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Infantile hemangioma: Analysis underscores importance of early propranolol treatment

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Tue, 01/10/2023 - 11:21

Among patients with infantile hemangioma (IH), initiation of oral propranolol 3 mg/kg/day prior to 10 weeks of age was associated with a significantly better rate of treatment success, results from a post-hoc analysis of phase 2 and 3 clinical trial data showed.

“It is widely accepted that oral propranolol should be started early to improve the success rate, but proposed thresholds have lacked supportive data,” researchers led by Christine Léauté-Labrèze, MD, of the department of dermatology at Pellegrin Children’s Hospital, Bordeaux, France, wrote in the study, which was published online in Pediatric Dermatology. In the pivotal phase 2/3 trial of propranolol of 460 infants, published in 2015, the mean initiation of treatment was 104 days, they added, but “in real-life studies, most infants are referred later than this.”

In addition, a European expert consensus panel set the ideal age for a patient to be seen by a specialist at between 3 and 5 weeks of age, while an American Academy of Pediatrics Clinical Practice Guideline set the ideal age at 1 month.

To determine factors associated with a higher success rate with oral propranolol treatment, such as age at treatment initiation, the researchers analyzed data from the pivotal phase 2-3 clinical trial of oral propranolol in IH. They used Generalized Additive Model (GAM) charts with Generalized Linear Models (GLM), then a rule discovery algorithm, to identify subgroups presenting a high probability of occurrence of the predefined outcome: success at 6 months of treatment (defined as complete or nearly complete resolution of the target hemangioma). Study coauthors were Ilona J. Frieden, MD, of the department of dermatology at the University of California, San Francisco, and director of the UCSF Birthmarks & Vascular Anomalies Center; and Alain Delarue, MD, of medical affairs at Pierre Fabre Dermatologie, Lavaur, France, which markets the pediatric formulation of propranolol approved by the Food and Drug Administration in 2014 for treating IH.

They found that patients who started oral propranolol 3 mg/kg/day before the age of 10 weeks had a success rate of 86%, while those who started treatment after 10 weeks of age had a success rate of 60%. “Our clinical experience suggested that starting early propranolol gave better results on infantile hemangiomas; however, we were surprised” by the significance of the difference, the three study authors stated in an e-mail reply to this news organization.



“It therefore seemed essential to communicate the importance of early treatment to maximize the possibilities of recovery for children. Our findings support early treatment of at-risk infantile hemangiomas, without waiting for complications such as ulceration and/or functional consequences,” they added.

In their e-mail reply, the authors stated that treatment of high-risk IH should be initiated whenever possible before 10 weeks of age. Ideally, infants should be examined by a practitioner between 2 and 5 weeks of age and referred to a specialized center if they have features of an at-risk IH. Tools such as the Infantile Hemangioma Referral Score (IHReS) and consensus guidelines such as the AAP Clinical Practice Guideline “can help guide clinicians seeing newborns and young infants to recognize which IH may need early intervention,” they stated.

For rural-based providers whose patients and their families may not live close to an expert center, the study authors especially recommend using the IHReS scoring tool, which is readily available online and “will be very helpful in assessing whether patients need referral.” For those who do, they added, “triage using photographs is an excellent way to reach out to a referral center for advice and possible urgent referral.” In addition, a recent study emphasized that telemedicine using either live interactive portals or store-and-forward can be helpful in evaluation and management of patients with IH.

Dr. Léauté-Labrèze and colleagues acknowledged certain limitations of the analysis, including the fact that it was performed post-hoc on an existing study and the challenge of translating its findings into clinical practice.

The three study authors were also authors of the 2015 NEJM study; Dr. Léauté-Labrèze was the lead author.

Dr. Léauté-Labrèze disclosed that she has served as a speaker and consultant for Pierre Fabre. Dr. Delarue is an employee of the company. Dr. Frieden reported having no disclosures relevant to the analysis.

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Among patients with infantile hemangioma (IH), initiation of oral propranolol 3 mg/kg/day prior to 10 weeks of age was associated with a significantly better rate of treatment success, results from a post-hoc analysis of phase 2 and 3 clinical trial data showed.

“It is widely accepted that oral propranolol should be started early to improve the success rate, but proposed thresholds have lacked supportive data,” researchers led by Christine Léauté-Labrèze, MD, of the department of dermatology at Pellegrin Children’s Hospital, Bordeaux, France, wrote in the study, which was published online in Pediatric Dermatology. In the pivotal phase 2/3 trial of propranolol of 460 infants, published in 2015, the mean initiation of treatment was 104 days, they added, but “in real-life studies, most infants are referred later than this.”

In addition, a European expert consensus panel set the ideal age for a patient to be seen by a specialist at between 3 and 5 weeks of age, while an American Academy of Pediatrics Clinical Practice Guideline set the ideal age at 1 month.

To determine factors associated with a higher success rate with oral propranolol treatment, such as age at treatment initiation, the researchers analyzed data from the pivotal phase 2-3 clinical trial of oral propranolol in IH. They used Generalized Additive Model (GAM) charts with Generalized Linear Models (GLM), then a rule discovery algorithm, to identify subgroups presenting a high probability of occurrence of the predefined outcome: success at 6 months of treatment (defined as complete or nearly complete resolution of the target hemangioma). Study coauthors were Ilona J. Frieden, MD, of the department of dermatology at the University of California, San Francisco, and director of the UCSF Birthmarks & Vascular Anomalies Center; and Alain Delarue, MD, of medical affairs at Pierre Fabre Dermatologie, Lavaur, France, which markets the pediatric formulation of propranolol approved by the Food and Drug Administration in 2014 for treating IH.

They found that patients who started oral propranolol 3 mg/kg/day before the age of 10 weeks had a success rate of 86%, while those who started treatment after 10 weeks of age had a success rate of 60%. “Our clinical experience suggested that starting early propranolol gave better results on infantile hemangiomas; however, we were surprised” by the significance of the difference, the three study authors stated in an e-mail reply to this news organization.



“It therefore seemed essential to communicate the importance of early treatment to maximize the possibilities of recovery for children. Our findings support early treatment of at-risk infantile hemangiomas, without waiting for complications such as ulceration and/or functional consequences,” they added.

In their e-mail reply, the authors stated that treatment of high-risk IH should be initiated whenever possible before 10 weeks of age. Ideally, infants should be examined by a practitioner between 2 and 5 weeks of age and referred to a specialized center if they have features of an at-risk IH. Tools such as the Infantile Hemangioma Referral Score (IHReS) and consensus guidelines such as the AAP Clinical Practice Guideline “can help guide clinicians seeing newborns and young infants to recognize which IH may need early intervention,” they stated.

For rural-based providers whose patients and their families may not live close to an expert center, the study authors especially recommend using the IHReS scoring tool, which is readily available online and “will be very helpful in assessing whether patients need referral.” For those who do, they added, “triage using photographs is an excellent way to reach out to a referral center for advice and possible urgent referral.” In addition, a recent study emphasized that telemedicine using either live interactive portals or store-and-forward can be helpful in evaluation and management of patients with IH.

Dr. Léauté-Labrèze and colleagues acknowledged certain limitations of the analysis, including the fact that it was performed post-hoc on an existing study and the challenge of translating its findings into clinical practice.

The three study authors were also authors of the 2015 NEJM study; Dr. Léauté-Labrèze was the lead author.

Dr. Léauté-Labrèze disclosed that she has served as a speaker and consultant for Pierre Fabre. Dr. Delarue is an employee of the company. Dr. Frieden reported having no disclosures relevant to the analysis.

Among patients with infantile hemangioma (IH), initiation of oral propranolol 3 mg/kg/day prior to 10 weeks of age was associated with a significantly better rate of treatment success, results from a post-hoc analysis of phase 2 and 3 clinical trial data showed.

“It is widely accepted that oral propranolol should be started early to improve the success rate, but proposed thresholds have lacked supportive data,” researchers led by Christine Léauté-Labrèze, MD, of the department of dermatology at Pellegrin Children’s Hospital, Bordeaux, France, wrote in the study, which was published online in Pediatric Dermatology. In the pivotal phase 2/3 trial of propranolol of 460 infants, published in 2015, the mean initiation of treatment was 104 days, they added, but “in real-life studies, most infants are referred later than this.”

