Dermatology News

Most patients with active chronic prurigo nodularis are not satisfied with their treatment, according to a large European survey.

The eye-opening results of the 406-patient, 12-country European patient survey indicate “high levels of disbelief in currently available treatment options and an overall dissatisfaction with treatment,” Manuel P. Pereira, MD, PhD, said in presenting the findings at the annual congress of the European Academy of Dermatology and Venereology.
 

Only 5.3% of patients pronounced themselves “very satisfied” with their treatment. Another 28% were “rather satisfied.”

“Remarkably, almost 10% of patients were not being treated for prurigo despite having active disease,” said Dr. Pereira, a dermatologist at the Center for Chronic Pruritus at University Hospital Münster (Germany).

When survey participants were asked to identify their most important unmet treatment needs, 79.5% named improvement of itch, 57.2% sought improvement in skin lesions, and 30.5% wanted better sleep.

The most widely used treatments were emollients, prescribed in 84.5% of patients; topical steroids, in 55.7%; antihistamines, 55.2%; and phototherapy, 42.1%. Far fewer patients were on more potent medications: Cyclosporine, systemic corticosteroids, or other immunosuppressants were prescribed for 21.9% of patients; gabapentin and related compounds in 17%; and topical immunomodulators in 8.6%. Twenty-three percent of patients were on antidepressants.

None of the available treatment options, all of which are off label, received high marks from patients. For example, only 1 in 10 patients on antihistamines during the last 6 months rated the drugs as effective. Topical immunomodulators were deemed effective by 1.1% of patients with active prurigo nodularis; gabapentinoids by 3.1%; phototherapy by 9.9%; and antidepressants were rated as effective for the chronic skin disease by only 2.3% of patients. The top-rated therapies were topical steroids, deemed effective by 12.8% of patients; systemic immunosuppressants, favored by 12.2%; and emollients, deemed effective by 10.5% of patients, even though more than 80% of survey participants were using them.

Dr. Pereira said the survey results highlight a pressing need for guidelines aimed at improving clinical care for patients with chronic prurigo nodularis. The first-ever such guidelines on the diagnosis and management of this debilitating disease, developed by Dr. Pereira and other members of the International Forum for the Study of Itch (IFSI), were recently published in the journal Itch. The new guidelines advocate a multimodal treatment approach incorporating a combination of topical and systemic therapies.

At present, there is no approved treatment for prurigo nodularis. Given the unmet need, however, the pace of research has quickened. Innovative potential treatments in the developmental pipeline include Janus kinase inhibitors, topical phosphodiesterase-4 inhibitors, systemic opioid receptor modulators, and neurokinin-1 receptor antagonists.

The patient survey was funded by the EADV and carried out by the EADV’s Pruritus Task Force as part of the European Prurigo Project. Dr. Pereira reported receiving research funding from the EADV and the German Research Foundation. He is a paid speaker for AbbVie, Galderma, Menlo Therapeutics (now VYNE Therapeutics), Novartis, and Trevi.

bjancin@mdedge.com

Most patients with active chronic prurigo nodularis are not satisfied with their treatment, according to a large European survey.

The eye-opening results of the 406-patient, 12-country European patient survey indicate “high levels of disbelief in currently available treatment options and an overall dissatisfaction with treatment,” Manuel P. Pereira, MD, PhD, said in presenting the findings at the annual congress of the European Academy of Dermatology and Venereology.
 

Only 5.3% of patients pronounced themselves “very satisfied” with their treatment. Another 28% were “rather satisfied.”

“Remarkably, almost 10% of patients were not being treated for prurigo despite having active disease,” said Dr. Pereira, a dermatologist at the Center for Chronic Pruritus at University Hospital Münster (Germany).

When survey participants were asked to identify their most important unmet treatment needs, 79.5% named improvement of itch, 57.2% sought improvement in skin lesions, and 30.5% wanted better sleep.

The most widely used treatments were emollients, prescribed in 84.5% of patients; topical steroids, in 55.7%; antihistamines, 55.2%; and phototherapy, 42.1%. Far fewer patients were on more potent medications: Cyclosporine, systemic corticosteroids, or other immunosuppressants were prescribed for 21.9% of patients; gabapentin and related compounds in 17%; and topical immunomodulators in 8.6%. Twenty-three percent of patients were on antidepressants.

None of the available treatment options, all of which are off label, received high marks from patients. For example, only 1 in 10 patients on antihistamines during the last 6 months rated the drugs as effective. Topical immunomodulators were deemed effective by 1.1% of patients with active prurigo nodularis; gabapentinoids by 3.1%; phototherapy by 9.9%; and antidepressants were rated as effective for the chronic skin disease by only 2.3% of patients. The top-rated therapies were topical steroids, deemed effective by 12.8% of patients; systemic immunosuppressants, favored by 12.2%; and emollients, deemed effective by 10.5% of patients, even though more than 80% of survey participants were using them.

Dr. Pereira said the survey results highlight a pressing need for guidelines aimed at improving clinical care for patients with chronic prurigo nodularis. The first-ever such guidelines on the diagnosis and management of this debilitating disease, developed by Dr. Pereira and other members of the International Forum for the Study of Itch (IFSI), were recently published in the journal Itch. The new guidelines advocate a multimodal treatment approach incorporating a combination of topical and systemic therapies.

At present, there is no approved treatment for prurigo nodularis. Given the unmet need, however, the pace of research has quickened. Innovative potential treatments in the developmental pipeline include Janus kinase inhibitors, topical phosphodiesterase-4 inhibitors, systemic opioid receptor modulators, and neurokinin-1 receptor antagonists.

The patient survey was funded by the EADV and carried out by the EADV’s Pruritus Task Force as part of the European Prurigo Project. Dr. Pereira reported receiving research funding from the EADV and the German Research Foundation. He is a paid speaker for AbbVie, Galderma, Menlo Therapeutics (now VYNE Therapeutics), Novartis, and Trevi.

bjancin@mdedge.com

Most patients with active chronic prurigo nodularis are not satisfied with their treatment, according to a large European survey.

The eye-opening results of the 406-patient, 12-country European patient survey indicate “high levels of disbelief in currently available treatment options and an overall dissatisfaction with treatment,” Manuel P. Pereira, MD, PhD, said in presenting the findings at the annual congress of the European Academy of Dermatology and Venereology.
 

Only 5.3% of patients pronounced themselves “very satisfied” with their treatment. Another 28% were “rather satisfied.”

“Remarkably, almost 10% of patients were not being treated for prurigo despite having active disease,” said Dr. Pereira, a dermatologist at the Center for Chronic Pruritus at University Hospital Münster (Germany).

When survey participants were asked to identify their most important unmet treatment needs, 79.5% named improvement of itch, 57.2% sought improvement in skin lesions, and 30.5% wanted better sleep.

The most widely used treatments were emollients, prescribed in 84.5% of patients; topical steroids, in 55.7%; antihistamines, 55.2%; and phototherapy, 42.1%. Far fewer patients were on more potent medications: Cyclosporine, systemic corticosteroids, or other immunosuppressants were prescribed for 21.9% of patients; gabapentin and related compounds in 17%; and topical immunomodulators in 8.6%. Twenty-three percent of patients were on antidepressants.

None of the available treatment options, all of which are off label, received high marks from patients. For example, only 1 in 10 patients on antihistamines during the last 6 months rated the drugs as effective. Topical immunomodulators were deemed effective by 1.1% of patients with active prurigo nodularis; gabapentinoids by 3.1%; phototherapy by 9.9%; and antidepressants were rated as effective for the chronic skin disease by only 2.3% of patients. The top-rated therapies were topical steroids, deemed effective by 12.8% of patients; systemic immunosuppressants, favored by 12.2%; and emollients, deemed effective by 10.5% of patients, even though more than 80% of survey participants were using them.

Dr. Pereira said the survey results highlight a pressing need for guidelines aimed at improving clinical care for patients with chronic prurigo nodularis. The first-ever such guidelines on the diagnosis and management of this debilitating disease, developed by Dr. Pereira and other members of the International Forum for the Study of Itch (IFSI), were recently published in the journal Itch. The new guidelines advocate a multimodal treatment approach incorporating a combination of topical and systemic therapies.

At present, there is no approved treatment for prurigo nodularis. Given the unmet need, however, the pace of research has quickened. Innovative potential treatments in the developmental pipeline include Janus kinase inhibitors, topical phosphodiesterase-4 inhibitors, systemic opioid receptor modulators, and neurokinin-1 receptor antagonists.

