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Dairy doesn’t do a body good in midlife women
Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.
And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.
“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.
Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.
“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
SWAN study: White women consume the most dairy
As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.
The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.
A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.
“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.
“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.
They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.
There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
Findings on dairy and bone are inconsistent
The authors caution that several factors should be taken into account when considering these new findings.
“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.
Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.
They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.
But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.
In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.
Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”
The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.
We “may need to look at different types of dairy products,” he said.
Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
Vitamin D data were not available; dairy may help in this respect
Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.
Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.
A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.
Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.
And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.
“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.
Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.
“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
SWAN study: White women consume the most dairy
As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.
The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.
A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.
“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.
“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.
They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.
There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
Findings on dairy and bone are inconsistent
The authors caution that several factors should be taken into account when considering these new findings.
“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.
Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.
They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.
But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.
In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.
Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”
The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.
We “may need to look at different types of dairy products,” he said.
Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
Vitamin D data were not available; dairy may help in this respect
Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.
Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.
A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.
Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.
And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.
“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.
Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.
“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
SWAN study: White women consume the most dairy
As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.
The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.
A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.
“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.
“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.
They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.
There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
Findings on dairy and bone are inconsistent
The authors caution that several factors should be taken into account when considering these new findings.
“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.
Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.
They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.
But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.
In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.
Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”
The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.
We “may need to look at different types of dairy products,” he said.
Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
Vitamin D data were not available; dairy may help in this respect
Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.
Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.
A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.
Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FDA revokes emergency use of hydroxychloroquine
The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.
The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.
Remdesivir was granted emergency use authorization by the FDA on May 1.
“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
Controversy over hydroxychloroquine
Even with such federal permission, since late March the use of these two agents has been mired in controversy.
President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.
The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.
The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.
Remdesivir was granted emergency use authorization by the FDA on May 1.
“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
Controversy over hydroxychloroquine
Even with such federal permission, since late March the use of these two agents has been mired in controversy.
President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.
The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.
This article first appeared on Medscape.com.
The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.
The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.
Remdesivir was granted emergency use authorization by the FDA on May 1.
“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
Controversy over hydroxychloroquine
Even with such federal permission, since late March the use of these two agents has been mired in controversy.
President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.
The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”
“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.
This article first appeared on Medscape.com.
Perfect storm of SARS-CoV-2 during flu season
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.
Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.
Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.
Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?
The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?
Minimize double whammy infections. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.
Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.
One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.
Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days1 vs. 15-23 days2 for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.
Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.
1. Aim to exceed 75% influenza vaccine uptake in your patients.
a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.
2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.
3. Plan safe and efficient processes to vaccinate large numbers in August through November.
a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.
b. What social distancing and masking rules will be needed?
i. Will patients need to bring their own masks, or will you supply them?
c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?
d. Remember younger patients need two doses before Dec 1, 2020.
e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?
f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?
Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
References
1.. HCUP Statistical Brief #253. 2019 Oct.
2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
Learning the ICU
Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.1 “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.
A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.
“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”
Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.
References
1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.
Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.1 “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.
A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.
“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”
Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.
References
1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.
Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.1 “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.
A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.
“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”
Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.
References
1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.
I am part of the problem
Race is not something I’ve spent that much time contemplating. I grew up in Elizabeth, N.J., a city of just over 100,000, in the 1970s and attended public schools where people came in all shapes and colors; diversity came with the turf, it wasn’t something anyone needed to strive for.
My high school had more than 4,000 students with roughly even numbers of white, black, and Hispanic students. Armed police patrolled the halls, the thick aroma of weed settled in the stairwells and restrooms, girls brought their babies to school to show them off on half-days, and the “preppies” wore Fair Isle sweaters and played on the tennis team. The school’s campus was brand new and every lab, studio, and athletic amenity was state of the art; at the time, it was the most expensive public high school ever built in America. There were black teachers, librarians, and administrators, and segregation was something we read about in history books. I lived in a world of Technicolor and the Civil Rights movement of the 1960s, while still fresh in the minds of the adults, was something that showed up on black-and-white footage from another time.
My world became both wealthier and whiter when I went to college. There were minority students, but many of the black students at the University of Pennsylvania chose to live in the W.E.B. Du Bois College House.
People are often more comfortable being with others who share their backgrounds and this makes for an interesting conundrum: We all agree that desegregation is a good thing, but not everyone wishes to be told either where to go or not go, and there is an odd unbalance to creating a safe place for black students to be, one that both integrates and separates them from the larger community. Perhaps all our lines get fuzzy – I recall when I was on the Maryland Psychiatric Society Women’s Committee and a male psychiatrist signed up to join us – he was politely told that he could not join, but 20 years later, I’m wondering if it was okay to exclude a man who expressed interest in women’s issues.
In medical school, we were taught to note a patient’s age, race, and marital status, and we might learn that certain illnesses were more prevalent in certain populations, but there was no discussion of racial inequities in health care or anywhere else.
What was really different about the world back then, however, was what we didn’t see and what we didn’t talk about. Social media has opened a world where we can share our pain in the moment and we can band together to speak out against crimes and injustices in every realm. From the MeToo moments, to racially motivated police brutality. Cell phone cameras let us record and publicize these moments so the world can be the judge. George Floyd’s sadistic murder by a police officer, as other officers stood by and watched 8 minutes and 46 seconds of torture, left us all triggered, distressed, angry, sad, and activated. Maybe now we can make real progress on a discussion that began in 1992 with the videotape of Rodney King’s assault, a discussion we’ve had over and over to no avail.
