Dermatology News

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Using high-intensity focused electromagnetic (HIFEM) technology to strengthen pelvic floor muscles for the improvement of urinary incontinence (UI) and female sexual function was safe and effective at 9 months follow-up, results from a multicenter study showed.

“The pelvic floor consists of three pairs of muscles: the pubococcygeus, the iliococcygeus, and the puborectalis,” lead study author Joseph Berenholz, MD, and a diplomate of the American Board of Obstetics & Gynecology, said during the annual conference of the American Society for Laser Medicine and Surgery. “They control continence through support of pelvic organs. The urethra, the vagina, and the rectum pass through that diaphragm. It also contributes to sexual sensation and arousal. A deconditioning of the pelvic floor is usually the result of child-bearing years or aging, which usually results in urinary incontinence and impairment of sexual function. The noninvasive strengthening of the pelvic floor muscles helps to regain muscle tone and strength.”

In a prospective, open-label, single-arm study conducted at four sites, Dr. Berenholz, medical director of the Michigan Center for Women’s Health in Farmington Hills, and colleagues investigated the long-term effectiveness of HIFEM-induced pelvic floor muscle (PFM) strengthening for improvement of UI and sexual function. HIFEM selectively targets neuromuscular tissue and induces supramaximal PFM contractions that cannot be achieved voluntarily, he said, causing muscle strengthening due to muscle fiber hypertrophy, which helps patients to better isolate and command their muscles.

The study population consisted of 33 females with a mean age of 49 years who had UI and UI-related problems in sexual life. They received six 28-minute HIFEM treatments of the pelvic floor with the BTL Emsella, which is FDA cleared for both stress and urge incontinence. The frequency of visits was two treatments per week and the intensity of HIFEM was adjusted between 0% and 100% based on the patient’s tolerance threshold. Evaluations were conducted at baseline, after the last treatment, at 1, 3, 6, and 9 months. The primary outcomes were change in urine leakage based on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-UI-SF) and change in sexual function based on the Female Sexual Function Index (FSFI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Secondary endpoints were adverse events and the comfort of therapy based on a 7-point Likert scale.

Dr. Berenholz reported that from baseline the severity of UI based on the ICIQ-SF significantly decreased 60% by a mean of 8.1 points between baseline and 9 months (P < .001). At 1 month, the FSFI score improved 32% by a mean of 7.1 points (P < .001) and was sustained throughout the study. The most prominent changes were seen in the subdomains of desire, arousal, lubrication, and orgasm response.

The PISQ-12 score incrementally increased 25% to a mean improvement of 8.2 points at 9 months (P < .001). Subjects improved most in the emotive subdomain, reporting more frequent orgasms, increased desire, and sexual excitement. The minimal important difference was 6 points.

“This is a true paradigm shift in the treatment of incontinence and sexual dysfunction,” Dr. Berenholz said. “The therapy was safe, comfortable, no adverse events emerged, and 31 subjects (94%) described the therapy as comfortable. Interim data suggest that treatment effect was maintained for 9 months, and there were no significant declines in scores in the long term. The upcoming 12-month follow-up data will let us know if more maintenance therapy is needed.”

During a question-and-answer session, one of the abstract section chairs, Albert Wolkerstorfer, MD, PhD, wondered about the potential for combination treatments in this patient population. “I can imagine that something that is working on the muscle tone has a totally different mechanism than something that is working on the mucosa and the underlying tissue without really affecting the muscle,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam. “Would a combination be the way to go?”

Dr. Berenholz said that he sometimes combines HIFEM with the ULTRA Femme 360, a radiofrequency thermal energy device. “We thought this addresses two issues,” he said. “One is fascial muscle, which is the underlying structural issue for incontinence. The other is thermal energy to aid in incontinence prevention by inducing production of elastin and collagen in the midurethra, but also to promote lubrication and heightened sensitivity in the patient who’s either menopausal or has undergone chemotherapy for breast cancer.”

Dr. Berenholz reported having no financial disclosures. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.

[email protected]

Using high-intensity focused electromagnetic (HIFEM) technology to strengthen pelvic floor muscles for the improvement of urinary incontinence (UI) and female sexual function was safe and effective at 9 months follow-up, results from a multicenter study showed.

“The pelvic floor consists of three pairs of muscles: the pubococcygeus, the iliococcygeus, and the puborectalis,” lead study author Joseph Berenholz, MD, and a diplomate of the American Board of Obstetics & Gynecology, said during the annual conference of the American Society for Laser Medicine and Surgery. “They control continence through support of pelvic organs. The urethra, the vagina, and the rectum pass through that diaphragm. It also contributes to sexual sensation and arousal. A deconditioning of the pelvic floor is usually the result of child-bearing years or aging, which usually results in urinary incontinence and impairment of sexual function. The noninvasive strengthening of the pelvic floor muscles helps to regain muscle tone and strength.”

In a prospective, open-label, single-arm study conducted at four sites, Dr. Berenholz, medical director of the Michigan Center for Women’s Health in Farmington Hills, and colleagues investigated the long-term effectiveness of HIFEM-induced pelvic floor muscle (PFM) strengthening for improvement of UI and sexual function. HIFEM selectively targets neuromuscular tissue and induces supramaximal PFM contractions that cannot be achieved voluntarily, he said, causing muscle strengthening due to muscle fiber hypertrophy, which helps patients to better isolate and command their muscles.

The study population consisted of 33 females with a mean age of 49 years who had UI and UI-related problems in sexual life. They received six 28-minute HIFEM treatments of the pelvic floor with the BTL Emsella, which is FDA cleared for both stress and urge incontinence. The frequency of visits was two treatments per week and the intensity of HIFEM was adjusted between 0% and 100% based on the patient’s tolerance threshold. Evaluations were conducted at baseline, after the last treatment, at 1, 3, 6, and 9 months. The primary outcomes were change in urine leakage based on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-UI-SF) and change in sexual function based on the Female Sexual Function Index (FSFI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Secondary endpoints were adverse events and the comfort of therapy based on a 7-point Likert scale.

Dr. Berenholz reported that from baseline the severity of UI based on the ICIQ-SF significantly decreased 60% by a mean of 8.1 points between baseline and 9 months (P < .001). At 1 month, the FSFI score improved 32% by a mean of 7.1 points (P < .001) and was sustained throughout the study. The most prominent changes were seen in the subdomains of desire, arousal, lubrication, and orgasm response.

The PISQ-12 score incrementally increased 25% to a mean improvement of 8.2 points at 9 months (P < .001). Subjects improved most in the emotive subdomain, reporting more frequent orgasms, increased desire, and sexual excitement. The minimal important difference was 6 points.

“This is a true paradigm shift in the treatment of incontinence and sexual dysfunction,” Dr. Berenholz said. “The therapy was safe, comfortable, no adverse events emerged, and 31 subjects (94%) described the therapy as comfortable. Interim data suggest that treatment effect was maintained for 9 months, and there were no significant declines in scores in the long term. The upcoming 12-month follow-up data will let us know if more maintenance therapy is needed.”

During a question-and-answer session, one of the abstract section chairs, Albert Wolkerstorfer, MD, PhD, wondered about the potential for combination treatments in this patient population. “I can imagine that something that is working on the muscle tone has a totally different mechanism than something that is working on the mucosa and the underlying tissue without really affecting the muscle,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam. “Would a combination be the way to go?”

Dr. Berenholz said that he sometimes combines HIFEM with the ULTRA Femme 360, a radiofrequency thermal energy device. “We thought this addresses two issues,” he said. “One is fascial muscle, which is the underlying structural issue for incontinence. The other is thermal energy to aid in incontinence prevention by inducing production of elastin and collagen in the midurethra, but also to promote lubrication and heightened sensitivity in the patient who’s either menopausal or has undergone chemotherapy for breast cancer.”

Dr. Berenholz reported having no financial disclosures. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.

[email protected]

Using high-intensity focused electromagnetic (HIFEM) technology to strengthen pelvic floor muscles for the improvement of urinary incontinence (UI) and female sexual function was safe and effective at 9 months follow-up, results from a multicenter study showed.