In addition, a European expert consensus panel set the ideal age for a patient to be seen by a specialist at between 3 and 5 weeks of age, while an American Academy of Pediatrics Clinical Practice Guideline set the ideal age at 1 month.

To determine factors associated with a higher success rate with oral propranolol treatment, such as age at treatment initiation, the researchers analyzed data from the pivotal phase 2-3 clinical trial of oral propranolol in IH. They used Generalized Additive Model (GAM) charts with Generalized Linear Models (GLM), then a rule discovery algorithm, to identify subgroups presenting a high probability of occurrence of the predefined outcome: success at 6 months of treatment (defined as complete or nearly complete resolution of the target hemangioma). Study coauthors were Ilona J. Frieden, MD, of the department of dermatology at the University of California, San Francisco, and director of the UCSF Birthmarks & Vascular Anomalies Center; and Alain Delarue, MD, of medical affairs at Pierre Fabre Dermatologie, Lavaur, France, which markets the pediatric formulation of propranolol approved by the Food and Drug Administration in 2014 for treating IH.

They found that patients who started oral propranolol 3 mg/kg/day before the age of 10 weeks had a success rate of 86%, while those who started treatment after 10 weeks of age had a success rate of 60%. “Our clinical experience suggested that starting early propranolol gave better results on infantile hemangiomas; however, we were surprised” by the significance of the difference, the three study authors stated in an e-mail reply to this news organization.



“It therefore seemed essential to communicate the importance of early treatment to maximize the possibilities of recovery for children. Our findings support early treatment of at-risk infantile hemangiomas, without waiting for complications such as ulceration and/or functional consequences,” they added.

In their e-mail reply, the authors stated that treatment of high-risk IH should be initiated whenever possible before 10 weeks of age. Ideally, infants should be examined by a practitioner between 2 and 5 weeks of age and referred to a specialized center if they have features of an at-risk IH. Tools such as the Infantile Hemangioma Referral Score (IHReS) and consensus guidelines such as the AAP Clinical Practice Guideline “can help guide clinicians seeing newborns and young infants to recognize which IH may need early intervention,” they stated.

For rural-based providers whose patients and their families may not live close to an expert center, the study authors especially recommend using the IHReS scoring tool, which is readily available online and “will be very helpful in assessing whether patients need referral.” For those who do, they added, “triage using photographs is an excellent way to reach out to a referral center for advice and possible urgent referral.” In addition, a recent study emphasized that telemedicine using either live interactive portals or store-and-forward can be helpful in evaluation and management of patients with IH.

Dr. Léauté-Labrèze and colleagues acknowledged certain limitations of the analysis, including the fact that it was performed post-hoc on an existing study and the challenge of translating its findings into clinical practice.

The three study authors were also authors of the 2015 NEJM study; Dr. Léauté-Labrèze was the lead author.

Dr. Léauté-Labrèze disclosed that she has served as a speaker and consultant for Pierre Fabre. Dr. Delarue is an employee of the company. Dr. Frieden reported having no disclosures relevant to the analysis.

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Do collagen supplements benefit the skin?

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Tue, 01/10/2023 - 11:27

– When patients ask if collagen supplements can benefit their skin, what should you tell them?

According to Ava Shamban, MD, a dermatologist who practices in Santa Monica, Calif., limited data exist to suggest that consuming collagen-dense foods can directly benefit skin or joint health. And in her opinion, more research is needed to establish knowledge of the effects and physiologic mechanism of collagen supplementation.

Dr. Ava Shamban

“Collagen is the most abundant protein in the skin; it is found only in animal flesh like meat and fish that contain connective tissue,” she said at the annual Masters of Aesthetics Symposium. “We produce less collagen as we age. External factors can slow down our collagen production, including smoking, sun exposure, lack of sleep/exercise, and alcohol consumption.”

Though human studies are lacking, some trials have found that collagen supplements may improve skin hydration and elasticity. “Maybe there’s some benefit, but the digestive process breaks collagen down into amino acids, so I don’t buy it,” she said.

At the meeting, Dr. Shamban discussed other topics related to the effect of supplements and nutrition on the skin:

Can Nutrafol reverse permanent hair loss? “It definitely doesn’t do that,” she said. “Can it help regrow hair? Perhaps.” Nutrafol is an over-the-counter supplement that aims to relieve moderate hair thinning or strengthen hair to prevent breakage, and is physician-formulated with medical-grade ingredients that target root causes of thinning such as stress, lifestyle, hormones, and nutrition.

As for biotin, “we now know that high levels of biotin can actually cause hair loss,” she said. “If you have advanced hair loss, supplements may not work for you. There is no hair regrowth supplement that can bring back a dead hair follicle. Can it help a miniaturized hair follicle? Maybe. Platelet-rich plasma injections have been shown to stimulate hair growth, but only if the follicle is miniaturized, not if it’s totally gone.”

How does the human microbiome affect skin? In a review of sequencing surveys of healthy adults, “the composition of microbial communities was found to be primarily dependent on the physiology of the skin site, with changes in the relative abundance of bacterial taxa associated with moist, dry, and sebaceous environments,” the authors reported . “The microbiome is the genetic material of all the microbes that live inside the body, including bacteria, fungi, protozoa, and viruses,” Dr. Shamban said. “The more diverse the microbiota is, the healthier it’s considered. That diversity is enriched through a diet full of various vegetables and fruits.”



Nearly all adults are colonized with Cutibacterium acnes (formerly Propionibacterium acnes), but only a minority have acne, which highlights the importance of studying diseases in the broader context of host genetics, immune or barrier defects, the microbiome, and the environment, she added. For example, the decreased diversity of the skin microbiome in people with atopic dermatitis has been linked to a reduction in environmental biodiversity in the areas surrounding their homes.

Do adaptogens have a role in skin care? Adaptogens such as ashwagandha, elderberry, ginseng, licorice root, neem, moringa, and reishi mushrooms have been used in Chinese and Ayurvedic medicine for centuries and are purported to promote adaptability, resilience, and survival of living organisms in stress. They appear to affect the neuroendocrine immune system and at low doses may function as mild stress mimetics.

“The idea is that combining adaptogens into skin care can reinforce and support the skin’s resistance against stressors that can accelerate visible signs of aging,” said Dr. Shamban. “They share some similarities with antioxidants in that their main purpose is to protect the body from external stressors such as UV rays, oxidation, and pollution.” More studies should be conducted to verify effectiveness, she said, “but Eastern practices that have incorporated it for centuries shouldn’t be fully dismissed. Most doctors believe adaptogens are safe, but how they interact with the mechanics of the body’s stress response system remains a mystery.”

Embrace the consumption of micronutrients. Inspired by work from dermatologist Zoe Diana Draelos, MD, Dr. Shamban advises patients to eat a “rainbow of different colored foods” every day, especially those rich in vitamins A, C, and E. Green foods are generally rich in vitamin E, brown foods are rich in trace minerals, and blue/purple foods are rich in antioxidants. “It’s always best to get nutrients from a rich, healthy diet, but sometimes our skin requires extra help,” she said.

A randomized, placebo-controlled, double-blind study by French researchers, which showed that skin is prone to seasonal changes during the winter, particularly in exposed areas, also looked at whether a daily micronutrient supplement with ingredients that included green tea extract, blackcurrant seed oil, and magnesium, had an impact on the negative effects of winter weather on the skin. “The data indicate that oral micronutrient supplementation can be a safe treatment, with no serious side effects, and may prevent or even eliminate the negative effects of winter on the skin,” she said.

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

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– When patients ask if collagen supplements can benefit their skin, what should you tell them?

According to Ava Shamban, MD, a dermatologist who practices in Santa Monica, Calif., limited data exist to suggest that consuming collagen-dense foods can directly benefit skin or joint health. And in her opinion, more research is needed to establish knowledge of the effects and physiologic mechanism of collagen supplementation.

Dr. Ava Shamban

“Collagen is the most abundant protein in the skin; it is found only in animal flesh like meat and fish that contain connective tissue,” she said at the annual Masters of Aesthetics Symposium. “We produce less collagen as we age. External factors can slow down our collagen production, including smoking, sun exposure, lack of sleep/exercise, and alcohol consumption.”

Though human studies are lacking, some trials have found that collagen supplements may improve skin hydration and elasticity. “Maybe there’s some benefit, but the digestive process breaks collagen down into amino acids, so I don’t buy it,” she said.

