Dermatology News

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.

State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”

“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.

Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.

The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.

“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”

Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .

Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.

“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”

Sources

Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”

South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”

WebMD Health News © 2020 

This article first appeared on Medscape.com.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

The effort to increase use of sun protection among Black individuals and others with relatively dark skin is likely to require tailoring of strategies to address barriers and alter perceptions, according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.

“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.

One obstacle is appearance. For instance, some products appear chalky on dark skin.

“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.

Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.

“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.

Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.

According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.

“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.

There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.

The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.

For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”

When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.

“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.

Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.

“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.

In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.

One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.

Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

Mitigating risk

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

[email protected]

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

Researchers and several medical groups on Oct. 23 pressed for changes to the US Food and Drug Administration’s (FDA) current plans for deciding how to eventually clear vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA’s Vaccines and Related Biological Products Advisory Committee met for a wide-ranging discussion beginning around 10 am. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel’s feedback on a series of questions, including considerations for continuing phase 3 trials if a product were to get an interim clearance known as an emergency use authorization (EUA).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency’s deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer Inc, AstraZeneca, Johnson & Johnson, and Moderna.
 

‘Time for a reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election on November 3, last month spoke about being able to begin distributing a vaccine in October.

“Until now the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires,” Lurie told the FDA advisory panel. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board (IRB) discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won’t answer the right questions about the COVID-19 vaccines.

“We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount,” Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an October 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.
 

Risks of a ‘rushed vaccine’

Other complaints about the FDA’s approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that seeks to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an October 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a means of slowing transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

“Resulting infections may offset the vaccine’s impact and end up increasing the mortality and morbidity burden,” ECRI said in the brief.

“The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough,” ECRI Chief Executive Officer Marcus Schabacker, MD, PhD, said in a statement prepared for the hearing.

This article first appeared on Medscape.com.

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

The available data suggest that the risks posed by COVID-19 infection to patients with psoriasis, including those on therapies that affect immune function, are modest at most, according to a summary of published studies and expert opinions summarized at the annual Coastal Dermatology Symposium, held virtually.

For patients with psoriasis concerned about their outcome if infected with COVID-19, “there is no evidence to support stopping biologics or systemic agents, so I am asking my patients to continue,” Kristina C. Duffin, MD, professor and chair of dermatology at the University of Utah, Salt Lake City, said at the meeting.

The National Psoriasis Foundation, which created a COVID-19 task force and maintains a COVID-19 Resource Center on its website, has provided similar advice. Many statements are phrased cautiously and clinicians are encouraged to practice shared decision-making, but the NPF guidance supports continuing effective therapy – or, in newly diagnosed patients, starting effective therapy – among those who are not infected with SARS-CoV2.

Patients with a new diagnosis of psoriasis “should be aware that untreated psoriatic disease is associated with serious impact on physical and emotional health, and in the case of psoriatic arthritis, can lead to permanent joint damage and disability,” according to the NPF guidance.

Overall, the “existing data generally suggest” that most treatments for psoriasis and psoriatic arthritis “do not meaningfully alter the risks of contracting SARS-CoV2 or having a worse course of COVID-19 illness,” the current guidance states. Yet, because of limited data this “is not known with certainty.”

Chronic systemic steroids are an exception. In a review of recently published studies evaluating whether psoriasis or its therapies increase risk of adverse outcomes in patients with COVID-19 infection, Dr. Duffin pointed to several that associated systemic steroids with hospitalization or other markers of severe disease.

The NPF guidance also recommends avoiding chronic systemic steroids in patients with psoriasis during the current COVID-19 era “if possible.” In patients with psoriatic arthritis who require systemic steroids, the guidance recommends “the lowest dose necessary to achieve the desired therapeutic effect.”

This is not necessarily true in patients with psoriasis and COVID-19 infection. Based on the potential for systemic steroids to improve outcomes in hospitalized COVID-19 patients requiring oxygen, steroids “should not be withheld” even when the justification is concern about the potential risk of flares with withdrawal, according to the NPF guidance statement.

The NPF guidance specifically cautions against use of hydroxychloroquine or chloroquine for prevention or treatment of COVID-19. In addition to an uncertain benefit, these antimalarial drugs have been associated previously with flares of psoriasis.

