients with AA. The investigators found that, at a median 2.14 months after infection, 44% of those who had COVID-19 vs. 12% of those who were COVID negative had a relapse. Finally, a case report noted a patient with preexisting AA whose condition worsened following COVID infection.
The findings suggest that AA “could be a dermatological manifestation of COVID-19, with cases most often appearing 1-2 months following infection,” the authors wrote. “However, the heterogeneity of study designs and high proportion of case reports make it challenging to draw any conclusion.”
In an interview, dermatologist Brett King, MD, PhD, of the department of dermatology, Yale University, New Haven, Conn., said the review findings suggest that “there is little concern of alopecia areata following COVID infection.
Does new-onset AA happen, and are there exacerbations of preexisting disease related to COVID infection? Probably yes, but rarely.”
However, he noted that another form of alopecia, telogen effluvium (TE), is more common after COVID-19 infection. According to Dr. King, who was not involved with the systematic review, TE is typically time-limited, compared with AA’s more common chronic waxing-and-waning course.
“Distinguishing TE and AA is usually straightforward because AA typically presents with well-circumscribed patches of hair loss,” such as circular patches, “while TE manifests as diffuse hair loss,” he explained. “Rarely, however, AA does manifest diffuse hair loss without patches, similar to TE. In those cases, it may be difficult to distinguish them. A biopsy may be helpful if there is a question of the diagnosis.”
No study funding is reported. The review authors and Dr. King report no relevant disclosures.
A new
If there is a connection, it’s likely not a strong one, said study author Rachel E. Christensen, a graduate student at Rutgers Robert Wood Johnson Medical School, in an interview. “Based on the reported number of cases following COVID-19, alopecia areata appears to be low on the list of common skin manifestations of COVID-19,” she said. Of 402 articles screened from three databases in the review, only 11 were identified as related to alopecia areata (AA) and COVID-19, and only 9 of those met the study inclusion criteria. “This number alone highlights the very low number of published articles investigating this connection.”
The review was published in JAAD International.
While COVID-19 has been linked to a variety of skin conditions, a 2021 South Korean study of 7,958 cases and 218,779 controls found no connection between infection and AA even after covariates such as age, gender, and income level were taken into account. In a letter to the editor published in 2020, dermatologists in Turkey reported that the percentage of patients with AA at the dermatology outpatient clinic jumped from 0.97% in May 2019 to 1.48% in May 2020. The number of patients in each group wasn’t reported.
Systematic review
The investigators launched the systematic review to gain a wider perspective, although there are still limitations. On the one hand, Ms. Christensen said, “we do know that COVID-19, like other viruses, has been linked to various dermatological disorders.”
However, “it is difficult to tease apart whether any worsening of alopecia areata we see following COVID-19 is due to the virus itself or the increased psychological burden related to the infection or to the pandemic in general,” she said. Indeed, the authors of the report in Turkey attributed the rise in cases to stress.
For the review, the researchers analyzed studies from Italy (four), Turkey (two), Brazil (one), the United States (one), and Poland (one).
Six of the studies reported cases of new-onset AA following COVID-19 infection (seven cases; average age, 37 years; females, three). Another study was a retrospective review of 32 patients with preexisting AA who developed COVID-19; none experienced significant worsening of AA within 6 months.
The review also included a study based on a survey of 389 patients with AA. The investigators found that, at a median 2.14 months after infection, 44% of those who had COVID-19 vs. 12% of those who were COVID negative had a relapse. Finally, a case report noted a patient with preexisting AA whose condition worsened following COVID infection.
The findings suggest that AA “could be a dermatological manifestation of COVID-19, with cases most often appearing 1-2 months following infection,” the authors wrote. “However, the heterogeneity of study designs and high proportion of case reports make it challenging to draw any conclusion.”
In an interview, dermatologist Brett King, MD, PhD, of the department of dermatology, Yale University, New Haven, Conn., said the review findings suggest that “there is little concern of alopecia areata following COVID infection.
Does new-onset AA happen, and are there exacerbations of preexisting disease related to COVID infection? Probably yes, but rarely.”
However, he noted that another form of alopecia, telogen effluvium (TE), is more common after COVID-19 infection. According to Dr. King, who was not involved with the systematic review, TE is typically time-limited, compared with AA’s more common chronic waxing-and-waning course.