Obviously, I have also been provoked by the events of the past weeks – like many Americans, I’ve paused to wonder how I can help the cause, both personally and as a psychiatrist. I would not normally write about racial topics – as a white woman I can listen, but I don’t feel this pain in the same way as someone who has lived with a lifetime of discrimination and oppression. Dr. Lorenzo Norris and Dr. Brandon Newsome,two black psychiatrists, put out a special edition of the MDEdge Psychcast, “The fallout from George Floyd’s death,” and Dr. Norris noted that two of his white colleagues told him they thought of checking on him, but they didn’t know what to say. Yes, I thought, that’s exactly it, I don’t know what to say and I worry that I might unintentionally say something that would worsen someone else’s pain. Staying silent has always seemed to be the safest option. With this article, I’m moving from a place of comfort.
I started my career with a mix of private practice and community psychiatry. There were things I loved about working in a community clinic: the social aspects of being part of a team, seeing a full range of psychopathology, and treating patients in which the racial and ethnic demographics mirrored that of the community. There were things I didn’t like, however. The pay was low, there were constant institutional requirements that were not relevant to the practice of psychiatry, and my relationship with the patients as their prescriber was much less fulfilling than the relationship I have with those I see for both psychotherapy and medication. Ultimately, the hospital shift to electronic medical records was the final distraction that caused me to leave community work.
Like roughly half of psychiatrists in private practice, I don’t participate with commercial or public insurance plans. Early in my career, I worked in a group setting with billing secretaries, and I did participate with Blue Cross, but even with administrative help, nothing about this was easy, and when I left to do solo practice, I left insurance participation behind. I love the autonomy of my career, I’m proud of the care I am able to give in this setting, and I don’t miss the hassles. But – the out-of-pocket cost of care is higher and the effort of trying to get reimbursed falls to the patient. It means that most of the patients I see have the means to pay for care, none are impoverished or homeless, and while I work in a city that is 62% black, black patients make up a small percentage of my caseload. I don’t think I am unique in this; I would be shocked if any white private practice psychiatrist who specializes in psychotherapy is serving a racially proportionate population. As we start to embrace the idea that people don’t neatly divide into being racist or not, and that bias affects us all, we must acknowledge that medical practices that don’t support racially balanced access to care are part of the problem.
Amy R. Greensfelder, LMSW, is the executive director of Maryland’s Pro Bono Counseling Project (PBCP), an organization that coordinates mental health professionals in private practice in Maryland to volunteer their services to those with limited resources. PBCP has found that 50% of those seeking services share that they are black or African American, and an additional 5% identify as multiracial. Of all of those seeking care approximately 65% are black, Indigenous, or People of Color (BIPOC), and and 14% are Latino/a/x/Hispanic. She says: “We see the racial composition of our clients as a direct demonstration of who is being left behind in the mental health system as it’s currently set up, as BIPOC individuals are represented to a greater degree in our clients than they are in the general population of Maryland. During our intake interview, we provide an opportunity for clients to share if there are certain characteristics they are looking for in a therapist – often black clients share that they would prefer to be matched with a black therapist or a therapist who has received specific training on working with black clients.”
While 13% of the American population is black, only 4% of physicians, 2% of psychiatrists, and 4% of psychologists are black. In her Psychology Today blog post, “Why African Americans Avoid Psychotherapy,” Monnica T. Williams, PhD, notes: “Apprehension about clashing with the values or worldview of the clinician can cause ambivalence about seeking help, and this may be especially true for the many who believe that mental health treatment was designed by white people for white people.” Dr. Williams notes that black Americans also are less likely to seek care because of increased stigma and fear of judgment, concerns about the treatment process, and fears of being involuntarily hospitalized, cost and lack of insurance, and finally logistical issues with work, transportation, and family responsibilities.
George Floyd’s tragic death has led us to a moment of crisis. It’s my hope that the dialogue is now galvanized to make meaningful changes toward fixing racial inequities. I am part of the problem and these conversations need to include more equitable access to psychiatric care.
My thanks to Rachel Donabedian and Gina Henderson for their help with this article.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Race is not something I’ve spent that much time contemplating. I grew up in Elizabeth, N.J., a city of just over 100,000, in the 1970s and attended public schools where people came in all shapes and colors; diversity came with the turf, it wasn’t something anyone needed to strive for.
My high school had more than 4,000 students with roughly even numbers of white, black, and Hispanic students. Armed police patrolled the halls, the thick aroma of weed settled in the stairwells and restrooms, girls brought their babies to school to show them off on half-days, and the “preppies” wore Fair Isle sweaters and played on the tennis team. The school’s campus was brand new and every lab, studio, and athletic amenity was state of the art; at the time, it was the most expensive public high school ever built in America. There were black teachers, librarians, and administrators, and segregation was something we read about in history books. I lived in a world of Technicolor and the Civil Rights movement of the 1960s, while still fresh in the minds of the adults, was something that showed up on black-and-white footage from another time.
My world became both wealthier and whiter when I went to college. There were minority students, but many of the black students at the University of Pennsylvania chose to live in the W.E.B. Du Bois College House.
People are often more comfortable being with others who share their backgrounds and this makes for an interesting conundrum: We all agree that desegregation is a good thing, but not everyone wishes to be told either where to go or not go, and there is an odd unbalance to creating a safe place for black students to be, one that both integrates and separates them from the larger community. Perhaps all our lines get fuzzy – I recall when I was on the Maryland Psychiatric Society Women’s Committee and a male psychiatrist signed up to join us – he was politely told that he could not join, but 20 years later, I’m wondering if it was okay to exclude a man who expressed interest in women’s issues.
In medical school, we were taught to note a patient’s age, race, and marital status, and we might learn that certain illnesses were more prevalent in certain populations, but there was no discussion of racial inequities in health care or anywhere else.