Dr. Duffin agreed and went on to warn that COVID-19 infection itself is a potential trigger for flares. She cited two published case reports of flares associated with psoriasis. Although one patient had also been exposed to hydroxychloroquine, she said the risk of psoriasis-induced flare “makes sense” based on previous associations made between flares and other viral infections and stress.

In patients with psoriasis who contract COVID-19 infection, Dr. Duffin concurred with the NPF guidance that management decisions should be made on a “case-by-case basis.” Although the NPF guidance states that “most patients can restart psoriasis and/or psoriatic arthritis treatments after complete resolution of COVID-19 symptoms,” no specific advice was offered on the decision to stop treatments.

For protecting psoriasis patients from infection and managing COVID-19 in those who become infected, much of the NPF advice is consistent with that offered to patients without psoriasis. This involves practicing infection control that reduces risk of transmission. Both the NPF guidance and Dr. Duffin suggested telemedicine is appropriate for limiting in-patient visits under pandemic conditions.

Although patients with psoriasis are more likely than the general population to have the comorbidities associated with bad COVID-19 infection outcomes, according to the NPF guidance, Dr. Duffin called the overall data evaluating susceptibility among psoriasis patients “reassuring.” She cautioned that the data are still limited, but the evidence so far suggests that neither psoriasis nor biologics are independent risk factors for acquiring COVID-19 or having a worse outcome if infected.

Yet, more definitive data are needed, and Dr. Duffin advised clinicians and patients to consult the NPF website for updates. “More up-to-date information will certainly be added as we go forward,” she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

This NPF task force on COVID-19 is meeting every 2 weeks, according to Joel M. Gelfand, MD, professor of dermatology, University of Pennsylvania, Philadelphia, and cochair of the task force. Dr. Gelfand reported that updates are based on a discussion of the available data.

“We will be releasing additional recommendations as necessary based on the developments,” he said in an interview. Updates are not necessarily required at this frequency but can be if appropriate. The goal is to keep recommendations current and evidence-based.

Dr. Duffin reported financial relationships with Amgen, AbbVie, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Siena, and UCB. Dr. Gelfand reported financial relationships with AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Pfizer, Roche, and UCB.

This publication and Global Academy for Medical Education are owned by the same parent company.
 

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

When assessing inflammatory dermatoses in children with skin of color, it may be necessary to train the eye to recognize subtle changes and colors other than red, a doctor suggested at the virtual American Academy of Pediatrics annual meeting.

First, doctors should see whether they can detect any erythema, said Latanya T. Benjamin, MD, associate professor of pediatric dermatology at Florida Atlantic University, Boca Raton. “If the answer is no because of the background competing chromophore, then shift your focus off of the erythema and perhaps onto other colors that the skin can demonstrate,” such as red-brown, violaceous, or grayish hues.

Comparing involved areas with normal skin also may help. “Sometimes you can pick up subtleties in colors that way,” Dr. Benjamin said.

Finally, look for other changes that could relate to the patient’s condition. For example, when diagnosing acne, Dr. Benjamin looks for pigmentary sequelae like hyperpigmentation. “If a patient has atopic dermatitis, is there hypopigmentation on other areas of the face?”

Consider cutaneous T-cell lymphoma in the differential diagnosis of generalized hypopigmented patches and plaques in patients with darker skin types, Dr. Benjamin noted. Other diagnoses that may result in hypopigmentation include pityriasis alba, vitiligo, tinea versicolor, ash-leaf macules, Hansen’s disease, postinflammatory hypopigmentation secondary to atopic dermatitis, and tinea corporis.

Be sensitive to the fact that changes in skin color can be “very annoying or devastating to the family,” even with medically benign conditions such as pityriasis alba, Dr. Benjamin added.

Detecting redness in brown skin tones can take practice, Candrice R. Heath, MD, a member of the board of directors for the Skin of Color Society, commented in an interview.

Furthermore, presentations vary. For instance, depictions of atopic dermatitis in educational materials may focus on red patches and plaques but “miss that there are several presentations in those with darker skin tones, including follicular prominence, hyperpigmented plaques, and coin-shaped lesions,” said Dr. Heath, assistant professor of dermatology at Temple University, Philadelphia.

“The skin of color population is growing,” noted Dr. Heath. “By 2023, there will be more children with skin of color than without in the United States.”