The patient survey was funded by the EADV and carried out by the EADV’s Pruritus Task Force as part of the European Prurigo Project. Dr. Pereira reported receiving research funding from the EADV and the German Research Foundation. He is a paid speaker for AbbVie, Galderma, Menlo Therapeutics (now VYNE Therapeutics), Novartis, and Trevi.

bjancin@mdedge.com

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

President Joe Biden kicked off his new administration Jan. 20 with an immediate focus on attempts to stop the spread of COVID-19, including closer coordination with other nations.

Mr. Biden signed 17 executive orders, memoranda, and directives addressing not only the pandemic but also economic concerns, climate change, and racial inequity.

At the top of the list of actions was what his transition team called a “100 Days Masking Challenge.” Mr. Biden issued an executive order requiring masks and physical distancing in all federal buildings, on all federal lands, and by federal employees and contractors.

The president also halted the Trump administration’s process of withdrawing from the World Health Organization. Instead, Mr. Biden named Anthony Fauci, MD, the director of the National Institute for Allergy and Infectious Diseases, as the head of a delegation to participate in the WHO executive board meeting that is being held this week.

Mr. Biden also signed an executive order creating the position of COVID-19 response coordinator, which will report directly to the president and be responsible for coordinating all elements of the COVID-19 response across government, including the production and distribution of vaccines and medical supplies.

The newly inaugurated president also intends to restore the National Security Council’s Directorate for Global Health Security and Biodefense, which will aid in the response to the pandemic, his transition team said.

The American Medical Association was among the first to commend the first-day actions.

“Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus – wearing masks, practicing physical distancing, and washing hands,” said AMA President Susan R. Bailey, MD in a news release. “We are pleased by the Biden administration’s steps today, including universal mask wearing within federal jurisdictions, providing federal leadership for COVID-19 response, and reengaging with the World Health Organization. Taking these actions on day 1 of the administration sends the right message – that our nation is laser focused on stopping the ravages of COVID-19.”

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

When the COVID-19 pandemic first hit, cancer screening in the United States came to an abrupt halt. That experience, coupled with the financial fallout of the pandemic, has led some doctors to reassess business as usual.

In particular, a trio has taken aim at skin cancer screening – arguing that it should stop – in a ‘sounding board’ commentary published online Jan. 7 in the New England Journal of Medicine.

“The COVID-19 pandemic has functionally stopped skin cancer screening; what is important is not to restart it,” wrote the authors, led by H. Gilbert Welch, MD, MPH, at Brigham and Women’s Hospital, Boston, Massachusetts. Dr. Welch has often raised questions about cancer screening and highlighted the issue of overdiagnosis.

In this latest essay, Dr. Welch teamed up with pathologist Benjamin Mazer, MD, Yale University, New Haven, Conn., who writes commentaries for this news organization, and dermatologist Adewole S. Adamson, MD, University of Texas, Austin, to argue that screening for skin cancer has led to an overdiagnosis of melanoma.

However, two melanoma experts pointed out flaws in some of their arguments, and said the issue is more nuanced than they present.


 

Arguing that melanoma is overdiagnosed

The incidence of melanoma is six times as high as it was 40 years ago, making it the third most common cancer in the United States, the investigators pointed out. However, while case rates have skyrocketed, death rates from melanoma have remained about the same, which points to overdiagnosis.

They described a cycle of increased diagnostic scrutiny that is driving overdiagnosis of melanoma. This includes heightened awareness (perhaps overly) among patients, widespread skin screenings, lower clinical thresholds for biopsy, and lower thresholds among pathologists for diagnosis of melanoma. Fear of missing cancer, legal concerns, and financial incentives may all contribute.

“We view the rise in the incidence of melanoma as a sentinel event, a warning that an epidemic of inspection, surveillance, and biopsy of pigmented skin lesions is permeating through the general population,” they wrote.

Furthermore, overdiagnosis could contribute to unnecessary intervention.

Between 2004 and 2017, rates of biopsy among fee-for-service Medicare recipients almost doubled (from 5% to 8%), according to coding trends data cited in the article. Overdiagnosis and unnecessary intervention could cause psychological, financial, and physical harm to the patient, and the authors argued for interrupting the cycle.

“The most important step to break the cycle of melanoma overdiagnosis is to stop population-wide screening for skin cancer,” they wrote.

The U.S. Preventive Services Task Force currently states that there is insufficient evidence to weigh the balances versus the harms of skin cancer screening, leaving it open to interpretation.

“[T]he increase in melanoma diagnoses by a factor of 6, with at least an order of magnitude more persons undergoing a biopsy and no apparent effect on mortality, is more than enough to recommend against population-wide screening,” Dr. Welch and colleagues concluded.

But the issue may be more nuanced, argued a melanoma expert.

“Everyone agrees that screening high-risk groups has the greatest chance of reducing cancer mortality. In melanoma, the strongest risk factor is the number of moles and presence of clinically atypical moles,” David Polsky, MD, PhD, commented in an interview. Dr. Polsky is a professor of dermatologic oncology at the Perlmutter Cancer Center at New York University Langone Health.

However, population-based studies have shown that at least half of melanoma patients are not considered high risk based on the appearance of the mole, he explained.

“Studies to identify genetic risk factors for melanoma have not yet progressed to the point where these can be tested in the clinic. We clearly have a knowledge gap that needs to be addressed,” he said.

Moreover, it’s not easy to predict which early melanomas will metastasize, said dermatologist Jennifer Stein, MD, PhD, who specializes in treating patients at high risk for melanoma at NYU Langone.

“This paper suggests that it may not be important to detect and treat melanoma in situ, and that the increase in diagnosis of melanoma in situ has led to more harms than good,” she said. “There is evidence that most melanomas do originate as in situ lesions. Unfortunately, we cannot predict which ones will become more aggressive. For this reason, we treat melanoma in situ.”
 

Taking issue with some of the arguments

Both Dr. Polsky and Dr. Stein took issue with several of the arguments put forward by Dr. Welch and colleagues.

For instance, Dr. Welch and colleagues cited research suggesting that UV light is a weak risk factor for melanoma, but Dr. Polsky disagreed. “There are many lines of evidence ranging from epidemiological, clinical, and biological studies that prove the causative association between ultraviolet light and melanoma, while acknowledging that other factors, such as genetic predisposition, play an important role,” he said. “Since ultraviolet light in the form of outdoor sunburns or indoor tanning exposure are modifiable risk factors, it is important that we continue with our current public messaging on their causal role in the development of melanoma.”

Furthermore, the 2012 study that the authors cited to support their argument that pathologists today are more likely to diagnose melanoma than in years past is flawed, according to Dr. Stein. The study was very small and included just nine contemporary pathologists. Unlike in real life, pathologists in the study could not diagnose lesions as “atypical,” and may have erred on the side of caution by calling them malignant.

“There were multiple limitations to this study that were acknowledged by its authors, who stated that it was a hypothesis-generating study and may not be generalizable,” Dr. Stein said.

In addition, Dr. Polsky took issue with the suggestion that awareness about melanoma among the general public is overly heightened.

“Reducing melanoma awareness would not be wise,” he said. “Studies have shown that awareness of melanoma is associated with the diagnosis of earlier-stage lesions that can be cured by simple skin surgery, without the need for more costly interventions utilized for more advanced melanomas.”

Dr. Mazer reported receiving travel compensation from Hillcrest Healthcare Systems, and is a commentator for this new organization. Dr. Welch has written three books on the subjects of overdiagnosis and testing for cancer. Dr. Adamson disclosed no relevant financial relationships.

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

When the COVID-19 pandemic first hit, cancer screening in the United States came to an abrupt halt. That experience, coupled with the financial fallout of the pandemic, has led some doctors to reassess business as usual.

In particular, a trio has taken aim at skin cancer screening – arguing that it should stop – in a ‘sounding board’ commentary published online Jan. 7 in the New England Journal of Medicine.

“The COVID-19 pandemic has functionally stopped skin cancer screening; what is important is not to restart it,” wrote the authors, led by H. Gilbert Welch, MD, MPH, at Brigham and Women’s Hospital, Boston, Massachusetts. Dr. Welch has often raised questions about cancer screening and highlighted the issue of overdiagnosis.

In this latest essay, Dr. Welch teamed up with pathologist Benjamin Mazer, MD, Yale University, New Haven, Conn., who writes commentaries for this news organization, and dermatologist Adewole S. Adamson, MD, University of Texas, Austin, to argue that screening for skin cancer has led to an overdiagnosis of melanoma.