What was really different about the world back then, however, was what we didn’t see and what we didn’t talk about. Social media has opened a world where we can share our pain in the moment and we can band together to speak out against crimes and injustices in every realm. From the MeToo moments, to racially motivated police brutality. Cell phone cameras let us record and publicize these moments so the world can be the judge. George Floyd’s sadistic murder by a police officer, as other officers stood by and watched 8 minutes and 46 seconds of torture, left us all triggered, distressed, angry, sad, and activated. Maybe now we can make real progress on a discussion that began in 1992 with the videotape of Rodney King’s assault, a discussion we’ve had over and over to no avail.
Obviously, I have also been provoked by the events of the past weeks – like many Americans, I’ve paused to wonder how I can help the cause, both personally and as a psychiatrist. I would not normally write about racial topics – as a white woman I can listen, but I don’t feel this pain in the same way as someone who has lived with a lifetime of discrimination and oppression. Dr. Lorenzo Norris and Dr. Brandon Newsome,two black psychiatrists, put out a special edition of the MDEdge Psychcast, “The fallout from George Floyd’s death,” and Dr. Norris noted that two of his white colleagues told him they thought of checking on him, but they didn’t know what to say. Yes, I thought, that’s exactly it, I don’t know what to say and I worry that I might unintentionally say something that would worsen someone else’s pain. Staying silent has always seemed to be the safest option. With this article, I’m moving from a place of comfort.
I started my career with a mix of private practice and community psychiatry. There were things I loved about working in a community clinic: the social aspects of being part of a team, seeing a full range of psychopathology, and treating patients in which the racial and ethnic demographics mirrored that of the community. There were things I didn’t like, however. The pay was low, there were constant institutional requirements that were not relevant to the practice of psychiatry, and my relationship with the patients as their prescriber was much less fulfilling than the relationship I have with those I see for both psychotherapy and medication. Ultimately, the hospital shift to electronic medical records was the final distraction that caused me to leave community work.
Like roughly half of psychiatrists in private practice, I don’t participate with commercial or public insurance plans. Early in my career, I worked in a group setting with billing secretaries, and I did participate with Blue Cross, but even with administrative help, nothing about this was easy, and when I left to do solo practice, I left insurance participation behind. I love the autonomy of my career, I’m proud of the care I am able to give in this setting, and I don’t miss the hassles. But – the out-of-pocket cost of care is higher and the effort of trying to get reimbursed falls to the patient. It means that most of the patients I see have the means to pay for care, none are impoverished or homeless, and while I work in a city that is 62% black, black patients make up a small percentage of my caseload. I don’t think I am unique in this; I would be shocked if any white private practice psychiatrist who specializes in psychotherapy is serving a racially proportionate population. As we start to embrace the idea that people don’t neatly divide into being racist or not, and that bias affects us all, we must acknowledge that medical practices that don’t support racially balanced access to care are part of the problem.
Amy R. Greensfelder, LMSW, is the executive director of Maryland’s Pro Bono Counseling Project (PBCP), an organization that coordinates mental health professionals in private practice in Maryland to volunteer their services to those with limited resources. PBCP has found that 50% of those seeking services share that they are black or African American, and an additional 5% identify as multiracial. Of all of those seeking care approximately 65% are black, Indigenous, or People of Color (BIPOC), and and 14% are Latino/a/x/Hispanic. She says: “We see the racial composition of our clients as a direct demonstration of who is being left behind in the mental health system as it’s currently set up, as BIPOC individuals are represented to a greater degree in our clients than they are in the general population of Maryland. During our intake interview, we provide an opportunity for clients to share if there are certain characteristics they are looking for in a therapist – often black clients share that they would prefer to be matched with a black therapist or a therapist who has received specific training on working with black clients.”
While 13% of the American population is black, only 4% of physicians, 2% of psychiatrists, and 4% of psychologists are black. In her Psychology Today blog post, “Why African Americans Avoid Psychotherapy,” Monnica T. Williams, PhD, notes: “Apprehension about clashing with the values or worldview of the clinician can cause ambivalence about seeking help, and this may be especially true for the many who believe that mental health treatment was designed by white people for white people.” Dr. Williams notes that black Americans also are less likely to seek care because of increased stigma and fear of judgment, concerns about the treatment process, and fears of being involuntarily hospitalized, cost and lack of insurance, and finally logistical issues with work, transportation, and family responsibilities.
George Floyd’s tragic death has led us to a moment of crisis. It’s my hope that the dialogue is now galvanized to make meaningful changes toward fixing racial inequities. I am part of the problem and these conversations need to include more equitable access to psychiatric care.
My thanks to Rachel Donabedian and Gina Henderson for their help with this article.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Race is not something I’ve spent that much time contemplating. I grew up in Elizabeth, N.J., a city of just over 100,000, in the 1970s and attended public schools where people came in all shapes and colors; diversity came with the turf, it wasn’t something anyone needed to strive for.
My high school had more than 4,000 students with roughly even numbers of white, black, and Hispanic students. Armed police patrolled the halls, the thick aroma of weed settled in the stairwells and restrooms, girls brought their babies to school to show them off on half-days, and the “preppies” wore Fair Isle sweaters and played on the tennis team. The school’s campus was brand new and every lab, studio, and athletic amenity was state of the art; at the time, it was the most expensive public high school ever built in America. There were black teachers, librarians, and administrators, and segregation was something we read about in history books. I lived in a world of Technicolor and the Civil Rights movement of the 1960s, while still fresh in the minds of the adults, was something that showed up on black-and-white footage from another time.
My world became both wealthier and whiter when I went to college. There were minority students, but many of the black students at the University of Pennsylvania chose to live in the W.E.B. Du Bois College House.
