Dermatology News

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

The Food and Drug Administration on Feb. 22 updated its October 2020 guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.

Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
 

Tailoring may be necessary

Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.

In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.

Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.

Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
 

Variants and testing

The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.

However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
 

Updated guidance for therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.

“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”

While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.

The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”

Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”

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

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

More than half of respondents to a recent survey looking at how the COVID-19 pandemic has affected people with psoriasis or psoriatic arthritis (PsA) said that they had avoided seeking medical care in person with a doctor or at a hospital.

Courtesy National Psoriasis Foundation

Moreover, around a quarter had their appointment with a rheumatologist canceled, rescheduled, or conducted virtually. Another 1 in 10 had their treatment plan disrupted, and 6% had to change or stop treatment entirely.

The mental health impact of living with these conditions during the pandemic was also notable, said Rachael Manion, the executive director of the Canadian Association of Psoriasis Patients (CAPP), which conducted the survey in collaboration with the Canadian Psoriasis Network (CPN) and Unmasking Psoriasis.

“It’s important to know that there have been a lot of different impacts of the pandemic on people living with psoriatic arthritis and psoriasis. Mental health in particular has had a really big hit as a result,” she said at the Canadian Arthritis Research Conference: Research with Impact.

“About half of the people who responded to our survey noted that their mental health was ‘worse’ or ‘much worse’ during the pandemic,” she said at the meeting, which was sponsored by the Arthritis Society, the Canadian Rheumatology Association, and Canada’s Institute of Musculoskeletal Health and Arthritis. Anxiety and feelings of isolation were reported by a respective 57% and 58% of respondents, and 40% reported depression.

“We can compare that to our earlier information around depression,” Ms. Manion said, which showed that, prior to the pandemic, 24% of people with psoriasis and 23% of those with PsA had said they experienced depression.

“What I found alarming looking at these results was that about a third of people were experiencing despair. Now that’s a really big, scary, overwhelming emotion that has a lot of burden on your mental health,” Ms. Manion said.

Despite the substantial effects on mental health, only 29% of respondents said they had been able to access mental health services during the pandemic.

To look at the impact of the COVID-19 pandemic on the psoriasis and PsA community in Canada, three patient advocacy groups – CAPP, CPN, and Unmasking Psoriasis – codeveloped a survey to look at the disease experience before and after the start of the COVID-19 pandemic. The survey was performed once, with 830 respondents providing information on their lives with psoriasis or PsA in the months before the start of the pandemic and at the time they were surveyed in September and October 2020.

Most of the survey respondents lived in Ontario, Quebec, British Columbia, or Alberta, although other provinces or territories were represented. Almost all respondents (96%) had psoriasis, and 60% also had PsA.

Pre-COVID, nearly half (49%) of patients said that they had not been seen by a rheumatologist, and 39% had not seen a dermatologist for treatment. Asked why, 56% and 27%, respectively, had not been referred, 9% and 15% said they had no specialist located nearby, and 7% and 10% stated that the wait list was too long.

“This tells us that there’s a lot more work that can be done and a lot more education of general practitioners and family medicine professionals about the benefits and the value of specialized care for psoriatic arthritis,” Ms. Manion suggested.

Before the pandemic, joint pain was occurring in 88% of patients, stiffness in 71%, and joint swelling in 67%. Disease flares or sudden periods of worsening occurred on a daily basis for 17%, and around one in five (21%) experienced multiple flares every month.

Prepandemic data also highlighted the negative impact that living with psoriasis or PsA has on people’s ability to sleep, interactions and intimacy with others, and on their school or work lives.

During the pandemic, around a quarter (26%) of respondents said they had worse or much worse access to employment, as well as its benefits such as a stable income (24%). A minority of respondent also described worse access to prescription medication (15%) and over-the-counter medication (13%).

“There are all kinds of things going on for patients in our community: changes to their work, changes to their drug coverage, their ability to sleep and sleep well, their mental health, and their ability to access care and treatments as part of their disease management,” Ms. Manion said.

Her final message to health care professionals was: “I just want to encourage you to continue to check in with your patients about what their experiences have been during the pandemic, and to really consider those impacts as you’re working with them to manage their disease.”

The survey received funding support from AbbVie, Bausch Health, Boehringer Ingelheim, Janssen, LEO Pharma, and Novartis.

Patients with actinic keratosis (AK) had significantly more total or partial clearance of their lesions with a 5-day course of tirbanibulin 1% ointment, compared with those on placebo, “with transient local reactions,” according to the results of two identically designed trials.

However, the results, assessed at day 57 and out to 1 year of follow-up, were associated with recurrence of lesions at 1 year, noted lead author Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and colleagues.

“The incidence of recurrence with conventional treatment has ranged from 20% to 96%,” they noted. “Among patients who had complete clearance at day 57 in the current trials, the estimated incidence of recurrence of previously cleared lesions was 47% at 1 year.” At 1 year, they added, “the estimated incidence of any lesions (new or recurrent) within the application area was 73%” and the estimate of sustained complete clearance was 27%.

A total of 700 adults completed the two multicenter, double-blind, parallel-group, vehicle-controlled trials, conducted concurrently between September 2017 and April 2019 at 62 U.S. sites. The results were published in the New England Journal of Medicine.

To be eligible, patients, mostly White men, had to have four to eight clinically typical, visible, and discrete AK lesions on the face or scalp within a contiguous area measuring 25 cm². They were randomly assigned to treatment with either tirbanibulin 1% ointment or vehicle ointment (containing monoglycerides, diglycerides, and propylene glycol), which they applied once daily to the entire contiguous area for 5 days.

Pooled data across the two trials showed that the primary outcome, complete clearance of all lesions at day 57, occurred in 49% of the tirbanibulin groups versus 9% of the vehicle groups, and partial clearance (the secondary outcome) occurred in 72% versus 18% respectively. For both outcomes, and in both trials, all results were statistically significant.

Of the 174 patients who received tirbanibulin and had complete clearance, 124 had one or more lesions develop within the application area during follow-up, the authors reported. Of these, 58% had recurrences, while 42% had new lesions.

While individual AK lesions are typically treated with cryosurgery, the study authors noted that treatment of multiple lesions involves topical agents, such as fluorouracil, diclofenac, imiquimod, or ingenol mebutate, and photodynamic therapy, some of which have to be administered over periods of weeks or months and “may be associated with local reactions of pain, irritation, erosions, ulcerations, and irreversible skin changes of pigmentation and scarring,” which may reduce adherence.

In contrast, the current studies showed the most common local reactions to tirbanibulin were erythema in 91% of patients and flaking or scaling in 82%, with transient adverse events including application-site pain in 10% and pruritus in 9%.

“Unlike with most topical treatments for actinic keratosis ... severe local reactions, including vesiculation or pustulation and erosion or ulceration, were infrequent with tirbanibulin ointment,” the authors noted. “This could be due to the relatively short, 5-day course of once-daily treatment.”