However, two melanoma experts pointed out flaws in some of their arguments, and said the issue is more nuanced than they present.


 

Arguing that melanoma is overdiagnosed

The incidence of melanoma is six times as high as it was 40 years ago, making it the third most common cancer in the United States, the investigators pointed out. However, while case rates have skyrocketed, death rates from melanoma have remained about the same, which points to overdiagnosis.

They described a cycle of increased diagnostic scrutiny that is driving overdiagnosis of melanoma. This includes heightened awareness (perhaps overly) among patients, widespread skin screenings, lower clinical thresholds for biopsy, and lower thresholds among pathologists for diagnosis of melanoma. Fear of missing cancer, legal concerns, and financial incentives may all contribute.

“We view the rise in the incidence of melanoma as a sentinel event, a warning that an epidemic of inspection, surveillance, and biopsy of pigmented skin lesions is permeating through the general population,” they wrote.

Furthermore, overdiagnosis could contribute to unnecessary intervention.

Between 2004 and 2017, rates of biopsy among fee-for-service Medicare recipients almost doubled (from 5% to 8%), according to coding trends data cited in the article. Overdiagnosis and unnecessary intervention could cause psychological, financial, and physical harm to the patient, and the authors argued for interrupting the cycle.

“The most important step to break the cycle of melanoma overdiagnosis is to stop population-wide screening for skin cancer,” they wrote.

The U.S. Preventive Services Task Force currently states that there is insufficient evidence to weigh the balances versus the harms of skin cancer screening, leaving it open to interpretation.

“[T]he increase in melanoma diagnoses by a factor of 6, with at least an order of magnitude more persons undergoing a biopsy and no apparent effect on mortality, is more than enough to recommend against population-wide screening,” Dr. Welch and colleagues concluded.

But the issue may be more nuanced, argued a melanoma expert.

“Everyone agrees that screening high-risk groups has the greatest chance of reducing cancer mortality. In melanoma, the strongest risk factor is the number of moles and presence of clinically atypical moles,” David Polsky, MD, PhD, commented in an interview. Dr. Polsky is a professor of dermatologic oncology at the Perlmutter Cancer Center at New York University Langone Health.

However, population-based studies have shown that at least half of melanoma patients are not considered high risk based on the appearance of the mole, he explained.

“Studies to identify genetic risk factors for melanoma have not yet progressed to the point where these can be tested in the clinic. We clearly have a knowledge gap that needs to be addressed,” he said.

Moreover, it’s not easy to predict which early melanomas will metastasize, said dermatologist Jennifer Stein, MD, PhD, who specializes in treating patients at high risk for melanoma at NYU Langone.

“This paper suggests that it may not be important to detect and treat melanoma in situ, and that the increase in diagnosis of melanoma in situ has led to more harms than good,” she said. “There is evidence that most melanomas do originate as in situ lesions. Unfortunately, we cannot predict which ones will become more aggressive. For this reason, we treat melanoma in situ.”
 

Taking issue with some of the arguments

Both Dr. Polsky and Dr. Stein took issue with several of the arguments put forward by Dr. Welch and colleagues.

For instance, Dr. Welch and colleagues cited research suggesting that UV light is a weak risk factor for melanoma, but Dr. Polsky disagreed. “There are many lines of evidence ranging from epidemiological, clinical, and biological studies that prove the causative association between ultraviolet light and melanoma, while acknowledging that other factors, such as genetic predisposition, play an important role,” he said. “Since ultraviolet light in the form of outdoor sunburns or indoor tanning exposure are modifiable risk factors, it is important that we continue with our current public messaging on their causal role in the development of melanoma.”

Furthermore, the 2012 study that the authors cited to support their argument that pathologists today are more likely to diagnose melanoma than in years past is flawed, according to Dr. Stein. The study was very small and included just nine contemporary pathologists. Unlike in real life, pathologists in the study could not diagnose lesions as “atypical,” and may have erred on the side of caution by calling them malignant.

“There were multiple limitations to this study that were acknowledged by its authors, who stated that it was a hypothesis-generating study and may not be generalizable,” Dr. Stein said.

In addition, Dr. Polsky took issue with the suggestion that awareness about melanoma among the general public is overly heightened.

“Reducing melanoma awareness would not be wise,” he said. “Studies have shown that awareness of melanoma is associated with the diagnosis of earlier-stage lesions that can be cured by simple skin surgery, without the need for more costly interventions utilized for more advanced melanomas.”

Dr. Mazer reported receiving travel compensation from Hillcrest Healthcare Systems, and is a commentator for this new organization. Dr. Welch has written three books on the subjects of overdiagnosis and testing for cancer. Dr. Adamson disclosed no relevant financial relationships.

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

When the COVID-19 pandemic first hit, cancer screening in the United States came to an abrupt halt. That experience, coupled with the financial fallout of the pandemic, has led some doctors to reassess business as usual.

In particular, a trio has taken aim at skin cancer screening – arguing that it should stop – in a ‘sounding board’ commentary published online Jan. 7 in the New England Journal of Medicine.

“The COVID-19 pandemic has functionally stopped skin cancer screening; what is important is not to restart it,” wrote the authors, led by H. Gilbert Welch, MD, MPH, at Brigham and Women’s Hospital, Boston, Massachusetts. Dr. Welch has often raised questions about cancer screening and highlighted the issue of overdiagnosis.

In this latest essay, Dr. Welch teamed up with pathologist Benjamin Mazer, MD, Yale University, New Haven, Conn., who writes commentaries for this news organization, and dermatologist Adewole S. Adamson, MD, University of Texas, Austin, to argue that screening for skin cancer has led to an overdiagnosis of melanoma.

However, two melanoma experts pointed out flaws in some of their arguments, and said the issue is more nuanced than they present.


 

Arguing that melanoma is overdiagnosed

The incidence of melanoma is six times as high as it was 40 years ago, making it the third most common cancer in the United States, the investigators pointed out. However, while case rates have skyrocketed, death rates from melanoma have remained about the same, which points to overdiagnosis.

They described a cycle of increased diagnostic scrutiny that is driving overdiagnosis of melanoma. This includes heightened awareness (perhaps overly) among patients, widespread skin screenings, lower clinical thresholds for biopsy, and lower thresholds among pathologists for diagnosis of melanoma. Fear of missing cancer, legal concerns, and financial incentives may all contribute.

“We view the rise in the incidence of melanoma as a sentinel event, a warning that an epidemic of inspection, surveillance, and biopsy of pigmented skin lesions is permeating through the general population,” they wrote.

Furthermore, overdiagnosis could contribute to unnecessary intervention.

Between 2004 and 2017, rates of biopsy among fee-for-service Medicare recipients almost doubled (from 5% to 8%), according to coding trends data cited in the article. Overdiagnosis and unnecessary intervention could cause psychological, financial, and physical harm to the patient, and the authors argued for interrupting the cycle.

“The most important step to break the cycle of melanoma overdiagnosis is to stop population-wide screening for skin cancer,” they wrote.

The U.S. Preventive Services Task Force currently states that there is insufficient evidence to weigh the balances versus the harms of skin cancer screening, leaving it open to interpretation.

“[T]he increase in melanoma diagnoses by a factor of 6, with at least an order of magnitude more persons undergoing a biopsy and no apparent effect on mortality, is more than enough to recommend against population-wide screening,” Dr. Welch and colleagues concluded.

But the issue may be more nuanced, argued a melanoma expert.

“Everyone agrees that screening high-risk groups has the greatest chance of reducing cancer mortality. In melanoma, the strongest risk factor is the number of moles and presence of clinically atypical moles,” David Polsky, MD, PhD, commented in an interview. Dr. Polsky is a professor of dermatologic oncology at the Perlmutter Cancer Center at New York University Langone Health.

However, population-based studies have shown that at least half of melanoma patients are not considered high risk based on the appearance of the mole, he explained.

“Studies to identify genetic risk factors for melanoma have not yet progressed to the point where these can be tested in the clinic. We clearly have a knowledge gap that needs to be addressed,” he said.

Moreover, it’s not easy to predict which early melanomas will metastasize, said dermatologist Jennifer Stein, MD, PhD, who specializes in treating patients at high risk for melanoma at NYU Langone.

“This paper suggests that it may not be important to detect and treat melanoma in situ, and that the increase in diagnosis of melanoma in situ has led to more harms than good,” she said. “There is evidence that most melanomas do originate as in situ lesions. Unfortunately, we cannot predict which ones will become more aggressive. For this reason, we treat melanoma in situ.”
 