“The pelvic floor consists of three pairs of muscles: the pubococcygeus, the iliococcygeus, and the puborectalis,” lead study author Joseph Berenholz, MD, and a diplomate of the American Board of Obstetics & Gynecology, said during the annual conference of the American Society for Laser Medicine and Surgery. “They control continence through support of pelvic organs. The urethra, the vagina, and the rectum pass through that diaphragm. It also contributes to sexual sensation and arousal. A deconditioning of the pelvic floor is usually the result of child-bearing years or aging, which usually results in urinary incontinence and impairment of sexual function. The noninvasive strengthening of the pelvic floor muscles helps to regain muscle tone and strength.”

In a prospective, open-label, single-arm study conducted at four sites, Dr. Berenholz, medical director of the Michigan Center for Women’s Health in Farmington Hills, and colleagues investigated the long-term effectiveness of HIFEM-induced pelvic floor muscle (PFM) strengthening for improvement of UI and sexual function. HIFEM selectively targets neuromuscular tissue and induces supramaximal PFM contractions that cannot be achieved voluntarily, he said, causing muscle strengthening due to muscle fiber hypertrophy, which helps patients to better isolate and command their muscles.

The study population consisted of 33 females with a mean age of 49 years who had UI and UI-related problems in sexual life. They received six 28-minute HIFEM treatments of the pelvic floor with the BTL Emsella, which is FDA cleared for both stress and urge incontinence. The frequency of visits was two treatments per week and the intensity of HIFEM was adjusted between 0% and 100% based on the patient’s tolerance threshold. Evaluations were conducted at baseline, after the last treatment, at 1, 3, 6, and 9 months. The primary outcomes were change in urine leakage based on the International Consultation on Incontinence Questionnaire–Short Form (ICIQ-UI-SF) and change in sexual function based on the Female Sexual Function Index (FSFI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Secondary endpoints were adverse events and the comfort of therapy based on a 7-point Likert scale.

Dr. Berenholz reported that from baseline the severity of UI based on the ICIQ-SF significantly decreased 60% by a mean of 8.1 points between baseline and 9 months (P < .001). At 1 month, the FSFI score improved 32% by a mean of 7.1 points (P < .001) and was sustained throughout the study. The most prominent changes were seen in the subdomains of desire, arousal, lubrication, and orgasm response.

The PISQ-12 score incrementally increased 25% to a mean improvement of 8.2 points at 9 months (P < .001). Subjects improved most in the emotive subdomain, reporting more frequent orgasms, increased desire, and sexual excitement. The minimal important difference was 6 points.

“This is a true paradigm shift in the treatment of incontinence and sexual dysfunction,” Dr. Berenholz said. “The therapy was safe, comfortable, no adverse events emerged, and 31 subjects (94%) described the therapy as comfortable. Interim data suggest that treatment effect was maintained for 9 months, and there were no significant declines in scores in the long term. The upcoming 12-month follow-up data will let us know if more maintenance therapy is needed.”

During a question-and-answer session, one of the abstract section chairs, Albert Wolkerstorfer, MD, PhD, wondered about the potential for combination treatments in this patient population. “I can imagine that something that is working on the muscle tone has a totally different mechanism than something that is working on the mucosa and the underlying tissue without really affecting the muscle,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam. “Would a combination be the way to go?”

Dr. Berenholz said that he sometimes combines HIFEM with the ULTRA Femme 360, a radiofrequency thermal energy device. “We thought this addresses two issues,” he said. “One is fascial muscle, which is the underlying structural issue for incontinence. The other is thermal energy to aid in incontinence prevention by inducing production of elastin and collagen in the midurethra, but also to promote lubrication and heightened sensitivity in the patient who’s either menopausal or has undergone chemotherapy for breast cancer.”

Dr. Berenholz reported having no financial disclosures. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.

[email protected]

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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

The Food and Drug Administration is adding a warning to mRNA COVID-19 vaccines’ fact sheets as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA’s division of vaccines and related products applications, told a Centers for Disease Control and Prevention expert panel on June 23 that the FDA is finalizing language on a warning statement for health care providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

“Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae,” Dr. Fink said, describing the statement to the Advisory Committee on Immunization Practices, independent experts who advise the CDC.

“Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention,” he said.
 

Benefits outweigh risks

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

“To me it’s clear, based on current information, that the benefits of vaccine clearly outweigh the risks,” said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Mich., a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation’s major physician, nurse, and public health associations issued a statement supporting continued vaccination: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 per 1 million after the second Pfizer dose and 19.8 per 1 million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC’s Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

“Most postvaccine myocarditis has been responding to minimal treatment,” pediatric cardiologist Matthew Oster, MD, MPH, from Children’s Healthcare of Atlanta, told the panel.
 

COVID ‘risks are higher’

Overall, the CDC has reported 2,767 COVID-19 deaths among people aged 12-29 years, and there have been 4,018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to 1 MIS-C case in every 3,200 COVID infections – 36% of them among teens aged 12-20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every 1 million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5,700 cases of COVID-19, 215 hospitalizations, 71 ICU admissions, and 2 deaths. There could also be 56-69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP’s COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford (Calif.) Children’s Health.

“If you’re in an area with low vaccination, the risks are higher,” she said. “The benefits [of the vaccine] are going to be far, far greater than any risk.”

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University, Nashville, Tenn., and medical director of the National Foundation for Infectious Diseases.

“The story is not over,” Dr. Schaffner said in an interview. “Clearly, we are still working in the face of a pandemic, so there’s urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis.”
 

Booster possibilities

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine – mRNA versus adenovirus vector – for their booster? Most important, how long do antibodies last?

“Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage,” said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University. “That will protect everyone.”

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

A large retrospective U.S. study published June 23 in JAMA Dermatology finds that chilblains, an inflammatory skin condition marked by erythema and also known as ‘COVID toes,’ is likely not associated with a COVID-19 diagnosis, despite an unprecedented number of new chilblain cases reported in 2020.

This study follows a report published almost 2 weeks earlier, of 17 adolescents in Italy with chilblain lesions of the toes. That report indicated that the lesions were not related to current or past infections, and that lifestyle changes may have been a contributing factor .

Early last year, clinicians in Europe and the United States began reporting an unusually high number of chilblain cases, but few of the patients described in the cases were positive for SARS-CoV-2 or its antibodies. The possible connection was explored in studies and featured extensively in the lay press. After all, viral infections, including SARS-CoV-2, are known to be associated with skin rashes. Plus, SARS-CoV-2 infections are known to exhibit a number of dermatological manifestations, such as urticarial and morbilliform eruptions, and vesicular eruptions. More than 150 papers have been published on the spectrum of cutaneous reactions to this virus.

In the new study, led by Patrick E. McCleskey, MD, a dermatologist with Kaiser Permanente Oakland (Calif.) Medical Center, a review of chilblain cases from six Bay Area counties in Northern California found a weak correlation confirming 2% of chilblain cases as potentially secondary to COVID-19.

“While chilblains do seem to follow COVID-19 infection in some cases, most cases of chilblains in our study were not shown to be related to SARS-CoV-2 infection,” Dr. McCleskey said in an interview.

“We think the increase in cases probably had more to do with changes in behavior as children and adults were at home instead of work and school. The highest incidence in chilblains were seen in children ages 13-19, who were staying home from school. Only 6% in our study said they wear shoes at home, and half of our patients don’t have home heating in northern California,” he said.

The condition of chilblains primarily affects the dorsal feet or hands and is almost uniquely associated with spending an inordinate amount of time in damp and cold conditions. There are some medical conditions associated with chilblains, such as Raynaud’s disease, systemic lupus erythematosus, antiphospholipid syndrome, rheumatoid arthritis, hyperhidrosis, and lymphomas and leukemias. And, as with COVID-19, chilblains affect more women than men.