They concluded that “larger and longer trials are necessary to determine the effects and risks” of treatment with tirbanibulin for treating AK.

Tirbanibulin, a synthetic inhibitor of tubulin polymerization and Src kinase signaling, was approved by the Food and Drug Administration in December 2020, for the topical treatment of AK of the face or scalp.

Asked to comment on the findings, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, who was not involved with the study, said that “a treatment with a 5-day course and excellent tolerability will make dermatologists rethink the old practice of ‘freeze and go.’ ”

In an interview, he added, “tirbanibulin comes to the U.S. market for treating AKs at a great time, as ingenol mebutate has been withdrawn and the others are not widely supported. The mechanism of promoting apoptosis and inducing cell cycle arrest directly correlates to the local skin reaction profile of less crusting, vesiculation, and overall signs of skin necrosis as compared to [5-fluorouracil] and ingenol mebutate, which work via that pathway. As a result, there is a direct impact on the hyperproliferation of atypical keratinocytes that will treat visible and subclinical disease.”

“The ointment vehicle is also novel as previous therapies have been in either creams or gels,” he said.

The two trials were funded by tirbanibulin manufacturer Athenex. Dr. Blauvelt reported receiving consulting fees from Athenex and other pharmaceutical companies, including Almirall, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences. Other author disclosures included serving as a consultant to Athenex and other companies. Several authors are Athenex employees. Dr. Bhatia disclosed that he is an adviser and consultant for Almirall and has been an investigator for multiple other AK treatments.

Patients with actinic keratosis (AK) had significantly more total or partial clearance of their lesions with a 5-day course of tirbanibulin 1% ointment, compared with those on placebo, “with transient local reactions,” according to the results of two identically designed trials.

However, the results, assessed at day 57 and out to 1 year of follow-up, were associated with recurrence of lesions at 1 year, noted lead author Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and colleagues.

“The incidence of recurrence with conventional treatment has ranged from 20% to 96%,” they noted. “Among patients who had complete clearance at day 57 in the current trials, the estimated incidence of recurrence of previously cleared lesions was 47% at 1 year.” At 1 year, they added, “the estimated incidence of any lesions (new or recurrent) within the application area was 73%” and the estimate of sustained complete clearance was 27%.

A total of 700 adults completed the two multicenter, double-blind, parallel-group, vehicle-controlled trials, conducted concurrently between September 2017 and April 2019 at 62 U.S. sites. The results were published in the New England Journal of Medicine.

To be eligible, patients, mostly White men, had to have four to eight clinically typical, visible, and discrete AK lesions on the face or scalp within a contiguous area measuring 25 cm². They were randomly assigned to treatment with either tirbanibulin 1% ointment or vehicle ointment (containing monoglycerides, diglycerides, and propylene glycol), which they applied once daily to the entire contiguous area for 5 days.

Pooled data across the two trials showed that the primary outcome, complete clearance of all lesions at day 57, occurred in 49% of the tirbanibulin groups versus 9% of the vehicle groups, and partial clearance (the secondary outcome) occurred in 72% versus 18% respectively. For both outcomes, and in both trials, all results were statistically significant.

Of the 174 patients who received tirbanibulin and had complete clearance, 124 had one or more lesions develop within the application area during follow-up, the authors reported. Of these, 58% had recurrences, while 42% had new lesions.

While individual AK lesions are typically treated with cryosurgery, the study authors noted that treatment of multiple lesions involves topical agents, such as fluorouracil, diclofenac, imiquimod, or ingenol mebutate, and photodynamic therapy, some of which have to be administered over periods of weeks or months and “may be associated with local reactions of pain, irritation, erosions, ulcerations, and irreversible skin changes of pigmentation and scarring,” which may reduce adherence.

In contrast, the current studies showed the most common local reactions to tirbanibulin were erythema in 91% of patients and flaking or scaling in 82%, with transient adverse events including application-site pain in 10% and pruritus in 9%.

“Unlike with most topical treatments for actinic keratosis ... severe local reactions, including vesiculation or pustulation and erosion or ulceration, were infrequent with tirbanibulin ointment,” the authors noted. “This could be due to the relatively short, 5-day course of once-daily treatment.”

They concluded that “larger and longer trials are necessary to determine the effects and risks” of treatment with tirbanibulin for treating AK.

Tirbanibulin, a synthetic inhibitor of tubulin polymerization and Src kinase signaling, was approved by the Food and Drug Administration in December 2020, for the topical treatment of AK of the face or scalp.

Asked to comment on the findings, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, who was not involved with the study, said that “a treatment with a 5-day course and excellent tolerability will make dermatologists rethink the old practice of ‘freeze and go.’ ”

In an interview, he added, “tirbanibulin comes to the U.S. market for treating AKs at a great time, as ingenol mebutate has been withdrawn and the others are not widely supported. The mechanism of promoting apoptosis and inducing cell cycle arrest directly correlates to the local skin reaction profile of less crusting, vesiculation, and overall signs of skin necrosis as compared to [5-fluorouracil] and ingenol mebutate, which work via that pathway. As a result, there is a direct impact on the hyperproliferation of atypical keratinocytes that will treat visible and subclinical disease.”

“The ointment vehicle is also novel as previous therapies have been in either creams or gels,” he said.

The two trials were funded by tirbanibulin manufacturer Athenex. Dr. Blauvelt reported receiving consulting fees from Athenex and other pharmaceutical companies, including Almirall, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences. Other author disclosures included serving as a consultant to Athenex and other companies. Several authors are Athenex employees. Dr. Bhatia disclosed that he is an adviser and consultant for Almirall and has been an investigator for multiple other AK treatments.

Patients with actinic keratosis (AK) had significantly more total or partial clearance of their lesions with a 5-day course of tirbanibulin 1% ointment, compared with those on placebo, “with transient local reactions,” according to the results of two identically designed trials.

However, the results, assessed at day 57 and out to 1 year of follow-up, were associated with recurrence of lesions at 1 year, noted lead author Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and colleagues.

“The incidence of recurrence with conventional treatment has ranged from 20% to 96%,” they noted. “Among patients who had complete clearance at day 57 in the current trials, the estimated incidence of recurrence of previously cleared lesions was 47% at 1 year.” At 1 year, they added, “the estimated incidence of any lesions (new or recurrent) within the application area was 73%” and the estimate of sustained complete clearance was 27%.

A total of 700 adults completed the two multicenter, double-blind, parallel-group, vehicle-controlled trials, conducted concurrently between September 2017 and April 2019 at 62 U.S. sites. The results were published in the New England Journal of Medicine.

To be eligible, patients, mostly White men, had to have four to eight clinically typical, visible, and discrete AK lesions on the face or scalp within a contiguous area measuring 25 cm². They were randomly assigned to treatment with either tirbanibulin 1% ointment or vehicle ointment (containing monoglycerides, diglycerides, and propylene glycol), which they applied once daily to the entire contiguous area for 5 days.

