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The leading independent newspaper covering dermatology news and commentary.
FDA’s fast-track approval process exposed as lax, in need of reform
an in-depth investigation published in The BMJ has determined.
“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.
The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
Required studies rarely completed
As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.
However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.
The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.
In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.
Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.
For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.
As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.
Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.
“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
Call for reform
As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.
In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.
“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.
In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.
Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.
One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.
“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.
An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”
“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.
A version of this article first appeared on Medscape.com.
an in-depth investigation published in The BMJ has determined.
“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.
The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
Required studies rarely completed
As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.
However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.
The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.
In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.
Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.
For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.
As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.
Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.
“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
Call for reform
As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.
In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.
“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.
In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.
Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.
One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.
“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.
An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”
“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.
A version of this article first appeared on Medscape.com.
an in-depth investigation published in The BMJ has determined.
“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited – to the detriment of patients, who may be prescribed a drug that offers little benefit and possible harm, and to taxpayers,” writes Elisabeth Mahase, clinical reporter at The BMJ, who carried out the analysis.
The FDA’s accelerated approval pathway is intended to provide earlier access to drugs for serious diseases when there is lingering uncertainty at the time of approval regarding the drug’s ultimate clinical benefit.
Required studies rarely completed
As part of this fast-track pathway, drug manufacturers must conduct postapproval, phase 4 confirmatory trials to verify the anticipated clinical benefit. If these trials indicate no benefit, FDA approval can be withdrawn.
However, the analysis of FDA data shows once they are approved drugs are rarely taken off the market.
The BMJ investigation that analyzed data up to the end of 2020 shows that 112 of the 253 (44%) medications granted accelerated approval have not been confirmed to be effective.
In addition, 24 (21%) of these questionable drugs have been on the market for more than 5 years and some have been on the market for more than 20 years – often with a hefty price tag.
Furthermore, only 16 drugs approved through the accelerated approval process have ever been withdrawn, and most were shown to be ineffective, but in some cases the confirmatory trials were never done, Ms. Mahase reports.
For example, the COX-2 inhibitor celecoxib (Celebrex), which was granted accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because efficacy trials were never completed.
As part of The BMJ’s investigation, Ms. Mahase asked manufacturers of the 24 drugs that have remained on the market for more than 5 years whether they had conducted the required phase 4 confirmatory trials. Six of the drugs had been withdrawn, approved, or postponed.
Of the remaining 18 drugs, the manufacturers provided the relevant trial information for only six. Only four drugmakers had started to recruit patients; two said they were still in discussion with the FDA over the final trial design.
“These products routinely have side effects, but the benefit information is a lot less certain. That’s what we’re concerned about – that we may have drugs on the market that don’t have any benefits, but certainly predictably have harms associated with them,” Huseyin Naci, PhD, MHS, with the London School of Economics, comments in the report.
Call for reform
As reported by this news organization, a 2015 report by the General Accountability Office (GAO) concluded that the FDA does not do an effective job of tracking the clinical efficacy or the safety of drugs with expedited approval after they hit the market.
In April of this year, the Institute for Clinical and Economic Review (ICER) cited a lack of “credible threats” to withdraw approval if companies don’t do confirmatory trials – meaning drugmakers have little incentive to do the trials.
“There are some instances where the companies really do seem to be taking advantage of the accelerated approval pathway and are using it in a way that makes it harder to get at the truth about whether these products really are safe and effective,” Rachel Sachs, JD, MPH, Washington University, St. Louis, said in The BMJ article.
In addition, the authors of a recent viewpoint article in JAMA Internal Medicine assert the recent approval of the controversial anti-amyloid drug aducanumab (Aduhelm, Biogen) shows that the accelerated approval pathway needs to be reformed.
Despite the concerns, Ms. Mahase said all experts who spoke to The BMJ believe the accelerated approval pathway is still useful and can be beneficial to patients, although some changes are needed.
One effective reform might be to have confirmatory trials designed, and even started, as part of accelerated approval.
“One important piece of the puzzle is for the FDA itself to be tougher on these companies, to hold them to the bargain that they have agreed to, and to take action when the company has not met their obligations,” Ms. Sachs told the journal.
An FDA spokesperson told the BMJ that the agency is “committed to working with sponsors to ensure that confirmatory studies are completed in a timely manner.”
“We expect sponsors to commit all resources needed to move trials forward as effectively as possible, with the aim of completing trials as soon as is feasible, while assuring the quality of the data and the robustness of the results,” the agency said.
A version of this article first appeared on Medscape.com.
COVID-19 leaves wake of medical debt among U.S. adults
Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.
The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.
For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.
“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.
“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.
Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.
Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.
“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.
When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.
According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.
George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.
“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”
He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.
“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”
For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.
Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.
“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”
Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.
A version of this article first appeared on Medscape.com.
Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.
The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.
For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.
“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.
“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.
Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.
Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.
“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.
When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.
According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.
George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.
“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”
He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.
“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”
For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.
Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.
“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”
Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.
A version of this article first appeared on Medscape.com.
Despite the passage of four major relief bills in 2020 and 2021 and federal efforts to offset pandemic- and job-related coverage loss, many people continued to face financial challenges, especially those with a low income and those who are Black or Latino.
The survey, which included responses from 5,450 adults, revealed that 10% of adults aged 19-64 were uninsured during the first half of 2021, a rate lower than what was recorded in 2020 and 2019 in both federal and private surveys. However, uninsured rates were highest among those with low income, those younger than 50 years old, and Black and Latino adults.
For most adults who lost employee health insurance, the coverage gap was relatively brief, with 54% saying their coverage gap lasted 3-4 months. Only 16% of adults said coverage gaps lasted a year or longer.
“The good news is that this survey is suggesting that the coverage losses during the pandemic may have been offset by federal efforts to help people get and maintain health insurance coverage,” lead author Sara Collins, PhD, Commonwealth Fund vice president for health care coverage, access, and tracking, said in an interview.
“The bad news is that a third of Americans continue to struggle with medical bills and medical debt, even among those who have health insurance coverage,” Dr. Collins added.
Indeed, the survey found that about one-third of insured adults reported a medical bill problem or that they were paying off medical debt, as did approximately half of those who were uninsured. Medical debt caused 35% of respondents to use up most or all of their savings to pay it off.
Meanwhile, 27% of adults said medical bills left them unable to pay for necessities such as food, heat, or rent. What surprised Dr. Collins was that 43% of adults said they received a lower credit rating as a result of their medical debt, and 35% said they had taken on more credit card debt to pay off these bills.
