Dermatology News

More clinical data suggesting that men may have a better response to immunotherapy than women in certain circumstances have been reported.

In a population-based cohort study, women with advanced melanoma and prior ipilimumab treatment who then received combination nivolumab and ipilimumab immunotherapy had a more than twofold increase in the risk for death in comparison with their male counterparts.

The hazard ratio (HR) for mortality among women versus men treated with the combination immunotherapy after prior ipilimumab treatment was 2.06 (P = .003). No such difference was observed among those receiving single-agent therapy with pembrolizumab or nivolumab (HR for mortality in women vs. men, 0.97; P = .85) or among patients without prior ipilimumab use (HR, 0.85; P = .16).

Women with prior ipilimumab use also had a nearly threefold increase in the risk for death with combination immunotherapy versus with single-agent anti–programmed cell death protein–1 (anti-PD-1) therapy (HR, 2.82), but no such difference was seen among the men in the study.

The findings were published online Dec. 2 in JAMA Network Open.

They come from an analysis of Surveillance, Epidemiology, and End Results (SEERS)–Medicare linked data for 982 men and 387 women with stage III or IV melanoma whose median age was 75 years.

The findings suggest that the patient’s sex should be considered in treatment planning to optimize outcomes, the authors noted.

“These novel findings suggest that, for women with a prior history of ipilimumab, treatment with anti-PD-1 therapy may be preferable to combination therapy, whereas for men, it is unclear which treatment is better,” they wrote.

In a press release, principal author Grace Lu-Yao, PhD, a professor at Thomas Jefferson University, Philadelphia, acknowledged that it remains unclear whether the increased risk for death in women is a result of treatment side effects or lack of efficacy, but she stressed that “this is a powerful signal in real-world data that we need to investigate further.

“This data is a wake-up call based on the experience of hundreds of patients on these drugs,” said Dr. Lu-Yao. “This real-world data demonstrates that the results derived from men might not be applicable to women and it is critical to design studies with sufficient power to evaluate treatment effectiveness by sex.”
 

Relevance for routine practice is unclear

The relevance of the findings for routine practice is unclear, given the median age of the cohort and a lack of data on whether excess mortality was cancer- or toxicity-related or due to another cause, Jeffrey S. Weber, MD, PhD, told this news organization. Dr. Weber is a professor and deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University.

“The study is interesting and detailed, but it is a rather narrowly defined cohort that is over 65 and has a median of age 75, [which is] very different than most melanoma patient cohorts of patients treated with immunotherapy, whose median age is 10 years younger,” Dr. Weber said in an interview.

Furthermore, “in practice, almost no current patients will have been previously treated with ipilimumab and then receive combination immunotherapy,” he said. “Overall, these data would not impact on how I treat patients,” he said.
 

Gender differences in response

This study is not the first to show a gender-based difference in outcomes after immunotherapy. As previously reported by this news organization, a meta-analysis published in The Lancet Oncology in 2018 showed that immune checkpoint inhibitors are twice as effective as standard cancer therapies in men with advanced solid tumors, compared with their female counterparts.

However, sex-based differences remain under-assessed despite “accumulating evidence of the potential role played by sex in drug effectiveness owing to the biological differences between men and women,” wrote the authors of the latest study in melanoma.

“This lack of attention on the association of sex with the effectiveness of immune checkpoint inhibitor (ICI)–based immunotherapy may have significant negative consequences, especially because these treatments are associated with high toxicity and high treatment cost. For future trials, it would be crucial to examine effect modification by sex,” they added.

The study was funded by the Sidney Kimmel Cancer Center. Dr. Lu-Yao and coauthors have disclosed no relevant financial relationships. Dr. Weber is a regular contributor to Medscape. He reports relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck & Co, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi-Sankyo, and Eli Lilly and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

More clinical data suggesting that men may have a better response to immunotherapy than women in certain circumstances have been reported.

In a population-based cohort study, women with advanced melanoma and prior ipilimumab treatment who then received combination nivolumab and ipilimumab immunotherapy had a more than twofold increase in the risk for death in comparison with their male counterparts.