Pooled data across the two trials showed that the primary outcome, complete clearance of all lesions at day 57, occurred in 49% of the tirbanibulin groups versus 9% of the vehicle groups, and partial clearance (the secondary outcome) occurred in 72% versus 18% respectively. For both outcomes, and in both trials, all results were statistically significant.

Of the 174 patients who received tirbanibulin and had complete clearance, 124 had one or more lesions develop within the application area during follow-up, the authors reported. Of these, 58% had recurrences, while 42% had new lesions.

While individual AK lesions are typically treated with cryosurgery, the study authors noted that treatment of multiple lesions involves topical agents, such as fluorouracil, diclofenac, imiquimod, or ingenol mebutate, and photodynamic therapy, some of which have to be administered over periods of weeks or months and “may be associated with local reactions of pain, irritation, erosions, ulcerations, and irreversible skin changes of pigmentation and scarring,” which may reduce adherence.

In contrast, the current studies showed the most common local reactions to tirbanibulin were erythema in 91% of patients and flaking or scaling in 82%, with transient adverse events including application-site pain in 10% and pruritus in 9%.

“Unlike with most topical treatments for actinic keratosis ... severe local reactions, including vesiculation or pustulation and erosion or ulceration, were infrequent with tirbanibulin ointment,” the authors noted. “This could be due to the relatively short, 5-day course of once-daily treatment.”

They concluded that “larger and longer trials are necessary to determine the effects and risks” of treatment with tirbanibulin for treating AK.

Tirbanibulin, a synthetic inhibitor of tubulin polymerization and Src kinase signaling, was approved by the Food and Drug Administration in December 2020, for the topical treatment of AK of the face or scalp.

Asked to comment on the findings, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, who was not involved with the study, said that “a treatment with a 5-day course and excellent tolerability will make dermatologists rethink the old practice of ‘freeze and go.’ ”

In an interview, he added, “tirbanibulin comes to the U.S. market for treating AKs at a great time, as ingenol mebutate has been withdrawn and the others are not widely supported. The mechanism of promoting apoptosis and inducing cell cycle arrest directly correlates to the local skin reaction profile of less crusting, vesiculation, and overall signs of skin necrosis as compared to [5-fluorouracil] and ingenol mebutate, which work via that pathway. As a result, there is a direct impact on the hyperproliferation of atypical keratinocytes that will treat visible and subclinical disease.”

“The ointment vehicle is also novel as previous therapies have been in either creams or gels,” he said.

The two trials were funded by tirbanibulin manufacturer Athenex. Dr. Blauvelt reported receiving consulting fees from Athenex and other pharmaceutical companies, including Almirall, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences. Other author disclosures included serving as a consultant to Athenex and other companies. Several authors are Athenex employees. Dr. Bhatia disclosed that he is an adviser and consultant for Almirall and has been an investigator for multiple other AK treatments.

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com

The rate of hospital admissions in the United Kingdom for food-induced anaphylaxis more than tripled over the 20 years from 1998 to 2018, but the case fatality rate fell by more than half, researchers report in BMJ.

“Cow’s milk is increasingly identified as the culprit allergen for fatal food reactions and is now the commonest cause of fatal anaphylaxis in children,” write Alessia Baseggio Conrado, PhD, a biochemist with the National Heart and Lung Institute at Imperial College London, and colleagues. “More education is needed to highlight the specific risks posed by cow’s milk to people who are allergic to increase awareness among food businesses.”

Whereas recognition of the risks posed by nut allergies has increased, people think milk allergy is mild, says senior author Paul. J. Turner, BMBCh, PhD, an allergist/immunologist at Imperial College. “This is often true in very young children, but school-aged children who still have milk allergy tend to have a more allergic profile, often with other allergies, including asthma,” Dr. Turner told this news organization. “Also, milk is very common in our diet, and you don’t need much milk to achieve a decent dose of allergen.”

During the study period, 101,891 people were hospitalized for anaphylaxis; 30,700 cases (30%) were coded as having been triggered by food.

These food-related admissions represent an increase from 1.23 to 4.04 per 100,000 population per year, for an annual increase of 5.7% (95% confidence interval, 5.5-5.9; P < .001), the authors write.

The largest jump occurred among children younger than 15 years, for whom admissions rose from 2.1 to 9.2 per 100,000 population per year, an annual increase of 6.6% (95% CI, 6.3-7.0). The annual increases were 5.9% (95% CI, 5.6-6.2) among persons aged 15 to 59 years and 2.1% (95% CI, 1.8-3.1) among those aged 60 years and older.

The investigators used data from England, Scotland, Wales, and Northern Ireland to track temporal trends and age and sex distributions for hospital admissions for which the primary diagnosis was anaphylaxis attributable to both food and nonfood triggers. These data were compared with nationally reported fatalities.

Over the 20-year period, 152 deaths were attributed to likely food-induced anaphylaxis. During that time, the case fatality rate for confirmed fatal food anaphylaxis fell from 0.7% to 0.19% (rate ratio, 0.931; 95% CI, 0.904-0.959; P < .001) and declined to 0.30% for suspected fatal food anaphylaxis (rate ratio, 0.970; 95% CI, 0.945-0.996; P = .024).

Between 1992 and 2018, at least 46% of all anaphylactic fatalities were deemed to be triggered by peanut or tree nut. Among school-aged children, 26% of anaphylactic fatalities were attributed to cow’s milk.

Not surprisingly, during the study period, there was an increase of 336% in prescriptions for adrenaline autoinjectors. Such prescriptions increased 11% per year.

Global trend

The data extend findings Dr. Turner and colleagues reported for England and Wales in 2014 regarding the entire United Kingdom population and align with epidemiologic trends in hospital admissions for anaphylaxis in the United States and Australia.

The researchers say better recognition and management of anaphylaxis could partly explain the decrease in fatalities, but the rise in hospitalizations remains puzzling. “Whether a true increase in the prevalence of anaphylaxis has occurred (rather than a reduction in the threshold to admit patients presenting with anaphylaxis) is unclear because evidence is lacking for an increase in prevalence of food allergy in the [United Kingdom] (and elsewhere) over the same time period,” they write.

Ronna L. Campbell, MD, PhD, an emergency physician at the Mayo Clinic in Rochester, Minn., has noted similar trends in the United States. “It may be that anaphylaxis recognition and diagnosis have improved, resulting in earlier administration of epinephrine,” Dr. Campbell said in an interview. “So while cases are increasing, earlier recognition and treatment result in decreased fatalities.” She is unaware of any new guidelines recommending increased hospitalization that would explain the puzzling rise in admissions.