Taking issue with some of the arguments

Both Dr. Polsky and Dr. Stein took issue with several of the arguments put forward by Dr. Welch and colleagues.

For instance, Dr. Welch and colleagues cited research suggesting that UV light is a weak risk factor for melanoma, but Dr. Polsky disagreed. “There are many lines of evidence ranging from epidemiological, clinical, and biological studies that prove the causative association between ultraviolet light and melanoma, while acknowledging that other factors, such as genetic predisposition, play an important role,” he said. “Since ultraviolet light in the form of outdoor sunburns or indoor tanning exposure are modifiable risk factors, it is important that we continue with our current public messaging on their causal role in the development of melanoma.”

Furthermore, the 2012 study that the authors cited to support their argument that pathologists today are more likely to diagnose melanoma than in years past is flawed, according to Dr. Stein. The study was very small and included just nine contemporary pathologists. Unlike in real life, pathologists in the study could not diagnose lesions as “atypical,” and may have erred on the side of caution by calling them malignant.

“There were multiple limitations to this study that were acknowledged by its authors, who stated that it was a hypothesis-generating study and may not be generalizable,” Dr. Stein said.

In addition, Dr. Polsky took issue with the suggestion that awareness about melanoma among the general public is overly heightened.

“Reducing melanoma awareness would not be wise,” he said. “Studies have shown that awareness of melanoma is associated with the diagnosis of earlier-stage lesions that can be cured by simple skin surgery, without the need for more costly interventions utilized for more advanced melanomas.”

Dr. Mazer reported receiving travel compensation from Hillcrest Healthcare Systems, and is a commentator for this new organization. Dr. Welch has written three books on the subjects of overdiagnosis and testing for cancer. Dr. Adamson disclosed no relevant financial relationships.

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

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

bjancin@mdedge.com

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

bjancin@mdedge.com

The “maskne” phenomenon – that is, new onset or exacerbation of preexisting acne due to prolonged wearing of protective face masks – has become commonplace during the COVID-19 pandemic. Less well appreciated is that rosacea often markedly worsens, too, Giovanni Damiani, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

filadendron/E+

“This is particularly interesting because two inflammatory dermatoses with different pathogenesis are both mechanically and microbiologically triggered by mask use,” observed Dr. Damiani, a dermatologist at the University of Milan.

He presented an observational study of 36 patients with rosacea evaluated before and again 1 month into the strict quarantine imposed in the Milan area during the initial wave of the pandemic. These patients – 23 with papulopustular and 13 with erythematotelangiectatic rosacea – were wearing face masks for at least 6 hours per day during quarantine. Most were using what Dr. Damiani termed “community masks,” meaning they weren’t approved by the European regulatory agency as personal protective equipment.

Every yardstick Dr. Damiani and coinvestigators employed to characterize the patients’ rosacea demonstrated that the dermatosis was significantly worse during the prolonged mask-wearing period. For example, the average prequarantine score on the Global Flushing Severity Scale was 2.56, jumping to 3.97 after a month of masked quarantine. The flushing score climbed from 1.83 to 2.78 in the subgroup with papulopustular rosacea, and from 3.85 to 6.08 in patients with erythematotelangiectatic rosacea. Scores on the Clinician’s Erythema Assessment rose from 1.09 to 1.7 in the papulopustular rosacea patients, and from 2.46 to 3.54 in those with erythematotelangiectatic rosacea.

Scores on the Dermatology Life Quality Index climbed from 7.35 prequarantine to 10.65 in the subgroup with papulopustular rosacea and from 5.15 to 8.69 in patients with erythematotelangiectatic rosacea. Investigator Global Assessment and Patient’s Self-Assessment scores also deteriorated significantly after a month in masked quarantine.

Clinically, the mask-aggravated rosacea, or “maskacea,” was mainly localized to the dorsal lower third of the nose as well as the cheeks. The ocular and perioral areas and the chin were least affected.

Dr. Damiani advised his colleagues to intensify therapy promptly when patients report any worsening of their preexisting rosacea in connection with use of face masks. He has found this condition is often relatively treatment resistant so long as affected patients continue to wear face masks as an essential tool in preventing transmission of COVID-19.

The dermatologist noted that not all face masks are equal offenders when it comes to aggravating common facial dermatoses. During the spring 2020 pandemic quarantine in Milan, 11.6% of 318 mask wearers, none health care professionals, presented to Dr. Damiani and coinvestigators for treatment of facial dermatoses. The facial dermatosis rate was 5.4% among 168 users of masks bearing the European Union CE mark signifying the devices met relevant safety and performance standards, compared with 18.7% in 150 users of community masks with no CE mark. The rate of irritant contact dermatitis was zero with the CE mark masks and 4.7% with the community masks.

During quarantine, however, these patients wore their protective face masks for only a limited time, since for the most part they were restricted to home. In contrast, during the first week after the quarantine was lifted in early May and the daily hours of mask use increased, facial dermatoses were diagnosed in 8.7% of 23 users of CE-approved masks, compared with 45% of 71 wearers of community masks. Dr. Damiani and colleagues diagnosed irritant contact dermatitis in 16% of the community mask wearers post quarantine, but in not a single user of a mask bearing the CE mark.

The National Rosacea Society has issued patient guidance on avoiding rosacea flare-ups during the Covid-19 pandemic.

Dr. Damiani reported having no financial conflicts regarding his study.

bjancin@mdedge.com

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

By the time he tested positive for COVID-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain, and fever – all warning signs to Mr. Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of COVID.

“The thing with transplant patients is we can crash in a heartbeat,” said Mr. Herritz, 39. “The outcome for transplant patients [with COVID] is not good.”

On Twitter, Mr. Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk COVID patients. But as his symptoms worsened, Mr. Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Miss., he spent 2 days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital – and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Mr. Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Mr. Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment – available for free – have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, U.S. Department of Health & Human Services officials said.

Scores of high-risk COVID patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive COVID test. But many would-be recipients have missed this crucial window because of a patchwork system in the United States that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep COVID-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Dr. Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The COVID treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk – those 65 and older or with underlying health conditions – finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Mr. Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about COVID treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s COVID hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive COVID test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient COVID cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who cohosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’ ”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 COVID patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states – California, Arizona, and Nevada – to set up infusion centers that are treating dozens of COVID patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest COVID infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the COVID load.

More than 130 people have been treated, all patients who were able to get the 2-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Dr. Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word of mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’ ” Dr. Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Mr. Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Mr. Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.

Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office.

“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.

When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.

Either way, Biden may run into difficulty meeting that 100 million mark.

“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.

While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at Kaiser Family Foundation. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.

Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.

This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.

The same problems could plague the Biden administration, said experts.

States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.

“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Dr. Plescia. “Or at least not in the early stages of the 100 days.”

Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.

“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns – all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”

The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.

But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.

Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.

Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.

There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.

In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.

On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave on Jan. 15 detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.

Outgoing Health and Human Services Secretary Alex Azar also said on Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.

In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Ms. Hannan.

“Everyone needs to understand what the goal is and how it’s going to work,” she said.

A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.

Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.

With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Ms. Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.

Jan. 20, 2021, marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama. 

 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF, which is not affiliated with Kaiser Permanente.

Certainly, this has been a tumultuous year for health care, as well as the nation in general. There is so much to cover it is hard to know where to begin.

KLH49/iStock/Getty Images

Against a background of a swelling pandemic, I remain confused about the new evaluation and management coding system, and suspect there will be much more training to be rolled out. It is excellent news that the Paycheck Protection Program has been renewed for a second pass, if you can demonstrate that you suffered at least a 25% drop in income for at least one quarter last year, and have fewer than 300 employees – which covers most dermatology practices. I plan to discuss the impact of price transparency in a future column, but today will discuss one area, where we have had the passage of major health care legislation, that may have been overlooked.

The surprise medical billing act, or “No Surprises Act,” was a bipartisan congressional agreement, which means it is likely to “stick” no matter the change in executive or legislative branches.

Starting in January 2022, patients are protected from surprise medical bills. For nonemergency services and services outside hospitals and other facilities, a patient can only be billed for the coinsurance/copay that they would have had if the patient had been in network unless you go through a consent process by which you inform the patient that you are out-of-network, inform them of the costs, and inform them of other in-network providers. It also requires that patients’ in-network cost-sharing payments for out-of-network surprise bills are attributed to a patient’s in-network deductible.