People are often more comfortable being with others who share their backgrounds and this makes for an interesting conundrum: We all agree that desegregation is a good thing, but not everyone wishes to be told either where to go or not go, and there is an odd unbalance to creating a safe place for black students to be, one that both integrates and separates them from the larger community. Perhaps all our lines get fuzzy – I recall when I was on the Maryland Psychiatric Society Women’s Committee and a male psychiatrist signed up to join us – he was politely told that he could not join, but 20 years later, I’m wondering if it was okay to exclude a man who expressed interest in women’s issues.
In medical school, we were taught to note a patient’s age, race, and marital status, and we might learn that certain illnesses were more prevalent in certain populations, but there was no discussion of racial inequities in health care or anywhere else.
What was really different about the world back then, however, was what we didn’t see and what we didn’t talk about. Social media has opened a world where we can share our pain in the moment and we can band together to speak out against crimes and injustices in every realm. From the MeToo moments, to racially motivated police brutality. Cell phone cameras let us record and publicize these moments so the world can be the judge. George Floyd’s sadistic murder by a police officer, as other officers stood by and watched 8 minutes and 46 seconds of torture, left us all triggered, distressed, angry, sad, and activated. Maybe now we can make real progress on a discussion that began in 1992 with the videotape of Rodney King’s assault, a discussion we’ve had over and over to no avail.
Obviously, I have also been provoked by the events of the past weeks – like many Americans, I’ve paused to wonder how I can help the cause, both personally and as a psychiatrist. I would not normally write about racial topics – as a white woman I can listen, but I don’t feel this pain in the same way as someone who has lived with a lifetime of discrimination and oppression. Dr. Lorenzo Norris and Dr. Brandon Newsome,two black psychiatrists, put out a special edition of the MDEdge Psychcast, “The fallout from George Floyd’s death,” and Dr. Norris noted that two of his white colleagues told him they thought of checking on him, but they didn’t know what to say. Yes, I thought, that’s exactly it, I don’t know what to say and I worry that I might unintentionally say something that would worsen someone else’s pain. Staying silent has always seemed to be the safest option. With this article, I’m moving from a place of comfort.
I started my career with a mix of private practice and community psychiatry. There were things I loved about working in a community clinic: the social aspects of being part of a team, seeing a full range of psychopathology, and treating patients in which the racial and ethnic demographics mirrored that of the community. There were things I didn’t like, however. The pay was low, there were constant institutional requirements that were not relevant to the practice of psychiatry, and my relationship with the patients as their prescriber was much less fulfilling than the relationship I have with those I see for both psychotherapy and medication. Ultimately, the hospital shift to electronic medical records was the final distraction that caused me to leave community work.
Like roughly half of psychiatrists in private practice, I don’t participate with commercial or public insurance plans. Early in my career, I worked in a group setting with billing secretaries, and I did participate with Blue Cross, but even with administrative help, nothing about this was easy, and when I left to do solo practice, I left insurance participation behind. I love the autonomy of my career, I’m proud of the care I am able to give in this setting, and I don’t miss the hassles. But – the out-of-pocket cost of care is higher and the effort of trying to get reimbursed falls to the patient. It means that most of the patients I see have the means to pay for care, none are impoverished or homeless, and while I work in a city that is 62% black, black patients make up a small percentage of my caseload. I don’t think I am unique in this; I would be shocked if any white private practice psychiatrist who specializes in psychotherapy is serving a racially proportionate population. As we start to embrace the idea that people don’t neatly divide into being racist or not, and that bias affects us all, we must acknowledge that medical practices that don’t support racially balanced access to care are part of the problem.
Amy R. Greensfelder, LMSW, is the executive director of Maryland’s Pro Bono Counseling Project (PBCP), an organization that coordinates mental health professionals in private practice in Maryland to volunteer their services to those with limited resources. PBCP has found that 50% of those seeking services share that they are black or African American, and an additional 5% identify as multiracial. Of all of those seeking care approximately 65% are black, Indigenous, or People of Color (BIPOC), and and 14% are Latino/a/x/Hispanic. She says: “We see the racial composition of our clients as a direct demonstration of who is being left behind in the mental health system as it’s currently set up, as BIPOC individuals are represented to a greater degree in our clients than they are in the general population of Maryland. During our intake interview, we provide an opportunity for clients to share if there are certain characteristics they are looking for in a therapist – often black clients share that they would prefer to be matched with a black therapist or a therapist who has received specific training on working with black clients.”
While 13% of the American population is black, only 4% of physicians, 2% of psychiatrists, and 4% of psychologists are black. In her Psychology Today blog post, “Why African Americans Avoid Psychotherapy,” Monnica T. Williams, PhD, notes: “Apprehension about clashing with the values or worldview of the clinician can cause ambivalence about seeking help, and this may be especially true for the many who believe that mental health treatment was designed by white people for white people.” Dr. Williams notes that black Americans also are less likely to seek care because of increased stigma and fear of judgment, concerns about the treatment process, and fears of being involuntarily hospitalized, cost and lack of insurance, and finally logistical issues with work, transportation, and family responsibilities.
George Floyd’s tragic death has led us to a moment of crisis. It’s my hope that the dialogue is now galvanized to make meaningful changes toward fixing racial inequities. I am part of the problem and these conversations need to include more equitable access to psychiatric care.
My thanks to Rachel Donabedian and Gina Henderson for their help with this article.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Antinuclear antibody test interpretation guidance gets updated
New recommendations from the European League Against Rheumatism on interpreting the results of antinuclear antibody (ANA) testing advised taking the test methodology into account because of differences in performance.
ANA results vary not only by the test being used but also by the underlying disease they are being used to assess, warned Pier Luigi Meroni, MD, director of the Immunorheumatology Research Laboratory at the IRCCS Istituto Auxologico Italiano in Milan.