According to the study authors, the clinical criteria used to diagnose anaphylaxis in the United Kingdom did not change during the study period. Although national guidance recommending the hospitalization of children younger than 16 who are suspected of having anaphylaxis was introduced in 2011 and may have boosted admissions, the year-on-year rate of increase has persisted since 2014. “Therefore the increase over the past 5 years cannot be attributed to the impact of the guidance,” they write.

The study was funded by grants from the U.K. Medical Research Council and U.K. Food Standards Agency. Two coauthors have disclosed financial relationships with industry outside of the submitted work. Dr. Conrado has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com

Videos on social media showing children using insulin delivery pens to self-inject hyaluronic acid has prompted a safety warning from the American Society for Dermatologic Surgery Association.

In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.

The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.

“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.  

Videos on social media showing children using insulin delivery pens to self-inject hyaluronic acid has prompted a safety warning from the American Society for Dermatologic Surgery Association.

In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.

The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.

“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.  

Videos on social media showing children using insulin delivery pens to self-inject hyaluronic acid has prompted a safety warning from the American Society for Dermatologic Surgery Association.

In the safety warning, issued on Feb. 18, the ASDSA reported that ASDSA members, all board-certified dermatologists, have seen evidence online of young people using so-called “hyaluron pens” to inject hyaluronic acid filler in the epidermal and upper dermal skin.

The pens being used and promoted in social media for do-it-yourself filler injections are medical devices originally developed for insulin injections. “The use of air pressure technology causes these pens to deliver the hyaluronic acid to insert nanoscale molecules of the filler through the skin,” according to the ASDSA statement. Marketing materials state that the pens can be used to create volume and shape in the lips, and to improve the appearance of nasolabial lines, marionette lines, brow lines known as “elevens,” and forehead wrinkles. Claims that the hyaluronic acid only reaches the papillary layer of the dermis, and is therefore safe, do not alleviate the risk of injury in inexperienced hands, the ASDSA statement points out.

“We are concerned about California children falling prey to products that are not appropriate and safe for them to use,” Elan Newland, MD, member of the ASDSA and the California Society for Dermatology and Dermatological Surgery (CalDerm), said in the statement. “The power of social media is very strong, especially for impressionable teenagers. CalDerm supports alerting consumers and regulators of the dangers of these pens,” he said.  

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Work load, not personal vulnerability, may be at the root of the current physician burnout crisis, a recent study has concluded.

The cutting-edge research utilized cognitive theory and work load analysis to get at the source of burnout among practitioners. The findings indicate that, although some institutions continue to emphasize personal responsibility of physicians to address the issue, it may be the amount and structure of the work itself that triggers burnout in doctors.

“We evaluated the cognitive load of a clinical workday in a national sample of U.S. physicians and its relationship with burnout and professional satisfaction,” wrote Elizabeth Harry, MD, SFHM, a hospitalist at the University of Colorado at Denver, Aurora and coauthors. The results were reported in the Joint Commission Journal on Quality and Patient Safety.

The researchers investigated whether task load correlated with burnout scores in a large national study of U.S. physicians from October 2017 to March 2018.

As the delivery of health care becomes more complex, physicians are charged with ever-increasing amount of administrative and cognitive tasks. Recent evidence indicates that this growing complexity of work is tied to a greater risk of burnout in physicians, compared with workers in other fields. Cognitive load theory, pioneered by psychologist Jonathan Sweller, identified limitations in working memory that humans depend on to carry out cognitive tasks. Cognitive load refers to the amount of working memory used, which can be reduced in the presence of external emotional or physiological stressors. While a potential link between cognitive load and burnout may seem self-evident, the correlation between the cognitive load of physicians and burnout has not been evaluated in a large-scale study until recently.

wutwhanfoto/Getty Images

Physician task load (PTL) was measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX), a validated questionnaire frequently used to evaluate the cognitive load of work environments, including health care environments. Four domains (perception of effort and mental, physical, and temporal demands) were used to calculate the total PTL score.

Burnout was evaluated using the Emotional Exhaustion and Depersonalization scales of the Maslach Burnout Inventory, a validated tool considered the gold standard for measurement.

The survey sample consisted of physicians of all specialties and was assembled using the American Medical Association Physician Masterfile, an almost complete record of all U.S. physicians independent of AMA membership. All responses were anonymous and participation was voluntary.
 

Results

Among 30,456 physicians who received the survey, 5,197 (17.1%) responded. In total, 5,276 physicians were included in the analysis.

The median age of respondents was 53 years, and 61.8% self-identified as male. Twenty-four specialties were identified: 23.8% were from a primary care discipline and internal medicine represented the largest respondent group (12.1%).

Almost half of respondents (49.7%) worked in private practice, and 44.8% had been in practice for 21 years or longer.

Overall, 44.0% had at least one symptom of burnout, 38.8% of participants scored in the high range for emotional exhaustion, and 27.4% scored in the high range for depersonalization. The mean score in task load dimension varied by specialty.

The mean PTL score was 260.9 (standard deviation, 71.4). The specialties with the highest PTL score were emergency medicine (369.8), urology (353.7), general surgery subspecialties (343.9), internal medicine subspecialties (342.2), and radiology (341.6).

Aside from specialty, PTL scores also varied by practice setting, gender, age, number of hours worked per week, number of nights on call per week, and years in practice.

The researchers observed a dose response relationship between PTL and risk of burnout. For every 40-point (10%) reduction in PTL, there was 33% lower odds of experiencing burnout (odds ratio, 0.67; 95% confidence interval, 0.65-0.70; P < .0001). Multivariable analyses also indicated that PTL was a significant predictor of burnout, independent of practice setting, specialty, age, gender, and hours worked.
 

Organizational strategies to reduce physician burnout

Coauthors of the study, Tait D. Shanafelt, MD, professor of medicine at Stanford (Calif.) University and Colin P. West, MD, PhD, of the Mayo Clinic in Rochester, Minn., are both experts on physician well-being and are passionate about finding new ways to reduce physician distress and improving health care delivery.

“Authentic efforts to address this problem must move beyond personal resilience,” Dr. Shanafelt said in an interview. “Organizations that fail to get serious about this issue are going to be left behind and struggle in the war for talent.

“Much like our efforts to improve quality, advancing clinician well-being requires organizations to make it a priority and establish the structure, process, and leadership to promote the desired outcomes,” said Dr. Shanafelt.

One potential strategy for improvement is appointing a chief wellness officer, a dedicated individual within the health care system that leads the organizational effort, explained Dr. Shanafelt. “Over 30 vanguard institutions across the United States have already taken this step.”

Dr. West, a coauthor of the study, explained that conducting an analysis of PTL is fairly straightforward for hospitals and individual institutions. “The NASA-TLX tool is widely available, free to use, and not overly complex, and it could be used to provide insight into physician effort and mental, physical, and temporal demand levels,” he said in an interview.