While Dr. Heath has lectured about skin of color as it relates to pediatric patients for years, “now with the nation’s renewed interest in disparities in health care, it is the perfect time to highlight conditions that present more commonly in skin of color and present differently in those with skin of color.”

Dr. Benjamin had no conflicts of interest. Dr. Heath serves as associate editor of Cutis, which is owned by the same company as this publication.

[email protected]

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The Centers for Disease Control and Prevention updated its recommendations for likely person-to-person spread of SARS-CoV-2 to warn about the risk of multiple, brief, “close contact” encounters with others who are positive for COVID-19.

New data suggest each close encounter – coming within 6 feet of an infected person – can increase the risk for transmission, CDC director Robert Redfield, MD, said during a media briefing.

“As we get more data and understand the science of COVID, we’re going to continue to incorporate that in our recommendations,” Dr. Redfield said in response to a reporter’s question about a recent study.

Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces.

In a new report published online Oct. 21 in Morbidity and Mortality Weekly Report, however, investigators “determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.”
 

Beware of brief encounters?

On July 28, a 20-year-old male correctional officer in Vermont had multiple brief encounters with six transferred incarcerated or detained people while their SARS-CoV-2 test results were pending. The six were asymptomatic at the time and were housed in a quarantine unit, reported CDC researcher Julia Pringle, PhD, and colleagues.

The following day, all six inmates tested polymerase chain reaction (PCR) positive for COVID-19. The correctional officer did not spend 15 minutes or more within 6 feet of any of the inmates, according to video surveillance footage, and he continued to work.

On Aug. 4, however, he developed symptoms that included loss of smell and taste, myalgia, runny nose, cough, shortness of breath, headache, loss of appetite, and gastrointestinal symptoms. He stayed home starting the next day and tested PCR positive for COVID-19 on Aug. 11.

Further review of the surveillance video showed that the officer had numerous brief encounters of approximately 1 minute each that cumulatively exceeded 15 minutes over a 24-hour period, the researchers reported.

During all the interactions with inmates, the correctional officer wore a cloth mask, gown, and eye protection. The inmates wore masks while in their cells but did not have them on during brief cell doorway interactions or in the recreation room, according to the report.
 

No interaction is 100% safe

“We know that every activity that involves interacting with others has some degree of risk right now,” said Jay Butler, MD, CDC deputy director for infectious diseases.

“Unfortunately, we’re seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country,” he said. “We’ve confirmed 8.1 million cases and, sadly, over 220,000 deaths since January.

“I know these are numbers, but these are also people,” Dr. Butler added.

“The pandemic is not over,” Dr. Redfield said. “Earlier this week, COVID virus cases reached over 40 million globally. Here in the United States we are approaching a critical phase.”

Four factors associated with higher risk for transmission are the proximity of each encounter, its duration, whether an interaction takes place indoors or outdoors, and the number of people encountered, Dr. Butler said.

Dr. Butler acknowledged widespread fatigue with adherence to personal protection measures, but added that social distancing, mask-wearing, and other measures are more important now than ever. He noted that more Americans will be spending time indoors with the onset of cooler weather and the upcoming holidays.
 

A note of optimism

Dr. Redfield remains optimistic about the limited availability of a vaccine or vaccines by year’s end but added that “it’s important for all of us to remain diligent in our efforts to defeat this virus.”

“There is hope on the way, in the form of safe and effective vaccines in a matter of weeks or months. To bridge to that next phase, we have to take steps to keep ourselves, our families, and our communities safe,” said Alex Azar, secretary of the Department of Health & Human Services.

“I know it’s been a difficult year for Americans, but we are going to come through this on the other side,” Dr. Redfield said.

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration approved remdesivir (Veklury) Oct. 22 as a treatment for hospitalized COVID-19 patients aged 12 and up, making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.

The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.

An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.

Today’s approval is based on three randomized controlled trials, according to Gilead.

Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.

The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.

The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).

The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.

The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.

The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.

This article first appeared on Medscape.com.

This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.
 

This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.
 

This is the third in a series of columns discussing the important roles that dermatologists have played in the skin care industry. This section will discuss those dermatologists who worked behind the scenes with the cosmetic industry, rather than developing their own skin care lines.
 