At the meeting, Dr. Shamban discussed other topics related to the effect of supplements and nutrition on the skin:

Can Nutrafol reverse permanent hair loss? “It definitely doesn’t do that,” she said. “Can it help regrow hair? Perhaps.” Nutrafol is an over-the-counter supplement that aims to relieve moderate hair thinning or strengthen hair to prevent breakage, and is physician-formulated with medical-grade ingredients that target root causes of thinning such as stress, lifestyle, hormones, and nutrition.

As for biotin, “we now know that high levels of biotin can actually cause hair loss,” she said. “If you have advanced hair loss, supplements may not work for you. There is no hair regrowth supplement that can bring back a dead hair follicle. Can it help a miniaturized hair follicle? Maybe. Platelet-rich plasma injections have been shown to stimulate hair growth, but only if the follicle is miniaturized, not if it’s totally gone.”

How does the human microbiome affect skin? In a review of sequencing surveys of healthy adults, “the composition of microbial communities was found to be primarily dependent on the physiology of the skin site, with changes in the relative abundance of bacterial taxa associated with moist, dry, and sebaceous environments,” the authors reported . “The microbiome is the genetic material of all the microbes that live inside the body, including bacteria, fungi, protozoa, and viruses,” Dr. Shamban said. “The more diverse the microbiota is, the healthier it’s considered. That diversity is enriched through a diet full of various vegetables and fruits.”



Nearly all adults are colonized with Cutibacterium acnes (formerly Propionibacterium acnes), but only a minority have acne, which highlights the importance of studying diseases in the broader context of host genetics, immune or barrier defects, the microbiome, and the environment, she added. For example, the decreased diversity of the skin microbiome in people with atopic dermatitis has been linked to a reduction in environmental biodiversity in the areas surrounding their homes.

Do adaptogens have a role in skin care? Adaptogens such as ashwagandha, elderberry, ginseng, licorice root, neem, moringa, and reishi mushrooms have been used in Chinese and Ayurvedic medicine for centuries and are purported to promote adaptability, resilience, and survival of living organisms in stress. They appear to affect the neuroendocrine immune system and at low doses may function as mild stress mimetics.

“The idea is that combining adaptogens into skin care can reinforce and support the skin’s resistance against stressors that can accelerate visible signs of aging,” said Dr. Shamban. “They share some similarities with antioxidants in that their main purpose is to protect the body from external stressors such as UV rays, oxidation, and pollution.” More studies should be conducted to verify effectiveness, she said, “but Eastern practices that have incorporated it for centuries shouldn’t be fully dismissed. Most doctors believe adaptogens are safe, but how they interact with the mechanics of the body’s stress response system remains a mystery.”

Embrace the consumption of micronutrients. Inspired by work from dermatologist Zoe Diana Draelos, MD, Dr. Shamban advises patients to eat a “rainbow of different colored foods” every day, especially those rich in vitamins A, C, and E. Green foods are generally rich in vitamin E, brown foods are rich in trace minerals, and blue/purple foods are rich in antioxidants. “It’s always best to get nutrients from a rich, healthy diet, but sometimes our skin requires extra help,” she said.

A randomized, placebo-controlled, double-blind study by French researchers, which showed that skin is prone to seasonal changes during the winter, particularly in exposed areas, also looked at whether a daily micronutrient supplement with ingredients that included green tea extract, blackcurrant seed oil, and magnesium, had an impact on the negative effects of winter weather on the skin. “The data indicate that oral micronutrient supplementation can be a safe treatment, with no serious side effects, and may prevent or even eliminate the negative effects of winter on the skin,” she said.

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

– When patients ask if collagen supplements can benefit their skin, what should you tell them?

According to Ava Shamban, MD, a dermatologist who practices in Santa Monica, Calif., limited data exist to suggest that consuming collagen-dense foods can directly benefit skin or joint health. And in her opinion, more research is needed to establish knowledge of the effects and physiologic mechanism of collagen supplementation.

Dr. Ava Shamban

“Collagen is the most abundant protein in the skin; it is found only in animal flesh like meat and fish that contain connective tissue,” she said at the annual Masters of Aesthetics Symposium. “We produce less collagen as we age. External factors can slow down our collagen production, including smoking, sun exposure, lack of sleep/exercise, and alcohol consumption.”

Though human studies are lacking, some trials have found that collagen supplements may improve skin hydration and elasticity. “Maybe there’s some benefit, but the digestive process breaks collagen down into amino acids, so I don’t buy it,” she said.

At the meeting, Dr. Shamban discussed other topics related to the effect of supplements and nutrition on the skin:

Can Nutrafol reverse permanent hair loss? “It definitely doesn’t do that,” she said. “Can it help regrow hair? Perhaps.” Nutrafol is an over-the-counter supplement that aims to relieve moderate hair thinning or strengthen hair to prevent breakage, and is physician-formulated with medical-grade ingredients that target root causes of thinning such as stress, lifestyle, hormones, and nutrition.

As for biotin, “we now know that high levels of biotin can actually cause hair loss,” she said. “If you have advanced hair loss, supplements may not work for you. There is no hair regrowth supplement that can bring back a dead hair follicle. Can it help a miniaturized hair follicle? Maybe. Platelet-rich plasma injections have been shown to stimulate hair growth, but only if the follicle is miniaturized, not if it’s totally gone.”

How does the human microbiome affect skin? In a review of sequencing surveys of healthy adults, “the composition of microbial communities was found to be primarily dependent on the physiology of the skin site, with changes in the relative abundance of bacterial taxa associated with moist, dry, and sebaceous environments,” the authors reported . “The microbiome is the genetic material of all the microbes that live inside the body, including bacteria, fungi, protozoa, and viruses,” Dr. Shamban said. “The more diverse the microbiota is, the healthier it’s considered. That diversity is enriched through a diet full of various vegetables and fruits.”



Nearly all adults are colonized with Cutibacterium acnes (formerly Propionibacterium acnes), but only a minority have acne, which highlights the importance of studying diseases in the broader context of host genetics, immune or barrier defects, the microbiome, and the environment, she added. For example, the decreased diversity of the skin microbiome in people with atopic dermatitis has been linked to a reduction in environmental biodiversity in the areas surrounding their homes.

Do adaptogens have a role in skin care? Adaptogens such as ashwagandha, elderberry, ginseng, licorice root, neem, moringa, and reishi mushrooms have been used in Chinese and Ayurvedic medicine for centuries and are purported to promote adaptability, resilience, and survival of living organisms in stress. They appear to affect the neuroendocrine immune system and at low doses may function as mild stress mimetics.

“The idea is that combining adaptogens into skin care can reinforce and support the skin’s resistance against stressors that can accelerate visible signs of aging,” said Dr. Shamban. “They share some similarities with antioxidants in that their main purpose is to protect the body from external stressors such as UV rays, oxidation, and pollution.” More studies should be conducted to verify effectiveness, she said, “but Eastern practices that have incorporated it for centuries shouldn’t be fully dismissed. Most doctors believe adaptogens are safe, but how they interact with the mechanics of the body’s stress response system remains a mystery.”

Embrace the consumption of micronutrients. Inspired by work from dermatologist Zoe Diana Draelos, MD, Dr. Shamban advises patients to eat a “rainbow of different colored foods” every day, especially those rich in vitamins A, C, and E. Green foods are generally rich in vitamin E, brown foods are rich in trace minerals, and blue/purple foods are rich in antioxidants. “It’s always best to get nutrients from a rich, healthy diet, but sometimes our skin requires extra help,” she said.

A randomized, placebo-controlled, double-blind study by French researchers, which showed that skin is prone to seasonal changes during the winter, particularly in exposed areas, also looked at whether a daily micronutrient supplement with ingredients that included green tea extract, blackcurrant seed oil, and magnesium, had an impact on the negative effects of winter weather on the skin. “The data indicate that oral micronutrient supplementation can be a safe treatment, with no serious side effects, and may prevent or even eliminate the negative effects of winter on the skin,” she said.

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

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Berdazimer gel under review at FDA for treating molluscum contagiosum

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Fri, 01/06/2023 - 15:15

A new drug application for berdazimer gel 10.3% for treating molluscum contagiosum (MC) has been submitted to the Food and Drug Administration, the manufacturer announced.