Northern California study

The retrospective cohort study evaluated 780 patients (464 female; mean age 36.8 years) from six Bay Area counties in Northern California, who were treated for chilblains between April and December 2020 when stay-at-home orders were in effect in California. Of the 780 patients, 456 were tested for SARS-CoV-2, and 17 patients (3.7%) tested positive for the virus. In nine patients (2%), a COVID-19 infection was preceded by 6 weeks of chilblains. By September, testing for the COVID-19 virus was more reliable. Testing showed that of 97 chilblains cases, 1% were positive for the virus.

“The finding that some patients with COVID-19 developed chilblains at the same time, or subsequent to the infection, is suggestive of secondary chilblains due to COVID-19,” Dr. McCleskey said.

The 2020 cases were compared with 539 patients (mean age 44.7 years) with chilblains who were treated during the same period in 2016, 2017, 2018 and 2019. During these years, the annual incidence of chilblains was 5.2 (95% confidence interval, 4.8-5.6) per 100,000 person years, compared with 28.6 (95% CI, 26.8-30.4) in 2020, during the pandemic.
 

Possible explanations

The authors suggest there are several explanations for the increased reports of chilblains in 2020. First, the lack of shoes: During the pandemic, children between the ages of 13 and 19 years had more cases of chilblains than any other age group despite the fact that teenagers have a low-risk of contracting SARS-CoV-2. Six percent of teenagers with newly diagnosed chilblains wore shoes at home during the study period in 2020.

Chilblains was almost three times more common in Asian American (42.5; 95% CI, 37.7-47.8) and White individuals (35.7; 95% CI, 32.6-39.1), compared with Black (11.6; 95% CI, 7.8-17.3) and Latinx (12.5; 95% CI, 10.1-15.4) individuals. But the authors noted that the Latinx community had the highest number of COVID-19 cases (62.5; 95% CI, 61.9-63.1), three times more than Asian Americans (19.0; 95% CI, 18.6-19.3) and White individuals (17.9; 95% CI, 17.7-18.2) and two times more than in Black individuals (29.2; 95% CI, 28.4-29.9).

“Latinx patients had the highest rates of COVID-19 infections in our population, but the lowest rates of chilblains. Groups in Northern California who were more likely to stay home during the pandemic because they could work from home – White and Asian American and White patients – had much higher rates of chilblains than groups who were more likely to have to work outside the home – Latinx and African American patients,” Dr. McCleskey said.

A report by the Bay Area Council in December 2020 found that Asian Americans and Whites were more likely to work from home during the pandemic (52% and 50% respectively) compared with Black and Latinx workers (33% and 30% respectively). While Latinx individuals made up 46% of all COVID-19 cases, they accounted for 9% of chilblain cases in 2020 (but cases may have been underreported), the authors wrote.

And while there may have been more cases of chilblains during the pandemic in 2020, they did not occur in cities with higher rates of COVID-19. “If chilblains were occurring in the same communities where COVID-19 cases were occurring, the Spearman coefficient would be closer to 1,” wrote the authors, referring to the measure used to rank correlation in the study. In this case, the Spearman coefficient was 0.18.

Another explanation for the increase in chilblain cases could be that more patients sought care in response to news reports about ‘COVID toes.’

“The exact cause of chilblains is still elusive. Some publications coming out of the pandemic suggest an interferon response is part of the pathophysiology of chilblains, but this was not the focus of our research,” Dr. McCleskey said.

The authors hypothesized that in affected individuals, particularly younger patients, the immune response to SARS-CoV-2 contributed to chilblains in asymptomatic individuals. “It is possible that some patients with chilblains were exposed to SARS-CoV-2 but produced such a robust innate immune response that it was later difficult to find any evidence of infection,” they wrote.

They suggested that better testing may help identify past exposure to SARS-CoV-2 and secondary chilblains.

The strengths of this study included its size, community base, a control group dating back to 2016, validation by medical records review, and the ability to control for geographic variation allowing investigators to track weather, which can be a factor in chilblain cases. The authors noted several limitations to the study, including the lack of reliable antibody testing early in the year and the lack of IgA antibody testing.

The authors had no disclosures. The study was funded by The Permanente Medical Group Delivery Science and Applied Research initiative.

A large retrospective U.S. study published June 23 in JAMA Dermatology finds that chilblains, an inflammatory skin condition marked by erythema and also known as ‘COVID toes,’ is likely not associated with a COVID-19 diagnosis, despite an unprecedented number of new chilblain cases reported in 2020.

This study follows a report published almost 2 weeks earlier, of 17 adolescents in Italy with chilblain lesions of the toes. That report indicated that the lesions were not related to current or past infections, and that lifestyle changes may have been a contributing factor .

Early last year, clinicians in Europe and the United States began reporting an unusually high number of chilblain cases, but few of the patients described in the cases were positive for SARS-CoV-2 or its antibodies. The possible connection was explored in studies and featured extensively in the lay press. After all, viral infections, including SARS-CoV-2, are known to be associated with skin rashes. Plus, SARS-CoV-2 infections are known to exhibit a number of dermatological manifestations, such as urticarial and morbilliform eruptions, and vesicular eruptions. More than 150 papers have been published on the spectrum of cutaneous reactions to this virus.

In the new study, led by Patrick E. McCleskey, MD, a dermatologist with Kaiser Permanente Oakland (Calif.) Medical Center, a review of chilblain cases from six Bay Area counties in Northern California found a weak correlation confirming 2% of chilblain cases as potentially secondary to COVID-19.

“While chilblains do seem to follow COVID-19 infection in some cases, most cases of chilblains in our study were not shown to be related to SARS-CoV-2 infection,” Dr. McCleskey said in an interview.

“We think the increase in cases probably had more to do with changes in behavior as children and adults were at home instead of work and school. The highest incidence in chilblains were seen in children ages 13-19, who were staying home from school. Only 6% in our study said they wear shoes at home, and half of our patients don’t have home heating in northern California,” he said.

The condition of chilblains primarily affects the dorsal feet or hands and is almost uniquely associated with spending an inordinate amount of time in damp and cold conditions. There are some medical conditions associated with chilblains, such as Raynaud’s disease, systemic lupus erythematosus, antiphospholipid syndrome, rheumatoid arthritis, hyperhidrosis, and lymphomas and leukemias. And, as with COVID-19, chilblains affect more women than men.

Northern California study

The retrospective cohort study evaluated 780 patients (464 female; mean age 36.8 years) from six Bay Area counties in Northern California, who were treated for chilblains between April and December 2020 when stay-at-home orders were in effect in California. Of the 780 patients, 456 were tested for SARS-CoV-2, and 17 patients (3.7%) tested positive for the virus. In nine patients (2%), a COVID-19 infection was preceded by 6 weeks of chilblains. By September, testing for the COVID-19 virus was more reliable. Testing showed that of 97 chilblains cases, 1% were positive for the virus.

“The finding that some patients with COVID-19 developed chilblains at the same time, or subsequent to the infection, is suggestive of secondary chilblains due to COVID-19,” Dr. McCleskey said.

The 2020 cases were compared with 539 patients (mean age 44.7 years) with chilblains who were treated during the same period in 2016, 2017, 2018 and 2019. During these years, the annual incidence of chilblains was 5.2 (95% confidence interval, 4.8-5.6) per 100,000 person years, compared with 28.6 (95% CI, 26.8-30.4) in 2020, during the pandemic.
 

Possible explanations

The authors suggest there are several explanations for the increased reports of chilblains in 2020. First, the lack of shoes: During the pandemic, children between the ages of 13 and 19 years had more cases of chilblains than any other age group despite the fact that teenagers have a low-risk of contracting SARS-CoV-2. Six percent of teenagers with newly diagnosed chilblains wore shoes at home during the study period in 2020.

Chilblains was almost three times more common in Asian American (42.5; 95% CI, 37.7-47.8) and White individuals (35.7; 95% CI, 32.6-39.1), compared with Black (11.6; 95% CI, 7.8-17.3) and Latinx (12.5; 95% CI, 10.1-15.4) individuals. But the authors noted that the Latinx community had the highest number of COVID-19 cases (62.5; 95% CI, 61.9-63.1), three times more than Asian Americans (19.0; 95% CI, 18.6-19.3) and White individuals (17.9; 95% CI, 17.7-18.2) and two times more than in Black individuals (29.2; 95% CI, 28.4-29.9).