“The fact that it’s bleeding over into people’s financial security in terms of their credit scores, I think is something that really needs to be looked at by policymakers,” Dr. Collins said.
When analyzed by race/ethnicity, the researchers found that 55% of Black adults and 44% of Latino/Hispanic adults reported medical bills and debt problems, compared with 32% of White adults. In addition, 47% of those living below the poverty line also reported problems with medical bills.
According to the survey, 45% of respondents were directly affected by the pandemic in at least one of three ways – testing positive or getting sick from COVID-19, losing income, or losing employer coverage – with Black and Latinx adults and those with lower incomes at greater risk.
George Abraham, MD, president of the American College of Physicians, said the Commonwealth Fund’s findings were not surprising because it has always been known that underrepresented populations struggle for access to care because of socioeconomic factors. He said these populations were more vulnerable in terms of more severe infections and disease burden during the pandemic.
“[This study] validates what primary care physicians have been saying all along in regard to our patients’ access to care and their ability to cover health care costs,” said Dr. Abraham, who was not involved with the study. “This will hopefully be an eye-opener and wake-up call that reiterates that we still do not have equitable access to care and vulnerable populations are disproportionately affected.”
He believes that, although people are insured, many of them may contend with medical debt when they fall ill because they can’t afford the premiums.
“Even though they may have been registered for health coverage, they may not have active coverage at the time of illness simply because they weren’t able to make their last premium payments because they’ve been down, because they lost their job, or whatever else,” Dr. Abraham explained. “On paper, they appear to have health care coverage. But in reality, clearly, that coverage does not match their needs or it’s not affordable.”
For Dr. Abraham, the study emphasizes the need to continue support for health care reform, including pricing it so that insurance is available for those with fewer socioeconomic resources.
Yalda Jabbarpour, MD, medical director of the Robert Graham Center for Policy Studies, Washington, said high-deductible health plans need to be “reined in” because they can lead to greater debt, particularly among vulnerable populations.
“Hopefully this will encourage policymakers to look more closely at the problem of medical debt as a contributing factor to financial instability,” Dr. Jabbarpour said. “Federal relief is important, so is expanding access to comprehensive, affordable health care coverage.”
Dr. Collins said there should also be a way to raise awareness of the health care marketplace and coverage options so that people have an easier time getting insured.
A version of this article first appeared on Medscape.com.
Study highlights impact of acne in adult women on quality of life, mental health
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
results from a qualitative study demonstrated.
“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”
For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.
The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).
More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.
In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.
“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”
In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”
Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”
In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”
A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”
For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”
This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.
FROM JAMA DERMATOLOGY
Money buys life, and a cigarette maker wants to ‘unsmoke the world’
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
With COVID, the fun never ends
Welcome to America’s favorite pandemic-themed game show! Let’s play Covidiot Proof! And now, here’s your host, the lovely and talented Anthony Grouchy!
Tony: Hello everyone! Our first category today is America or [blank], and the first clue is for you, Don. This country requires “individuals to use a health pass to patronize indoor establishments such as restaurants, bars, nightclubs and cinemas.”
Don: Freedom-loving Americans would never stand for that, Tony, so I’m going to say Greece.
Tony: That’s correct, Don. One hundred points for you. Okay Joe, here’s your clue: In this country, some people wear disguises to get a COVID vaccination so their friends and families won’t find out.
Joe: Sounds like communism to me, Tony. I’ll say Cuba.
Tony: Sorry Joe, that’s incorrect. Don?
Don: The friends and families sound like freedom-loving Americans, so it must be America.
Tony: It is America. Missouri, to be exact. And now, one last question for both of you to win the game. True or false? Did the pastor of a church in Tennessee say that mask-wearers would be kicked out of the building because “I am not playing these Democrat games up in this church”?
Joe: That’s fake news, Tony. It’s gotta be false.
Tony: Incorrect! It’s absolutely true. That means today’s winner is … Joe? Yes, I’m being told that Tennessee goes to Joe.
Don: That’s bulls#&@! I won this thing! I’ll see you in court!
More money, more life
Does it seem to you that the wealthy live forever, while the less financially comfortable live shorter lives? If you answered, yes, it turns out that you’re right.
Researchers analyzed the effect of net worth at midlife with mortality. To take out genetic differences among the sample of 5,400 adults aged 46 years, the investigators also studied a subset of 2,490 twin and sibling pairs.
“The within-family association provides strong evidence that an association between wealth accumulation and life expectancy exists, because comparing siblings within the same family to each other controls for all of the life experience and biology that they share,” said coauthor Eric Finegood of Northwestern University, Chicago.
But what if one sibling has a history of cancer, heart disease, or other health conditions? The cost of treatment and employment limitations could affect someone’s ability to stack their wealth, right? Absolutely. The researchers took that into account and looked at only healthy individuals and found the same results. More money, longer life.
We have the policies and programs in place for heart health, diabetes prevention, and smoking cessation, as they are seen as major threats to public health. So why not do the same for financial security? A low bank account may just be more harmful.
Holding the ‘health care and wellness’ gun
Cigarettes are not good for us. We know this.
It’s, therefore, not surprising to learn that a business has requested for a U.K. ban on the sale of cigarettes by 2030. However, when that someone turns out to be the CEO of Philip Morris International, tobacco company and maker of Marlboro cigarettes, things get a little confusing.
Banning cigarettes, according to Jacek Olczak, would reduce confusion among consumers, many of whom feel that the alternatives are worse for their health. His company can “see the world without cigarettes ... and actually, the sooner it happens, the better it is for everyone.” A truly noble sentiment from the CEO of a large tobacco company. Nothing nefarious going on here.
And if those aren’t egregious business euphemisms, we don’t know what is.
Of course, for all the completely believable and sincere rhetoric, the fact is that Marlboros are still on the shelves. Philip Morris is still making and advertising them. If their concern was genuine, why wouldn’t they just stop manufacturing them now?
So, we ask ourselves if this a selfless act of kindness or is it an unscrupulous corporate act to get a leg up on their competitors? We’ll leave it up to the readers to decide.
Okay, we lied, it’s the second one.
Autopsy of the living dead
Imagine the absolute terror you’d feel if you opened your eyes to bright, blinding white lights only to see a bone saw 3 inches from your forehead and getting closer by the second. Horrifying for you, certainly, but think about the poor pathologist behind the saw who probably thought a zombie apocalypse was coming. This was close to being a reality for a 29-year-old prisoner at the Asturias Central Penitentiary in Spain.