In section 103, it further states that, where out-of-network rates are determined, there will be a 30-day open negotiation period for providers and payers to settle out-of-network claims. It also states that if the parties are unable to reach a negotiated agreement, they may access a binding arbitration process – referred to as an independent dispute resolution (IDR) – in which one offer prevails. Providers may batch similar services in one proceeding when claims are from the same payer. The IDR process will be administered by independent, unbiased entities with no affiliation to providers or payers.

The IDR entity is required to consider the market-based median in-network rate, alongside relevant information brought by either party, information requested by the reviewer, as well as factors such as the provider’s training and experience patient acuity, and the complexity of furnishing the item or service, in the case of a provider that is a facility. Other factors include the teaching status, case mix and scope of services of such facility, demonstrations of good faith efforts (or lack of good faith efforts) to enter into a network agreement, prior contracted rates during the previous 4 plan-years, and other items. Billed charges and public payer (Medicare and Medicaid) rates are excluded from consideration. This should result in a payment closer to private insurance rates.

As many of you know, another one of the long-term outrages by insurers has been the closure of their networks and delisting of dermatologists. I have written about this situation before in this column. Insurers have also refused to update their provider lists, effectively denying care by the magical process of not having to pay for medical care, because there aren’t any medical providers.

 

Inaccurate physician rosters

Obviously, one source of surprise medical bills that is easily correctable are inaccurate insurance company physician rosters. The Centers for Medicare & Medicaid Services implemented new rules with stiff fines instructing Medicare advantage plans to improve the accuracy of physician rosters, after a scathing General Accounting Office report 5 years ago. This process, however, was effectively neutered by the last administration by referring all enforcement action to the states, which did not have the manpower or political will to enforce them. This new surprise billing law directly addresses this issue, requiring insurers to update their provider directories every 90 days and keeping them available to patients on line.

This law also eliminates gag clauses between physicians and patients regarding insurer policies.

In short, this bill solves many problems for dermatologists in their constant struggle with insurers. In particular, accurate provider directories will allow patients and companies buying insurance for their employees, to see what they are getting. I suspect the revelation of the paucity of dermatologists in many of these networks will result in increased demand for your services and perhaps provide you a little negotiating leverage.

Also, if I read this law correctly, and I inform patients of our out-of-network status and give them a reasonable estimate of the cost of their care, network participation will no longer restrict patients who want to see me. I acknowledge that we will have to make good-faith efforts to join their networks (which most of us have repeatedly) and learn how to navigate the arbitration process, but this could be a boon for small-practice dermatologists who have been shut out of participating. In fact, it may be less trouble for insurers to simply invite us in, than going through repeated arbitration.

In the bigger picture, I would remind you of the importance of your legislative participation at the past American Academy of Dermatology Association Washington fly-ins, your support of the American Medical Association, and your support of SkinPac. These issues were always in our top three asks in Washington. All this favorable language was suggested, supported, and aided by your efforts and support of organized medicine.

There is a sign on my desk my wife gave me that reads “Never, Never, Never, Give Up.” I am proud of all of you for never giving up, and think you all deserve a “way to go” and a pat on the back. This law, which is a far walk from abusive air ambulance bills and unexpected anesthesia charges, amply and happily demonstrates that things can be changed for the better, and that access to care for our patients can be improved.

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

Certainly, this has been a tumultuous year for health care, as well as the nation in general. There is so much to cover it is hard to know where to begin.

KLH49/iStock/Getty Images

Against a background of a swelling pandemic, I remain confused about the new evaluation and management coding system, and suspect there will be much more training to be rolled out. It is excellent news that the Paycheck Protection Program has been renewed for a second pass, if you can demonstrate that you suffered at least a 25% drop in income for at least one quarter last year, and have fewer than 300 employees – which covers most dermatology practices. I plan to discuss the impact of price transparency in a future column, but today will discuss one area, where we have had the passage of major health care legislation, that may have been overlooked.

The surprise medical billing act, or “No Surprises Act,” was a bipartisan congressional agreement, which means it is likely to “stick” no matter the change in executive or legislative branches.

Starting in January 2022, patients are protected from surprise medical bills. For nonemergency services and services outside hospitals and other facilities, a patient can only be billed for the coinsurance/copay that they would have had if the patient had been in network unless you go through a consent process by which you inform the patient that you are out-of-network, inform them of the costs, and inform them of other in-network providers. It also requires that patients’ in-network cost-sharing payments for out-of-network surprise bills are attributed to a patient’s in-network deductible.

In section 103, it further states that, where out-of-network rates are determined, there will be a 30-day open negotiation period for providers and payers to settle out-of-network claims. It also states that if the parties are unable to reach a negotiated agreement, they may access a binding arbitration process – referred to as an independent dispute resolution (IDR) – in which one offer prevails. Providers may batch similar services in one proceeding when claims are from the same payer. The IDR process will be administered by independent, unbiased entities with no affiliation to providers or payers.

The IDR entity is required to consider the market-based median in-network rate, alongside relevant information brought by either party, information requested by the reviewer, as well as factors such as the provider’s training and experience patient acuity, and the complexity of furnishing the item or service, in the case of a provider that is a facility. Other factors include the teaching status, case mix and scope of services of such facility, demonstrations of good faith efforts (or lack of good faith efforts) to enter into a network agreement, prior contracted rates during the previous 4 plan-years, and other items. Billed charges and public payer (Medicare and Medicaid) rates are excluded from consideration. This should result in a payment closer to private insurance rates.

As many of you know, another one of the long-term outrages by insurers has been the closure of their networks and delisting of dermatologists. I have written about this situation before in this column. Insurers have also refused to update their provider lists, effectively denying care by the magical process of not having to pay for medical care, because there aren’t any medical providers.

 

Inaccurate physician rosters

Obviously, one source of surprise medical bills that is easily correctable are inaccurate insurance company physician rosters. The Centers for Medicare & Medicaid Services implemented new rules with stiff fines instructing Medicare advantage plans to improve the accuracy of physician rosters, after a scathing General Accounting Office report 5 years ago. This process, however, was effectively neutered by the last administration by referring all enforcement action to the states, which did not have the manpower or political will to enforce them. This new surprise billing law directly addresses this issue, requiring insurers to update their provider directories every 90 days and keeping them available to patients on line.

This law also eliminates gag clauses between physicians and patients regarding insurer policies.

In short, this bill solves many problems for dermatologists in their constant struggle with insurers. In particular, accurate provider directories will allow patients and companies buying insurance for their employees, to see what they are getting. I suspect the revelation of the paucity of dermatologists in many of these networks will result in increased demand for your services and perhaps provide you a little negotiating leverage.

Also, if I read this law correctly, and I inform patients of our out-of-network status and give them a reasonable estimate of the cost of their care, network participation will no longer restrict patients who want to see me. I acknowledge that we will have to make good-faith efforts to join their networks (which most of us have repeatedly) and learn how to navigate the arbitration process, but this could be a boon for small-practice dermatologists who have been shut out of participating. In fact, it may be less trouble for insurers to simply invite us in, than going through repeated arbitration.

In the bigger picture, I would remind you of the importance of your legislative participation at the past American Academy of Dermatology Association Washington fly-ins, your support of the American Medical Association, and your support of SkinPac. These issues were always in our top three asks in Washington. All this favorable language was suggested, supported, and aided by your efforts and support of organized medicine.

There is a sign on my desk my wife gave me that reads “Never, Never, Never, Give Up.” I am proud of all of you for never giving up, and think you all deserve a “way to go” and a pat on the back. This law, which is a far walk from abusive air ambulance bills and unexpected anesthesia charges, amply and happily demonstrates that things can be changed for the better, and that access to care for our patients can be improved.

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

Certainly, this has been a tumultuous year for health care, as well as the nation in general. There is so much to cover it is hard to know where to begin.

KLH49/iStock/Getty Images

Against a background of a swelling pandemic, I remain confused about the new evaluation and management coding system, and suspect there will be much more training to be rolled out. It is excellent news that the Paycheck Protection Program has been renewed for a second pass, if you can demonstrate that you suffered at least a 25% drop in income for at least one quarter last year, and have fewer than 300 employees – which covers most dermatology practices. I plan to discuss the impact of price transparency in a future column, but today will discuss one area, where we have had the passage of major health care legislation, that may have been overlooked.

The surprise medical billing act, or “No Surprises Act,” was a bipartisan congressional agreement, which means it is likely to “stick” no matter the change in executive or legislative branches.

Starting in January 2022, patients are protected from surprise medical bills. For nonemergency services and services outside hospitals and other facilities, a patient can only be billed for the coinsurance/copay that they would have had if the patient had been in network unless you go through a consent process by which you inform the patient that you are out-of-network, inform them of the costs, and inform them of other in-network providers. It also requires that patients’ in-network cost-sharing payments for out-of-network surprise bills are attributed to a patient’s in-network deductible.