The hazard ratio (HR) for mortality among women versus men treated with the combination immunotherapy after prior ipilimumab treatment was 2.06 (P = .003). No such difference was observed among those receiving single-agent therapy with pembrolizumab or nivolumab (HR for mortality in women vs. men, 0.97; P = .85) or among patients without prior ipilimumab use (HR, 0.85; P = .16).

Women with prior ipilimumab use also had a nearly threefold increase in the risk for death with combination immunotherapy versus with single-agent anti–programmed cell death protein–1 (anti-PD-1) therapy (HR, 2.82), but no such difference was seen among the men in the study.

The findings were published online Dec. 2 in JAMA Network Open.

They come from an analysis of Surveillance, Epidemiology, and End Results (SEERS)–Medicare linked data for 982 men and 387 women with stage III or IV melanoma whose median age was 75 years.

The findings suggest that the patient’s sex should be considered in treatment planning to optimize outcomes, the authors noted.

“These novel findings suggest that, for women with a prior history of ipilimumab, treatment with anti-PD-1 therapy may be preferable to combination therapy, whereas for men, it is unclear which treatment is better,” they wrote.

In a press release, principal author Grace Lu-Yao, PhD, a professor at Thomas Jefferson University, Philadelphia, acknowledged that it remains unclear whether the increased risk for death in women is a result of treatment side effects or lack of efficacy, but she stressed that “this is a powerful signal in real-world data that we need to investigate further.

“This data is a wake-up call based on the experience of hundreds of patients on these drugs,” said Dr. Lu-Yao. “This real-world data demonstrates that the results derived from men might not be applicable to women and it is critical to design studies with sufficient power to evaluate treatment effectiveness by sex.”
 

Relevance for routine practice is unclear

The relevance of the findings for routine practice is unclear, given the median age of the cohort and a lack of data on whether excess mortality was cancer- or toxicity-related or due to another cause, Jeffrey S. Weber, MD, PhD, told this news organization. Dr. Weber is a professor and deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University.

“The study is interesting and detailed, but it is a rather narrowly defined cohort that is over 65 and has a median of age 75, [which is] very different than most melanoma patient cohorts of patients treated with immunotherapy, whose median age is 10 years younger,” Dr. Weber said in an interview.

Furthermore, “in practice, almost no current patients will have been previously treated with ipilimumab and then receive combination immunotherapy,” he said. “Overall, these data would not impact on how I treat patients,” he said.
 

Gender differences in response

This study is not the first to show a gender-based difference in outcomes after immunotherapy. As previously reported by this news organization, a meta-analysis published in The Lancet Oncology in 2018 showed that immune checkpoint inhibitors are twice as effective as standard cancer therapies in men with advanced solid tumors, compared with their female counterparts.

However, sex-based differences remain under-assessed despite “accumulating evidence of the potential role played by sex in drug effectiveness owing to the biological differences between men and women,” wrote the authors of the latest study in melanoma.

“This lack of attention on the association of sex with the effectiveness of immune checkpoint inhibitor (ICI)–based immunotherapy may have significant negative consequences, especially because these treatments are associated with high toxicity and high treatment cost. For future trials, it would be crucial to examine effect modification by sex,” they added.

The study was funded by the Sidney Kimmel Cancer Center. Dr. Lu-Yao and coauthors have disclosed no relevant financial relationships. Dr. Weber is a regular contributor to Medscape. He reports relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck & Co, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi-Sankyo, and Eli Lilly and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

More clinical data suggesting that men may have a better response to immunotherapy than women in certain circumstances have been reported.

In a population-based cohort study, women with advanced melanoma and prior ipilimumab treatment who then received combination nivolumab and ipilimumab immunotherapy had a more than twofold increase in the risk for death in comparison with their male counterparts.

The hazard ratio (HR) for mortality among women versus men treated with the combination immunotherapy after prior ipilimumab treatment was 2.06 (P = .003). No such difference was observed among those receiving single-agent therapy with pembrolizumab or nivolumab (HR for mortality in women vs. men, 0.97; P = .85) or among patients without prior ipilimumab use (HR, 0.85; P = .16).