Gonzalo Montoya Jiménez was discovered in his cell unresponsive. Three physicians examined him and found he was showing signs of death, such as cyanosis and rigor mortis. Mr. Jiménez was processed like any other body and was sent, in a body bag, to a hospital mortuary, where he spent time in a freezer for body preservation. Just before he was due for his autopsy, he began showing signs of life.
It’s not completely clear why this happened to poor Mr. Jiménez, but it was reported that he wasn’t feeling well the day before and that he has epilepsy. Hospital officials suggested he may have been cataleptic, possibly because he had trouble adhering to his medication schedule.
Mr. Jiménez was moved to another hospital under armed guard after coming back to life and regained consciousness after a day or so. Talk about cheating death.
When is MRI useful in the management of congenital melanocytic nevi?
When used for appropriate patients, results from a small multi-institutional study showed.
“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”
One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.
“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.
To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.
The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).
“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.
The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.
All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”
The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.
Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.
“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”
Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.
Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.
When used for appropriate patients, results from a small multi-institutional study showed.
“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”
One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.
“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.
To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.
The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).
“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.
The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.
All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”
The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.
Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.
“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”
Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.
Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.
When used for appropriate patients, results from a small multi-institutional study showed.
“The majority of congenital nevi are considered low risk for cutaneous and/or systemic complications,” Holly Neale said at the annual meeting of the Society for Pediatric Dermatology. “However, a subset of children born with higher-risk congenital nevi require close monitoring, as some features of congenital nevi have been associated with cutaneous melanoma, central nervous system melanoma, melanin in the brain or spine, and structural irregularities in the brain or spine. It’s important to understand which congenital nevi are considered higher risk in order to guide management and counseling decisions.”
One major management decision is to do a screening magnetic resonance image of the CNS to evaluate for neurologic involvement, said Ms. Neale, a fourth-year medical student at the University of Massachusetts, Worcester. Prior studies have shown that congenital nevi that are bigger than 20 cm, posterior axial location, and having more than one congenital nevus may predict CNS abnormalities, while recent guidelines from experts in the field suggest that any child with more than one congenital nevus at birth undergo screening MRI.
“However, guidelines are evolving, and more data is required to better understand the CNS abnormalities and patient outcomes for children with congenital nevi,” said Ms. Neale, who spent the past year as a pediatric dermatology research fellow at Massachusetts General Hospital, Boston.
To address this knowledge gap, she and colleagues at the University of Massachusetts, Massachusetts General Hospital, and Boston Children’s Hospital performed a retrospective chart review between Jan. 1, 2009, and Dec. 31, 2019, of individuals ages 18 and younger who had an MRI of the brain or spine with at least one dermatologist-diagnosed nevus as identified via key words in the medical record. Of the 909 patients screened, 46 met inclusion criteria, evenly split between males and females.
The most common location of the largest nevus was the trunk (in 41% of patients), followed by lesions that spanned multiple regions. More than one-third of patients had giant nevi (greater than 40 cm).
“The majority of images were considered nonconcerning, which includes normal, benign, or other findings such as trauma related, infectious, or orthopedic, which we did not classify as abnormal as it did not guide our study question,” Ms. Neale said. Specifically, 8% of spine images and 27% of brain images were considered “concerning,” defined as any finding that prompted further workup or monitoring, which includes findings concerning for melanin.
The most common brain finding was melanin (in eight children), and one child with brain melanin also had findings suggestive of melanin in the thoracic spine. The most common finding in spine MRIs was fatty filum (in four children), requiring intervention for tethering in only one individual. No cases of cutaneous melanoma developed during the study period, and only one patient with abnormal imaging had CNS melanoma, which was fatal.
All patients with findings suggestive of CNS melanin had more than four nevi present at birth, which is in line with current imaging screening guidelines. In addition, children with concerning imaging had higher rates of death, neurodevelopmental problems, seizures, and neurosurgery, compared with their counterparts with unremarkable imaging findings. Describing preliminary analyses, Ms. Neale said that a chi square analysis was performed to test statistical significance of these differences, “and neurosurgery was the only variable that children with concerning imaging were significantly more likely to experience, although sample size limits detection for the other variables.”
The authors concluded that MRI is a helpful tool when used in the appropriate clinical context for the management of congenital nevi. “As more children undergo imaging, we may discover more nonmelanin abnormalities,” she said.
Joseph M. Lam, MD, who was asked to comment on the study, said that the increased risk of CNS melanin in patients with larger lesions and in those with multiple lesions confirms previous reports.
“It is interesting to note that some patients with nonconcerning imaging results still had neurodevelopmental problems and seizures, albeit at a lower rate than those with concerning imaging results,” said Dr. Lam, a pediatric dermatologist at British Columbia Children’s Hospital, Vancouver. “The lack of a control group for comparison of rates of neurological sequelae, such as NDP, seizures and nonmelanin structural anomalies, limits the generalizability of the findings. However, this is a nice study that helps us understand better the CNS anomalies in CMN.”
Ms. Neale acknowledged certain limitations of the study, including the lack of a control group without CMN, the small number of patients, the potential for referral bias, and its retrospective design. Also, the proximity of the study period does not allow for chronic follow-up and detection of the development of melanoma or other problems in the future.
Ms. Neale and associates reported having no relevant financial disclosures. Dr. Lam disclosed that he has received speaker fees from Pierre Fabre.
FROM SPD 2021
Study estimates carbon footprint reduction of virtual isotretinoin visits
: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.
In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.
The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.
Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)
The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.
In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.
Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.
“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.
The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”
Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.
In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.
Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.
Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.
Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.
While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.
Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)
Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.
: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.
In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.
The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.
Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)
The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.
In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.
Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.
“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.
The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”
Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.
In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.
Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.
Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.
Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.
While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.
Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)
Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.
: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.
In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.
The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.
Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)
The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.
In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.
Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.
“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.
The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”
Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.
In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.
Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.
Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.
Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.
While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.
Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)
Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.
FROM PEDIATRIC DERMATOLOGY
Are you at legal risk for speaking at conferences?
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
Common outcome measures for AD lack adequate reporting of race, skin tone
, according to results from a systematic review.