“Antinuclear antibody testing is a known diagnostic tool. But the recent advances in methodologies strongly suggests that we have to update our knowledge for a better interpretation of the results,” Dr. Meroni said in his presentation at the annual European Congress of Rheumatology, held online this year due to COVID-19.
There is “no doubt that ANA testing is useful,” he continued, adding that ANA is used as a primary screening tool in many rheumatic diseases, notably systemic lupus erythematosus (SLE), primary Sjögren’s syndrome, and systemic sclerosis. It’s also recently been suggested as an important entry criterion for the classification of SLE.
In fact, the 2019 SLE classification criteria – developed by EULAR in collaboration with the American College of Rheumatology – state that “testing by immunofluorescence on HEp-2 cells or a solid-phase ANA screening immunoassay with at least equivalent performance is highly recommended,” Dr. Meroni said.
The ideas underpinning that recommendation was that “ANA expression is invariable in SLE, and that ANA-negative lupus is quite rare,” he explained. Also, as SLE expression persists over time, ANA testing could be used for classification at any point in the disease course. These assumptions have been borne out in several studies, with very small percentages of patients (6% or less) having ANA-negative lupus, and more than 80% having a positive HEp-2 test over time, even with immunosuppressive treatment.
Which test methodology to use?
There are several methods that can be used to detect ANA, including the preferred HEp-2 indirect fluorescence assay (IFA), several solid-phase assays (SpA), and line- or dot-blot immunoassays. The issue is which assay should be used in which disease?
The performance of a particular assay can depend on the disease in which they are used. For instance, while the HEp-2 IFA and SpA are equivalent in SLE and in other connective tissue diseases, “this is not the case for other autoimmune diseases in which basically we don’t know exactly all the autoantigens,” Dr. Meroni explained. “Most of the autoantigens are undefined. They cannot be found in solid-phase kits, and we have to use the IFA for detecting all these autoantibodies.”
Importantly, neither the IFA nor the SpA is superior to the other. “We just say that one technique can detect relevant antibodies that are not detectable by the other one, and maybe the combination of the two techniques can be the right strategy to get the highest sensitivity,” Dr. Meroni said.
“Clinicians should be aware of the type of assay used for ANA detection,” he said, “because there are strong differences in the performance, for example between IFA and SpA, and such differences can have important clinical and relevant consequences.”
The test selected will depend on if the aim is to exclude or confirm a disease, and the optimal strategy will depend on pretest probability. For instance, IFA is more sensitive than SpA for SLE and scleroderma, whereas IFA is less sensitive than SpA for Sjögren’s. For SLE, it is suggested to use both the IFA and SpA. A combination of both tests is also considered optimal for scleroderma. SpA testing offers the best sensitivity for Sjögren’s.
“The story is a little bit more complicated for inflammatory myopathies in which we don’t have assays able to detect all the autoantibodies,” Dr. Meroni said. In that situation, several different techniques have to be used to check if the SpA results fit with the IFA pattern.
In 2019, the ACR released its own position statement on ANA testing, highlighting that it supported the use of the HEp-2 IFA assay as the preferred option for ANA testing and that labs should specify the methods being used to test for ANA when reporting their results. The ACR position statement also noted that “ordering health care professionals should select specific ANA subserologies based on a patient’s signs and symptoms and when there is a high pretest suspicion for a specific condition.”
Dr. Meroni disclosed serving as a consultant to Inova Diagnostics, Thermo Fisher Scientific, Pfizer, AbbVie, Merck Sharp & Dohme, and UCB.
New recommendations from the European League Against Rheumatism on interpreting the results of antinuclear antibody (ANA) testing advised taking the test methodology into account because of differences in performance.
ANA results vary not only by the test being used but also by the underlying disease they are being used to assess, warned Pier Luigi Meroni, MD, director of the Immunorheumatology Research Laboratory at the IRCCS Istituto Auxologico Italiano in Milan.
“Antinuclear antibody testing is a known diagnostic tool. But the recent advances in methodologies strongly suggests that we have to update our knowledge for a better interpretation of the results,” Dr. Meroni said in his presentation at the annual European Congress of Rheumatology, held online this year due to COVID-19.
There is “no doubt that ANA testing is useful,” he continued, adding that ANA is used as a primary screening tool in many rheumatic diseases, notably systemic lupus erythematosus (SLE), primary Sjögren’s syndrome, and systemic sclerosis. It’s also recently been suggested as an important entry criterion for the classification of SLE.
In fact, the 2019 SLE classification criteria – developed by EULAR in collaboration with the American College of Rheumatology – state that “testing by immunofluorescence on HEp-2 cells or a solid-phase ANA screening immunoassay with at least equivalent performance is highly recommended,” Dr. Meroni said.
The ideas underpinning that recommendation was that “ANA expression is invariable in SLE, and that ANA-negative lupus is quite rare,” he explained. Also, as SLE expression persists over time, ANA testing could be used for classification at any point in the disease course. These assumptions have been borne out in several studies, with very small percentages of patients (6% or less) having ANA-negative lupus, and more than 80% having a positive HEp-2 test over time, even with immunosuppressive treatment.
Which test methodology to use?
There are several methods that can be used to detect ANA, including the preferred HEp-2 indirect fluorescence assay (IFA), several solid-phase assays (SpA), and line- or dot-blot immunoassays. The issue is which assay should be used in which disease?
The performance of a particular assay can depend on the disease in which they are used. For instance, while the HEp-2 IFA and SpA are equivalent in SLE and in other connective tissue diseases, “this is not the case for other autoimmune diseases in which basically we don’t know exactly all the autoantigens,” Dr. Meroni explained. “Most of the autoantigens are undefined. They cannot be found in solid-phase kits, and we have to use the IFA for detecting all these autoantibodies.”