If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.



The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.

The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.

The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.

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A new drug application for berdazimer gel 10.3% for treating molluscum contagiosum (MC) has been submitted to the Food and Drug Administration, the manufacturer announced.

If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.



The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.

The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.

The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.

A new drug application for berdazimer gel 10.3% for treating molluscum contagiosum (MC) has been submitted to the Food and Drug Administration, the manufacturer announced.

If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.



The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.

The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.

The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.

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Five thoughts on the Damar Hamlin collapse

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Tue, 01/10/2023 - 11:50

 

The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Dr. John Mandrola

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

 

 

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

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The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Dr. John Mandrola

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

 

 

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

 

The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Dr. John Mandrola

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

 

 

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

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Small study finds high dose vitamin D relieved toxic erythema of chemotherapy

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Fri, 01/06/2023 - 12:09

High-dose vitamin D led to improvement of toxic erythema of chemotherapy (TEC) within 1 to 4 days in a retrospective case series of six patients seen on an inpatient dermatology consultative service.

Currently, chemotherapy cessation, delay, or dose modification are the “only reliable methods of resolving TEC,” and supportive agents such as topical corticosteroids, topical keratolytics, and pain control are associated with variable and “relatively slow improvement involving 2 to 4 weeks of recovery after chemotherapy interruption,” Cuong V. Nguyen, MD, of the department of dermatology at Northwestern University, Chicago, and colleagues, wrote in a research letter.

Dr. Adam Friedman

Onset of TEC in the six patients occurred a mean of 8.5 days after chemotherapy. Vitamin D – 50,000 IU for one patient and 100,000 IU for the others – was administered a mean of 4.3 days from rash onset and again in 7 days. Triamcinolone, 0.1%, or clobetasol, 0.05%, ointments were also prescribed.

All patients experienced symptomatic improvement in pain, pruritus, or swelling within a day of the first vitamin D treatment, and improvement in redness within 1 to 4 days, the authors said. The second treatment was administered for residual symptoms.

Adam Friedman, MD, professor and chair of dermatology and director of the supportive oncodermatology clinic at George Washington University, Washington, said that supporting patients through the “expected, disabling and often treatment-limiting side effects of oncologic therapies” is an area that is “in its infancy” and is characterized by limited evidence-based approaches.

“Creativity is therefore a must,” he said, commenting on the research letter. “Practice starts with anecdote, and this is certainly an exciting finding ... I look forward to trialing this with our patients at GW.”

Five of the six patients had a hematologic condition that required induction chemotherapy before hematopoietic stem cell transplant, and one was receiving regorafenib for treatment of glioblastoma multiforme. Diagnosis of TEC was established by clinical presentation, and five of the six patients underwent a biopsy. Biopsy findings were consistent with a TEC diagnosis in three patients, and showed nonspecific perivascular dermatitis in two, the investigators reported.

Further research is needed to determine optimal dosing, “delineate safety concerns and potential role in cancer treatment, and establish whether a durable response in patients with continuous chemotherapy, such as in an outpatient setting, is possible,” they said.

Dr. Nguyen and his coauthors reported no conflict of interest disclosures.

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High-dose vitamin D led to improvement of toxic erythema of chemotherapy (TEC) within 1 to 4 days in a retrospective case series of six patients seen on an inpatient dermatology consultative service.

Currently, chemotherapy cessation, delay, or dose modification are the “only reliable methods of resolving TEC,” and supportive agents such as topical corticosteroids, topical keratolytics, and pain control are associated with variable and “relatively slow improvement involving 2 to 4 weeks of recovery after chemotherapy interruption,” Cuong V. Nguyen, MD, of the department of dermatology at Northwestern University, Chicago, and colleagues, wrote in a research letter.

Dr. Adam Friedman

Onset of TEC in the six patients occurred a mean of 8.5 days after chemotherapy. Vitamin D – 50,000 IU for one patient and 100,000 IU for the others – was administered a mean of 4.3 days from rash onset and again in 7 days. Triamcinolone, 0.1%, or clobetasol, 0.05%, ointments were also prescribed.

All patients experienced symptomatic improvement in pain, pruritus, or swelling within a day of the first vitamin D treatment, and improvement in redness within 1 to 4 days, the authors said. The second treatment was administered for residual symptoms.

Adam Friedman, MD, professor and chair of dermatology and director of the supportive oncodermatology clinic at George Washington University, Washington, said that supporting patients through the “expected, disabling and often treatment-limiting side effects of oncologic therapies” is an area that is “in its infancy” and is characterized by limited evidence-based approaches.

“Creativity is therefore a must,” he said, commenting on the research letter. “Practice starts with anecdote, and this is certainly an exciting finding ... I look forward to trialing this with our patients at GW.”

Five of the six patients had a hematologic condition that required induction chemotherapy before hematopoietic stem cell transplant, and one was receiving regorafenib for treatment of glioblastoma multiforme. Diagnosis of TEC was established by clinical presentation, and five of the six patients underwent a biopsy. Biopsy findings were consistent with a TEC diagnosis in three patients, and showed nonspecific perivascular dermatitis in two, the investigators reported.

Further research is needed to determine optimal dosing, “delineate safety concerns and potential role in cancer treatment, and establish whether a durable response in patients with continuous chemotherapy, such as in an outpatient setting, is possible,” they said.

Dr. Nguyen and his coauthors reported no conflict of interest disclosures.

High-dose vitamin D led to improvement of toxic erythema of chemotherapy (TEC) within 1 to 4 days in a retrospective case series of six patients seen on an inpatient dermatology consultative service.

Currently, chemotherapy cessation, delay, or dose modification are the “only reliable methods of resolving TEC,” and supportive agents such as topical corticosteroids, topical keratolytics, and pain control are associated with variable and “relatively slow improvement involving 2 to 4 weeks of recovery after chemotherapy interruption,” Cuong V. Nguyen, MD, of the department of dermatology at Northwestern University, Chicago, and colleagues, wrote in a research letter.

Dr. Adam Friedman

Onset of TEC in the six patients occurred a mean of 8.5 days after chemotherapy. Vitamin D – 50,000 IU for one patient and 100,000 IU for the others – was administered a mean of 4.3 days from rash onset and again in 7 days. Triamcinolone, 0.1%, or clobetasol, 0.05%, ointments were also prescribed.

All patients experienced symptomatic improvement in pain, pruritus, or swelling within a day of the first vitamin D treatment, and improvement in redness within 1 to 4 days, the authors said. The second treatment was administered for residual symptoms.

Adam Friedman, MD, professor and chair of dermatology and director of the supportive oncodermatology clinic at George Washington University, Washington, said that supporting patients through the “expected, disabling and often treatment-limiting side effects of oncologic therapies” is an area that is “in its infancy” and is characterized by limited evidence-based approaches.

“Creativity is therefore a must,” he said, commenting on the research letter. “Practice starts with anecdote, and this is certainly an exciting finding ... I look forward to trialing this with our patients at GW.”

Five of the six patients had a hematologic condition that required induction chemotherapy before hematopoietic stem cell transplant, and one was receiving regorafenib for treatment of glioblastoma multiforme. Diagnosis of TEC was established by clinical presentation, and five of the six patients underwent a biopsy. Biopsy findings were consistent with a TEC diagnosis in three patients, and showed nonspecific perivascular dermatitis in two, the investigators reported.

Further research is needed to determine optimal dosing, “delineate safety concerns and potential role in cancer treatment, and establish whether a durable response in patients with continuous chemotherapy, such as in an outpatient setting, is possible,” they said.

Dr. Nguyen and his coauthors reported no conflict of interest disclosures.

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ED doctors call private equity staffing practices illegal and seek to ban them

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Thu, 01/05/2023 - 12:15

A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including CaliforniaMissouriTexas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

 

 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

 

 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including CaliforniaMissouriTexas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

 

 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

 

 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including CaliforniaMissouriTexas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

 

 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

 

 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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Medical practice gave 8,000 patients cancer for Christmas

Article Type
Changed
Tue, 01/10/2023 - 11:49

 

We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

 

 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

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We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

 

 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

 

We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

 

 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

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Surgeon’s license suspension spotlights hazards, ethics of live-streaming surgeries

Article Type
Changed
Wed, 01/04/2023 - 13:16

The State Medical Board of Ohio has suspended the license of a plastic surgeon after she live-streamed surgical procedures on TikTok, potentially endangering patients. The surgeon has a large social media following.