“AD is associated with considerable heterogeneity across different races and skin tones,” presenting study author Trisha Kaundinya said at the Revolutionizing Atopic Dermatitis symposium. “Compared with lighter skin tones, darker skin tones more commonly have diffuse xerosis, Dennis-Morgan lines, hyperlinearity of the palms, periorbital dark circles, lichenification, and prurigo nodularis. This heterogeneity can be challenging to assess in clinical trials and in practice.”
The Harmonizing Outcome Measures for Eczema (HOME) group has selected several scales by international consensus. For clinical trials, the group recommends the Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI). In clinical practice, the HOME group recommends the POEM, Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), and the Numeric Rating Scale (NRS)-itch measures. “The psychometric validity and reliability of these outcome measures have undergone robust investigation before, but the validity and reliability of these outcome measures remains uncertain across different races, ethnicities, and skin tones,” Ms. Kaundinya said.
Jonathan Silverberg, MD, PhD, associate professor of dermatology at George Washington University, Washington, in collaboration with Andrew F. Alexis, MD, MPH, vice-chair for diversity and inclusion for the department of dermatology at Weill-Cornell Medicine, New York, and Jacob P. Thyssen, MD, PhD, at the University of Copenhagen, Denmark, sought to examine reporting of race, ethnicity, and skin tone, and to compare results across these groups from studies of psychometric properties for outcome measures in AD. Under the mentorship of Dr. Silverberg, Ms. Kaundinya, a medical student at Northwestern University, Chicago, and her research associates conducted a systematic review that searched PubMed and Embase and identified 165 relevant published studies of 41,146 individuals.
Of the individuals participating in these 165 studies, 73% had an unspecified racial background, 18% were White, 4% were Asian, 2% were Black, 2% were Hispanic, 1% were multiracial/other, and the remainder were American Indian/Alaskan Native. Only 55 of the studies (33%) reported the distribution of race or ethnicity, 5 (3%) reported the distribution of skin tone, and 16 (10%) reported psychometric differences in patients with different races, ethnicities, or skin tones. In addition, only 5 of 113 (4%) studies that did not report race, ethnicity, or skin tone–based differences acknowledged absence of stratification as a limitation.
Of note, significant differential item functioning was found between race subgroups for one or more items of the PO-SCORAD, the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire (PIQ) Short Forms, POEM, DLQI, Hospital Anxiety and Depression Scale (HADS), Itchy Quality of Life (ItchyQOL) scale, 5-dimensions (5D) itch scale, Short Form (SF)-12, and NRS-itch. “Correlations of the POEM with the Investigator’s Global Assessment (IGA) differed the most between skin of color and lighter skin,” Ms. Kaundinya said.
“The POEM did seem to correlate similarly with the DLQI and the EASI in both white and nonwhite participants, which may indicate why this trifecta of instruments is recommended by the HOME group. One study found that substituting the erythema component of the EASI scale with greyness for darker skin, in which erythema is more challenging to assess, did not significantly improve the reliability of EASI. This indicates that further research is needed to investigate how EASI can be modified to perform better in darker skin tones.”
She pointed out that some studies of clinician-reported outcome measures were underpowered to detect meaningful differences between patient subgroups. “There were also insufficient data to perform meta-regression of differences between patient subgroups,” she said. “Overall, future studies are needed to determine whether outcome measures recommended by the HOME and other tools perform equally well across diverse patient populations. This systematic review indicates significant reporting and knowledge gaps for psychometric properties of outcome measures by race, ethnicity, or skin tone in AD.”
Ms. Kaundinya reported having no relevant financial disclosures. Dr. Silverberg, the study’s senior author, is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.
, according to results from a systematic review.
“AD is associated with considerable heterogeneity across different races and skin tones,” presenting study author Trisha Kaundinya said at the Revolutionizing Atopic Dermatitis symposium. “Compared with lighter skin tones, darker skin tones more commonly have diffuse xerosis, Dennis-Morgan lines, hyperlinearity of the palms, periorbital dark circles, lichenification, and prurigo nodularis. This heterogeneity can be challenging to assess in clinical trials and in practice.”
The Harmonizing Outcome Measures for Eczema (HOME) group has selected several scales by international consensus. For clinical trials, the group recommends the Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI). In clinical practice, the HOME group recommends the POEM, Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), and the Numeric Rating Scale (NRS)-itch measures. “The psychometric validity and reliability of these outcome measures have undergone robust investigation before, but the validity and reliability of these outcome measures remains uncertain across different races, ethnicities, and skin tones,” Ms. Kaundinya said.
Jonathan Silverberg, MD, PhD, associate professor of dermatology at George Washington University, Washington, in collaboration with Andrew F. Alexis, MD, MPH, vice-chair for diversity and inclusion for the department of dermatology at Weill-Cornell Medicine, New York, and Jacob P. Thyssen, MD, PhD, at the University of Copenhagen, Denmark, sought to examine reporting of race, ethnicity, and skin tone, and to compare results across these groups from studies of psychometric properties for outcome measures in AD. Under the mentorship of Dr. Silverberg, Ms. Kaundinya, a medical student at Northwestern University, Chicago, and her research associates conducted a systematic review that searched PubMed and Embase and identified 165 relevant published studies of 41,146 individuals.
Of the individuals participating in these 165 studies, 73% had an unspecified racial background, 18% were White, 4% were Asian, 2% were Black, 2% were Hispanic, 1% were multiracial/other, and the remainder were American Indian/Alaskan Native. Only 55 of the studies (33%) reported the distribution of race or ethnicity, 5 (3%) reported the distribution of skin tone, and 16 (10%) reported psychometric differences in patients with different races, ethnicities, or skin tones. In addition, only 5 of 113 (4%) studies that did not report race, ethnicity, or skin tone–based differences acknowledged absence of stratification as a limitation.
Of note, significant differential item functioning was found between race subgroups for one or more items of the PO-SCORAD, the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire (PIQ) Short Forms, POEM, DLQI, Hospital Anxiety and Depression Scale (HADS), Itchy Quality of Life (ItchyQOL) scale, 5-dimensions (5D) itch scale, Short Form (SF)-12, and NRS-itch. “Correlations of the POEM with the Investigator’s Global Assessment (IGA) differed the most between skin of color and lighter skin,” Ms. Kaundinya said.
“The POEM did seem to correlate similarly with the DLQI and the EASI in both white and nonwhite participants, which may indicate why this trifecta of instruments is recommended by the HOME group. One study found that substituting the erythema component of the EASI scale with greyness for darker skin, in which erythema is more challenging to assess, did not significantly improve the reliability of EASI. This indicates that further research is needed to investigate how EASI can be modified to perform better in darker skin tones.”