“Distinguishing TE and AA is usually straightforward because AA typically presents with well-circumscribed patches of hair loss,” such as circular patches, “while TE manifests as diffuse hair loss,” he explained. “Rarely, however, AA does manifest diffuse hair loss without patches, similar to TE. In those cases, it may be difficult to distinguish them. A biopsy may be helpful if there is a question of the diagnosis.”
No study funding is reported. The review authors and Dr. King report no relevant disclosures.
FROM JAAD INTERNATIONAL
‘We don’t want to be an inspiration’
Over 2.5 million people have fled the ghastly war in Ukraine for safety. But, not everyone is trying to leave. Shockingly, hundreds of thousands are actually flocking toward the danger in Ukraine right now. Many of them are women.
I was commuting to work when I first heard this story on a podcast. In astonishing numbers, women have chosen to return to or stay in Ukraine because they’re needed to fight and to protect their families. My reaction, like yours, was to be inspired. What amazing courage! Twitter and Instagram will swell with images of their balaclava masked faces standing in the breach once more. Like the women in medicine who armed themselves with surgical masks and face shields and babies on their backs to join the fight against COVID-19. They will be poster girls, blue sleeves rolled up and red polka dotted bandanas covering their hair.
But that’s not what they want. “We don’t want to be an inspiration,” said one fearless Ukrainian fighter in the story, “we want to be alive.”
At the time of this writing as we celebrate the brilliant accomplishments of women on March 8, International Women’s Day, I wonder if we don’t have it slightly wrong.
Although acknowledgment is appreciated, the women I work alongside don’t need me to be inspired by them. They need me to stand with them, to help them. . The “she-session” it’s been called, refers to the million women who have not rejoined the workforce since COVID-19. This is especially acute for us in medicine where women are significantly more likely than are men to report not working full time, or not working at all.
The truth is that even in 2022, the burdens of family life are still not borne equally. Bias against mothers in particular can be insidious. Take academia, where there is little sympathy for not publishing on schedule. Perhaps there are unexplained gaps, but where exactly on a CV does one put “recurrent pregnancy loss?” Do you know how many clinics or ORs a woman must cancel to attempt maddeningly unpredictable egg retrievals and embryo transfers? A lot. Not to mention the financial burden of doing so.
During the pandemic, female physicians were more likely to manage child care, schooling, and household duties, compared to male physicians.
And yet (perhaps even because of that?) women in medicine make less money. How much? About $80,000 less on average in dermatology. Inspired? Indeed. No thanks. Let’s #BreakTheBias rather.
I’m not a policy expert nor a sociologist. I don’t know what advice might be helpful here. I’d say raising our collective consciousness of the unfairness, highlighting discrepancies, and advocating for equality are good starts. But, International Women’s Day isn’t new. It’s old. Like over a hundred years old (since 1909 to be exact). We don’t just need a better hashtag, we need to do something. Give equity in pay. Offer opportunities for leadership that accommodate the extra duty women might have outside work. Create flexibility in schedules and without the penalty of having to pump at work or leave early to pick up a child. Not to mention all the opportunities we men have to do more of the household work that women currently do.
The gallant women of Ukraine don’t need our approbation. They need our aid and our prayers. Like the women in my department, at my medical center, in my community, they aren’t posing to be made into posters. There’s work to be done and they are flocking toward it right now.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Over 2.5 million people have fled the ghastly war in Ukraine for safety. But, not everyone is trying to leave. Shockingly, hundreds of thousands are actually flocking toward the danger in Ukraine right now. Many of them are women.
I was commuting to work when I first heard this story on a podcast. In astonishing numbers, women have chosen to return to or stay in Ukraine because they’re needed to fight and to protect their families. My reaction, like yours, was to be inspired. What amazing courage! Twitter and Instagram will swell with images of their balaclava masked faces standing in the breach once more. Like the women in medicine who armed themselves with surgical masks and face shields and babies on their backs to join the fight against COVID-19. They will be poster girls, blue sleeves rolled up and red polka dotted bandanas covering their hair.
But that’s not what they want. “We don’t want to be an inspiration,” said one fearless Ukrainian fighter in the story, “we want to be alive.”
At the time of this writing as we celebrate the brilliant accomplishments of women on March 8, International Women’s Day, I wonder if we don’t have it slightly wrong.
Although acknowledgment is appreciated, the women I work alongside don’t need me to be inspired by them. They need me to stand with them, to help them. . The “she-session” it’s been called, refers to the million women who have not rejoined the workforce since COVID-19. This is especially acute for us in medicine where women are significantly more likely than are men to report not working full time, or not working at all.