In November, the State Medical Board of Ohio temporarily suspended the license of Katherine Roxanne Grawe, MD, who practices in the wealthy Columbus suburb of Powell.

Among other accusations of misconduct, the board stated that “during some videos/live-streams you engage in dialogue to respond to viewers’ online questions while the surgical procedure remains actively ongoing.”

One patient needed emergency treatment following liposuction and was diagnosed with a perforated bowel and serious bacterial infection.

“Despite liposuction being a blind surgery that requires awareness of the tip of the cannula to avoid injury, your attention to the camera meant at those moments you were not looking at the patient or palpating the location of the tip of the cannula,” the medical board said.

Neither Dr. Grawe nor her attorney responded to requests for comment.

Dr. Grawe, known as “Dr. Roxy,” has a popular TikTok account – now set to private – with 841,600 followers and 14.6 million likes. She has another 123,000 followers on her Instagram account, also now private.

The Columbus Dispatch reported that Dr. Grawe had previously been warned to protect patient privacy on social media. The board has yet to make a final decision regarding her license.

According to Columbus TV station WSYX, she said in a TikTok video, “We show our surgeries every single day on Snapchat. Patients get to decide if they want to be part of it. And if you do, you can watch your own surgery.”

The TV station quoted former patients who described surgical complications. One said: “I went to her because, I thought, from all of her social media that she uplifted women. That she helped women empower themselves. But she didn’t.”

Dallas plastic surgeon Rod J. Rohrich, MD, who has written about social-media best practices and has 430,000 followers on Instagram, said in an interview that many surgeons have been reprimanded by state medical boards for being distracted by social media during procedures.

“It is best not to do live-streaming unless it is an educational event to demonstrate techniques and technology with full informed consent of the patient. It should be a very well-rehearsed event for education,” he said.

Nurses also have been disciplined for inappropriate posts on social media. In December 2022, an Atlanta hospital announced that four nurses were no longer on the job after they appeared in a TikTok video in scrubs and revealed their “icks” regarding obstetric care.

“My ick is when you ask me how much the baby weighs,” one worker said in the video, “and it’s still ... in your hands.”

Plastic surgeon Christian J. Vercler, MD, of the University of Michigan, Ann Arbor, who’s studied social-media guidelines for surgeons, said in an interview that plastic surgery content on TikTok has “blown up” in recent years.

“Five years or so ago, it was Snapchat where I saw a lot of inappropriate things posted by surgeons,” Dr. Vercler said in an interview. “That may still be happening on Snapchat, but I actually don’t ever use that platform anymore, and neither do my trainees.”

Dr. Vercler cautioned colleagues to consider their motivations for live-streaming surgery and to think about whether they can fully focus on the patient.

“There are many potential distractions in the OR. We get pages, phone calls, nurses asking us questions, anesthesiologists trying to talk to us. Social media is just one more thing competing for the surgeon’s attention,” he said. “Every surgeon should strive to eliminate unnecessary or unavoidable distractions, so the question becomes, ‘who is best being served by me focusing my attention on recording this operation on someone’s phone so we can post it on social media? Is it the patient?’ ”

Dr. Vercler added, “There are many, many plastic surgeons using social media as the powerful platform that it is to build their brands, to connect with potential patients, and to educate the public about what they do. I believe that most are doing this in a way that is respectful to patients and doesn’t exploit patients for the surgeon’s benefit.

“Unfortunately,” he concluded, “there are some who do see patients as merely instruments by which they can achieve fame, notoriety, and wealth.”

Dr. Rohrich and Dr. Vercler disclosed no relevant financial relationships.

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

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The State Medical Board of Ohio has suspended the license of a plastic surgeon after she live-streamed surgical procedures on TikTok, potentially endangering patients. The surgeon has a large social media following.

In November, the State Medical Board of Ohio temporarily suspended the license of Katherine Roxanne Grawe, MD, who practices in the wealthy Columbus suburb of Powell.

Among other accusations of misconduct, the board stated that “during some videos/live-streams you engage in dialogue to respond to viewers’ online questions while the surgical procedure remains actively ongoing.”

One patient needed emergency treatment following liposuction and was diagnosed with a perforated bowel and serious bacterial infection.

“Despite liposuction being a blind surgery that requires awareness of the tip of the cannula to avoid injury, your attention to the camera meant at those moments you were not looking at the patient or palpating the location of the tip of the cannula,” the medical board said.

Neither Dr. Grawe nor her attorney responded to requests for comment.

Dr. Grawe, known as “Dr. Roxy,” has a popular TikTok account – now set to private – with 841,600 followers and 14.6 million likes. She has another 123,000 followers on her Instagram account, also now private.

The Columbus Dispatch reported that Dr. Grawe had previously been warned to protect patient privacy on social media. The board has yet to make a final decision regarding her license.

According to Columbus TV station WSYX, she said in a TikTok video, “We show our surgeries every single day on Snapchat. Patients get to decide if they want to be part of it. And if you do, you can watch your own surgery.”

The TV station quoted former patients who described surgical complications. One said: “I went to her because, I thought, from all of her social media that she uplifted women. That she helped women empower themselves. But she didn’t.”

Dallas plastic surgeon Rod J. Rohrich, MD, who has written about social-media best practices and has 430,000 followers on Instagram, said in an interview that many surgeons have been reprimanded by state medical boards for being distracted by social media during procedures.

“It is best not to do live-streaming unless it is an educational event to demonstrate techniques and technology with full informed consent of the patient. It should be a very well-rehearsed event for education,” he said.

Nurses also have been disciplined for inappropriate posts on social media. In December 2022, an Atlanta hospital announced that four nurses were no longer on the job after they appeared in a TikTok video in scrubs and revealed their “icks” regarding obstetric care.

“My ick is when you ask me how much the baby weighs,” one worker said in the video, “and it’s still ... in your hands.”

Plastic surgeon Christian J. Vercler, MD, of the University of Michigan, Ann Arbor, who’s studied social-media guidelines for surgeons, said in an interview that plastic surgery content on TikTok has “blown up” in recent years.

“Five years or so ago, it was Snapchat where I saw a lot of inappropriate things posted by surgeons,” Dr. Vercler said in an interview. “That may still be happening on Snapchat, but I actually don’t ever use that platform anymore, and neither do my trainees.”

Dr. Vercler cautioned colleagues to consider their motivations for live-streaming surgery and to think about whether they can fully focus on the patient.

“There are many potential distractions in the OR. We get pages, phone calls, nurses asking us questions, anesthesiologists trying to talk to us. Social media is just one more thing competing for the surgeon’s attention,” he said. “Every surgeon should strive to eliminate unnecessary or unavoidable distractions, so the question becomes, ‘who is best being served by me focusing my attention on recording this operation on someone’s phone so we can post it on social media? Is it the patient?’ ”

Dr. Vercler added, “There are many, many plastic surgeons using social media as the powerful platform that it is to build their brands, to connect with potential patients, and to educate the public about what they do. I believe that most are doing this in a way that is respectful to patients and doesn’t exploit patients for the surgeon’s benefit.

“Unfortunately,” he concluded, “there are some who do see patients as merely instruments by which they can achieve fame, notoriety, and wealth.”

Dr. Rohrich and Dr. Vercler disclosed no relevant financial relationships.

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

The State Medical Board of Ohio has suspended the license of a plastic surgeon after she live-streamed surgical procedures on TikTok, potentially endangering patients. The surgeon has a large social media following.

In November, the State Medical Board of Ohio temporarily suspended the license of Katherine Roxanne Grawe, MD, who practices in the wealthy Columbus suburb of Powell.

Among other accusations of misconduct, the board stated that “during some videos/live-streams you engage in dialogue to respond to viewers’ online questions while the surgical procedure remains actively ongoing.”

One patient needed emergency treatment following liposuction and was diagnosed with a perforated bowel and serious bacterial infection.

“Despite liposuction being a blind surgery that requires awareness of the tip of the cannula to avoid injury, your attention to the camera meant at those moments you were not looking at the patient or palpating the location of the tip of the cannula,” the medical board said.