In section 103, it further states that, where out-of-network rates are determined, there will be a 30-day open negotiation period for providers and payers to settle out-of-network claims. It also states that if the parties are unable to reach a negotiated agreement, they may access a binding arbitration process – referred to as an independent dispute resolution (IDR) – in which one offer prevails. Providers may batch similar services in one proceeding when claims are from the same payer. The IDR process will be administered by independent, unbiased entities with no affiliation to providers or payers.

The IDR entity is required to consider the market-based median in-network rate, alongside relevant information brought by either party, information requested by the reviewer, as well as factors such as the provider’s training and experience patient acuity, and the complexity of furnishing the item or service, in the case of a provider that is a facility. Other factors include the teaching status, case mix and scope of services of such facility, demonstrations of good faith efforts (or lack of good faith efforts) to enter into a network agreement, prior contracted rates during the previous 4 plan-years, and other items. Billed charges and public payer (Medicare and Medicaid) rates are excluded from consideration. This should result in a payment closer to private insurance rates.

As many of you know, another one of the long-term outrages by insurers has been the closure of their networks and delisting of dermatologists. I have written about this situation before in this column. Insurers have also refused to update their provider lists, effectively denying care by the magical process of not having to pay for medical care, because there aren’t any medical providers.

 

Inaccurate physician rosters

Obviously, one source of surprise medical bills that is easily correctable are inaccurate insurance company physician rosters. The Centers for Medicare & Medicaid Services implemented new rules with stiff fines instructing Medicare advantage plans to improve the accuracy of physician rosters, after a scathing General Accounting Office report 5 years ago. This process, however, was effectively neutered by the last administration by referring all enforcement action to the states, which did not have the manpower or political will to enforce them. This new surprise billing law directly addresses this issue, requiring insurers to update their provider directories every 90 days and keeping them available to patients on line.

This law also eliminates gag clauses between physicians and patients regarding insurer policies.

In short, this bill solves many problems for dermatologists in their constant struggle with insurers. In particular, accurate provider directories will allow patients and companies buying insurance for their employees, to see what they are getting. I suspect the revelation of the paucity of dermatologists in many of these networks will result in increased demand for your services and perhaps provide you a little negotiating leverage.

Also, if I read this law correctly, and I inform patients of our out-of-network status and give them a reasonable estimate of the cost of their care, network participation will no longer restrict patients who want to see me. I acknowledge that we will have to make good-faith efforts to join their networks (which most of us have repeatedly) and learn how to navigate the arbitration process, but this could be a boon for small-practice dermatologists who have been shut out of participating. In fact, it may be less trouble for insurers to simply invite us in, than going through repeated arbitration.

In the bigger picture, I would remind you of the importance of your legislative participation at the past American Academy of Dermatology Association Washington fly-ins, your support of the American Medical Association, and your support of SkinPac. These issues were always in our top three asks in Washington. All this favorable language was suggested, supported, and aided by your efforts and support of organized medicine.

There is a sign on my desk my wife gave me that reads “Never, Never, Never, Give Up.” I am proud of all of you for never giving up, and think you all deserve a “way to go” and a pat on the back. This law, which is a far walk from abusive air ambulance bills and unexpected anesthesia charges, amply and happily demonstrates that things can be changed for the better, and that access to care for our patients can be improved.

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

By addressing the vascular component of melasma, off-label use of oral tranexamic acid has been a beneficial adjunct for this difficult-to-treat condition. For on-label use treating menorrhagia (the oral form) and short-term prophylaxis of bleeding in hemophilia patients undergoing dental procedures – (the injectable form), tranexamic acid acts as an antifibrinolytic.

By inhibiting plasminogen activation, according to a 2018 review article “tranexamic acid mitigates UV radiation–induced melanogenesis and neovascularization,” both exhibited in the clinical manifestations of melasma.¹ In addition to inhibiting fibrinolysis, tranexamic acid has direct effects on UV-induced pigmentation, “via its inhibitory effects on UV light–induced plasminogen activator on keratinocytes and [subsequent] plasmin activity,” the article states. “Plasminogen activator induces tyrosinase activity, resulting in increased melanin synthesis. The presence of plasmin [which dissolves clots by degrading fibrin] results in increased production of both arachidonic acid and fibroblast growth factor, which stimulate melanogenesis and neovascularization, respectively.”

With oral use, the risk of clot formation, especially in those who have a history of blood clots, clotting disorders (such as factor V Leiden), smoking, or other hypercoagulability risks should be weighed.

Topical tranexamic acid used locally mitigates systemic risk, and according to published studies, has been found to be efficacious for hemostasis in knee and hip arthroplasty surgery and for epistaxis. However, clinical outcomes with the topical treatment have largely not been on par with regards to efficacy for melasma when compared with oral tranexamic acid.

A potentially more efficacious way to deliver topical tranexamic acid for treating melasma and

pigmentation is with laser-assisted delivery. Topical tranexamic acid, in my experience, when applied immediately after fractional 1927-nm diode laser treatment, not only has been noted by patients to feel soothing, but anecdotally has been found to improve pigmentation.

Moreover, there are now several peer-reviewed studies showing some benefit for treating pigmentation from photodamage or melasma with laser-assisted delivery of topical tranexamic acid. Treatment of these conditions may also benefit from nonablative 1927-nm laser alone.

In one recently published study, 10 female melasma patients, Fitzpatrick skin types II-IV, underwent five full-face low-energy, low-density (power 4-5 W, fluence 2-8 mJ, 2-8 passes) 1927-nm fractional thulium fiber laser treatment.² Topical tranexamic acid was applied immediately after laser treatment and continued twice daily for 7 days. Seven patients completed the study. Based on the Global Aesthetics Improvement Scale (GAIS) ratings, all seven patients noted improvement at day 180, at which time six of the patients were considered to have improved from baseline, according to the investigator GAIS ratings. Using the Melasma Area Severity Index (MASI) score, the greatest degree of improvement was seen at day 90; there were three recurrences of melasma with worsening of the MASI score between day 90 and day 180.

In a split-face, double-blind, randomized controlled study, 46 patients with Fitzpatrick skin types III-V, with recalcitrant melasma received four weekly treatments of full-face fractional 1927-nm thulium laser; topical tranexamic acid was applied to one side of the face and normal saline applied to the other side under occlusion, immediately after treatment.³ At 3 months, significant improvements from baseline were seen with Melanin Index (MI) and modified MASI (mMASI) scores for the sides treated with tranexamic acid and the control side, with no statistically significant differences between the two. However, at month 6, among the 29 patients available for follow-up, significant differences in MI and mMASI scores from baseline were still evident, with the exception of MI scores on the control sides.

No adverse events from using topical tranexamic acid with laser were noted in either study. Split-face randomized control studies with use of topical tranexamic acid after fractional 1927-nm diode laser in comparison to fractional 1927-nm thulium laser would be notable in this vascular and heat-sensitive condition as well.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

1. Sheu SL. Cutis. 2018 Feb;101(2):E7-E8.

2. Wang, JV et al. J Cosmet Dermatol. 2021 Jan;20(1):105-9.

3. Wanitphakdeedecha R. et al. Lasers Med Sci. 2020 Dec;35(9):2015-21.

By addressing the vascular component of melasma, off-label use of oral tranexamic acid has been a beneficial adjunct for this difficult-to-treat condition. For on-label use treating menorrhagia (the oral form) and short-term prophylaxis of bleeding in hemophilia patients undergoing dental procedures – (the injectable form), tranexamic acid acts as an antifibrinolytic.

By inhibiting plasminogen activation, according to a 2018 review article “tranexamic acid mitigates UV radiation–induced melanogenesis and neovascularization,” both exhibited in the clinical manifestations of melasma.¹ In addition to inhibiting fibrinolysis, tranexamic acid has direct effects on UV-induced pigmentation, “via its inhibitory effects on UV light–induced plasminogen activator on keratinocytes and [subsequent] plasmin activity,” the article states. “Plasminogen activator induces tyrosinase activity, resulting in increased melanin synthesis. The presence of plasmin [which dissolves clots by degrading fibrin] results in increased production of both arachidonic acid and fibroblast growth factor, which stimulate melanogenesis and neovascularization, respectively.”

With oral use, the risk of clot formation, especially in those who have a history of blood clots, clotting disorders (such as factor V Leiden), smoking, or other hypercoagulability risks should be weighed.