The truth is that even in 2022, the burdens of family life are still not borne equally. Bias against mothers in particular can be insidious. Take academia, where there is little sympathy for not publishing on schedule. Perhaps there are unexplained gaps, but where exactly on a CV does one put “recurrent pregnancy loss?” Do you know how many clinics or ORs a woman must cancel to attempt maddeningly unpredictable egg retrievals and embryo transfers? A lot. Not to mention the financial burden of doing so.
During the pandemic, female physicians were more likely to manage child care, schooling, and household duties, compared to male physicians.
And yet (perhaps even because of that?) women in medicine make less money. How much? About $80,000 less on average in dermatology. Inspired? Indeed. No thanks. Let’s #BreakTheBias rather.
I’m not a policy expert nor a sociologist. I don’t know what advice might be helpful here. I’d say raising our collective consciousness of the unfairness, highlighting discrepancies, and advocating for equality are good starts. But, International Women’s Day isn’t new. It’s old. Like over a hundred years old (since 1909 to be exact). We don’t just need a better hashtag, we need to do something. Give equity in pay. Offer opportunities for leadership that accommodate the extra duty women might have outside work. Create flexibility in schedules and without the penalty of having to pump at work or leave early to pick up a child. Not to mention all the opportunities we men have to do more of the household work that women currently do.
The gallant women of Ukraine don’t need our approbation. They need our aid and our prayers. Like the women in my department, at my medical center, in my community, they aren’t posing to be made into posters. There’s work to be done and they are flocking toward it right now.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Over 2.5 million people have fled the ghastly war in Ukraine for safety. But, not everyone is trying to leave. Shockingly, hundreds of thousands are actually flocking toward the danger in Ukraine right now. Many of them are women.
I was commuting to work when I first heard this story on a podcast. In astonishing numbers, women have chosen to return to or stay in Ukraine because they’re needed to fight and to protect their families. My reaction, like yours, was to be inspired. What amazing courage! Twitter and Instagram will swell with images of their balaclava masked faces standing in the breach once more. Like the women in medicine who armed themselves with surgical masks and face shields and babies on their backs to join the fight against COVID-19. They will be poster girls, blue sleeves rolled up and red polka dotted bandanas covering their hair.
But that’s not what they want. “We don’t want to be an inspiration,” said one fearless Ukrainian fighter in the story, “we want to be alive.”
At the time of this writing as we celebrate the brilliant accomplishments of women on March 8, International Women’s Day, I wonder if we don’t have it slightly wrong.
Although acknowledgment is appreciated, the women I work alongside don’t need me to be inspired by them. They need me to stand with them, to help them. . The “she-session” it’s been called, refers to the million women who have not rejoined the workforce since COVID-19. This is especially acute for us in medicine where women are significantly more likely than are men to report not working full time, or not working at all.
The truth is that even in 2022, the burdens of family life are still not borne equally. Bias against mothers in particular can be insidious. Take academia, where there is little sympathy for not publishing on schedule. Perhaps there are unexplained gaps, but where exactly on a CV does one put “recurrent pregnancy loss?” Do you know how many clinics or ORs a woman must cancel to attempt maddeningly unpredictable egg retrievals and embryo transfers? A lot. Not to mention the financial burden of doing so.
During the pandemic, female physicians were more likely to manage child care, schooling, and household duties, compared to male physicians.
And yet (perhaps even because of that?) women in medicine make less money. How much? About $80,000 less on average in dermatology. Inspired? Indeed. No thanks. Let’s #BreakTheBias rather.
I’m not a policy expert nor a sociologist. I don’t know what advice might be helpful here. I’d say raising our collective consciousness of the unfairness, highlighting discrepancies, and advocating for equality are good starts. But, International Women’s Day isn’t new. It’s old. Like over a hundred years old (since 1909 to be exact). We don’t just need a better hashtag, we need to do something. Give equity in pay. Offer opportunities for leadership that accommodate the extra duty women might have outside work. Create flexibility in schedules and without the penalty of having to pump at work or leave early to pick up a child. Not to mention all the opportunities we men have to do more of the household work that women currently do.
The gallant women of Ukraine don’t need our approbation. They need our aid and our prayers. Like the women in my department, at my medical center, in my community, they aren’t posing to be made into posters. There’s work to be done and they are flocking toward it right now.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.