“Latinx patients had the highest rates of COVID-19 infections in our population, but the lowest rates of chilblains. Groups in Northern California who were more likely to stay home during the pandemic because they could work from home – White and Asian American and White patients – had much higher rates of chilblains than groups who were more likely to have to work outside the home – Latinx and African American patients,” Dr. McCleskey said.

A report by the Bay Area Council in December 2020 found that Asian Americans and Whites were more likely to work from home during the pandemic (52% and 50% respectively) compared with Black and Latinx workers (33% and 30% respectively). While Latinx individuals made up 46% of all COVID-19 cases, they accounted for 9% of chilblain cases in 2020 (but cases may have been underreported), the authors wrote.

And while there may have been more cases of chilblains during the pandemic in 2020, they did not occur in cities with higher rates of COVID-19. “If chilblains were occurring in the same communities where COVID-19 cases were occurring, the Spearman coefficient would be closer to 1,” wrote the authors, referring to the measure used to rank correlation in the study. In this case, the Spearman coefficient was 0.18.

Another explanation for the increase in chilblain cases could be that more patients sought care in response to news reports about ‘COVID toes.’

“The exact cause of chilblains is still elusive. Some publications coming out of the pandemic suggest an interferon response is part of the pathophysiology of chilblains, but this was not the focus of our research,” Dr. McCleskey said.

The authors hypothesized that in affected individuals, particularly younger patients, the immune response to SARS-CoV-2 contributed to chilblains in asymptomatic individuals. “It is possible that some patients with chilblains were exposed to SARS-CoV-2 but produced such a robust innate immune response that it was later difficult to find any evidence of infection,” they wrote.

They suggested that better testing may help identify past exposure to SARS-CoV-2 and secondary chilblains.

The strengths of this study included its size, community base, a control group dating back to 2016, validation by medical records review, and the ability to control for geographic variation allowing investigators to track weather, which can be a factor in chilblain cases. The authors noted several limitations to the study, including the lack of reliable antibody testing early in the year and the lack of IgA antibody testing.

The authors had no disclosures. The study was funded by The Permanente Medical Group Delivery Science and Applied Research initiative.

A large retrospective U.S. study published June 23 in JAMA Dermatology finds that chilblains, an inflammatory skin condition marked by erythema and also known as ‘COVID toes,’ is likely not associated with a COVID-19 diagnosis, despite an unprecedented number of new chilblain cases reported in 2020.

This study follows a report published almost 2 weeks earlier, of 17 adolescents in Italy with chilblain lesions of the toes. That report indicated that the lesions were not related to current or past infections, and that lifestyle changes may have been a contributing factor .

Early last year, clinicians in Europe and the United States began reporting an unusually high number of chilblain cases, but few of the patients described in the cases were positive for SARS-CoV-2 or its antibodies. The possible connection was explored in studies and featured extensively in the lay press. After all, viral infections, including SARS-CoV-2, are known to be associated with skin rashes. Plus, SARS-CoV-2 infections are known to exhibit a number of dermatological manifestations, such as urticarial and morbilliform eruptions, and vesicular eruptions. More than 150 papers have been published on the spectrum of cutaneous reactions to this virus.

In the new study, led by Patrick E. McCleskey, MD, a dermatologist with Kaiser Permanente Oakland (Calif.) Medical Center, a review of chilblain cases from six Bay Area counties in Northern California found a weak correlation confirming 2% of chilblain cases as potentially secondary to COVID-19.

“While chilblains do seem to follow COVID-19 infection in some cases, most cases of chilblains in our study were not shown to be related to SARS-CoV-2 infection,” Dr. McCleskey said in an interview.

“We think the increase in cases probably had more to do with changes in behavior as children and adults were at home instead of work and school. The highest incidence in chilblains were seen in children ages 13-19, who were staying home from school. Only 6% in our study said they wear shoes at home, and half of our patients don’t have home heating in northern California,” he said.

The condition of chilblains primarily affects the dorsal feet or hands and is almost uniquely associated with spending an inordinate amount of time in damp and cold conditions. There are some medical conditions associated with chilblains, such as Raynaud’s disease, systemic lupus erythematosus, antiphospholipid syndrome, rheumatoid arthritis, hyperhidrosis, and lymphomas and leukemias. And, as with COVID-19, chilblains affect more women than men.

Northern California study

The retrospective cohort study evaluated 780 patients (464 female; mean age 36.8 years) from six Bay Area counties in Northern California, who were treated for chilblains between April and December 2020 when stay-at-home orders were in effect in California. Of the 780 patients, 456 were tested for SARS-CoV-2, and 17 patients (3.7%) tested positive for the virus. In nine patients (2%), a COVID-19 infection was preceded by 6 weeks of chilblains. By September, testing for the COVID-19 virus was more reliable. Testing showed that of 97 chilblains cases, 1% were positive for the virus.

“The finding that some patients with COVID-19 developed chilblains at the same time, or subsequent to the infection, is suggestive of secondary chilblains due to COVID-19,” Dr. McCleskey said.

The 2020 cases were compared with 539 patients (mean age 44.7 years) with chilblains who were treated during the same period in 2016, 2017, 2018 and 2019. During these years, the annual incidence of chilblains was 5.2 (95% confidence interval, 4.8-5.6) per 100,000 person years, compared with 28.6 (95% CI, 26.8-30.4) in 2020, during the pandemic.
 

Possible explanations

The authors suggest there are several explanations for the increased reports of chilblains in 2020. First, the lack of shoes: During the pandemic, children between the ages of 13 and 19 years had more cases of chilblains than any other age group despite the fact that teenagers have a low-risk of contracting SARS-CoV-2. Six percent of teenagers with newly diagnosed chilblains wore shoes at home during the study period in 2020.

Chilblains was almost three times more common in Asian American (42.5; 95% CI, 37.7-47.8) and White individuals (35.7; 95% CI, 32.6-39.1), compared with Black (11.6; 95% CI, 7.8-17.3) and Latinx (12.5; 95% CI, 10.1-15.4) individuals. But the authors noted that the Latinx community had the highest number of COVID-19 cases (62.5; 95% CI, 61.9-63.1), three times more than Asian Americans (19.0; 95% CI, 18.6-19.3) and White individuals (17.9; 95% CI, 17.7-18.2) and two times more than in Black individuals (29.2; 95% CI, 28.4-29.9).

“Latinx patients had the highest rates of COVID-19 infections in our population, but the lowest rates of chilblains. Groups in Northern California who were more likely to stay home during the pandemic because they could work from home – White and Asian American and White patients – had much higher rates of chilblains than groups who were more likely to have to work outside the home – Latinx and African American patients,” Dr. McCleskey said.

A report by the Bay Area Council in December 2020 found that Asian Americans and Whites were more likely to work from home during the pandemic (52% and 50% respectively) compared with Black and Latinx workers (33% and 30% respectively). While Latinx individuals made up 46% of all COVID-19 cases, they accounted for 9% of chilblain cases in 2020 (but cases may have been underreported), the authors wrote.

And while there may have been more cases of chilblains during the pandemic in 2020, they did not occur in cities with higher rates of COVID-19. “If chilblains were occurring in the same communities where COVID-19 cases were occurring, the Spearman coefficient would be closer to 1,” wrote the authors, referring to the measure used to rank correlation in the study. In this case, the Spearman coefficient was 0.18.

Another explanation for the increase in chilblain cases could be that more patients sought care in response to news reports about ‘COVID toes.’

“The exact cause of chilblains is still elusive. Some publications coming out of the pandemic suggest an interferon response is part of the pathophysiology of chilblains, but this was not the focus of our research,” Dr. McCleskey said.

The authors hypothesized that in affected individuals, particularly younger patients, the immune response to SARS-CoV-2 contributed to chilblains in asymptomatic individuals. “It is possible that some patients with chilblains were exposed to SARS-CoV-2 but produced such a robust innate immune response that it was later difficult to find any evidence of infection,” they wrote.

They suggested that better testing may help identify past exposure to SARS-CoV-2 and secondary chilblains.