She pointed out that some studies of clinician-reported outcome measures were underpowered to detect meaningful differences between patient subgroups. “There were also insufficient data to perform meta-regression of differences between patient subgroups,” she said. “Overall, future studies are needed to determine whether outcome measures recommended by the HOME and other tools perform equally well across diverse patient populations. This systematic review indicates significant reporting and knowledge gaps for psychometric properties of outcome measures by race, ethnicity, or skin tone in AD.”
Ms. Kaundinya reported having no relevant financial disclosures. Dr. Silverberg, the study’s senior author, is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.
, according to results from a systematic review.
“AD is associated with considerable heterogeneity across different races and skin tones,” presenting study author Trisha Kaundinya said at the Revolutionizing Atopic Dermatitis symposium. “Compared with lighter skin tones, darker skin tones more commonly have diffuse xerosis, Dennis-Morgan lines, hyperlinearity of the palms, periorbital dark circles, lichenification, and prurigo nodularis. This heterogeneity can be challenging to assess in clinical trials and in practice.”
The Harmonizing Outcome Measures for Eczema (HOME) group has selected several scales by international consensus. For clinical trials, the group recommends the Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI). In clinical practice, the HOME group recommends the POEM, Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), and the Numeric Rating Scale (NRS)-itch measures. “The psychometric validity and reliability of these outcome measures have undergone robust investigation before, but the validity and reliability of these outcome measures remains uncertain across different races, ethnicities, and skin tones,” Ms. Kaundinya said.
Jonathan Silverberg, MD, PhD, associate professor of dermatology at George Washington University, Washington, in collaboration with Andrew F. Alexis, MD, MPH, vice-chair for diversity and inclusion for the department of dermatology at Weill-Cornell Medicine, New York, and Jacob P. Thyssen, MD, PhD, at the University of Copenhagen, Denmark, sought to examine reporting of race, ethnicity, and skin tone, and to compare results across these groups from studies of psychometric properties for outcome measures in AD. Under the mentorship of Dr. Silverberg, Ms. Kaundinya, a medical student at Northwestern University, Chicago, and her research associates conducted a systematic review that searched PubMed and Embase and identified 165 relevant published studies of 41,146 individuals.
Of the individuals participating in these 165 studies, 73% had an unspecified racial background, 18% were White, 4% were Asian, 2% were Black, 2% were Hispanic, 1% were multiracial/other, and the remainder were American Indian/Alaskan Native. Only 55 of the studies (33%) reported the distribution of race or ethnicity, 5 (3%) reported the distribution of skin tone, and 16 (10%) reported psychometric differences in patients with different races, ethnicities, or skin tones. In addition, only 5 of 113 (4%) studies that did not report race, ethnicity, or skin tone–based differences acknowledged absence of stratification as a limitation.
Of note, significant differential item functioning was found between race subgroups for one or more items of the PO-SCORAD, the Patient-Reported Outcomes Measurement Information System (PROMIS) Itch Questionnaire (PIQ) Short Forms, POEM, DLQI, Hospital Anxiety and Depression Scale (HADS), Itchy Quality of Life (ItchyQOL) scale, 5-dimensions (5D) itch scale, Short Form (SF)-12, and NRS-itch. “Correlations of the POEM with the Investigator’s Global Assessment (IGA) differed the most between skin of color and lighter skin,” Ms. Kaundinya said.
“The POEM did seem to correlate similarly with the DLQI and the EASI in both white and nonwhite participants, which may indicate why this trifecta of instruments is recommended by the HOME group. One study found that substituting the erythema component of the EASI scale with greyness for darker skin, in which erythema is more challenging to assess, did not significantly improve the reliability of EASI. This indicates that further research is needed to investigate how EASI can be modified to perform better in darker skin tones.”
She pointed out that some studies of clinician-reported outcome measures were underpowered to detect meaningful differences between patient subgroups. “There were also insufficient data to perform meta-regression of differences between patient subgroups,” she said. “Overall, future studies are needed to determine whether outcome measures recommended by the HOME and other tools perform equally well across diverse patient populations. This systematic review indicates significant reporting and knowledge gaps for psychometric properties of outcome measures by race, ethnicity, or skin tone in AD.”
Ms. Kaundinya reported having no relevant financial disclosures. Dr. Silverberg, the study’s senior author, is a consultant to and/or an advisory board member for several pharmaceutical companies. He is also a speaker for Regeneron and Sanofi and has received a grant from Galderma.
FROM REVOLUTIONIZING AD 2021
COVID-19 vaccination does not increase risk of flare in patients with lupus
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
COVID-19 vaccinations appear to be well tolerated in patients with systemic lupus erythematosus (SLE) and come with a low risk of flare, according to the results of a global, web-based survey.
“Disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE,” wrote lead author Renaud Felten, MD, of Strasbourg (France) University Hospital. Their results were published as a comment in Lancet Rheumatology.
To assess vaccine tolerability among lupus patients, the cross-sectional Tolerance and Consequences of Vaccination Against COVID-19 in Lupus Patients (VACOLUP) study analyzed a 43-question survey of 696 participants with a self-reported, medically confirmed diagnosis of SLE from 30 countries between March 22, 2021, and May 17, 2021. The cohort was 96% women, and their median age was 42 (interquartile range, 34-51). Nearly 36% of respondents were from Italy, 27% were from Chile, 13% were from France, and just under 9% were Americans. All participants received at least one dose of COVID-19 vaccine, and 49% received a second dose. The most common vaccines were Pfizer-BioNTech (57%), Sinovac (22%), AstraZeneca (10%), and Moderna (8%).
Only 21 participants (3%) reported a medically confirmed SLE flare after a median of 3 days (IQR, 0-29) post COVID vaccination, with most experiencing musculoskeletal symptoms (90%) and fatigue (86%). Of the 21 cases, 15 reported a subsequent change in SLE treatment and 4 were admitted to the hospital. A previous flare that occurred within a year before vaccination was associated with an increased risk of flare post vaccination (relative risk, 5.52; 95% confidence interval, 2.17-14.03; P < .0001).
Side effects – including swelling, soreness, fever, chills, fatigue, joint and muscle pain, nausea, and headache – were reported in 45% of participants (n = 316) after their first dose and in 53% of the 343 participants who received a second dose. There was no notable difference in the likelihood of side effects across gender and age or in patients who received mRNA vaccines, compared with vaccines with other modes of action. Patients who reported side effects after the first dose were more likely to also report them after the second, compared with those who reported none (109 [81%] of 135 vs. 72 [35%] of 205; RR, 2.30; 95% CI, 1.88-2.82; P < .0001).