Topical tranexamic acid used locally mitigates systemic risk, and according to published studies, has been found to be efficacious for hemostasis in knee and hip arthroplasty surgery and for epistaxis. However, clinical outcomes with the topical treatment have largely not been on par with regards to efficacy for melasma when compared with oral tranexamic acid.

A potentially more efficacious way to deliver topical tranexamic acid for treating melasma and

pigmentation is with laser-assisted delivery. Topical tranexamic acid, in my experience, when applied immediately after fractional 1927-nm diode laser treatment, not only has been noted by patients to feel soothing, but anecdotally has been found to improve pigmentation.

Moreover, there are now several peer-reviewed studies showing some benefit for treating pigmentation from photodamage or melasma with laser-assisted delivery of topical tranexamic acid. Treatment of these conditions may also benefit from nonablative 1927-nm laser alone.

In one recently published study, 10 female melasma patients, Fitzpatrick skin types II-IV, underwent five full-face low-energy, low-density (power 4-5 W, fluence 2-8 mJ, 2-8 passes) 1927-nm fractional thulium fiber laser treatment.² Topical tranexamic acid was applied immediately after laser treatment and continued twice daily for 7 days. Seven patients completed the study. Based on the Global Aesthetics Improvement Scale (GAIS) ratings, all seven patients noted improvement at day 180, at which time six of the patients were considered to have improved from baseline, according to the investigator GAIS ratings. Using the Melasma Area Severity Index (MASI) score, the greatest degree of improvement was seen at day 90; there were three recurrences of melasma with worsening of the MASI score between day 90 and day 180.

In a split-face, double-blind, randomized controlled study, 46 patients with Fitzpatrick skin types III-V, with recalcitrant melasma received four weekly treatments of full-face fractional 1927-nm thulium laser; topical tranexamic acid was applied to one side of the face and normal saline applied to the other side under occlusion, immediately after treatment.³ At 3 months, significant improvements from baseline were seen with Melanin Index (MI) and modified MASI (mMASI) scores for the sides treated with tranexamic acid and the control side, with no statistically significant differences between the two. However, at month 6, among the 29 patients available for follow-up, significant differences in MI and mMASI scores from baseline were still evident, with the exception of MI scores on the control sides.

No adverse events from using topical tranexamic acid with laser were noted in either study. Split-face randomized control studies with use of topical tranexamic acid after fractional 1927-nm diode laser in comparison to fractional 1927-nm thulium laser would be notable in this vascular and heat-sensitive condition as well.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

1. Sheu SL. Cutis. 2018 Feb;101(2):E7-E8.

2. Wang, JV et al. J Cosmet Dermatol. 2021 Jan;20(1):105-9.

3. Wanitphakdeedecha R. et al. Lasers Med Sci. 2020 Dec;35(9):2015-21.

By addressing the vascular component of melasma, off-label use of oral tranexamic acid has been a beneficial adjunct for this difficult-to-treat condition. For on-label use treating menorrhagia (the oral form) and short-term prophylaxis of bleeding in hemophilia patients undergoing dental procedures – (the injectable form), tranexamic acid acts as an antifibrinolytic.

By inhibiting plasminogen activation, according to a 2018 review article “tranexamic acid mitigates UV radiation–induced melanogenesis and neovascularization,” both exhibited in the clinical manifestations of melasma.¹ In addition to inhibiting fibrinolysis, tranexamic acid has direct effects on UV-induced pigmentation, “via its inhibitory effects on UV light–induced plasminogen activator on keratinocytes and [subsequent] plasmin activity,” the article states. “Plasminogen activator induces tyrosinase activity, resulting in increased melanin synthesis. The presence of plasmin [which dissolves clots by degrading fibrin] results in increased production of both arachidonic acid and fibroblast growth factor, which stimulate melanogenesis and neovascularization, respectively.”

With oral use, the risk of clot formation, especially in those who have a history of blood clots, clotting disorders (such as factor V Leiden), smoking, or other hypercoagulability risks should be weighed.

Topical tranexamic acid used locally mitigates systemic risk, and according to published studies, has been found to be efficacious for hemostasis in knee and hip arthroplasty surgery and for epistaxis. However, clinical outcomes with the topical treatment have largely not been on par with regards to efficacy for melasma when compared with oral tranexamic acid.

A potentially more efficacious way to deliver topical tranexamic acid for treating melasma and

pigmentation is with laser-assisted delivery. Topical tranexamic acid, in my experience, when applied immediately after fractional 1927-nm diode laser treatment, not only has been noted by patients to feel soothing, but anecdotally has been found to improve pigmentation.

Moreover, there are now several peer-reviewed studies showing some benefit for treating pigmentation from photodamage or melasma with laser-assisted delivery of topical tranexamic acid. Treatment of these conditions may also benefit from nonablative 1927-nm laser alone.

In one recently published study, 10 female melasma patients, Fitzpatrick skin types II-IV, underwent five full-face low-energy, low-density (power 4-5 W, fluence 2-8 mJ, 2-8 passes) 1927-nm fractional thulium fiber laser treatment.² Topical tranexamic acid was applied immediately after laser treatment and continued twice daily for 7 days. Seven patients completed the study. Based on the Global Aesthetics Improvement Scale (GAIS) ratings, all seven patients noted improvement at day 180, at which time six of the patients were considered to have improved from baseline, according to the investigator GAIS ratings. Using the Melasma Area Severity Index (MASI) score, the greatest degree of improvement was seen at day 90; there were three recurrences of melasma with worsening of the MASI score between day 90 and day 180.

In a split-face, double-blind, randomized controlled study, 46 patients with Fitzpatrick skin types III-V, with recalcitrant melasma received four weekly treatments of full-face fractional 1927-nm thulium laser; topical tranexamic acid was applied to one side of the face and normal saline applied to the other side under occlusion, immediately after treatment.³ At 3 months, significant improvements from baseline were seen with Melanin Index (MI) and modified MASI (mMASI) scores for the sides treated with tranexamic acid and the control side, with no statistically significant differences between the two. However, at month 6, among the 29 patients available for follow-up, significant differences in MI and mMASI scores from baseline were still evident, with the exception of MI scores on the control sides.

No adverse events from using topical tranexamic acid with laser were noted in either study. Split-face randomized control studies with use of topical tranexamic acid after fractional 1927-nm diode laser in comparison to fractional 1927-nm thulium laser would be notable in this vascular and heat-sensitive condition as well.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

1. Sheu SL. Cutis. 2018 Feb;101(2):E7-E8.

2. Wang, JV et al. J Cosmet Dermatol. 2021 Jan;20(1):105-9.

3. Wanitphakdeedecha R. et al. Lasers Med Sci. 2020 Dec;35(9):2015-21.

The pandemic has isolated our patients to an unprecedented degree, forcing them to find other ways to communicate with us, including email. I wondered how private offices were handling the marked increase in email communications since the pandemic began; so I queried several physician blogs and social media pages.

Responses varied all over the map. Some refuse the medium entirely. “I politely say that I don’t practice dermatology via email,” said one. “Please schedule a teledermatology appointment and I’d be happy to help.”

Others are ambivalent: “I do email with some patients who have complex situations or quick questions, but if it gets out of hand then I let them know someone will call to make an appointment.” Another office treats them as a one-way street: “We set up one account to receive patients’ emails, but we tell them clearly that we don’t respond ... my staff or I call them back.”

Still others have assimilated it completely. “Patients email through the portal and my MA routes [them] to me. I answer questions and the MA responds ... staff loves it because it’s so much faster than the phone.”

A 1998 study in JAMA was more scientifically designed, but basically reached the same conclusion. The authors found “a striking lack of consensus” on how to deal with patient emails: 50% responded to them, but 31% of responders refused to give advice without seeing the patient, while 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to a follow-up questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient emails are needed.”

Indeed, my own unscientific survey suggests that, more than 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association and the American Medical Association have proposed standards, but none have been generally accepted. Until that happens, it seems prudent for each individual practice to adopt its own guidelines. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your attorney to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive emails from states in which you are not licensed), and of course, confidentiality.

Contrary to popular belief, HIPAA does not prohibit email communication with patients, nor require that it be encrypted. The HIPAA website specifically says: “Patients may initiate communications with a provider using email. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Proofpoint, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion and klara are among the leading vendors of secure messaging services.

The important thing is to make a firm decision on how you want to deal with emails, and stick with that method. And follow your guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

The pandemic has isolated our patients to an unprecedented degree, forcing them to find other ways to communicate with us, including email. I wondered how private offices were handling the marked increase in email communications since the pandemic began; so I queried several physician blogs and social media pages.