The strengths of this study included its size, community base, a control group dating back to 2016, validation by medical records review, and the ability to control for geographic variation allowing investigators to track weather, which can be a factor in chilblain cases. The authors noted several limitations to the study, including the lack of reliable antibody testing early in the year and the lack of IgA antibody testing.

The authors had no disclosures. The study was funded by The Permanente Medical Group Delivery Science and Applied Research initiative.

For well over a year, the COVID-19 pandemic has been the biggest story in the world, costing millions of lives, impacting a presidential election, and quaking economies around the world.

But as vaccination rates increase and restrictions relax across the United States, relief is beginning to mix with reflection. Part of that contemplation means grappling with how the media depicted the crisis – in ways that were helpful, harmful, and somewhere in between.

“This story was so overwhelming, and the amount of journalism done about it was also overwhelming, and it’s going to be a while before we can do any kind of comprehensive overview of how journalism really performed,” said Maryn McKenna, an independent journalist and journalism professor at Emory University, Atlanta, who specializes in public and global health.
 

Some ‘heroically good’ reporting

The pandemic hit at a time when journalism was under a lot of pressure from external forces – undermined by politics, swimming through a sea of misinformation, and pressed by financial pressure to produce more stories more quickly, said Emily Bell, founding director of the Tow Center for Digital Journalism at Columbia University, New York.

The pandemic drove enormous audiences to news outlets, as people searched for reliable information, and increased the appreciation many people felt for the work of journalists, she said.

“I think there’s been some heroically good reporting and some really empathetic reporting as well,” said Ms. Bell. She cites The New York Times stories honoring the nearly 100,000 people lost to COVID-19 in May 2020 and The Atlantic’s COVID Tracking Project as exceptionally good examples.

Journalism is part of a complex, and evolving, information ecosystem characterized by “traditional” television, radio, and newspapers but also social media, search engine results, niche online news outlets, and clickbait sites.

On the one hand, social media provided a way for physicians, nurses, and scientists to speak directly to the world about their experiences and research. On the other hand, it’s challenging to elevate the really good work of traditional media over all of the bad or unhelpful signals, said Ms. Bell.

But, at the end of the day, much of journalism is a business. There are incentives in the market for tabloids to do sensational coverage and for outlets to push misleading, clickbait headlines, Ms. Bell said.

“Sometimes we’ll criticize journalists for ‘getting it wrong,’ but they might be getting it right in their business model but getting it wrong in terms of what it’s doing for society,” she said.

“We need to do a self-examination, when or if the dust from this ever settles, [on] how much of the past year was viewed as a business opportunity and did that get in the way of informing the public adequately,” Ms. McKenna said.

Digital platforms and journalists also need to reflect on how narratives build on one another, particularly online, said Ms. Bell. If you search for side effects of the Johnson & Johnson vaccine, for example, you will see a list of dozens of headlines that might give you the impression this is a major problem without the context that these effects are exceedingly rare, she notes.

There was also a personnel problem. Shrinking newsrooms over the last decade meant many outlets didn’t have dedicated science and health reporting, or very few staffers, if any. During the pandemic, suddenly general assignment and politics reporters had to be science and health reporters, too.

“You have a hard enough time with these issues if you’re a fairly seasoned science journalist,” said Gary Schwitzer, a former head of the health care news unit for CNN, journalism professor at the University of Minnesota, and founder of the watchdog site HealthNewsReview.org.

And outlets that had the staffing didn’t always put science reporters to full use, Ms. McKenna said. In March and April of 2020, major media outlets should have sent science reporters, not politics reporters, to President Donald Trump’s White House press briefings, which often included incorrect statements about COVID-19 science.

“I just don’t feel that the big outlets understood that that expertise would have made a difference,” she said.
 

New challenges, old problems

Some of the science journalism done during the pandemic has been some of the best ever seen in this country, said Mr. Schwitzer. But between the peaks of excellence, there is “the daily drumbeat coverage of dreck,” he added.

Many of the issues with this dreck coverage aren’t new or unique to the pandemic. For example, over the last year there have been far too many news stories based solely on weak information sources, like a drug company press release or a not-yet-peer-reviewed preprint article that hasn’t been put into proper context, said Mr. Schwitzer.

A quality science story should always include an independent perspective, he said, but many COVID-19 stories missed that perspective. This isn’t a new issue for science coverage – at Health News Review, Mr. Schwitzer and his colleagues saw stories without appropriate independent sources every day for 15 years.

It’s also challenging to write about uncertainty without over- or underselling what scientists know about a particular phenomenon. “We know that the media in general tends to portray science as more certain than it is,” said Dominique Brossard, PhD, professor and department chair at the University of Wisconsin–Madison and an expert on the intersection between science, media, and policy. This can lead to confusion when the science, and the advice based on that science, changes.

“The public has a really difficult time understanding what uncertainty means within science,” said Todd P. Newman, PhD, assistant professor at the University of Wisconsin–Madison who studies strategic communication within the context of science, technology, and the environment.

“I think the media generally has been good on the subject,” said Paul Offit, MD, director of the Vaccine Education Center, attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, and a prominent expert voice throughout the pandemic. “I think where they’ve been imperfect is they tend to be a little more dramatic in terms of how we’re doing.”

Dr. Offit isn’t the only expert to point to the drama of COVID-19 coverage. A study published in March 2021 by the National Bureau of Economic Research found 87% of stories by major U.S. media outlets leaned negative in the tone of their COVID-19 reporting, compared with 50% of stories from non-U.S. major outlets and 64% of articles in scientific journals. The negative emphasis persists even around positive developments, like vaccine trials and school re-openings.

John Whyte, MD, chief medical officer for WebMD, said he is very proud of the way WebMD and Medscape ramped up production of video series and other content to give health care providers the most up-to-date guidance on a rapidly evolving medical situation.

“But I think as [we] started to make progress – especially in the last 6 months – the coverage was never balanced enough; any positive news was immediately proceeded by negative,” he said.

“You want to be honest, but you also don’t want to be alarmist – and that’s where I think the challenge is at times in the media,” said Dr. Whyte. “We didn’t put enough optimism in at times, especially in recent months.”

“Any good coverage on vaccines immediately [was] covered by ‘[we] might need boosters in the fall.’ Why can’t [we] have an opportunity to breathe for a little while and see the good news?” he asked.
 

Variants or scariants?

Negativity and fear shaped much of the coverage around variants and vaccines earlier this year. In February 2021, Zeynep Tufekci, PhD, a sociologist at the University of North Carolina at Chapel Hill school of information and library science, wrote in The Atlantic about how much reporting has not reflected “the truly amazing reality of these vaccines,” and has instead highlighted “a chorus of relentless pessimism.”

This felt especially true earlier in 2021, when lots of coverage repeatedly emphasized what vaccinated people still could not do.

Eric Topol, MD, editor-in-chief of Medscape and executive vice president of Scripps Research in La Jolla, California, said New York Times editors told him earlier in the pandemic that he couldn’t use the word “scariant” in an opinion piece about the media’s overly fearful and sometimes inaccurate reporting around COVID-19 variants because they worried it would seem like the Times was coming after other media outlets.

“A variant is innocent until proven guilty,” said Dr. Topol. Had journalists approached the subject from that point of view, he said we would have seen “much more faithful reporting.”

Dr. Brossard and Dr. Newman worry that focusing on uncommon negative behavior, like people who break social distancing and mask rules by gathering at the beach or the bar, makes those actions seem more common than they actually are.

The evidence suggests that “if you show these kinds of things to people, you encourage them to do the same behavior,” said Dr. Brossard.

There have been other mistakes along the way, too. Early in the pandemic, many outlets pointed viewers to official government sources of information, some of which, like the White House press briefings in March and April of 2020, ended up being some of the most virulent spreaders of misinformation, said Ms. Bell.

Before that, a handful of journalists like Roxanne Khamsi were the few pushing back against the dominant media narrative in early 2020 that the novel coronavirus was less concerning than the seasonal flu.

“Science journalists have always been writing about studies that sometimes contradict each other, and what’s happened is that has only been condensed in time,” said Ms. Khamsi, a health care reporter for outlets like WIRED magazine and The New York Times and a former chief news editor for Nature Medicine.
 