Norman Orentreich, MD

Dr. Orentreich was a successful New York City dermatologist and the first to perform hair transplants. This new technique brought him fame and notoriety and arguably made him the first “celebrity dermatologist.” (He was also a member of the original advisory board of Dermatology News, at that time Skin & Allergy News, in January 1970.) Dr. Orentreich was a seminal figure in the trend to link the cosmetic industry and dermatology. In August 1967, Vogue magazine¹ published an article on him, titled “Can Great Skin be Created?” This popular article caught the attention of Leonard Lauder, of Estée Lauder, who recruited Dr. Orentreich to help create the skin care line Clinique. Clinique was intended to be a brand with a medical look that promoted its products as “allergy tested,” with packaging that has an antiseptic look and beauty counter salespeople wearing white coats.

Dr. Orentreich’s input into the development of a skin type–based skin care line was fundamental to the development of this brand. The four-question questionnaire with an iconic plastic lever that customers slide left or right instantly provided them with an assessment of their skin type at the beauty counter, with one of four skin types: Very Dry to Dry Skin (Skin Type 1), Dry Combination (Skin Type 2), Combination Oily (Skin Type 3), and Oily (Skin Type 4).

Although this skin-typing system was not scientifically accurate (there is no scientific definition of combination skin), it was reminiscent of the system developed by cosmetic company tycoon Helena Rubinstein in the 1940s that classified people into four skin types: oily, dry, combination, and sensitive. Clinique became a blockbuster skin care brand and was one of the first developed by a dermatologist – although Dr. Orentreich did not put his name on it.

In 1972, Dr. Orentreich filed a patent² for an exfoliating pad for the skin that later became known as the “Buf-Puf.” I heard years ago that he got the idea from the machines used to buff the floors in the hospital. The buffing pad had a hole in the center where the machine attached. Dr. Orentreich purportedly thought “I wonder what they do with the cut-out centers?” He looked into this, and subsequently used the centers to create the Buf-Puf. I cannot find a reference for this, but I love this story and hope it’s true. If any readers have any knowledge of this, please let me know, so I can amend my story if it is incorrect.
 

Almay

Almay, an amalgamation of the founders’ names, Alfred and Fanny May Woititz, was the first hypoallergenic brand, established in 1931, and the first to provide hypoallergenic cosmetics, long before Clinique. In addition, the company was the first skin care brand to become available by prescription only (as it was initially), fully disclose all individual ingredients in its products (well before this became mandatory in 1976), provide totally fragrance-free products, develop a hypoallergenic fragrance – and provide patch tests and other materials to physicians to identify contact allergens.

Over 90 years, the company was also the first among skin care brands to do the following:

• Provide custom formulations to individuals proven to be allergic to a specific ingredient, through their physicians.
• Perform a full range of premarket safety testing on all products for allergy and irritation, and test all its products for comedogenicity.
• Formulate cosmetics for use around the eye area (eye shadows and eyeliners) specifically for contact lens wearers.
• Formulate hypoallergenic regimens for specific skin types in the mass market.
• Provide a specific cosmetic regimen for acne-prone women, including a silicone-based makeup and active ingredients for treatment in cosmetics and skin care.

I recently interviewed Stanley Levy, MD, who was one of the consultants to Almay, and practices in Chapel Hill, N.C., where he has an academic niche related to skin care formulation and safety. He told me how Almay provided patch test materials to dermatologists to help identify contact dermatitis to cosmetic ingredients, and described Almay’s relationship with the dermatology field as follows: “From the outset, Almay was linked to dermatology. In 1930, a chemist and pharmacist in New York City, Al Woititz, was looking to compound cosmetics for his wife suffering from cosmetic allergies, Fannie May. He enlisted the counsel of the preeminent dermatologic expert in contact dermatitis at the time, Dr. Marion Sulzberger, to suggest ingredients to avoid. [Dr. Sulzberger was also a member of the original Dermatology News editorial advisory board.] Soon, dermatologists around New York City were recommending these formulations. This led to a product line free of the known allergens and a fledgling company trademarked as Almay. For the past 90 years, [the company] has kept a close relationship with dermatologists, well before that was the norm.”

The Almay research overseen by Dr. Levy and others contributed greatly to our understanding of the allergenicity of skin care.
 

