Dermatology News

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Physician authors of clinical practice guidelines for psoriatic arthritis in the United States and Japan received payments from pharmaceutical companies totaling over $7 million during 2016-2018, according to a retrospective analysis of all authors on the most recent guidelines issued by the American College of Rheumatology (ACR) and the Japanese Dermatological Association (JDA).

In addition to finding that the majority of the authors of psoriatic arthritis (PsA) clinical practice guidelines (CPGs) issued by the JDA and ACR received substantial personal payments from pharmaceutical companies before and during CPG development, researchers led by Hanano Mamada and Anju Murayama of the Medical Governance Research Institute, Tokyo, wrote in Arthritis Care & Research that “several CPG authors self-cited their articles without the disclosure of NFCOI [nonfinancial conflicts of interest], and most of the recommendations were based on low or very low quality of evidence. Although the COI policies used by JDA and ACR are clearly inadequate, no significant revisions have been made for the last 3 years.”

Based on their findings, which were made using payment data from major Japanese pharmaceutical companies and the U.S. Open Payments Database from 2016 to 2018, the researchers suggested that the medical societies should:

• Adopt global standard COI policies from organizations such as the National Academy of Medicine and Guidelines International Network, including a 3-year lookback period for COI declaration.
• Consider a comprehensive definition and rigorous management with full disclosure of NFCOI.
• Publish a list of authors making each recommendation to grasp the implications of COI in clinical practice guidelines.
• Mention the detailed date of the COI disclosure, which should be close to the publication date as much as possible.

Financial conflicts of interest

The researchers used payment data published between 2016 and 2018 for all 83 companies belonging to the Japan Pharmaceutical Manufacturers Association, focusing on personal payments (for lecturing, writing, and consultancy) and excluding research payments, “since in Japan, the name, institution, and position of the author or researcher who received the research payment is not disclosed, which makes assessing research payments difficult.” To evaluate authors’ FCOI in the ACR’s CPG, the researchers analyzed the U.S. Open Payments Database “for all categories of general payments such as speaking, consulting, meals, and travel expenses 3 years from before the guideline’s first online publication on November 30, 2018.”

The 2018 ACR/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis had 36 authors and the JDA’s Clinical Practice Guideline for the Treatment of Psoriatic Arthritis 2019 had 23. Overall, 61% of JDA authors and half of ACR authors voluntarily declared FCOI with pharmaceutical companies; 25 of the ACR authors were U.S. physicians and could be included in the Open Payments Database search.

A total of 21 (91.3%) JDA authors and 21 (84.0%) ACR authors received at least one payment, with the combined total of $3,335,413 and $4,081,629 payments, respectively, over the 3 years. The average and median personal payments were $145,018 and $123,876 for JDA authors and $162,825 and $58,826 for ACR authors. When the payments to ACR authors were limited to lecturing, writing, and consulting fees that are required under the ACR’s COI policy, the mean was $130,102 and median was $39,375. The corresponding payments for JDA authors were $123,876 and $8,170, respectively,

The researchers found undisclosed payments for more than three-quarters of physician authors of the Japanese guideline, and nearly half of the doctors authoring the American guideline had undisclosed payments. These added up to $474,000 for the JDA, which amounted to 38% of the total for personal payments that must be reported to the JDA based on its COI policy for clinical practice guidelines, and $218,000 for the ACR, amounting to 18% of the total for personal payments that must be reported to the society based on its COI policy.

Of the 11 ACR authors who were not eligible for the U.S. Open Payments Database search, 5 declared FCOI with pharmaceutical companies in the guideline, meaning that 26 (72%) of the 36 authors had FCOI with pharmaceutical companies.

The ACR only required authors to declare FCOI covering 1 year before and during guideline development, and although the JDA required authors to declare their FCOI for the past 3 years of guideline development, the study authors noted that the JDA guideline disclosed them for only 2 years (between Jan. 1, 2017, and Dec. 31, 2018).

“It is true that influential doctors such as clinical practice guideline authors tend to receive various types of payments from pharmaceutical companies and that it is difficult to conduct research without funding from pharmaceutical companies. However, our current research mainly focuses on personal payments from pharmaceutical companies such as lecture fees and consulting fees. These payments are recognized as pocket money and are not used for research. Thus, it is questionable that the observed relationships are something evitable,” the researchers wrote.
 

Nonfinancial conflicts of interest

Many authors of the ACR’s CPG and the JDA’s CPG also had NFCOI, defined objectively in this study as self-citation rate. NFCOI have been more broadly defined by the International Committee of Medical Journal Editors (ICMJE) as “conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs”; the ICMJE recommends reporting NFCOI on its COI form.

The JDA guideline included self-citations by 78% of its authors, compared with 32% of the ACR guideline authors, but this weighed differently among the two guidelines in that only 12 of the 354 (3.4%) citations in the JDA guideline were self-cited, compared with 46 of 137 (34%) citations in the ACR guideline.

The researchers noted that while the self-citation rates between JDA and ACR authors “differed remarkably,” the impact of ACR authors on CPG recommendations was much more direct. Three-quarters of JDA authors’ self-cited articles were about observational studies, whereas 52% of the ACR authors’ self-cited articles were clinical trials, most of which were randomized, controlled studies, and these NFCOI were not disclosed in the guideline.

Half of the strong recommendations in the JDA guideline were based on low or very low quality of evidence, whereas the ACR guideline had no strong recommendations based on low or very low quality of evidence.