Politics and misinformation

It’s impossible to talk about media coverage of COVID-19 without touching on politics and misinformation.

Coverage of the pandemic was politicized and polarized from the very beginning, said Sedona Chinn, PhD, an assistant professor at the University of Wisconsin–Madison who researches the prevalence and effects of scientific disagreements in media.

By looking at network news transcripts and articles from national outlets like the Washington Post and The New York Times, Dr. Chinn and her colleagues were able to determine politicization of coverage by counting the mentions of politicians versus scientists in COVID-19 coverage and polarization by looking at how different or similar the language was surrounding mentions of Republicans and Democrats.

If the two parties were working together or on the same page, they reasoned, the language would be similar.

From mid-March through May 2020, Dr. Chinn and fellow researchers found politicians were featured more often than scientists in newspaper coverage and as frequently as scientists in network news coverage. They also found polarized language around Republicans and Democrats, particularly in stories describing duels between the (at the time) Republican national government and Democratic state and local leaders.

It’s possible that polarization in news coverage helped contribute to polarized attitudes around the virus, the authors write in the study, which was published in August 2020 in the journal Science Communication.

The politicization and polarization of the issue is mirrored in our fractured media environment, where people tend to read, listen, and watch outlets that align with their political leanings. If that trusted outlet features misinformation, the people who follow it are more likely to accept that false information as truth, said Matt Motta, PhD, a political scientist at Oklahoma State University whose research includes public opinion and science communication.

This is true across the political spectrum, he said. When it comes to COVID-19, however, right-wing media outlets like Fox News and Breitbart are more likely to promote conspiratorial tropes and misinformation about the pandemic, according to Dr. Motta and his collaborator Dominik Stecula, PhD, a political scientist at Colorado State University who studies the news media environment and its effects on society.

Across the media ecosystem, reporting on the “infodemic” accompanying the pandemic – the rapid spread of misinformation and disinformation about the virus – has been a major challenge. Outlets may not be creating the misinformation, but they are the ones choosing to give it a platform, said Dr. Motta.

By repeating a false idea, even with the goal of debunking it, you can unintentionally cause the information to stick in people’s minds, said Dr. Brossard.

“Just because something is controversial doesn’t mean it’s worth covering,” said Dr. Motta. Using vaccines as an example, he said many reporters and scientists alike assume that if people have all the facts, they’ll land on the side of science.

“That is just fundamentally not how people think about the decision to get vaccinated,” he said. Instead, the choice is wrapped up with cultural factors, religious beliefs, political identity, and more.

The factors and challenges that shaped the media’s coverage of the pandemic aren’t going anywhere. Improving science and medical coverage in the future is a collective project for journalists, scientists, and everyone in between, said Dr. Newman.

“I call on scientists, too, to think really deeply about how they’re communicating – and especially how they’re communicating what they know and don’t know,” he said.

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

For well over a year, the COVID-19 pandemic has been the biggest story in the world, costing millions of lives, impacting a presidential election, and quaking economies around the world.

But as vaccination rates increase and restrictions relax across the United States, relief is beginning to mix with reflection. Part of that contemplation means grappling with how the media depicted the crisis – in ways that were helpful, harmful, and somewhere in between.

“This story was so overwhelming, and the amount of journalism done about it was also overwhelming, and it’s going to be a while before we can do any kind of comprehensive overview of how journalism really performed,” said Maryn McKenna, an independent journalist and journalism professor at Emory University, Atlanta, who specializes in public and global health.
 

Some ‘heroically good’ reporting

The pandemic hit at a time when journalism was under a lot of pressure from external forces – undermined by politics, swimming through a sea of misinformation, and pressed by financial pressure to produce more stories more quickly, said Emily Bell, founding director of the Tow Center for Digital Journalism at Columbia University, New York.

The pandemic drove enormous audiences to news outlets, as people searched for reliable information, and increased the appreciation many people felt for the work of journalists, she said.

“I think there’s been some heroically good reporting and some really empathetic reporting as well,” said Ms. Bell. She cites The New York Times stories honoring the nearly 100,000 people lost to COVID-19 in May 2020 and The Atlantic’s COVID Tracking Project as exceptionally good examples.

Journalism is part of a complex, and evolving, information ecosystem characterized by “traditional” television, radio, and newspapers but also social media, search engine results, niche online news outlets, and clickbait sites.

On the one hand, social media provided a way for physicians, nurses, and scientists to speak directly to the world about their experiences and research. On the other hand, it’s challenging to elevate the really good work of traditional media over all of the bad or unhelpful signals, said Ms. Bell.

But, at the end of the day, much of journalism is a business. There are incentives in the market for tabloids to do sensational coverage and for outlets to push misleading, clickbait headlines, Ms. Bell said.

“Sometimes we’ll criticize journalists for ‘getting it wrong,’ but they might be getting it right in their business model but getting it wrong in terms of what it’s doing for society,” she said.

“We need to do a self-examination, when or if the dust from this ever settles, [on] how much of the past year was viewed as a business opportunity and did that get in the way of informing the public adequately,” Ms. McKenna said.

Digital platforms and journalists also need to reflect on how narratives build on one another, particularly online, said Ms. Bell. If you search for side effects of the Johnson & Johnson vaccine, for example, you will see a list of dozens of headlines that might give you the impression this is a major problem without the context that these effects are exceedingly rare, she notes.

There was also a personnel problem. Shrinking newsrooms over the last decade meant many outlets didn’t have dedicated science and health reporting, or very few staffers, if any. During the pandemic, suddenly general assignment and politics reporters had to be science and health reporters, too.

“You have a hard enough time with these issues if you’re a fairly seasoned science journalist,” said Gary Schwitzer, a former head of the health care news unit for CNN, journalism professor at the University of Minnesota, and founder of the watchdog site HealthNewsReview.org.

And outlets that had the staffing didn’t always put science reporters to full use, Ms. McKenna said. In March and April of 2020, major media outlets should have sent science reporters, not politics reporters, to President Donald Trump’s White House press briefings, which often included incorrect statements about COVID-19 science.

“I just don’t feel that the big outlets understood that that expertise would have made a difference,” she said.
 

New challenges, old problems

Some of the science journalism done during the pandemic has been some of the best ever seen in this country, said Mr. Schwitzer. But between the peaks of excellence, there is “the daily drumbeat coverage of dreck,” he added.

Many of the issues with this dreck coverage aren’t new or unique to the pandemic. For example, over the last year there have been far too many news stories based solely on weak information sources, like a drug company press release or a not-yet-peer-reviewed preprint article that hasn’t been put into proper context, said Mr. Schwitzer.

A quality science story should always include an independent perspective, he said, but many COVID-19 stories missed that perspective. This isn’t a new issue for science coverage – at Health News Review, Mr. Schwitzer and his colleagues saw stories without appropriate independent sources every day for 15 years.

It’s also challenging to write about uncertainty without over- or underselling what scientists know about a particular phenomenon. “We know that the media in general tends to portray science as more certain than it is,” said Dominique Brossard, PhD, professor and department chair at the University of Wisconsin–Madison and an expert on the intersection between science, media, and policy. This can lead to confusion when the science, and the advice based on that science, changes.

“The public has a really difficult time understanding what uncertainty means within science,” said Todd P. Newman, PhD, assistant professor at the University of Wisconsin–Madison who studies strategic communication within the context of science, technology, and the environment.

“I think the media generally has been good on the subject,” said Paul Offit, MD, director of the Vaccine Education Center, attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, and a prominent expert voice throughout the pandemic. “I think where they’ve been imperfect is they tend to be a little more dramatic in terms of how we’re doing.”

Dr. Offit isn’t the only expert to point to the drama of COVID-19 coverage. A study published in March 2021 by the National Bureau of Economic Research found 87% of stories by major U.S. media outlets leaned negative in the tone of their COVID-19 reporting, compared with 50% of stories from non-U.S. major outlets and 64% of articles in scientific journals. The negative emphasis persists even around positive developments, like vaccine trials and school re-openings.