Importantly, neither the IFA nor the SpA is superior to the other. “We just say that one technique can detect relevant antibodies that are not detectable by the other one, and maybe the combination of the two techniques can be the right strategy to get the highest sensitivity,” Dr. Meroni said.
“Clinicians should be aware of the type of assay used for ANA detection,” he said, “because there are strong differences in the performance, for example between IFA and SpA, and such differences can have important clinical and relevant consequences.”
The test selected will depend on if the aim is to exclude or confirm a disease, and the optimal strategy will depend on pretest probability. For instance, IFA is more sensitive than SpA for SLE and scleroderma, whereas IFA is less sensitive than SpA for Sjögren’s. For SLE, it is suggested to use both the IFA and SpA. A combination of both tests is also considered optimal for scleroderma. SpA testing offers the best sensitivity for Sjögren’s.
“The story is a little bit more complicated for inflammatory myopathies in which we don’t have assays able to detect all the autoantibodies,” Dr. Meroni said. In that situation, several different techniques have to be used to check if the SpA results fit with the IFA pattern.
In 2019, the ACR released its own position statement on ANA testing, highlighting that it supported the use of the HEp-2 IFA assay as the preferred option for ANA testing and that labs should specify the methods being used to test for ANA when reporting their results. The ACR position statement also noted that “ordering health care professionals should select specific ANA subserologies based on a patient’s signs and symptoms and when there is a high pretest suspicion for a specific condition.”
Dr. Meroni disclosed serving as a consultant to Inova Diagnostics, Thermo Fisher Scientific, Pfizer, AbbVie, Merck Sharp & Dohme, and UCB.
New recommendations from the European League Against Rheumatism on interpreting the results of antinuclear antibody (ANA) testing advised taking the test methodology into account because of differences in performance.
ANA results vary not only by the test being used but also by the underlying disease they are being used to assess, warned Pier Luigi Meroni, MD, director of the Immunorheumatology Research Laboratory at the IRCCS Istituto Auxologico Italiano in Milan.
“Antinuclear antibody testing is a known diagnostic tool. But the recent advances in methodologies strongly suggests that we have to update our knowledge for a better interpretation of the results,” Dr. Meroni said in his presentation at the annual European Congress of Rheumatology, held online this year due to COVID-19.
There is “no doubt that ANA testing is useful,” he continued, adding that ANA is used as a primary screening tool in many rheumatic diseases, notably systemic lupus erythematosus (SLE), primary Sjögren’s syndrome, and systemic sclerosis. It’s also recently been suggested as an important entry criterion for the classification of SLE.
In fact, the 2019 SLE classification criteria – developed by EULAR in collaboration with the American College of Rheumatology – state that “testing by immunofluorescence on HEp-2 cells or a solid-phase ANA screening immunoassay with at least equivalent performance is highly recommended,” Dr. Meroni said.
The ideas underpinning that recommendation was that “ANA expression is invariable in SLE, and that ANA-negative lupus is quite rare,” he explained. Also, as SLE expression persists over time, ANA testing could be used for classification at any point in the disease course. These assumptions have been borne out in several studies, with very small percentages of patients (6% or less) having ANA-negative lupus, and more than 80% having a positive HEp-2 test over time, even with immunosuppressive treatment.
Which test methodology to use?
There are several methods that can be used to detect ANA, including the preferred HEp-2 indirect fluorescence assay (IFA), several solid-phase assays (SpA), and line- or dot-blot immunoassays. The issue is which assay should be used in which disease?
The performance of a particular assay can depend on the disease in which they are used. For instance, while the HEp-2 IFA and SpA are equivalent in SLE and in other connective tissue diseases, “this is not the case for other autoimmune diseases in which basically we don’t know exactly all the autoantigens,” Dr. Meroni explained. “Most of the autoantigens are undefined. They cannot be found in solid-phase kits, and we have to use the IFA for detecting all these autoantibodies.”
Importantly, neither the IFA nor the SpA is superior to the other. “We just say that one technique can detect relevant antibodies that are not detectable by the other one, and maybe the combination of the two techniques can be the right strategy to get the highest sensitivity,” Dr. Meroni said.
“Clinicians should be aware of the type of assay used for ANA detection,” he said, “because there are strong differences in the performance, for example between IFA and SpA, and such differences can have important clinical and relevant consequences.”
The test selected will depend on if the aim is to exclude or confirm a disease, and the optimal strategy will depend on pretest probability. For instance, IFA is more sensitive than SpA for SLE and scleroderma, whereas IFA is less sensitive than SpA for Sjögren’s. For SLE, it is suggested to use both the IFA and SpA. A combination of both tests is also considered optimal for scleroderma. SpA testing offers the best sensitivity for Sjögren’s.
“The story is a little bit more complicated for inflammatory myopathies in which we don’t have assays able to detect all the autoantibodies,” Dr. Meroni said. In that situation, several different techniques have to be used to check if the SpA results fit with the IFA pattern.
In 2019, the ACR released its own position statement on ANA testing, highlighting that it supported the use of the HEp-2 IFA assay as the preferred option for ANA testing and that labs should specify the methods being used to test for ANA when reporting their results. The ACR position statement also noted that “ordering health care professionals should select specific ANA subserologies based on a patient’s signs and symptoms and when there is a high pretest suspicion for a specific condition.”
Dr. Meroni disclosed serving as a consultant to Inova Diagnostics, Thermo Fisher Scientific, Pfizer, AbbVie, Merck Sharp & Dohme, and UCB.