Responses varied all over the map. Some refuse the medium entirely. “I politely say that I don’t practice dermatology via email,” said one. “Please schedule a teledermatology appointment and I’d be happy to help.”

Others are ambivalent: “I do email with some patients who have complex situations or quick questions, but if it gets out of hand then I let them know someone will call to make an appointment.” Another office treats them as a one-way street: “We set up one account to receive patients’ emails, but we tell them clearly that we don’t respond ... my staff or I call them back.”

Still others have assimilated it completely. “Patients email through the portal and my MA routes [them] to me. I answer questions and the MA responds ... staff loves it because it’s so much faster than the phone.”

A 1998 study in JAMA was more scientifically designed, but basically reached the same conclusion. The authors found “a striking lack of consensus” on how to deal with patient emails: 50% responded to them, but 31% of responders refused to give advice without seeing the patient, while 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to a follow-up questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient emails are needed.”

Indeed, my own unscientific survey suggests that, more than 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association and the American Medical Association have proposed standards, but none have been generally accepted. Until that happens, it seems prudent for each individual practice to adopt its own guidelines. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your attorney to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive emails from states in which you are not licensed), and of course, confidentiality.

Contrary to popular belief, HIPAA does not prohibit email communication with patients, nor require that it be encrypted. The HIPAA website specifically says: “Patients may initiate communications with a provider using email. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Proofpoint, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion and klara are among the leading vendors of secure messaging services.

The important thing is to make a firm decision on how you want to deal with emails, and stick with that method. And follow your guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

The pandemic has isolated our patients to an unprecedented degree, forcing them to find other ways to communicate with us, including email. I wondered how private offices were handling the marked increase in email communications since the pandemic began; so I queried several physician blogs and social media pages.

Responses varied all over the map. Some refuse the medium entirely. “I politely say that I don’t practice dermatology via email,” said one. “Please schedule a teledermatology appointment and I’d be happy to help.”

Others are ambivalent: “I do email with some patients who have complex situations or quick questions, but if it gets out of hand then I let them know someone will call to make an appointment.” Another office treats them as a one-way street: “We set up one account to receive patients’ emails, but we tell them clearly that we don’t respond ... my staff or I call them back.”

Still others have assimilated it completely. “Patients email through the portal and my MA routes [them] to me. I answer questions and the MA responds ... staff loves it because it’s so much faster than the phone.”

A 1998 study in JAMA was more scientifically designed, but basically reached the same conclusion. The authors found “a striking lack of consensus” on how to deal with patient emails: 50% responded to them, but 31% of responders refused to give advice without seeing the patient, while 59% offered a diagnosis, and a third of that group went on to provide specific advice about therapy. In response to a follow-up questionnaire, 28% said that they tended not to answer any patient emails, 24% said they usually replied with a standard message, and 24% said they answer each request individually. The authors concluded that “standards for physician response to unsolicited patient emails are needed.”

Indeed, my own unscientific survey suggests that, more than 20 years later, there is still nothing resembling a consensus on this issue. In the interim, several groups, including the American Medical Informatics Association and the American Medical Association have proposed standards, but none have been generally accepted. Until that happens, it seems prudent for each individual practice to adopt its own guidelines. For ideas, take a look at the proposals from the groups I mentioned, plus any others you can find. When you’re done, consider running your list past your attorney to make sure you haven’t forgotten anything, and that there are no unique requirements in your state.

Your guidelines may be very simple (if you decide never to answer any queries) or very complex, depending on your situation and personal philosophy. But all guidelines should cover such issues as authentication of correspondents, informed consent, licensing jurisdiction (if you receive emails from states in which you are not licensed), and of course, confidentiality.

Contrary to popular belief, HIPAA does not prohibit email communication with patients, nor require that it be encrypted. The HIPAA website specifically says: “Patients may initiate communications with a provider using email. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual.”

Still, if you are not comfortable with unencrypted communication, encryption software can be added to your practice’s email system. Proofpoint, Tumbleweed, Zix, and many other vendors sell encryption packages. (As always, I have no financial interest in any product or enterprise mentioned in this column.)

Another option is web-based messaging: Patients enter your website and send a message using an electronic template that you design. A designated staffer will be notified by regular email when messages are received, and can post a reply on a page that can only be accessed by the patient. Besides enhancing privacy and security, you can state your guidelines in plain English to preclude any misunderstanding of what you will and will not address online.

Web-based messaging services can be freestanding or incorporated into existing secure websites. Medfusion and klara are among the leading vendors of secure messaging services.

The important thing is to make a firm decision on how you want to deal with emails, and stick with that method. And follow your guidelines.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

The list of things to be ungrateful for last year is long. You’re not supposed to make this list, though. The best practice is to list what you’re grateful for, even when living in trying times. That’s a long list too, but I find making it similarly unfruitful.

Of course, I’m grateful I don’t have COVID-19, thankful my practice hasn’t been significantly impacted, grateful I got the vaccine. But simply repeating these gratitudes daily seems ineffective. I’ve learned a different “gratefulness practice” that perhaps works better.

AscentXmedia/E+

The last question is the best. We all spend time thinking about what others think of us. We should spend time thinking about what impact we’ve had on them. Like a cold shower, it’s both briskly awakening and easy to do. Go back through your day and reflect on what you did that made things difficult for others. It can be as simple as I started whining about how a patient waylaid me with her silly complaints. That led to my colleague’s joining in about difficult patients. Or I was late turning in my article, which made my editor have to work harder to get it completed in time.

There’s plenty of things we should be grateful for. In doing these exercises you’ll learn just how much others have cared for you and, I hope, how you might do things to make them grateful for you.

If you’re interested in learning more about Naikan, I discovered this from Brett McKay’s The Art of Manliness podcast and the teaching of Gregg Krech, summarized in his book, “Naikan: Gratitude, Grace, and the Japanese Art of Self-Reflection.”
 

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

The list of things to be ungrateful for last year is long. You’re not supposed to make this list, though. The best practice is to list what you’re grateful for, even when living in trying times. That’s a long list too, but I find making it similarly unfruitful.

Of course, I’m grateful I don’t have COVID-19, thankful my practice hasn’t been significantly impacted, grateful I got the vaccine. But simply repeating these gratitudes daily seems ineffective. I’ve learned a different “gratefulness practice” that perhaps works better.

AscentXmedia/E+

The last question is the best. We all spend time thinking about what others think of us. We should spend time thinking about what impact we’ve had on them. Like a cold shower, it’s both briskly awakening and easy to do. Go back through your day and reflect on what you did that made things difficult for others. It can be as simple as I started whining about how a patient waylaid me with her silly complaints. That led to my colleague’s joining in about difficult patients. Or I was late turning in my article, which made my editor have to work harder to get it completed in time.

There’s plenty of things we should be grateful for. In doing these exercises you’ll learn just how much others have cared for you and, I hope, how you might do things to make them grateful for you.

If you’re interested in learning more about Naikan, I discovered this from Brett McKay’s The Art of Manliness podcast and the teaching of Gregg Krech, summarized in his book, “Naikan: Gratitude, Grace, and the Japanese Art of Self-Reflection.”
 

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

The list of things to be ungrateful for last year is long. You’re not supposed to make this list, though. The best practice is to list what you’re grateful for, even when living in trying times. That’s a long list too, but I find making it similarly unfruitful.

Of course, I’m grateful I don’t have COVID-19, thankful my practice hasn’t been significantly impacted, grateful I got the vaccine. But simply repeating these gratitudes daily seems ineffective. I’ve learned a different “gratefulness practice” that perhaps works better.

AscentXmedia/E+

The last question is the best. We all spend time thinking about what others think of us. We should spend time thinking about what impact we’ve had on them. Like a cold shower, it’s both briskly awakening and easy to do. Go back through your day and reflect on what you did that made things difficult for others. It can be as simple as I started whining about how a patient waylaid me with her silly complaints. That led to my colleague’s joining in about difficult patients. Or I was late turning in my article, which made my editor have to work harder to get it completed in time.

There’s plenty of things we should be grateful for. In doing these exercises you’ll learn just how much others have cared for you and, I hope, how you might do things to make them grateful for you.

If you’re interested in learning more about Naikan, I discovered this from Brett McKay’s The Art of Manliness podcast and the teaching of Gregg Krech, summarized in his book, “Naikan: Gratitude, Grace, and the Japanese Art of Self-Reflection.”
 

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