John Whyte, MD, chief medical officer for WebMD, said he is very proud of the way WebMD and Medscape ramped up production of video series and other content to give health care providers the most up-to-date guidance on a rapidly evolving medical situation.

“But I think as [we] started to make progress – especially in the last 6 months – the coverage was never balanced enough; any positive news was immediately proceeded by negative,” he said.

“You want to be honest, but you also don’t want to be alarmist – and that’s where I think the challenge is at times in the media,” said Dr. Whyte. “We didn’t put enough optimism in at times, especially in recent months.”

“Any good coverage on vaccines immediately [was] covered by ‘[we] might need boosters in the fall.’ Why can’t [we] have an opportunity to breathe for a little while and see the good news?” he asked.
 

Variants or scariants?

Negativity and fear shaped much of the coverage around variants and vaccines earlier this year. In February 2021, Zeynep Tufekci, PhD, a sociologist at the University of North Carolina at Chapel Hill school of information and library science, wrote in The Atlantic about how much reporting has not reflected “the truly amazing reality of these vaccines,” and has instead highlighted “a chorus of relentless pessimism.”

This felt especially true earlier in 2021, when lots of coverage repeatedly emphasized what vaccinated people still could not do.

Eric Topol, MD, editor-in-chief of Medscape and executive vice president of Scripps Research in La Jolla, California, said New York Times editors told him earlier in the pandemic that he couldn’t use the word “scariant” in an opinion piece about the media’s overly fearful and sometimes inaccurate reporting around COVID-19 variants because they worried it would seem like the Times was coming after other media outlets.

“A variant is innocent until proven guilty,” said Dr. Topol. Had journalists approached the subject from that point of view, he said we would have seen “much more faithful reporting.”

Dr. Brossard and Dr. Newman worry that focusing on uncommon negative behavior, like people who break social distancing and mask rules by gathering at the beach or the bar, makes those actions seem more common than they actually are.

The evidence suggests that “if you show these kinds of things to people, you encourage them to do the same behavior,” said Dr. Brossard.

There have been other mistakes along the way, too. Early in the pandemic, many outlets pointed viewers to official government sources of information, some of which, like the White House press briefings in March and April of 2020, ended up being some of the most virulent spreaders of misinformation, said Ms. Bell.

Before that, a handful of journalists like Roxanne Khamsi were the few pushing back against the dominant media narrative in early 2020 that the novel coronavirus was less concerning than the seasonal flu.

“Science journalists have always been writing about studies that sometimes contradict each other, and what’s happened is that has only been condensed in time,” said Ms. Khamsi, a health care reporter for outlets like WIRED magazine and The New York Times and a former chief news editor for Nature Medicine.
 

Politics and misinformation

It’s impossible to talk about media coverage of COVID-19 without touching on politics and misinformation.

Coverage of the pandemic was politicized and polarized from the very beginning, said Sedona Chinn, PhD, an assistant professor at the University of Wisconsin–Madison who researches the prevalence and effects of scientific disagreements in media.

By looking at network news transcripts and articles from national outlets like the Washington Post and The New York Times, Dr. Chinn and her colleagues were able to determine politicization of coverage by counting the mentions of politicians versus scientists in COVID-19 coverage and polarization by looking at how different or similar the language was surrounding mentions of Republicans and Democrats.

If the two parties were working together or on the same page, they reasoned, the language would be similar.

From mid-March through May 2020, Dr. Chinn and fellow researchers found politicians were featured more often than scientists in newspaper coverage and as frequently as scientists in network news coverage. They also found polarized language around Republicans and Democrats, particularly in stories describing duels between the (at the time) Republican national government and Democratic state and local leaders.

It’s possible that polarization in news coverage helped contribute to polarized attitudes around the virus, the authors write in the study, which was published in August 2020 in the journal Science Communication.

The politicization and polarization of the issue is mirrored in our fractured media environment, where people tend to read, listen, and watch outlets that align with their political leanings. If that trusted outlet features misinformation, the people who follow it are more likely to accept that false information as truth, said Matt Motta, PhD, a political scientist at Oklahoma State University whose research includes public opinion and science communication.

This is true across the political spectrum, he said. When it comes to COVID-19, however, right-wing media outlets like Fox News and Breitbart are more likely to promote conspiratorial tropes and misinformation about the pandemic, according to Dr. Motta and his collaborator Dominik Stecula, PhD, a political scientist at Colorado State University who studies the news media environment and its effects on society.

Across the media ecosystem, reporting on the “infodemic” accompanying the pandemic – the rapid spread of misinformation and disinformation about the virus – has been a major challenge. Outlets may not be creating the misinformation, but they are the ones choosing to give it a platform, said Dr. Motta.

By repeating a false idea, even with the goal of debunking it, you can unintentionally cause the information to stick in people’s minds, said Dr. Brossard.

“Just because something is controversial doesn’t mean it’s worth covering,” said Dr. Motta. Using vaccines as an example, he said many reporters and scientists alike assume that if people have all the facts, they’ll land on the side of science.

“That is just fundamentally not how people think about the decision to get vaccinated,” he said. Instead, the choice is wrapped up with cultural factors, religious beliefs, political identity, and more.

The factors and challenges that shaped the media’s coverage of the pandemic aren’t going anywhere. Improving science and medical coverage in the future is a collective project for journalists, scientists, and everyone in between, said Dr. Newman.

“I call on scientists, too, to think really deeply about how they’re communicating – and especially how they’re communicating what they know and don’t know,” he said.

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

For well over a year, the COVID-19 pandemic has been the biggest story in the world, costing millions of lives, impacting a presidential election, and quaking economies around the world.

But as vaccination rates increase and restrictions relax across the United States, relief is beginning to mix with reflection. Part of that contemplation means grappling with how the media depicted the crisis – in ways that were helpful, harmful, and somewhere in between.

“This story was so overwhelming, and the amount of journalism done about it was also overwhelming, and it’s going to be a while before we can do any kind of comprehensive overview of how journalism really performed,” said Maryn McKenna, an independent journalist and journalism professor at Emory University, Atlanta, who specializes in public and global health.
 

Some ‘heroically good’ reporting

The pandemic hit at a time when journalism was under a lot of pressure from external forces – undermined by politics, swimming through a sea of misinformation, and pressed by financial pressure to produce more stories more quickly, said Emily Bell, founding director of the Tow Center for Digital Journalism at Columbia University, New York.

The pandemic drove enormous audiences to news outlets, as people searched for reliable information, and increased the appreciation many people felt for the work of journalists, she said.

“I think there’s been some heroically good reporting and some really empathetic reporting as well,” said Ms. Bell. She cites The New York Times stories honoring the nearly 100,000 people lost to COVID-19 in May 2020 and The Atlantic’s COVID Tracking Project as exceptionally good examples.

Journalism is part of a complex, and evolving, information ecosystem characterized by “traditional” television, radio, and newspapers but also social media, search engine results, niche online news outlets, and clickbait sites.

On the one hand, social media provided a way for physicians, nurses, and scientists to speak directly to the world about their experiences and research. On the other hand, it’s challenging to elevate the really good work of traditional media over all of the bad or unhelpful signals, said Ms. Bell.

But, at the end of the day, much of journalism is a business. There are incentives in the market for tabloids to do sensational coverage and for outlets to push misleading, clickbait headlines, Ms. Bell said.

“Sometimes we’ll criticize journalists for ‘getting it wrong,’ but they might be getting it right in their business model but getting it wrong in terms of what it’s doing for society,” she said.

“We need to do a self-examination, when or if the dust from this ever settles, [on] how much of the past year was viewed as a business opportunity and did that get in the way of informing the public adequately,” Ms. McKenna said.

Digital platforms and journalists also need to reflect on how narratives build on one another, particularly online, said Ms. Bell. If you search for side effects of the Johnson & Johnson vaccine, for example, you will see a list of dozens of headlines that might give you the impression this is a major problem without the context that these effects are exceedingly rare, she notes.