FROM THE EULAR 2020 E-CONGRESS
Daily Recap: FDA revokes emergency use of hydroxychloroquine; Hardest hit specialties ranked in financial report
Here are the stories our MDedge editors across specialties think you need to know about today:
It’s official: COVID-19 is bad for your health care business
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.
FDA revokes emergency use of hydroxychloroquine
The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.
"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.
Secondary infections common in COVID-19, implications unclear
Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.
“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."
An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.
Automated insulin delivery system ‘getting better and better’
Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest.
Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions.
Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.
“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.
Access more top news from the ADA virtual meeting.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
It’s official: COVID-19 is bad for your health care business
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.
FDA revokes emergency use of hydroxychloroquine
The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.
"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.
Secondary infections common in COVID-19, implications unclear
Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.
“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."
An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.
Automated insulin delivery system ‘getting better and better’
Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest.
Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions.
Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.
“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.
Access more top news from the ADA virtual meeting.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
It’s official: COVID-19 is bad for your health care business
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
“Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology,” according to the report. Read more.
FDA revokes emergency use of hydroxychloroquine
The FDA revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).
"Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19," the agency announced in a June 15 statement.
"In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," noted the FDA. Read more.
Secondary infections common in COVID-19, implications unclear
Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most physicians aren’t sure what to make of this understudied phenomenon.
“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection."
An early retrospective cohort study including 191 COVID-19 patients in Wuhan, China found that of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. physicians, who learned in training that many deaths during the so-called Spanish influenza epidemic were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP. Read more.
Automated insulin delivery system ‘getting better and better’
Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available model, particularly in young people with type 1 diabetes, new data suggest.
Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented during the virtual American Diabetes Association (ADA) 80th Scientific Sessions.
Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction.
“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They might make the quality of [patient] lives better. That’s really underappreciated,” session moderator Timothy S. Bailey, MD, commented. Read more.
Access more top news from the ADA virtual meeting.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
It’s official: COVID-19 was bad for the health care business
COVID-19 took a huge cut of clinicians’ business in March and April
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
COVID-19 took a huge cut of clinicians’ business in March and April
COVID-19 took a huge cut of clinicians’ business in March and April
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
It’s official: COVID-19 was bad for the health care business
COVID-19 took a huge cut of clinicians’ business in March and April
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
COVID-19 took a huge cut of clinicians’ business in March and April
COVID-19 took a huge cut of clinicians’ business in March and April
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
In the first 2 months of the COVID-19 pandemic, health care professionals experienced sharp drops in both utilization and revenue, according to an analysis of the nation’s largest collection of private health care claims data.
For the months of March and April 2020, use of medical professional services dropped by 65% and 68%, respectively, compared with last year, and estimated revenue fell by 45% and 48%, FAIR Health, a nonprofit organization that manages a database of 31 billion claim records, said in a new report.
For the Northeast states – the epicenter of the pandemic in March and April – patient volume was down by 60% in March and 80% in April, while revenue fell by 55% in March and 79% in April, the organization said.
For this analysis, “a professional service was defined as any service provided by an individual (e.g., physician, nurse, nurse practitioner, physician assistant) instead of being billed by a facility,” FAIR Health noted. Figures for 2019 were adjusted using the Consumer Price Index.
The size of the pandemic-related decreases in utilization and income varied by specialty. Of the seven specialties included in the study, oral surgery was hit the hardest, followed by gastroenterology, cardiology, orthopedics, dermatology, adult primary care, and pediatric primary care, FAIR Health said.
After experiencing a 2% drop in utilization this January and an increase of 4% in February, compared with 2019, gastroenterology saw corresponding drops of 73% in March and 77% in April. Estimated revenue for the specialty was flat in January and rose by 10% in February, but plummeted by 75% in March and 80% in April, the FAIR Health data show.
In cardiology, patient volume from 2019 to 2020 looked like this: Down by 4% in January, up 5% in February, down by 62% in March, and down by 71% in April. The earnings numbers tell a similar story: Down by 2% in January, up by 15% in February, down by 57% in March, and down by 73% in April, the organization reported.
Dermatology did the best among the non–primary care specialties, but that was just a relative success. Utilization still dropped by 62% and 68% in March and April of 2020, compared with last year, and revenue declined by 50% in March and 59% in April, FAIR Health said.
For adult primary care, the utilization numbers were similar, but revenue took a somewhat smaller hit. Patient volume from 2019 to 2020 was fairly steady in January and February, then nosedived in March (down 60%) and April (down 68%). Earnings were up initially, rising 1% in January and 2% in February, but fell 47% in March and 54% in April, FAIR Health said.
Pediatric primary care, it appears, may have been buoyed somewhat by its younger patients. The specialty as a whole saw utilization tumble by 52% in March and 58% in April, but revenue dropped by just 32% and 35%, respectively, according to the report.
A little extra data diving showed that the figures for preventive care visits for patients aged 0-4 years in March and April were –2% and 0% for volume and –2% and 1% for revenue. Meanwhile, the volume of immunizations only dropped by 14% and 10% and vaccine-related revenue slipped by just 7% and 2%, FAIR Health noted.
“Across many specialties from January to April 2020, office or other outpatient [evaluation and management] visits became more common relative to other procedures. ... This may have been due in part to the fact that many of these E&M services could be rendered via telehealth,” FAIR Health said.
Telehealth, however, was no panacea, the report explained: “Even when medical practices have continued to function via telehealth, many have experienced lower reimbursements for telehealth visits than for in-person visits and more time educating patients on how to use the technology.”
Results from two phase 3 trials of bimekizumab unveiled
Results from two late-breaking
“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.
Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)
The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.
At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).
“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”
In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.
The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.
“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”
As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.
“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”
Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..
Results from two late-breaking
“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.
Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)
The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.
At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).
“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”
In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.