Neither Dr. Grawe nor her attorney responded to requests for comment.

Dr. Grawe, known as “Dr. Roxy,” has a popular TikTok account – now set to private – with 841,600 followers and 14.6 million likes. She has another 123,000 followers on her Instagram account, also now private.

The Columbus Dispatch reported that Dr. Grawe had previously been warned to protect patient privacy on social media. The board has yet to make a final decision regarding her license.

According to Columbus TV station WSYX, she said in a TikTok video, “We show our surgeries every single day on Snapchat. Patients get to decide if they want to be part of it. And if you do, you can watch your own surgery.”

The TV station quoted former patients who described surgical complications. One said: “I went to her because, I thought, from all of her social media that she uplifted women. That she helped women empower themselves. But she didn’t.”

Dallas plastic surgeon Rod J. Rohrich, MD, who has written about social-media best practices and has 430,000 followers on Instagram, said in an interview that many surgeons have been reprimanded by state medical boards for being distracted by social media during procedures.

“It is best not to do live-streaming unless it is an educational event to demonstrate techniques and technology with full informed consent of the patient. It should be a very well-rehearsed event for education,” he said.

Nurses also have been disciplined for inappropriate posts on social media. In December 2022, an Atlanta hospital announced that four nurses were no longer on the job after they appeared in a TikTok video in scrubs and revealed their “icks” regarding obstetric care.

“My ick is when you ask me how much the baby weighs,” one worker said in the video, “and it’s still ... in your hands.”

Plastic surgeon Christian J. Vercler, MD, of the University of Michigan, Ann Arbor, who’s studied social-media guidelines for surgeons, said in an interview that plastic surgery content on TikTok has “blown up” in recent years.

“Five years or so ago, it was Snapchat where I saw a lot of inappropriate things posted by surgeons,” Dr. Vercler said in an interview. “That may still be happening on Snapchat, but I actually don’t ever use that platform anymore, and neither do my trainees.”

Dr. Vercler cautioned colleagues to consider their motivations for live-streaming surgery and to think about whether they can fully focus on the patient.

“There are many potential distractions in the OR. We get pages, phone calls, nurses asking us questions, anesthesiologists trying to talk to us. Social media is just one more thing competing for the surgeon’s attention,” he said. “Every surgeon should strive to eliminate unnecessary or unavoidable distractions, so the question becomes, ‘who is best being served by me focusing my attention on recording this operation on someone’s phone so we can post it on social media? Is it the patient?’ ”

Dr. Vercler added, “There are many, many plastic surgeons using social media as the powerful platform that it is to build their brands, to connect with potential patients, and to educate the public about what they do. I believe that most are doing this in a way that is respectful to patients and doesn’t exploit patients for the surgeon’s benefit.

“Unfortunately,” he concluded, “there are some who do see patients as merely instruments by which they can achieve fame, notoriety, and wealth.”

Dr. Rohrich and Dr. Vercler disclosed no relevant financial relationships.

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

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Long-term maintenance required in melasma patients

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Changed
Fri, 01/06/2023 - 10:38

When Arisa E. Ortiz, MD, meets with patients who seek treatment for melasma, she tells them that while she can make their hyperpigmentation better, no cure-all exists for the condition.

“They need to understand that melasma is going to require long-term maintenance,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual Masters of Aesthetics Symposium.

yuuurin/iStock/Getty Images

Hydroquinone is a mainstay of melasma therapy, but instead of the commonly used 4% formulation, she prefers to use 12% hydroquinone with 6% kojic acid in VersaBase cream. “It’s a high concentration but the VersaBase makes it more tolerable,” she said. “I have patients take a pea-sized amount and mix it in a regular moisturizer. It’s too strong to spot treat, so it goes on the whole face.”

Mindful that chronic hydroquinone use can cause ochronosis (permanent darkening), she has patients alternate with a nonhydroquinone bleaching agent such as lignin peroxidase, oligopeptide, Lytera, Melaplex, 4-n-butylresorcinol, Cysteamine cream, tranexamic acid, or oral antioxidants. In a study sponsored by SkinMedica, investigators conducted a randomized, double-blind, half-face study in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of three new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% hydroquinone. They found that the nonhydroquinone skin formulations were better tolerated and were just as effective as 4% hydroquinone.
 

Chemical peels and laser treatments

Chemical peels are another treatment option for melasma, but Dr. Ortiz prefers glycolic peels over salicylic and other peels, “because there is no downtime,” she said.

Dr. Arisa E. Ortiz

As for laser-based approaches, melasma patients respond best to low energy devices such as the 1,927-nm fractional diode laser at a 3.75% density. “This also can increase the skin permeability of topicals, so when you’re combining it with hydroquinone it can be more effective,” she said.

In an observational study of 27 women with refractory melasma, with phototypes II-V, New York City–based dermatologist Arielle Kauvar, MD, combined microdermabrasion with the Q-switched Nd:YAG laser. “The settings she used were very low fluence, so there was no clinical endpoint or no whitening,” said Dr. Ortiz, vice president of the American Society for Laser Medicine and Surgery (ASLMS). Specifically, Dr. Kauvar used the laser at 1.6-2 J/cm2 with a 5- or 6-mm spot size immediately following microdermabrasion every 4 weeks; Patients received an average of 2.6 treatments, and were assessed 3-12 months after the last treatment. Study participants were on a standard skin care regimen of a broad spectrum sunscreen, hydroquinone, and tretinoin or vitamin C.

Most of the patients showed at least 50% clearance of melasma 1 month after the first treatment, and 81% showed more than 75% clearance of melasma; remission lasted at least 6 months.

“I personally prefer to use picosecond over Q-switched lasers, because they deliver the energy faster, and you can use a 1,064-nm picosecond laser that is safe in all skin types,” Dr. Ortiz said. “There is minimal downtime, and it doesn’t require anesthesia. You have to consider these things when you’re treating melasma, because this usually requires monthly treatments. If you do something that requires a week of downtime every month, it’s not practical for patients.”

In a study published in 2021, Dr. Ortiz and Tanya Greywal, MD, used three passes of the 1,064-nm Nd:YAG laser to treat melasma in 10 patients with skin types II-V. The device had a 650-microsecond pulse duration, a 6-mm spot size, and an energy mode of 11-14 J/cm2. The researchers observed a mean melasma improvement of 26%-50% as early as 3 weeks. “There was no downtime, and no anesthesia was required,” Dr. Ortiz said.

Researchers have discovered a vascular component to melasma, which may have treatment implications. Houston-based dermatologist Paul M. Friedman, MD, and his colleagues used spectrocolorimetry to detect an underlying prominent vascular component in a retrospective review of 11 patients with melasma, with skin types II-IV. They determined that melasma lesions exhibiting subtle or subclinical telangiectatic erythema may be improved by combining vascular-targeted laser therapy with fractional low-powered diode laser therapy.

“So, combining a vascular laser with a 1,927-nm fractional diode laser showed more improvement than with just the diode laser alone,” said Dr. Ortiz, who was not involved with the analysis.

To optimize results following the laser treatment of melasma, she uses one application of clobetasol immediately after the procedure. “This can help reduce swelling and inflammation to decrease the risk of postinflammatory hyperpigmentation,” she said. “You can also use a skin cooling system like Cryomodulation for controlled cooling.”
 

 

 

Tranexamic acid and PLE

Another strategy for melasma patients involves oral treatment with extract of Polypodium leucotomos (PLE), a fern from the Polypodiaceae family with antioxidant properties that has been shown to be photoprotective against UVA and UVB radiation. “I explain to my patients that it’s like an internal sunscreen,” Dr. Ortiz said. “It does not replace your external sunscreen, but it adds extra protection.”

In a pilot placebo-controlled study of patients with melasma on their normal regimen of hydroquinone and sunscreen, 40 Asian patients with melasma were randomized to receive either oral PLE supplementation or placebo for 12 weeks. The authors found that PLE significantly improved and accelerated the outcome reached with hydroquinone and sunscreen from about the first month of treatment, compared with placebo.

Dr. Ortiz discussed the role of oral tranexamic acid, an antifibrinolytic, procoagulant agent that is approved by the Food and Drug Administration for the treatment of menorrhagia and to prevent hemorrhage in patients with hemophilia undergoing tooth extractions. “This is a game changer for melasma treatment,” she said, but its use has been limited by the risk for thromboembolism.