In the majority of cases (2,232 of 2,683), the side effects were of minor or moderate intensity and did not affect the participants’ ability to perform daily tasks. The study found no significant association between side effects and a SLE flare and SLE medications or previous SLE disease manifestations.
When asked to comment on the study, Amit Saxena, MD, of the Lupus Center at New York University Langone Health, said: “What we are seeing is pretty mild to moderate in terms of follow-up side effects or lupus-related activity. Several studies have shown this amongst our autoimmune rheumatology cohort, as well as what I’ve seen clinically in my own patients. More than anything else, numbers are the most important, and this is a large study.”
He acknowledged the benefits of going directly to patients to gauge their responses and reactions, giving them the opportunity to share concerns that physicians may not think about.
“As rheumatologists, we tend to focus on certain things that might not necessarily be what the patients themselves focus on,” he said. “I think the fact that this questionnaire dealt with a lot of what people complain about – fatigue, sore arm, things that we know are part of getting the vaccine – they aren’t necessarily things we capture with tools that screen for lupus flares, for example.”
More than anything, Dr. Saxena commended the study’s timeliness. “Patients are constantly asking us about the vaccine, and there’s so much misinformation,” he said. “People say, ‘Because I have lupus, I was told not to get vaccinated.’ I don’t know where they get that information from; we are telling everyone to get it, especially our lupus patients.”
The authors recognized their study’s main limitation as the self-reported and subjective nature of the survey, which they attempted to mitigate by asking for medically confirmed flares only. They noted, however, that the short median time between vaccination and flare onset could be caused by patients confusing expected side effects for something more serious, meaning the 3% figure “could be an overestimation of the actual flare rate.”
“Vaccination is recommended for patients with rheumatic and musculoskeletal diseases according to the American College of Rheumatology,” they added, “irrespective of disease activity and severity.”
Several authors reported potential conflicts of interest, including receiving consultancy fees and grants from Pfizer, GlaxoSmithKline, AbbVie, and Janssen, all unrelated to the study.
FROM THE LANCET RHEUMATOLOGY
Genetic testing for neurofibromatosis 1: An imperfect science
According to Peter Kannu, MB, ChB, DCH, PhD, a definitive diagnosis of NF1 can be made in most children using National Institutes of Health criteria published in 1988, which include the presence of two of the following:
- Six or more café au lait macules over 5 mm in diameter in prepubertal individuals and over 15 mm in greatest diameter in postpubertal individuals
- Two or more neurofibromas of any type or one plexiform neurofibroma
- Freckling in the axillary or inguinal regions
- Two or more Lisch nodules
- Optic glioma
- A distinctive osseous lesion such as sphenoid dysplasia or thinning of long bone cortex, with or without pseudarthrosis
- Having a first-degree relative with NF1
For example, in the case of an 8-year-old child who presents with multiple café au lait macules, axillary and inguinal freckling, Lisch nodules, and an optic glioma, “the diagnosis is secure and genetic testing is not going to change clinical management or surveillance,” Dr. Kannu, a clinical geneticist at the University of Alberta, Edmonton, said during the annual meeting of the Society for Pediatric Dermatology. “The only reason for genetic testing in this situation is so that we know the mutation in order to inform reproductive risk counseling in the future.”
However, while a diagnosis of NF1 may be suspected in a 6- to 12-month-old presenting with only café au lait macules, “the diagnosis is not secure because the clinical criteria cannot be met. In this situation, a genetic test can speed up the diagnosis,” he added. “Or, if the test is negative, it can decrease your suspicion for NF1 and you wouldn’t refer the child on to an NF1 screening clinic for intensive surveillance.”
Dr. Kannu based his remarks largely on his 5 years working at the multidisciplinary Genodermatoses Clinic at the Hospital for Sick Children, Toronto. Founded in 2015, the clinic is a “one-stop shop” designed to reduce the wait time for diagnosis and management and the number of hospital visits. The team – composed of a dermatologist, medical geneticist, genetic counselor, residents, and fellows – meets to review the charts of each patient before the appointment, and decides on a preliminary management plan. All children are then seen by one of the trainees in the clinic who devises a differential diagnosis that is presented to staff physicians, at which point genetic testing is decided on. A genetics counselor handles follow-up for those who do have genetic testing.
In 2018, Dr. Kannu and colleagues conducted an informal review of 300 patients who had been seen in the clinic. The mean age at referral was about 6 years, 51% were female, and the top three referral sources were pediatricians (51%), dermatologists (18%), and family physicians (18%). Of the 300 children, 84 (28%) were confirmed to have a diagnosis of NF1. Two patients were diagnosed with NF2 and 5% of the total cohort was diagnosed with mosaic NF1 (MNF1), “which is higher than what you would expect based on the incidence of MNF1 in the literature,” he said.
He separates genetic tests for NF1 into one of two categories: Conventional testing, which is offered by most labs in North America; and comprehensive testing, which is offered by the medical genomics lab at the University of Alabama at Birmingham. Conventional testing focuses on the exons, “the protein coding regions of the gene where most of the mutations lie,” he said. “The test also sequences about 20 base pairs or so of the intron exon boundary and may pick up some intronic mutations. But this test will not detect anything that’s hidden deep in the intronic region.”
Comprehensive testing, meanwhile, checks for mutations in both introns and exons.
Dr. Kannu and colleagues published a case of a paraspinal ganglioneuroma in the proband of a large family with mild cutaneous manifestations of NF1, carrying a deep NF1 intronic mutation. “The clinicians were suspicious that this was NF1, rightly so. The diagnosis was only confirmed after we sent samples to the University of Alabama lab where the deep intronic mutation was found,” he said.
The other situation where conventional genetic testing may be negative is in the case of MNF1, where there “are mutations in some cells but not all cells,” Dr. Kannu explained. “It may only be present in the melanocytes of the skin but not present in the lymphocytes in the blood. Mosaicism is characterized by the regional distribution of pigmentary or other NF1 associated findings. Mosaicism may be detected in the blood if it’s more than 20%. Anything less than that is not detected with conventional genetic testing using DNA from blood and requires extracting DNA from a punch biopsy sample of a café au lait macule.”