There was also a personnel problem. Shrinking newsrooms over the last decade meant many outlets didn’t have dedicated science and health reporting, or very few staffers, if any. During the pandemic, suddenly general assignment and politics reporters had to be science and health reporters, too.

“You have a hard enough time with these issues if you’re a fairly seasoned science journalist,” said Gary Schwitzer, a former head of the health care news unit for CNN, journalism professor at the University of Minnesota, and founder of the watchdog site HealthNewsReview.org.

And outlets that had the staffing didn’t always put science reporters to full use, Ms. McKenna said. In March and April of 2020, major media outlets should have sent science reporters, not politics reporters, to President Donald Trump’s White House press briefings, which often included incorrect statements about COVID-19 science.

“I just don’t feel that the big outlets understood that that expertise would have made a difference,” she said.
 

New challenges, old problems

Some of the science journalism done during the pandemic has been some of the best ever seen in this country, said Mr. Schwitzer. But between the peaks of excellence, there is “the daily drumbeat coverage of dreck,” he added.

Many of the issues with this dreck coverage aren’t new or unique to the pandemic. For example, over the last year there have been far too many news stories based solely on weak information sources, like a drug company press release or a not-yet-peer-reviewed preprint article that hasn’t been put into proper context, said Mr. Schwitzer.

A quality science story should always include an independent perspective, he said, but many COVID-19 stories missed that perspective. This isn’t a new issue for science coverage – at Health News Review, Mr. Schwitzer and his colleagues saw stories without appropriate independent sources every day for 15 years.

It’s also challenging to write about uncertainty without over- or underselling what scientists know about a particular phenomenon. “We know that the media in general tends to portray science as more certain than it is,” said Dominique Brossard, PhD, professor and department chair at the University of Wisconsin–Madison and an expert on the intersection between science, media, and policy. This can lead to confusion when the science, and the advice based on that science, changes.

“The public has a really difficult time understanding what uncertainty means within science,” said Todd P. Newman, PhD, assistant professor at the University of Wisconsin–Madison who studies strategic communication within the context of science, technology, and the environment.

“I think the media generally has been good on the subject,” said Paul Offit, MD, director of the Vaccine Education Center, attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, and a prominent expert voice throughout the pandemic. “I think where they’ve been imperfect is they tend to be a little more dramatic in terms of how we’re doing.”

Dr. Offit isn’t the only expert to point to the drama of COVID-19 coverage. A study published in March 2021 by the National Bureau of Economic Research found 87% of stories by major U.S. media outlets leaned negative in the tone of their COVID-19 reporting, compared with 50% of stories from non-U.S. major outlets and 64% of articles in scientific journals. The negative emphasis persists even around positive developments, like vaccine trials and school re-openings.

John Whyte, MD, chief medical officer for WebMD, said he is very proud of the way WebMD and Medscape ramped up production of video series and other content to give health care providers the most up-to-date guidance on a rapidly evolving medical situation.

“But I think as [we] started to make progress – especially in the last 6 months – the coverage was never balanced enough; any positive news was immediately proceeded by negative,” he said.

“You want to be honest, but you also don’t want to be alarmist – and that’s where I think the challenge is at times in the media,” said Dr. Whyte. “We didn’t put enough optimism in at times, especially in recent months.”

“Any good coverage on vaccines immediately [was] covered by ‘[we] might need boosters in the fall.’ Why can’t [we] have an opportunity to breathe for a little while and see the good news?” he asked.
 

Variants or scariants?

Negativity and fear shaped much of the coverage around variants and vaccines earlier this year. In February 2021, Zeynep Tufekci, PhD, a sociologist at the University of North Carolina at Chapel Hill school of information and library science, wrote in The Atlantic about how much reporting has not reflected “the truly amazing reality of these vaccines,” and has instead highlighted “a chorus of relentless pessimism.”

This felt especially true earlier in 2021, when lots of coverage repeatedly emphasized what vaccinated people still could not do.

Eric Topol, MD, editor-in-chief of Medscape and executive vice president of Scripps Research in La Jolla, California, said New York Times editors told him earlier in the pandemic that he couldn’t use the word “scariant” in an opinion piece about the media’s overly fearful and sometimes inaccurate reporting around COVID-19 variants because they worried it would seem like the Times was coming after other media outlets.

“A variant is innocent until proven guilty,” said Dr. Topol. Had journalists approached the subject from that point of view, he said we would have seen “much more faithful reporting.”

Dr. Brossard and Dr. Newman worry that focusing on uncommon negative behavior, like people who break social distancing and mask rules by gathering at the beach or the bar, makes those actions seem more common than they actually are.

The evidence suggests that “if you show these kinds of things to people, you encourage them to do the same behavior,” said Dr. Brossard.

There have been other mistakes along the way, too. Early in the pandemic, many outlets pointed viewers to official government sources of information, some of which, like the White House press briefings in March and April of 2020, ended up being some of the most virulent spreaders of misinformation, said Ms. Bell.

Before that, a handful of journalists like Roxanne Khamsi were the few pushing back against the dominant media narrative in early 2020 that the novel coronavirus was less concerning than the seasonal flu.

“Science journalists have always been writing about studies that sometimes contradict each other, and what’s happened is that has only been condensed in time,” said Ms. Khamsi, a health care reporter for outlets like WIRED magazine and The New York Times and a former chief news editor for Nature Medicine.
 

Politics and misinformation

It’s impossible to talk about media coverage of COVID-19 without touching on politics and misinformation.

Coverage of the pandemic was politicized and polarized from the very beginning, said Sedona Chinn, PhD, an assistant professor at the University of Wisconsin–Madison who researches the prevalence and effects of scientific disagreements in media.

By looking at network news transcripts and articles from national outlets like the Washington Post and The New York Times, Dr. Chinn and her colleagues were able to determine politicization of coverage by counting the mentions of politicians versus scientists in COVID-19 coverage and polarization by looking at how different or similar the language was surrounding mentions of Republicans and Democrats.

If the two parties were working together or on the same page, they reasoned, the language would be similar.

From mid-March through May 2020, Dr. Chinn and fellow researchers found politicians were featured more often than scientists in newspaper coverage and as frequently as scientists in network news coverage. They also found polarized language around Republicans and Democrats, particularly in stories describing duels between the (at the time) Republican national government and Democratic state and local leaders.

It’s possible that polarization in news coverage helped contribute to polarized attitudes around the virus, the authors write in the study, which was published in August 2020 in the journal Science Communication.

The politicization and polarization of the issue is mirrored in our fractured media environment, where people tend to read, listen, and watch outlets that align with their political leanings. If that trusted outlet features misinformation, the people who follow it are more likely to accept that false information as truth, said Matt Motta, PhD, a political scientist at Oklahoma State University whose research includes public opinion and science communication.

This is true across the political spectrum, he said. When it comes to COVID-19, however, right-wing media outlets like Fox News and Breitbart are more likely to promote conspiratorial tropes and misinformation about the pandemic, according to Dr. Motta and his collaborator Dominik Stecula, PhD, a political scientist at Colorado State University who studies the news media environment and its effects on society.

Across the media ecosystem, reporting on the “infodemic” accompanying the pandemic – the rapid spread of misinformation and disinformation about the virus – has been a major challenge. Outlets may not be creating the misinformation, but they are the ones choosing to give it a platform, said Dr. Motta.

By repeating a false idea, even with the goal of debunking it, you can unintentionally cause the information to stick in people’s minds, said Dr. Brossard.

“Just because something is controversial doesn’t mean it’s worth covering,” said Dr. Motta. Using vaccines as an example, he said many reporters and scientists alike assume that if people have all the facts, they’ll land on the side of science.

“That is just fundamentally not how people think about the decision to get vaccinated,” he said. Instead, the choice is wrapped up with cultural factors, religious beliefs, political identity, and more.

The factors and challenges that shaped the media’s coverage of the pandemic aren’t going anywhere. Improving science and medical coverage in the future is a collective project for journalists, scientists, and everyone in between, said Dr. Newman.

“I call on scientists, too, to think really deeply about how they’re communicating – and especially how they’re communicating what they know and don’t know,” he said.

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

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Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

[email protected]

Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

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A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]

A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]

A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]