Albert Kligman, MD

The turning point for the interface of dermatology with the cosmetic industry was the shift from a safety-based approach (hypoallergenic and noncomedogenic) to an emphasis on efficacy claims in the 1980s. Part of the impetus for this was the Dr. Kligman’s observation that retinoids could improve photoaging.

Dr. Kligman, a well-known dermatologist at the University of Pennsylvania, Philadelphia, showed that retinoids were an effective treatment for acne. For more about this, listen to my interview on the Dermatology Weekly podcast, with James Leyden, MD, about his work at the University of Pennsylvania with Dr. Kligman on the development of oral and topical retinoids. During Dr. Kligman’s research on acne, he noticed that wrinkles improved after treatment with tretinoin, and in 1986, he and Dr. Leyden (and several other authors) published the first article about tretinoin’s use for photoaged skin.³ This led to a double-blind study⁴ conducted by John J. Voorhees, MD, University of Michigan, Ann Arbor, and coauthors that showed statistically significant improvement of photoaged skin when treated with topical tretinoin. Dr. Voorhees and his group did many more studies on retinoids^5,6 and photoaging⁷ – so many that, at one time, he was (and maybe still is) the most widely published dermatologist in the United States. These studies showed that, not only did prescription tretinoin improve the appearance of wrinkles, but so did over-the-counter retinol.⁸ Retinoids remain the most efficacious prescription and cosmeceutical ingredients to treat wrinkled skin.

When studies conducted by Dr. Kligman, Dr. Voorhees, and by Barbara Gilcrest, MD, ^9,10 showed that retinoids improved wrinkles, a major change in the focus in the skin care industry occurred.

During the same time period, the studies on alpha hydroxy acids by Chérie Ditre, MD, Eugene Van Scott, MD, and colleages^11,12; and studies by Sheldon Pinnell, MD, on Vitamin C (see part 1 of this series) all demonstrated the efficacy of cosmetic ingredients on photoaged skin. This triggered a major change in how skin care products were marketed, with an efficacy approach rather than a safety approach.

With the shift from safety (hypoallergenic and noncomedogenic issues) to efficacy claims in the 1980s, and as nondrug active ingredients like retinol were shown to have biologic effects, the lines between the Food and Drug Administration’s definition of a drug versus a cosmetic became blurred. In 1984, Dr. Kligman suggested a new classification for the ingredients that fell in the middle, proposing the term “cosmeceutical” and thus, the concept of a cosmeceutical was introduced. To this day, cosmeceutical is not an official definition and the FDA has yet to deal with it as a quasi-drug category. FDA regulations as to what constitutes a drug versus a cosmetic date back to the 1938 Food, Drug and Cosmetic Act.

Once marketing focused on efficacy, many companies made outrageous claims. During the second half of the 1980s, the FDA issued some warning letters to some companies in an effort to control these claims.

Now efficacy claims abound and we, as dermatologists, should be the experts who back up these claims with scientific data. As the cosmeceutical market has evolved and grown, consumers are bewildered by the myriad of active ingredients being promoted and the number of products in the marketplace. As dermatologic innovation has led to more efficacious active ingredients, our patients look to us as knowledgeable and credible sources of information and for recommendations about the best skin care routines for their skin issues. This is all reflected in the fact that physician-dispensed skin care is becoming the fastest growing segment in this market. It is incumbent upon dermatologists to be knowledgeable and conversant about skin care products and skin care routines, and is particularly true for those of us who sell skin care products in our offices.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Burt’s Bees, Evolus, Galderma, and Revance. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Vogue Magazine, 1967 Aug 15. “Can Great Skin be Created?”

2. https://patents.google.com/patent/US3910284.

3. Kligman AM et al. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59.

4. Weiss JS et al. JAMA. 1988 Jan 22-29;259(4):527-32.

5. Goldfarb MT et al. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):645-50.

6. Ellis CN et al. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):629-37.

7. Kang S; Voorhees JJ. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S55-61.

8. Kafi R et al. Arch Dermatol. 2007 May;143(5):606-12.

9. Gilchrest BA. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):610-3.

10. Bhawan J et al. Arch Dermatol. 1991 May;127(5):666-72.

11. Griffin TD et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):196-203.

12. Ditre CM et al. J Am Acad Dermatol. 1996 Feb;34(2 Pt 1):187-95.