The differential diagnosis of café au lait macules includes several conditions associated mutations in the RAS pathway. “Neurofibromin is a key signal of molecules which regulates the activation of RAS,” Dr. Kannu said. “A close binding partner of NF1 is SPRED 1. We know that mutations in this gene cause Legius syndrome, a condition which presents with multiple café au lait macules.”
Two key receptors in the RAS pathway include EGFR and KITL, he continued. Mutations in the EGFR receptor cause a rare condition known as neonatal skin and bowel disease, while mutations in the KITL receptor cause familial progressive hyperpigmentation with or without hypopigmentation. “Looking into the pathway and focusing downstream of RAS, we have genes such as RAF and CBL, which are mutated in Noonan syndrome,” he said. “Further along in the pathway you have mutations in PTEN, which cause Cowden syndrome, and mutations in TSC1 and TSC2, which cause tuberous sclerosis. Mutations in any of these genes can also present with café au lait macules.”
During a question-and-answer session Dr. Kannu was asked to comment about revised diagnostic criteria for NF1 based on an international consensus recommendation, such as changes in the eye that require a formal opthalmologic examination, which were recently published.
“We are understanding more about the phenotype,” he said. “If you fulfill diagnostic criteria for NF1, the main reasons for doing genetic testing are, one, if the family wants to know that information, and two, it informs our reproductive risk counseling. Genotype-phenotype correlations do exist in NF1 but they’re not very robust, so that information is not clinically useful.”
Dr. Kannu disclosed that he has been an advisory board member for Ipsen, Novartis, and Alexion. He has also been a primary investigator for QED and Clementia.
According to Peter Kannu, MB, ChB, DCH, PhD, a definitive diagnosis of NF1 can be made in most children using National Institutes of Health criteria published in 1988, which include the presence of two of the following:
- Six or more café au lait macules over 5 mm in diameter in prepubertal individuals and over 15 mm in greatest diameter in postpubertal individuals
- Two or more neurofibromas of any type or one plexiform neurofibroma
- Freckling in the axillary or inguinal regions
- Two or more Lisch nodules
- Optic glioma
- A distinctive osseous lesion such as sphenoid dysplasia or thinning of long bone cortex, with or without pseudarthrosis
- Having a first-degree relative with NF1
For example, in the case of an 8-year-old child who presents with multiple café au lait macules, axillary and inguinal freckling, Lisch nodules, and an optic glioma, “the diagnosis is secure and genetic testing is not going to change clinical management or surveillance,” Dr. Kannu, a clinical geneticist at the University of Alberta, Edmonton, said during the annual meeting of the Society for Pediatric Dermatology. “The only reason for genetic testing in this situation is so that we know the mutation in order to inform reproductive risk counseling in the future.”
However, while a diagnosis of NF1 may be suspected in a 6- to 12-month-old presenting with only café au lait macules, “the diagnosis is not secure because the clinical criteria cannot be met. In this situation, a genetic test can speed up the diagnosis,” he added. “Or, if the test is negative, it can decrease your suspicion for NF1 and you wouldn’t refer the child on to an NF1 screening clinic for intensive surveillance.”
Dr. Kannu based his remarks largely on his 5 years working at the multidisciplinary Genodermatoses Clinic at the Hospital for Sick Children, Toronto. Founded in 2015, the clinic is a “one-stop shop” designed to reduce the wait time for diagnosis and management and the number of hospital visits. The team – composed of a dermatologist, medical geneticist, genetic counselor, residents, and fellows – meets to review the charts of each patient before the appointment, and decides on a preliminary management plan. All children are then seen by one of the trainees in the clinic who devises a differential diagnosis that is presented to staff physicians, at which point genetic testing is decided on. A genetics counselor handles follow-up for those who do have genetic testing.
In 2018, Dr. Kannu and colleagues conducted an informal review of 300 patients who had been seen in the clinic. The mean age at referral was about 6 years, 51% were female, and the top three referral sources were pediatricians (51%), dermatologists (18%), and family physicians (18%). Of the 300 children, 84 (28%) were confirmed to have a diagnosis of NF1. Two patients were diagnosed with NF2 and 5% of the total cohort was diagnosed with mosaic NF1 (MNF1), “which is higher than what you would expect based on the incidence of MNF1 in the literature,” he said.
He separates genetic tests for NF1 into one of two categories: Conventional testing, which is offered by most labs in North America; and comprehensive testing, which is offered by the medical genomics lab at the University of Alabama at Birmingham. Conventional testing focuses on the exons, “the protein coding regions of the gene where most of the mutations lie,” he said. “The test also sequences about 20 base pairs or so of the intron exon boundary and may pick up some intronic mutations. But this test will not detect anything that’s hidden deep in the intronic region.”
Comprehensive testing, meanwhile, checks for mutations in both introns and exons.
Dr. Kannu and colleagues published a case of a paraspinal ganglioneuroma in the proband of a large family with mild cutaneous manifestations of NF1, carrying a deep NF1 intronic mutation. “The clinicians were suspicious that this was NF1, rightly so. The diagnosis was only confirmed after we sent samples to the University of Alabama lab where the deep intronic mutation was found,” he said.
The other situation where conventional genetic testing may be negative is in the case of MNF1, where there “are mutations in some cells but not all cells,” Dr. Kannu explained. “It may only be present in the melanocytes of the skin but not present in the lymphocytes in the blood. Mosaicism is characterized by the regional distribution of pigmentary or other NF1 associated findings. Mosaicism may be detected in the blood if it’s more than 20%. Anything less than that is not detected with conventional genetic testing using DNA from blood and requires extracting DNA from a punch biopsy sample of a café au lait macule.”
The differential diagnosis of café au lait macules includes several conditions associated mutations in the RAS pathway. “Neurofibromin is a key signal of molecules which regulates the activation of RAS,” Dr. Kannu said. “A close binding partner of NF1 is SPRED 1. We know that mutations in this gene cause Legius syndrome, a condition which presents with multiple café au lait macules.”
Two key receptors in the RAS pathway include EGFR and KITL, he continued. Mutations in the EGFR receptor cause a rare condition known as neonatal skin and bowel disease, while mutations in the KITL receptor cause familial progressive hyperpigmentation with or without hypopigmentation. “Looking into the pathway and focusing downstream of RAS, we have genes such as RAF and CBL, which are mutated in Noonan syndrome,” he said. “Further along in the pathway you have mutations in PTEN, which cause Cowden syndrome, and mutations in TSC1 and TSC2, which cause tuberous sclerosis. Mutations in any of these genes can also present with café au lait macules.”