“Deeper evaluations could follow to identify specific potential solutions, particularly system-level approaches to alleviate PTL,” Dr. West explained. “In the short term, such analyses and solutions would have costs, but helping physicians work more optimally and with less chronic strain from excessive task load would save far more than these costs overall.”

Dr. West also noted that physician burnout is very expensive to a health care system, and strategies to promote physician well-being would be a prudent financial decision long term for health care organizations.

Dr. Harry, lead author of the study, agreed with Dr. West, noting that “quality improvement literature has demonstrated that improvements in inefficiencies that lead to increased demand in the workplace often has the benefit of reduced cost.

“Many studies have demonstrated the risk of turnover due to burnout and the significant cost of physician turn over,” she said in an interview. “This cost avoidance is well worth the investment in improved operations to minimize unnecessary task load.”

Dr. Harry also recommended the NASA-TLX tool as a free resource for health systems and organizations. She noted that future studies will further validate the reliability of the tool.

“At the core, we need to focus on system redesign at both the micro and the macro level,” Dr. Harry said. “Each health system will need to assess inefficiencies in their work flow, while regulatory bodies need to consider the downstream task load of mandates and reporting requirements, all of which contribute to more cognitive load.”

The study was supported by funding from the Stanford Medicine WellMD Center, the American Medical Association, and the Mayo Clinic department of medicine program on physician well-being. Coauthors Lotte N. Dyrbye, MD, and Dr. Shanafelt are coinventors of the Physician Well-being Index, Medical Student Well-Being Index, Nurse Well-Being, and Well-Being Index. Mayo Clinic holds the copyright to these instruments and has licensed them for external use. Dr. Dyrbye and Dr. Shanafelt receive a portion of any royalties paid to Mayo Clinic. All other authors reported no conflicts of interest.

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, walked through a multiagency attack plan for halting the spread of three COVID-19 variants earlier this week.

As part of JAMA’s Q&A series with JAMA editor in chief Howard Bauchner, MD, Dr. Walensky referenced the blueprint she coathored with Anthony Fauci, MD, the nation’s top infectious disease expert, and Henry T. Walke, MD, MPH, of the CDC, which was published on Feb. 17 in JAMA.

In the viewpoint article, they explain that the Department of Health & Human Services has established the SARS-CoV-2 Interagency Group to improve coordination among the CDC, the National Institutes of Health, the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, the Department of Agriculture, and the Department of Defense.

Dr. Walensky said the first objective is to reinforce vigilance regarding public health mitigation strategies to decrease the amount of virus that’s circulating.

As part of that strategy, she said, the CDC strongly urges against nonessential travel.

In addition, public health leaders are working on a surveillance system to better understand the SARS-CoV-2 variants. That will take ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.

She said the CDC is partnering with state health labs to obtain about 750 samples every week and is teaming up with commercial labs and academic centers to obtain an interim target of 6,000 samples per week.

She acknowledged the United States “is not where we need to be” with sequencing but has come a long way since January. At that time, they were sequencing 250 samples every week; they are currently sequencing thousands each week.

Data analysis is another concern: “We need to be able to understand at the basic science level what the information means,” Dr. Walensky said.

Researchers aren’t sure how the variants might affect use of convalescent plasma or monoclonal antibody treatments. It is expected that 5% of persons who are vaccinated against COVID-19 will nevertheless contract the disease. Sequencing will help answer whether such persons who have been vaccinated and who subsequently contract the virus are among those 5% or whether have been infected by a variant that evades the vaccine.

Accelerating vaccine administration globally and in the United States is essential, Dr. Walensky said.

As of Feb. 17, 56 million doses had been administered in the United States.
 

Top three threats

She updated the numbers on the three biggest variant threats.

Regarding B.1.1.7, which originated in the United Kingdom, she said: “So far, we’ve had over 1,200 cases in 41 states.” She noted that the variant is likely to be about 50% more transmissible and 30% to 50% more virulent.

“So far, it looks like that strain doesn’t have any real decrease in susceptibility to our vaccines,” she said.

The strain from South Africa (B.1.351) has been found in 19 cases in the United States.

The P.1. variant, which originated in Brazil, has been identified in two cases in two states.
 

Outlook for March and April

Dr. Bauchner asked Dr. Walensky what she envisions for March and April. He noted that public optimism is high in light of the continued reductions in COVID-19 case numbers, hospitalizations, and deaths, as well as the fact that warmer weather is coming and that more vaccinations are on the horizon.

“While I really am hopeful for what could happen in March and April,” Dr. Walensky said, “I really do know that this could go bad so fast. We saw it in November. We saw it in December.”

CDC models have projected that, by March, the more transmissible B.1.1.7 strain is likely to be the dominant strain, she reiterated.

“I worry that it will be spring, and we will all have had enough,” Dr. Walensky said. She noted that some states are already relaxing mask mandates.

“Around that time, life will look and feel a little better, and the motivation for those who might be vaccine hesitant may be diminished,” she said.

Dr. Bauchner also asked her to weigh in on whether a third vaccine, from Johnson & Johnson (J&J), may soon gain FDA emergency-use authorization – and whether its lower expected efficacy rate may result in a tiered system of vaccinations, with higher-risk populations receiving the more efficacious vaccines.

Dr. Walensky said more data are needed before that question can be answered.

“It may very well be that the data point us to the best populations in which to use this vaccine,” she said.

In phase 3 data, the J&J vaccine was shown to be 72% effective in the United States for moderate to severe disease.

Dr. Walensky said it’s important to remember that the projected efficacy for that vaccine is higher than that for the flu shot as well as many other vaccines currently in use for other diseases.

She said it also has several advantages. The vaccine has less-stringent storage requirements, requires just one dose, and protects against hospitalization and death, although it’s less efficacious in protecting against contracting the disease.

“I think many people would opt to get that one if they could get it sooner,” she said.

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

Recently, an interview titled “Dermatology a bellwether of health inequities during COVID-19,” was published by the AMA. In my opinion, the interview was largely accurate, but I took issue with the following statement in the article: “Dermatology is a lucrative specialty, and many dermatologists do not accept Medicaid.”

To me, this implies that physicians are to blame for poor health care access, which drives me insane. Dermatology is not a particularly lucrative specialty; it ranked 13th in a recent survey from the professional medical network Doximity. Furthermore, if payment for practice expense is removed, dermatology drops much further down, close to primary care.

There is a fundamental misunderstanding by the public and legislators about physician incomes. The reimbursements that are reported by Medicare for example, include the practice expense cost, which for dermatology is about 60% of the total remitted to the doctor, as I wrote in a 2015 column.

That is, the cost of providing the facility, supplies, staff, rent, and utilities are included in “reimbursement,” though this is money that goes out the door to pay the bills as quickly as it comes in. This is for overhead, nothing here for the practitioner’s time and work.

Even when dermatologists perform hospital consults, they usually bring their own supply kit from their office for skin biopsies, or other procedures since these are impossible to find in a hospital.