In a study of 561 patients with melasma, 90% improved after a median treatment duration of 4 months, and only 7% had side effects, most commonly abdominal bloating and pain. Treatment was discontinued in one patient who developed a deep vein thrombosis, and was diagnosed with familial protein S deficiency.

The daily dosing of tranexamic acid for menorrhagia is 3,900 mg daily, while the dose for treating melasma has ranged from 500 mg to 1,500 mg per day, Dr. Ortiz said. It’s available as a 650-mg tablet in the United States. “I prescribe 325 mg twice a day, but studies have shown that 650 mg once a day is just as effective,” she said.

Prior to prescribing tranexamic acid, Dr. Ortiz does not order labs, but she performs an extensive history of current illness and does not prescribe it in patients with an increased risk of clotting, including people who smoke and those who take oral contraceptives or are on hormone supplementation. Use is also contraindicated in people with a current malignancy, those with a history of stroke or DVT, and those who have any clotting disorder.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is cochair of the Masters of Aesthetics Symposium.

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When Arisa E. Ortiz, MD, meets with patients who seek treatment for melasma, she tells them that while she can make their hyperpigmentation better, no cure-all exists for the condition.

“They need to understand that melasma is going to require long-term maintenance,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual Masters of Aesthetics Symposium.

yuuurin/iStock/Getty Images

Hydroquinone is a mainstay of melasma therapy, but instead of the commonly used 4% formulation, she prefers to use 12% hydroquinone with 6% kojic acid in VersaBase cream. “It’s a high concentration but the VersaBase makes it more tolerable,” she said. “I have patients take a pea-sized amount and mix it in a regular moisturizer. It’s too strong to spot treat, so it goes on the whole face.”

Mindful that chronic hydroquinone use can cause ochronosis (permanent darkening), she has patients alternate with a nonhydroquinone bleaching agent such as lignin peroxidase, oligopeptide, Lytera, Melaplex, 4-n-butylresorcinol, Cysteamine cream, tranexamic acid, or oral antioxidants. In a study sponsored by SkinMedica, investigators conducted a randomized, double-blind, half-face study in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of three new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% hydroquinone. They found that the nonhydroquinone skin formulations were better tolerated and were just as effective as 4% hydroquinone.
 

Chemical peels and laser treatments

Chemical peels are another treatment option for melasma, but Dr. Ortiz prefers glycolic peels over salicylic and other peels, “because there is no downtime,” she said.

Dr. Arisa E. Ortiz

As for laser-based approaches, melasma patients respond best to low energy devices such as the 1,927-nm fractional diode laser at a 3.75% density. “This also can increase the skin permeability of topicals, so when you’re combining it with hydroquinone it can be more effective,” she said.

In an observational study of 27 women with refractory melasma, with phototypes II-V, New York City–based dermatologist Arielle Kauvar, MD, combined microdermabrasion with the Q-switched Nd:YAG laser. “The settings she used were very low fluence, so there was no clinical endpoint or no whitening,” said Dr. Ortiz, vice president of the American Society for Laser Medicine and Surgery (ASLMS). Specifically, Dr. Kauvar used the laser at 1.6-2 J/cm2 with a 5- or 6-mm spot size immediately following microdermabrasion every 4 weeks; Patients received an average of 2.6 treatments, and were assessed 3-12 months after the last treatment. Study participants were on a standard skin care regimen of a broad spectrum sunscreen, hydroquinone, and tretinoin or vitamin C.

Most of the patients showed at least 50% clearance of melasma 1 month after the first treatment, and 81% showed more than 75% clearance of melasma; remission lasted at least 6 months.

“I personally prefer to use picosecond over Q-switched lasers, because they deliver the energy faster, and you can use a 1,064-nm picosecond laser that is safe in all skin types,” Dr. Ortiz said. “There is minimal downtime, and it doesn’t require anesthesia. You have to consider these things when you’re treating melasma, because this usually requires monthly treatments. If you do something that requires a week of downtime every month, it’s not practical for patients.”

In a study published in 2021, Dr. Ortiz and Tanya Greywal, MD, used three passes of the 1,064-nm Nd:YAG laser to treat melasma in 10 patients with skin types II-V. The device had a 650-microsecond pulse duration, a 6-mm spot size, and an energy mode of 11-14 J/cm2. The researchers observed a mean melasma improvement of 26%-50% as early as 3 weeks. “There was no downtime, and no anesthesia was required,” Dr. Ortiz said.

Researchers have discovered a vascular component to melasma, which may have treatment implications. Houston-based dermatologist Paul M. Friedman, MD, and his colleagues used spectrocolorimetry to detect an underlying prominent vascular component in a retrospective review of 11 patients with melasma, with skin types II-IV. They determined that melasma lesions exhibiting subtle or subclinical telangiectatic erythema may be improved by combining vascular-targeted laser therapy with fractional low-powered diode laser therapy.

“So, combining a vascular laser with a 1,927-nm fractional diode laser showed more improvement than with just the diode laser alone,” said Dr. Ortiz, who was not involved with the analysis.

To optimize results following the laser treatment of melasma, she uses one application of clobetasol immediately after the procedure. “This can help reduce swelling and inflammation to decrease the risk of postinflammatory hyperpigmentation,” she said. “You can also use a skin cooling system like Cryomodulation for controlled cooling.”
 

 

 

Tranexamic acid and PLE

Another strategy for melasma patients involves oral treatment with extract of Polypodium leucotomos (PLE), a fern from the Polypodiaceae family with antioxidant properties that has been shown to be photoprotective against UVA and UVB radiation. “I explain to my patients that it’s like an internal sunscreen,” Dr. Ortiz said. “It does not replace your external sunscreen, but it adds extra protection.”

In a pilot placebo-controlled study of patients with melasma on their normal regimen of hydroquinone and sunscreen, 40 Asian patients with melasma were randomized to receive either oral PLE supplementation or placebo for 12 weeks. The authors found that PLE significantly improved and accelerated the outcome reached with hydroquinone and sunscreen from about the first month of treatment, compared with placebo.

Dr. Ortiz discussed the role of oral tranexamic acid, an antifibrinolytic, procoagulant agent that is approved by the Food and Drug Administration for the treatment of menorrhagia and to prevent hemorrhage in patients with hemophilia undergoing tooth extractions. “This is a game changer for melasma treatment,” she said, but its use has been limited by the risk for thromboembolism.



In a study of 561 patients with melasma, 90% improved after a median treatment duration of 4 months, and only 7% had side effects, most commonly abdominal bloating and pain. Treatment was discontinued in one patient who developed a deep vein thrombosis, and was diagnosed with familial protein S deficiency.

The daily dosing of tranexamic acid for menorrhagia is 3,900 mg daily, while the dose for treating melasma has ranged from 500 mg to 1,500 mg per day, Dr. Ortiz said. It’s available as a 650-mg tablet in the United States. “I prescribe 325 mg twice a day, but studies have shown that 650 mg once a day is just as effective,” she said.

Prior to prescribing tranexamic acid, Dr. Ortiz does not order labs, but she performs an extensive history of current illness and does not prescribe it in patients with an increased risk of clotting, including people who smoke and those who take oral contraceptives or are on hormone supplementation. Use is also contraindicated in people with a current malignancy, those with a history of stroke or DVT, and those who have any clotting disorder.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is cochair of the Masters of Aesthetics Symposium.

When Arisa E. Ortiz, MD, meets with patients who seek treatment for melasma, she tells them that while she can make their hyperpigmentation better, no cure-all exists for the condition.

“They need to understand that melasma is going to require long-term maintenance,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual Masters of Aesthetics Symposium.

yuuurin/iStock/Getty Images

Hydroquinone is a mainstay of melasma therapy, but instead of the commonly used 4% formulation, she prefers to use 12% hydroquinone with 6% kojic acid in VersaBase cream. “It’s a high concentration but the VersaBase makes it more tolerable,” she said. “I have patients take a pea-sized amount and mix it in a regular moisturizer. It’s too strong to spot treat, so it goes on the whole face.”