This study was supported by the nonprofit Medical Governance Research Institute, which receives donations from Ain Pharmacies Inc., other organizations, and private individuals. The study also received support from the Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. Three authors reported receiving personal fees from several pharmaceutical companies for work outside of the scope of this study.

Don’t like needles? Have we got a vaccine for you

Here’s a quick question: How do you turn the most annoying thing ever into something positive?

No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.

Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.

Courtesy Jim Gathany/CDC

In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.

More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.

The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.

Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
 

Climate change: Sleeping your life away

It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.

Public Domain Vectors

That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.

Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.

The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.

The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
 

Maybe it would have been a dragon WITH cancer

If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyll­gogery­chwyrn­drobwll­llan­tysilio­gogo­goch) and, two, the association with dragons. The Welsh flag even has a dragon on it.

evakocsan/Pixnio

With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.

Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.

Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.

Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.

Don’t like needles? Have we got a vaccine for you

Here’s a quick question: How do you turn the most annoying thing ever into something positive?

No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.

Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.

Courtesy Jim Gathany/CDC

In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.

More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.

The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.

Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
 

Climate change: Sleeping your life away

It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.

Public Domain Vectors

That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.

Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.

The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.

The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
 

Maybe it would have been a dragon WITH cancer

If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyll­gogery­chwyrn­drobwll­llan­tysilio­gogo­goch) and, two, the association with dragons. The Welsh flag even has a dragon on it.

evakocsan/Pixnio

With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.

Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.

Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.

Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.

Don’t like needles? Have we got a vaccine for you

Here’s a quick question: How do you turn the most annoying thing ever into something positive?

No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.

Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.

Courtesy Jim Gathany/CDC

In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.

More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.

The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.

Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
 

Climate change: Sleeping your life away

It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.

Public Domain Vectors

That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.

Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.

The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.

The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
 

Maybe it would have been a dragon WITH cancer

If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyll­gogery­chwyrn­drobwll­llan­tysilio­gogo­goch) and, two, the association with dragons. The Welsh flag even has a dragon on it.

evakocsan/Pixnio

With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.

Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.

Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.

Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.

“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.

The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.

Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.

Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.

“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”

What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.

“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.

“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.

One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed, the tension, stress, dangerous conditions during COVID, burnout, and other problems have made many physicians tired, frustrated, depressed, and more reactive to situations around them.
 

Self-selecting traits become an Achilles heel

“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.

Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.

In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).

One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
 

How to help avert disruptive behavior in medical settings

Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.

In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.

Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.

The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.

However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.

“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.

Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.

“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
 

Misinformation is professional misconduct

Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.

While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.

Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.

Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.

“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”

That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.

On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.

“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”

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

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

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

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

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

Efficacy of the investigational drug lebrikizumab is maintained in patients with moderate to severe atopic dermatitis for at least 1 year, according to new results from the phase 3 ADvocate1 and ADvocate2 trials.

“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.

Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).

“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.

“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.

Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.

“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.

“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.

“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.

These features could be very important for long-term dosing of the drug, he argued.
 

Lebrikizumab phase 3 trials

ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.

These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.

The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.

ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.

After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.

This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.

Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
 

Induction and maintenance phase results

At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).

A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).

In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”

In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.

EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.

As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.

Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
 

Different dosing results questioned

During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”

Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.

“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.

“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.

He added: “That’s highly speculative, of course.”

Short-term safety data

The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.

“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.

“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.

Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.

The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.

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

Ruxolitinib cream can help repigment the skin in many body areas affected with vitiligo, researchers reported at the annual congress of the European Academy of Dermatology and Venereology.

Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).

Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.

During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.

Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.

“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.

In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
 

First FDA-approved treatment for adults and adolescents with vitiligo

Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.

This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.

“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.

“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”

The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.

Pooled analysis performed

Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.

For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.

Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.

“We didn’t look at the face; that we know well, that is a very good result,” he said.

The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.

Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.

The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.

“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
 

Steady improvements, no new safety concerns

Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.

“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.

Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.

“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.

“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”

There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.

The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
 

An expert’s take-home

“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.

“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.

“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.

The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.

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

Ruxolitinib cream can help repigment the skin in many body areas affected with vitiligo, researchers reported at the annual congress of the European Academy of Dermatology and Venereology.

Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).

Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.

During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.

Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.

“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.

In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
 

First FDA-approved treatment for adults and adolescents with vitiligo

Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.

This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.

“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.

“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”

The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.

Pooled analysis performed

Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.

For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.

Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.

“We didn’t look at the face; that we know well, that is a very good result,” he said.

The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.

Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.

The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.

“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
 

Steady improvements, no new safety concerns

Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.

“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.

Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.

“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.

“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”

There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.

The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
 

An expert’s take-home

“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.

“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.

“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.

The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.

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

Ruxolitinib cream can help repigment the skin in many body areas affected with vitiligo, researchers reported at the annual congress of the European Academy of Dermatology and Venereology.

Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).

Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.

During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.

Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.

“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.

In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
 

First FDA-approved treatment for adults and adolescents with vitiligo

Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.

This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.

“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.

“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”

The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.

Pooled analysis performed

Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.

For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.

Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.

“We didn’t look at the face; that we know well, that is a very good result,” he said.

The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.

Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.

The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.

“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
 

Steady improvements, no new safety concerns

Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.

“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.

Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.

“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.

“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”

There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.

The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
 

An expert’s take-home

“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.

“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.

“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.

The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.

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

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

Medscape Live and this news organization are owned by the same parent company.

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

Medscape Live and this news organization are owned by the same parent company.

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

Medscape Live and this news organization are owned by the same parent company.