I also pointed out in my earlier column that most other specialties do not provide the majority of their procedures in the office, but instead, use the hospital, which provides supplies and staff for procedures. These other specialists are to be lauded for providing their services at charity rates, or for no pay at all, but at least they do not have to pay for the building, equipment, supplies, and staff out of pocket. Dermatologists do, since in a sense, they run their own “hospitals” as almost all of their procedures are based out of their offices.
 

The economics of a patient visit

I do not dispute that it is more difficult for a Medicaid patient to get an appointment with a dermatologist than it is for a patient with private insurance, but this is because Medicaid often pays less than the cost of supplies to see them. It is also easier to get an appointment for a cosmetic procedure than a rash because reimbursements in general are artificially suppressed, even for Medicare (which is also the benchmark for private insurers) by the federal government. Medicare reimbursements have not kept pace with inflation and are about 53% less than they were in 1992.

Let’s look at a skin biopsy. The supplies and equipment to perform a skin biopsy cost over $50. In Ohio, Medicare pays $96.19 for a skin biopsy. Medicaid pays $47.20. That’s correct: less than the cost of supplies and overhead. So, a private practitioner not only provides the service for free, but loses money on every visit that involves a skin biopsy. When I talk to legislators, I liken this to my standing in front of my office and handing out $5 bills. In Ohio, Medicare pays $105.04 for a level 3 office visit. Medicaid pays $57.76. Medicare overhead on a level 3 office visit is again about 50%, so the office visit is about a break-even proposition, if you donate your time.

Academic medical centers can charge additional facility fees, and some receive subsidies from the city and county to treat indigent patients, and are often obligated to see all. Most hospitals with high Medicaid and indigent patient loads pay their surgical specialists to take call at their emergency rooms and often subsidize their emergency room doctors as well.

I agree that dermatology is an important specialty to have access to in the COVID-19 pandemic. I agree that patients of color may be disproportionately impacted because they may be covered by Medicaid more often, or have no insurance at all. The finger of blame, however, should be squarely pointed at politicians who have woefully underfunded Medicaid reimbursement rates, as well as payments for physicians under the Affordable Care Act, while thumping their chests and boasting how they have provided health care to millions. I think this was eloquently demonstrated when as part of the “deal” Congress made with the AMA to get the ACA passed, Congress agreed to pay primary care physicians (but only primary care) Medicare rates for Medicaid patients for 2 years.

Some states have continued to pay enhanced Medicaid rates and have fewer Medicaid patient access issues.

Most convincing, perhaps, are the states that pay Medicare rates or better for their Medicaid enrollees, for example Alaska and Montana. In these states, you will not have access to care issues beyond the actual human shortage of physicians in remote areas.

So, in conclusion, I maintain that dermatology is not a particularly lucrative specialty, once the overhead expense payments are removed, and further argue, that even if it were, why does that obligate us to provide care to insurance plans at a loss? Medicaid access to dermatologists is a government economic issue, not a physician ethical one. Most Americans get to pick the charities they choose to donate to.

The federal government would love to force all physicians into a plan where you must see patients at their chosen rates or see no patients at all. Look no further than our Canadian neighbors, where long wait times to see specialists are legendary. It has been reported that there are only six to seven hundred dermatologists in all of Canada to serve 30 million people.

So, when the topic of poor patient access to care for the Medicaid enrollee or indigent comes up, stand tall and point your finger to your state capital. That is where the blame lies.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Recently, an interview titled “Dermatology a bellwether of health inequities during COVID-19,” was published by the AMA. In my opinion, the interview was largely accurate, but I took issue with the following statement in the article: “Dermatology is a lucrative specialty, and many dermatologists do not accept Medicaid.”

To me, this implies that physicians are to blame for poor health care access, which drives me insane. Dermatology is not a particularly lucrative specialty; it ranked 13th in a recent survey from the professional medical network Doximity. Furthermore, if payment for practice expense is removed, dermatology drops much further down, close to primary care.

There is a fundamental misunderstanding by the public and legislators about physician incomes. The reimbursements that are reported by Medicare for example, include the practice expense cost, which for dermatology is about 60% of the total remitted to the doctor, as I wrote in a 2015 column.

That is, the cost of providing the facility, supplies, staff, rent, and utilities are included in “reimbursement,” though this is money that goes out the door to pay the bills as quickly as it comes in. This is for overhead, nothing here for the practitioner’s time and work.

Even when dermatologists perform hospital consults, they usually bring their own supply kit from their office for skin biopsies, or other procedures since these are impossible to find in a hospital.

I also pointed out in my earlier column that most other specialties do not provide the majority of their procedures in the office, but instead, use the hospital, which provides supplies and staff for procedures. These other specialists are to be lauded for providing their services at charity rates, or for no pay at all, but at least they do not have to pay for the building, equipment, supplies, and staff out of pocket. Dermatologists do, since in a sense, they run their own “hospitals” as almost all of their procedures are based out of their offices.
 

The economics of a patient visit

I do not dispute that it is more difficult for a Medicaid patient to get an appointment with a dermatologist than it is for a patient with private insurance, but this is because Medicaid often pays less than the cost of supplies to see them. It is also easier to get an appointment for a cosmetic procedure than a rash because reimbursements in general are artificially suppressed, even for Medicare (which is also the benchmark for private insurers) by the federal government. Medicare reimbursements have not kept pace with inflation and are about 53% less than they were in 1992.

Let’s look at a skin biopsy. The supplies and equipment to perform a skin biopsy cost over $50. In Ohio, Medicare pays $96.19 for a skin biopsy. Medicaid pays $47.20. That’s correct: less than the cost of supplies and overhead. So, a private practitioner not only provides the service for free, but loses money on every visit that involves a skin biopsy. When I talk to legislators, I liken this to my standing in front of my office and handing out $5 bills. In Ohio, Medicare pays $105.04 for a level 3 office visit. Medicaid pays $57.76. Medicare overhead on a level 3 office visit is again about 50%, so the office visit is about a break-even proposition, if you donate your time.

Academic medical centers can charge additional facility fees, and some receive subsidies from the city and county to treat indigent patients, and are often obligated to see all. Most hospitals with high Medicaid and indigent patient loads pay their surgical specialists to take call at their emergency rooms and often subsidize their emergency room doctors as well.

I agree that dermatology is an important specialty to have access to in the COVID-19 pandemic. I agree that patients of color may be disproportionately impacted because they may be covered by Medicaid more often, or have no insurance at all. The finger of blame, however, should be squarely pointed at politicians who have woefully underfunded Medicaid reimbursement rates, as well as payments for physicians under the Affordable Care Act, while thumping their chests and boasting how they have provided health care to millions. I think this was eloquently demonstrated when as part of the “deal” Congress made with the AMA to get the ACA passed, Congress agreed to pay primary care physicians (but only primary care) Medicare rates for Medicaid patients for 2 years.