During a question-and-answer session Dr. Kannu was asked to comment about revised diagnostic criteria for NF1 based on an international consensus recommendation, such as changes in the eye that require a formal opthalmologic examination, which were recently published.
“We are understanding more about the phenotype,” he said. “If you fulfill diagnostic criteria for NF1, the main reasons for doing genetic testing are, one, if the family wants to know that information, and two, it informs our reproductive risk counseling. Genotype-phenotype correlations do exist in NF1 but they’re not very robust, so that information is not clinically useful.”
Dr. Kannu disclosed that he has been an advisory board member for Ipsen, Novartis, and Alexion. He has also been a primary investigator for QED and Clementia.
According to Peter Kannu, MB, ChB, DCH, PhD, a definitive diagnosis of NF1 can be made in most children using National Institutes of Health criteria published in 1988, which include the presence of two of the following:
- Six or more café au lait macules over 5 mm in diameter in prepubertal individuals and over 15 mm in greatest diameter in postpubertal individuals
- Two or more neurofibromas of any type or one plexiform neurofibroma
- Freckling in the axillary or inguinal regions
- Two or more Lisch nodules
- Optic glioma
- A distinctive osseous lesion such as sphenoid dysplasia or thinning of long bone cortex, with or without pseudarthrosis
- Having a first-degree relative with NF1
For example, in the case of an 8-year-old child who presents with multiple café au lait macules, axillary and inguinal freckling, Lisch nodules, and an optic glioma, “the diagnosis is secure and genetic testing is not going to change clinical management or surveillance,” Dr. Kannu, a clinical geneticist at the University of Alberta, Edmonton, said during the annual meeting of the Society for Pediatric Dermatology. “The only reason for genetic testing in this situation is so that we know the mutation in order to inform reproductive risk counseling in the future.”
However, while a diagnosis of NF1 may be suspected in a 6- to 12-month-old presenting with only café au lait macules, “the diagnosis is not secure because the clinical criteria cannot be met. In this situation, a genetic test can speed up the diagnosis,” he added. “Or, if the test is negative, it can decrease your suspicion for NF1 and you wouldn’t refer the child on to an NF1 screening clinic for intensive surveillance.”
Dr. Kannu based his remarks largely on his 5 years working at the multidisciplinary Genodermatoses Clinic at the Hospital for Sick Children, Toronto. Founded in 2015, the clinic is a “one-stop shop” designed to reduce the wait time for diagnosis and management and the number of hospital visits. The team – composed of a dermatologist, medical geneticist, genetic counselor, residents, and fellows – meets to review the charts of each patient before the appointment, and decides on a preliminary management plan. All children are then seen by one of the trainees in the clinic who devises a differential diagnosis that is presented to staff physicians, at which point genetic testing is decided on. A genetics counselor handles follow-up for those who do have genetic testing.
In 2018, Dr. Kannu and colleagues conducted an informal review of 300 patients who had been seen in the clinic. The mean age at referral was about 6 years, 51% were female, and the top three referral sources were pediatricians (51%), dermatologists (18%), and family physicians (18%). Of the 300 children, 84 (28%) were confirmed to have a diagnosis of NF1. Two patients were diagnosed with NF2 and 5% of the total cohort was diagnosed with mosaic NF1 (MNF1), “which is higher than what you would expect based on the incidence of MNF1 in the literature,” he said.
He separates genetic tests for NF1 into one of two categories: Conventional testing, which is offered by most labs in North America; and comprehensive testing, which is offered by the medical genomics lab at the University of Alabama at Birmingham. Conventional testing focuses on the exons, “the protein coding regions of the gene where most of the mutations lie,” he said. “The test also sequences about 20 base pairs or so of the intron exon boundary and may pick up some intronic mutations. But this test will not detect anything that’s hidden deep in the intronic region.”
Comprehensive testing, meanwhile, checks for mutations in both introns and exons.
Dr. Kannu and colleagues published a case of a paraspinal ganglioneuroma in the proband of a large family with mild cutaneous manifestations of NF1, carrying a deep NF1 intronic mutation. “The clinicians were suspicious that this was NF1, rightly so. The diagnosis was only confirmed after we sent samples to the University of Alabama lab where the deep intronic mutation was found,” he said.
The other situation where conventional genetic testing may be negative is in the case of MNF1, where there “are mutations in some cells but not all cells,” Dr. Kannu explained. “It may only be present in the melanocytes of the skin but not present in the lymphocytes in the blood. Mosaicism is characterized by the regional distribution of pigmentary or other NF1 associated findings. Mosaicism may be detected in the blood if it’s more than 20%. Anything less than that is not detected with conventional genetic testing using DNA from blood and requires extracting DNA from a punch biopsy sample of a café au lait macule.”
The differential diagnosis of café au lait macules includes several conditions associated mutations in the RAS pathway. “Neurofibromin is a key signal of molecules which regulates the activation of RAS,” Dr. Kannu said. “A close binding partner of NF1 is SPRED 1. We know that mutations in this gene cause Legius syndrome, a condition which presents with multiple café au lait macules.”
Two key receptors in the RAS pathway include EGFR and KITL, he continued. Mutations in the EGFR receptor cause a rare condition known as neonatal skin and bowel disease, while mutations in the KITL receptor cause familial progressive hyperpigmentation with or without hypopigmentation. “Looking into the pathway and focusing downstream of RAS, we have genes such as RAF and CBL, which are mutated in Noonan syndrome,” he said. “Further along in the pathway you have mutations in PTEN, which cause Cowden syndrome, and mutations in TSC1 and TSC2, which cause tuberous sclerosis. Mutations in any of these genes can also present with café au lait macules.”
During a question-and-answer session Dr. Kannu was asked to comment about revised diagnostic criteria for NF1 based on an international consensus recommendation, such as changes in the eye that require a formal opthalmologic examination, which were recently published.
“We are understanding more about the phenotype,” he said. “If you fulfill diagnostic criteria for NF1, the main reasons for doing genetic testing are, one, if the family wants to know that information, and two, it informs our reproductive risk counseling. Genotype-phenotype correlations do exist in NF1 but they’re not very robust, so that information is not clinically useful.”
Dr. Kannu disclosed that he has been an advisory board member for Ipsen, Novartis, and Alexion. He has also been a primary investigator for QED and Clementia.
FROM SPD 2021