The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.
“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”
As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.
“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”
Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..
Results from two late-breaking
“The rapid and lasting skin clearance observed in the majority of patients in both clinical studies demonstrate bimekizumab’s strong potential to deliver across three key areas: speed, depth and durability,” Kristian Reich, MD, said in an interview during the virtual annual meeting of the American Academy of Dermatology.
Bimekizumab selectively inhibits IL-17A and IL-17F, two key cytokines that drive inflammation and tissue damage across multiple diseases. In BE VIVID, Dr. Reich, of the Center for Translational Research in Inflammatory Skin Diseases at the University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 567 patients with moderate to severe psoriasis to bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based dosing at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16 then bimekizumab 320 mg Q4W). Coprimary endpoints were a Psoriasis Area and Severity Index (PASI) of at least 90 and an Investigator Global Assessment (IGA) response of 0 or 1. Secondary/other outcomes included PASI 100 at week 16; PASI 90, IGA 0/1, and PASI 100 at week 52; and safety. (Ustekinumab is an IL-12 and IL-23 antagonist.)
The mean age of patients was 46 years and 72% were male. The researchers found that the proportion of patients who achieved PASI 90 and an IGA of 0/1 was higher in the bimekizumab arm at week 16 (85.0% and 84.1%, respectively), compared with those in the ustekinumab arm (49.7% and 53.4%) and those on placebo (4.8% and 4.8%; P < .001 for all associations). In addition, 58.6% of patients in the bimekizumab arm achieved PASI 100, compared with 20.9% of those in the ustekinumab arm and none of those on placebo.
At week 52, patients in the bimekizumab arm achieved PASI 90, IGA 0/1, and PASI 100 response rates of 81.6%, 77.9%, and 64.2%, respectively, compared with 55.8%, 60.7%, and 38.0% of those in the ustekinumab arm. Over 52 weeks, incidence of serious treatment-emergent adverse events was 6.1% with bimekizumab arm, compared with 7.4% in the ustekinumab arm. Four deaths occurred (two in the bimekizumab arm, and one each in the ustekinumab and placebo arms), all considered unrelated to treatment. The most common reported adverse events in the bimekizumab arm through week 52 were nasopharyngitis (21.8%), oral candidiasis (15.2%), and upper respiratory tract infections (9.1%).
“The rapid and lasting skin clearance observed in the majority of patients treated with bimekizumab provide support for inhibiting IL-17F, in addition to IL-17A, to inhibit the IL-17 pathway,” Dr. Reich said. “This can make a meaningful difference for people living with psoriasis.” He added that the results of the head-to-head study of bimekizumab with secukinumab (an IL-17A antagonist) are expected later this year. “It will be very interesting to see if the marked differences in treatment effect seen in the BE VIVID study remain when comparing to an IL-17.”
In BE READY, a pivotal phase 3, randomized, withdrawal study, investigators led by Kenneth Gordon, MD, randomized 435 patients with moderate to severe psoriasis 4:1 to receive 320 mg Q4W or placebo, and followed them for 16 weeks. In a second part of the study, patients who had achieved at least a PASI 90 response at week 16 were rerandomized to receive continuous bimekizumab at two different dosing regimens: 320 mg Q4W or 320 mg every 8 weeks (Q8W), or to be withdrawn from treatment (placebo Q4W), and followed through week 56. Relapse was defined as a PASI score of less than 75 from week 20.
The mean age of patients was 44 years and 72% were male. At week 16, the proportion of patients who achieved a PASI 90 and an IGA of 0/1 was greatest in the bimekizumab arm (90.8% and 92.6%, respectively), compared with those on placebo. In addition, 68.2% of patients in the bimekizumab arm achieved PASI 100 at week 16, compared with only 1.2% of those on placebo (P < .001 for all associations). In the second part of the study, the researchers found that 86.8% of patients who received continuous bimekizumab 320 mg Q4W maintained PASI 90 at week 56, compared with 91% who were switched to bimekizumab 320 mg Q8W, and 16.2% of patients who were withdrawn from the trial.
“The speed of response and the number of patients who achieved clearance are extremely high, especially in a phase 3 trial,” Dr. Gordon, professor and Thomas R. Russell Family Chair of Dermatology at the Medical College of Wisconsin, Milwaukee, said in an interview. “However, the most surprising aspect may be the impressive maintenance of response in patients, even those who were treated with every-8-week dosing in the maintenance phase. While it is possible that there are some patients who may benefit from more frequent dosing in the long term, the possibility of every-8-week dosing would be a tremendous benefit for patients.”
As in the BE VIVID trial, the most frequently reported adverse events with bimekizumab between week 16 and week 56 in BE READY were nasopharyngitis (10.4% in the Q4W arm vs. 23% in the Q8W arm), oral candidiasis (11.3% Q4W vs. 9% Q8W), and upper respiratory tract infections (11.3% Q4W vs. 8% Q8W). The incidence of serious treatment-emergent adverse events with bimekizumab was 4.7% in the Q4W arm and 3% in the Q8W arm versus 3.8% in the placebo arm at week 56.
“The results from BE READY demonstrate that bimekizumab has the potential to deliver rapid and lasting skin improvement for psoriasis patients,” Dr. Gordon said. “The findings also support the hypothesis that inhibiting IL-17F, in addition to IL-17A, may be more effective in suppressing inflammation in suppressing inflammation in psoriasis than IL-17A inhibition alone.”
Both studies were funded by UCB Pharma. Dr. Reich disclosed that he has served as adviser and/or paid speaker for and/or participated in clinical trials sponsored by companies that include UCB. Dr. Gordon disclosed that he has received honoraria and/or research support from companies that include UCB..
FROM AAD 2020