Some states have continued to pay enhanced Medicaid rates and have fewer Medicaid patient access issues.

Most convincing, perhaps, are the states that pay Medicare rates or better for their Medicaid enrollees, for example Alaska and Montana. In these states, you will not have access to care issues beyond the actual human shortage of physicians in remote areas.

So, in conclusion, I maintain that dermatology is not a particularly lucrative specialty, once the overhead expense payments are removed, and further argue, that even if it were, why does that obligate us to provide care to insurance plans at a loss? Medicaid access to dermatologists is a government economic issue, not a physician ethical one. Most Americans get to pick the charities they choose to donate to.

The federal government would love to force all physicians into a plan where you must see patients at their chosen rates or see no patients at all. Look no further than our Canadian neighbors, where long wait times to see specialists are legendary. It has been reported that there are only six to seven hundred dermatologists in all of Canada to serve 30 million people.

So, when the topic of poor patient access to care for the Medicaid enrollee or indigent comes up, stand tall and point your finger to your state capital. That is where the blame lies.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Recently, an interview titled “Dermatology a bellwether of health inequities during COVID-19,” was published by the AMA. In my opinion, the interview was largely accurate, but I took issue with the following statement in the article: “Dermatology is a lucrative specialty, and many dermatologists do not accept Medicaid.”

To me, this implies that physicians are to blame for poor health care access, which drives me insane. Dermatology is not a particularly lucrative specialty; it ranked 13th in a recent survey from the professional medical network Doximity. Furthermore, if payment for practice expense is removed, dermatology drops much further down, close to primary care.

There is a fundamental misunderstanding by the public and legislators about physician incomes. The reimbursements that are reported by Medicare for example, include the practice expense cost, which for dermatology is about 60% of the total remitted to the doctor, as I wrote in a 2015 column.

That is, the cost of providing the facility, supplies, staff, rent, and utilities are included in “reimbursement,” though this is money that goes out the door to pay the bills as quickly as it comes in. This is for overhead, nothing here for the practitioner’s time and work.

Even when dermatologists perform hospital consults, they usually bring their own supply kit from their office for skin biopsies, or other procedures since these are impossible to find in a hospital.

I also pointed out in my earlier column that most other specialties do not provide the majority of their procedures in the office, but instead, use the hospital, which provides supplies and staff for procedures. These other specialists are to be lauded for providing their services at charity rates, or for no pay at all, but at least they do not have to pay for the building, equipment, supplies, and staff out of pocket. Dermatologists do, since in a sense, they run their own “hospitals” as almost all of their procedures are based out of their offices.
 

The economics of a patient visit

I do not dispute that it is more difficult for a Medicaid patient to get an appointment with a dermatologist than it is for a patient with private insurance, but this is because Medicaid often pays less than the cost of supplies to see them. It is also easier to get an appointment for a cosmetic procedure than a rash because reimbursements in general are artificially suppressed, even for Medicare (which is also the benchmark for private insurers) by the federal government. Medicare reimbursements have not kept pace with inflation and are about 53% less than they were in 1992.

Let’s look at a skin biopsy. The supplies and equipment to perform a skin biopsy cost over $50. In Ohio, Medicare pays $96.19 for a skin biopsy. Medicaid pays $47.20. That’s correct: less than the cost of supplies and overhead. So, a private practitioner not only provides the service for free, but loses money on every visit that involves a skin biopsy. When I talk to legislators, I liken this to my standing in front of my office and handing out $5 bills. In Ohio, Medicare pays $105.04 for a level 3 office visit. Medicaid pays $57.76. Medicare overhead on a level 3 office visit is again about 50%, so the office visit is about a break-even proposition, if you donate your time.

Academic medical centers can charge additional facility fees, and some receive subsidies from the city and county to treat indigent patients, and are often obligated to see all. Most hospitals with high Medicaid and indigent patient loads pay their surgical specialists to take call at their emergency rooms and often subsidize their emergency room doctors as well.

I agree that dermatology is an important specialty to have access to in the COVID-19 pandemic. I agree that patients of color may be disproportionately impacted because they may be covered by Medicaid more often, or have no insurance at all. The finger of blame, however, should be squarely pointed at politicians who have woefully underfunded Medicaid reimbursement rates, as well as payments for physicians under the Affordable Care Act, while thumping their chests and boasting how they have provided health care to millions. I think this was eloquently demonstrated when as part of the “deal” Congress made with the AMA to get the ACA passed, Congress agreed to pay primary care physicians (but only primary care) Medicare rates for Medicaid patients for 2 years.

Some states have continued to pay enhanced Medicaid rates and have fewer Medicaid patient access issues.

Most convincing, perhaps, are the states that pay Medicare rates or better for their Medicaid enrollees, for example Alaska and Montana. In these states, you will not have access to care issues beyond the actual human shortage of physicians in remote areas.

So, in conclusion, I maintain that dermatology is not a particularly lucrative specialty, once the overhead expense payments are removed, and further argue, that even if it were, why does that obligate us to provide care to insurance plans at a loss? Medicaid access to dermatologists is a government economic issue, not a physician ethical one. Most Americans get to pick the charities they choose to donate to.

The federal government would love to force all physicians into a plan where you must see patients at their chosen rates or see no patients at all. Look no further than our Canadian neighbors, where long wait times to see specialists are legendary. It has been reported that there are only six to seven hundred dermatologists in all of Canada to serve 30 million people.

So, when the topic of poor patient access to care for the Medicaid enrollee or indigent comes up, stand tall and point your finger to your state capital. That is where the blame lies.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.

Warning: This article will be about Tom Brady. If you love Tom Brady, hate Tom Brady, previously loved and now hate Tom Brady, I’m just warning you so you’ll be in the right frame of mind to continue. (If you don’t know who Tom Brady is, he’s Gisele’s husband).

Some of the best doctors I’ve ever seen in action were emeritus physicians. In medical school at Wake Forest University, one of my professors was Dr. Eben Alexander. A retired neurosurgeon, he taught a case-based critical thinking skills class. I recall his brilliant insight and coaching, working through cases that had nothing to do with the brain or with surgery. He used his vast experience and wisdom to teach us how to practice medicine. He was, at that time, nearly 90 years old. Despite having been retired for decades, he was still writing articles and editing journals. He was inspiring. For a minute, he had me thinking I’d like to be a neurosurgeon, so I could be just like Eben Alexander. I did not, but I learned things from him that still impact my practice as a dermatologist today.

I’m sure you’ve had similar experiences of older colleagues or mentors who were the best doctor in the clinic or the O.R. They are the Dr. Anthony Faucis, not just practicing, but leading while in their 8th or 9th decade. We are all so fortunate that they keep playing.