Mindful that chronic hydroquinone use can cause ochronosis (permanent darkening), she has patients alternate with a nonhydroquinone bleaching agent such as lignin peroxidase, oligopeptide, Lytera, Melaplex, 4-n-butylresorcinol, Cysteamine cream, tranexamic acid, or oral antioxidants. In a study sponsored by SkinMedica, investigators conducted a randomized, double-blind, half-face study in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of three new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% hydroquinone. They found that the nonhydroquinone skin formulations were better tolerated and were just as effective as 4% hydroquinone.
 

Chemical peels and laser treatments

Chemical peels are another treatment option for melasma, but Dr. Ortiz prefers glycolic peels over salicylic and other peels, “because there is no downtime,” she said.

Dr. Arisa E. Ortiz

As for laser-based approaches, melasma patients respond best to low energy devices such as the 1,927-nm fractional diode laser at a 3.75% density. “This also can increase the skin permeability of topicals, so when you’re combining it with hydroquinone it can be more effective,” she said.

In an observational study of 27 women with refractory melasma, with phototypes II-V, New York City–based dermatologist Arielle Kauvar, MD, combined microdermabrasion with the Q-switched Nd:YAG laser. “The settings she used were very low fluence, so there was no clinical endpoint or no whitening,” said Dr. Ortiz, vice president of the American Society for Laser Medicine and Surgery (ASLMS). Specifically, Dr. Kauvar used the laser at 1.6-2 J/cm2 with a 5- or 6-mm spot size immediately following microdermabrasion every 4 weeks; Patients received an average of 2.6 treatments, and were assessed 3-12 months after the last treatment. Study participants were on a standard skin care regimen of a broad spectrum sunscreen, hydroquinone, and tretinoin or vitamin C.

Most of the patients showed at least 50% clearance of melasma 1 month after the first treatment, and 81% showed more than 75% clearance of melasma; remission lasted at least 6 months.

“I personally prefer to use picosecond over Q-switched lasers, because they deliver the energy faster, and you can use a 1,064-nm picosecond laser that is safe in all skin types,” Dr. Ortiz said. “There is minimal downtime, and it doesn’t require anesthesia. You have to consider these things when you’re treating melasma, because this usually requires monthly treatments. If you do something that requires a week of downtime every month, it’s not practical for patients.”

In a study published in 2021, Dr. Ortiz and Tanya Greywal, MD, used three passes of the 1,064-nm Nd:YAG laser to treat melasma in 10 patients with skin types II-V. The device had a 650-microsecond pulse duration, a 6-mm spot size, and an energy mode of 11-14 J/cm2. The researchers observed a mean melasma improvement of 26%-50% as early as 3 weeks. “There was no downtime, and no anesthesia was required,” Dr. Ortiz said.

Researchers have discovered a vascular component to melasma, which may have treatment implications. Houston-based dermatologist Paul M. Friedman, MD, and his colleagues used spectrocolorimetry to detect an underlying prominent vascular component in a retrospective review of 11 patients with melasma, with skin types II-IV. They determined that melasma lesions exhibiting subtle or subclinical telangiectatic erythema may be improved by combining vascular-targeted laser therapy with fractional low-powered diode laser therapy.

“So, combining a vascular laser with a 1,927-nm fractional diode laser showed more improvement than with just the diode laser alone,” said Dr. Ortiz, who was not involved with the analysis.

To optimize results following the laser treatment of melasma, she uses one application of clobetasol immediately after the procedure. “This can help reduce swelling and inflammation to decrease the risk of postinflammatory hyperpigmentation,” she said. “You can also use a skin cooling system like Cryomodulation for controlled cooling.”
 

 

 

Tranexamic acid and PLE

Another strategy for melasma patients involves oral treatment with extract of Polypodium leucotomos (PLE), a fern from the Polypodiaceae family with antioxidant properties that has been shown to be photoprotective against UVA and UVB radiation. “I explain to my patients that it’s like an internal sunscreen,” Dr. Ortiz said. “It does not replace your external sunscreen, but it adds extra protection.”

In a pilot placebo-controlled study of patients with melasma on their normal regimen of hydroquinone and sunscreen, 40 Asian patients with melasma were randomized to receive either oral PLE supplementation or placebo for 12 weeks. The authors found that PLE significantly improved and accelerated the outcome reached with hydroquinone and sunscreen from about the first month of treatment, compared with placebo.

Dr. Ortiz discussed the role of oral tranexamic acid, an antifibrinolytic, procoagulant agent that is approved by the Food and Drug Administration for the treatment of menorrhagia and to prevent hemorrhage in patients with hemophilia undergoing tooth extractions. “This is a game changer for melasma treatment,” she said, but its use has been limited by the risk for thromboembolism.



In a study of 561 patients with melasma, 90% improved after a median treatment duration of 4 months, and only 7% had side effects, most commonly abdominal bloating and pain. Treatment was discontinued in one patient who developed a deep vein thrombosis, and was diagnosed with familial protein S deficiency.

The daily dosing of tranexamic acid for menorrhagia is 3,900 mg daily, while the dose for treating melasma has ranged from 500 mg to 1,500 mg per day, Dr. Ortiz said. It’s available as a 650-mg tablet in the United States. “I prescribe 325 mg twice a day, but studies have shown that 650 mg once a day is just as effective,” she said.

Prior to prescribing tranexamic acid, Dr. Ortiz does not order labs, but she performs an extensive history of current illness and does not prescribe it in patients with an increased risk of clotting, including people who smoke and those who take oral contraceptives or are on hormone supplementation. Use is also contraindicated in people with a current malignancy, those with a history of stroke or DVT, and those who have any clotting disorder.

Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is cochair of the Masters of Aesthetics Symposium.

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Why it’s important to offer cosmeceuticals in a cosmetic practice

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While laser procedures, injectables, and chemical peels may be considered the bread and butter of a cosmetic dermatology practice, don’t forget about cosmeceuticals, advised Ava Shamban, MD.

Dr. Ava Shamban

It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.

“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”



Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”

Bill Oxford/E+

During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

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While laser procedures, injectables, and chemical peels may be considered the bread and butter of a cosmetic dermatology practice, don’t forget about cosmeceuticals, advised Ava Shamban, MD.

Dr. Ava Shamban

It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.

“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”



Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”

Bill Oxford/E+

During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

While laser procedures, injectables, and chemical peels may be considered the bread and butter of a cosmetic dermatology practice, don’t forget about cosmeceuticals, advised Ava Shamban, MD.

Dr. Ava Shamban

It’s important to provide patients with high-quality products to take home with them and cosmeceuticals contain biologically active ingredients that enhance skin care efficacy, Dr. Shamban, a dermatologist who practices in Santa Monica, Calif., said at the annual Masters of Aesthetics Symposium. “You can do all the lasers, injectables, and peels that you want, but if you’re not giving your patients high-quality products to take home with them, you’re not doing your job,” she commented.

“Look for brands that are formulated and tested for effectiveness,” she added. “In my office, we like to have products that are designed for specific issues to accompany prescription products, everything from rosacea, acne, melasma, and eczema to psoriasis.”



Dr. Shamban, author of the 2011 book, “Heal Your Skin: The Breakthrough Plan for Renewal,” recommends that dermatologists devise a questionnaire for patients asking them to list their skin-related concerns and use the responses to create a list of products for them to use at home. Provide clear instructions on use, including proper layering of products, how often to use them, and the correct amount to apply. “If you’re not going to do this, someone else will,” she said. Next, instruct them that cosmeceuticals must be used routinely to achieve optimal benefit. “Nothing happens overnight, and be wary of anyone that promises you otherwise,” Dr. Shamban said. “Offering cosmeceuticals helps bridge the gap between at-home routines and in-office treatments. If in-office procedures are a marathon, view the consistent use of the right products at home as your training.”

Bill Oxford/E+

During her presentation, she showed a photo of the “beauty bar,” the dedicated space with a counter and shelves for displaying skin care products in her Santa Monica office. “It’s good to set something up like this in your office, even if it’s just a little corner, because it gives it authority,” Dr. Shamban said. “Encourage clients to explore the beauty bar after their appointment with you.” She emphasized the importance of offering a wide range of products to accommodate different lifestyles, budgets, skin types, ages, and specific skin concerns, and training staff about the products. “There is never a one-size-fits-all approach to skincare; it’s all about the individual,” she said. “It’s never about pushing product; it’s always about educating patients.”

Dr. Shamban disclosed that she conducts clinical trials for many pharmaceutical and device companies.

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