We’ve not made our final choices on whom to hire, but with two positions, I expect we’ll choose both a young doctor and an experienced one to add to our team. It will be fun to watch and learn from them. Just like it will be fun to watch Tom Brady in the Super Bowl again next year.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Warning: This article will be about Tom Brady. If you love Tom Brady, hate Tom Brady, previously loved and now hate Tom Brady, I’m just warning you so you’ll be in the right frame of mind to continue. (If you don’t know who Tom Brady is, he’s Gisele’s husband).

Some of the best doctors I’ve ever seen in action were emeritus physicians. In medical school at Wake Forest University, one of my professors was Dr. Eben Alexander. A retired neurosurgeon, he taught a case-based critical thinking skills class. I recall his brilliant insight and coaching, working through cases that had nothing to do with the brain or with surgery. He used his vast experience and wisdom to teach us how to practice medicine. He was, at that time, nearly 90 years old. Despite having been retired for decades, he was still writing articles and editing journals. He was inspiring. For a minute, he had me thinking I’d like to be a neurosurgeon, so I could be just like Eben Alexander. I did not, but I learned things from him that still impact my practice as a dermatologist today.

I’m sure you’ve had similar experiences of older colleagues or mentors who were the best doctor in the clinic or the O.R. They are the Dr. Anthony Faucis, not just practicing, but leading while in their 8th or 9th decade. We are all so fortunate that they keep playing.

We’ve not made our final choices on whom to hire, but with two positions, I expect we’ll choose both a young doctor and an experienced one to add to our team. It will be fun to watch and learn from them. Just like it will be fun to watch Tom Brady in the Super Bowl again next year.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Warning: This article will be about Tom Brady. If you love Tom Brady, hate Tom Brady, previously loved and now hate Tom Brady, I’m just warning you so you’ll be in the right frame of mind to continue. (If you don’t know who Tom Brady is, he’s Gisele’s husband).

Some of the best doctors I’ve ever seen in action were emeritus physicians. In medical school at Wake Forest University, one of my professors was Dr. Eben Alexander. A retired neurosurgeon, he taught a case-based critical thinking skills class. I recall his brilliant insight and coaching, working through cases that had nothing to do with the brain or with surgery. He used his vast experience and wisdom to teach us how to practice medicine. He was, at that time, nearly 90 years old. Despite having been retired for decades, he was still writing articles and editing journals. He was inspiring. For a minute, he had me thinking I’d like to be a neurosurgeon, so I could be just like Eben Alexander. I did not, but I learned things from him that still impact my practice as a dermatologist today.

I’m sure you’ve had similar experiences of older colleagues or mentors who were the best doctor in the clinic or the O.R. They are the Dr. Anthony Faucis, not just practicing, but leading while in their 8th or 9th decade. We are all so fortunate that they keep playing.

We’ve not made our final choices on whom to hire, but with two positions, I expect we’ll choose both a young doctor and an experienced one to add to our team. It will be fun to watch and learn from them. Just like it will be fun to watch Tom Brady in the Super Bowl again next year.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

The American Academy of Dermatology has announced a 3-year, multifaceted initiative to improve diversity, equity, and inclusion not only within the academy itself, but also in the profession of dermatology overall.

“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.

“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.

“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”

“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”

As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”

The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:

“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.

• “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
• “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
• “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.

The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.

The American Academy of Dermatology has announced a 3-year, multifaceted initiative to improve diversity, equity, and inclusion not only within the academy itself, but also in the profession of dermatology overall.

“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.

“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.

“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”

“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”

As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”

The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:

“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.

• “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
• “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
• “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.

The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.

The American Academy of Dermatology has announced a 3-year, multifaceted initiative to improve diversity, equity, and inclusion not only within the academy itself, but also in the profession of dermatology overall.

“Last year’s events surrounding social justice issues and the disproportionate impact of COVID-19 on minority communities underscored an urgent need for the academy to outline a strategy to address gaps in diversity, equity, and inclusion across the academy’s programs, provide better access to dermatologic care, and expand the pipeline for prospective dermatologists,” according to an AAD statement introducing the plan.

“The AAD has long recognized the importance of fostering diversity in the dermatology specialty and increasing dermatologic services to underserved populations as a key strategic goal,” Kanya Ferguson, MD, chair of the AAD’s diversity committee, said in an interview.

“The importance and urgency of furthering these goals have been underscored by the social justice events of 2020 and the disproportionate impact that COVID-19 has had, specifically on Black and Latino communities,” added Dr. Ferguson, of the department of dermatology, at the University of Iowa, Iowa City. “The 3-year plan comprehensively expands current diversity, equity, and inclusion initiatives in an effort to accelerate the Academy’s progress toward its strategic goals.”

“Numerous barriers persist that contribute to the narrowing pipeline in medicine and ultimately in dermatology,” Dr. Ferguson noted. “The AAD’s diversity, equity, and inclusion initiatives, toolkits, and resources aim to address some of these barriers through early exposure, pipeline programming, and mentorship.”

As for the next steps, “the diversity committee will be working hard over the next few years to coordinate the integration and adoption of initiatives throughout the Academy’s activities,” she added. “This work will take a significant amount of collaboration and the committee is excited to move this forward in a meaningful and sustainable way.”

The AAD’s diversity committee headed the development of the plan, unanimously approved by the AAD’s board of directors, which outlines four key goals for the next 3 years, presented in the Diversity in Dermatology plan as follows:

“Promote and facilitate diversity, equity, and inclusion within the AAD.” Steps toward this goal include facilitating diverse representation on AAD committees, councils, and task forces, increasing representation of skin of color session speakers and lecture topics at Academy meetings, and ensuring equity in the selection process for awards including the Leadership Forum, Academic Dermatology Leadership Program, Advanced Leadership Forum, Journal of the AAD Editorial Mentorship Program, and other leadership activities.

• “Ensure dermatologic education and research encompasses health disparities and skin of color, and advocate for Black and Latino patient representation in research.” Steps toward this goal include increasing use of images reflecting the full spectrum of skin types, ensuring that skin of color populations receive information about dermatologic diseases, and supporting underrepresented minority (URM) dermatology physician scientists in leadership and professional development.
• “Expand Academy’s Advocacy Priorities to prioritize addressing health inequities.” Steps toward this goal include prioritizing issues that affect minority and marginalized populations, establishing relationships with relevant congressional leadership, and advocating for patient support groups for diseases that disproportionately impact skin of color patients.
• “Increase the number of practicing dermatologists who are underrepresented minorities and provide leadership and professional development programming.” Steps toward this goal include expanding the AAD mentorship program to include physician scientists, expanding diversity champion programs, expanding outreach to URM college students in STEM majors, and launching an AAD Summer Diversity & Inclusion camp for younger students to promote interest in a medical career.

The AAD diversity committee also has assembled a toolkit of resources designed to help its members learn how to talk about race, be an effective ally, and achieve cultural competency. Additional updated resources include guidelines on mentorship and outreach.