Women with prior ipilimumab use also had a nearly threefold increase in the risk for death with combination immunotherapy versus with single-agent anti–programmed cell death protein–1 (anti-PD-1) therapy (HR, 2.82), but no such difference was seen among the men in the study.

The findings were published online Dec. 2 in JAMA Network Open.

They come from an analysis of Surveillance, Epidemiology, and End Results (SEERS)–Medicare linked data for 982 men and 387 women with stage III or IV melanoma whose median age was 75 years.

The findings suggest that the patient’s sex should be considered in treatment planning to optimize outcomes, the authors noted.

“These novel findings suggest that, for women with a prior history of ipilimumab, treatment with anti-PD-1 therapy may be preferable to combination therapy, whereas for men, it is unclear which treatment is better,” they wrote.

In a press release, principal author Grace Lu-Yao, PhD, a professor at Thomas Jefferson University, Philadelphia, acknowledged that it remains unclear whether the increased risk for death in women is a result of treatment side effects or lack of efficacy, but she stressed that “this is a powerful signal in real-world data that we need to investigate further.

“This data is a wake-up call based on the experience of hundreds of patients on these drugs,” said Dr. Lu-Yao. “This real-world data demonstrates that the results derived from men might not be applicable to women and it is critical to design studies with sufficient power to evaluate treatment effectiveness by sex.”
 

Relevance for routine practice is unclear

The relevance of the findings for routine practice is unclear, given the median age of the cohort and a lack of data on whether excess mortality was cancer- or toxicity-related or due to another cause, Jeffrey S. Weber, MD, PhD, told this news organization. Dr. Weber is a professor and deputy director of the Laura and Isaac Perlmutter Cancer Center at New York University.

“The study is interesting and detailed, but it is a rather narrowly defined cohort that is over 65 and has a median of age 75, [which is] very different than most melanoma patient cohorts of patients treated with immunotherapy, whose median age is 10 years younger,” Dr. Weber said in an interview.

Furthermore, “in practice, almost no current patients will have been previously treated with ipilimumab and then receive combination immunotherapy,” he said. “Overall, these data would not impact on how I treat patients,” he said.
 

Gender differences in response

This study is not the first to show a gender-based difference in outcomes after immunotherapy. As previously reported by this news organization, a meta-analysis published in The Lancet Oncology in 2018 showed that immune checkpoint inhibitors are twice as effective as standard cancer therapies in men with advanced solid tumors, compared with their female counterparts.

However, sex-based differences remain under-assessed despite “accumulating evidence of the potential role played by sex in drug effectiveness owing to the biological differences between men and women,” wrote the authors of the latest study in melanoma.

“This lack of attention on the association of sex with the effectiveness of immune checkpoint inhibitor (ICI)–based immunotherapy may have significant negative consequences, especially because these treatments are associated with high toxicity and high treatment cost. For future trials, it would be crucial to examine effect modification by sex,” they added.

The study was funded by the Sidney Kimmel Cancer Center. Dr. Lu-Yao and coauthors have disclosed no relevant financial relationships. Dr. Weber is a regular contributor to Medscape. He reports relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck & Co, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi-Sankyo, and Eli Lilly and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

International consensus recommendations on the use of energy‐based devices (EBDs) for the treatment of acne scars, published in Lasers in Surgery and Medicine, call for EBDs to be used as first-line treatment.

Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.

“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”

One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.

The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.

The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.

Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.

Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”

Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”

He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.

Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.

Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.

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

International consensus recommendations on the use of energy‐based devices (EBDs) for the treatment of acne scars, published in Lasers in Surgery and Medicine, call for EBDs to be used as first-line treatment.

Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.

“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”

One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.

The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.

The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.

Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.

Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”

Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”

He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.

Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.

Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.

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

International consensus recommendations on the use of energy‐based devices (EBDs) for the treatment of acne scars, published in Lasers in Surgery and Medicine, call for EBDs to be used as first-line treatment.

Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.

“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”

One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.

The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.

The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.

Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.

Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”

Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”

He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.

Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.

Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.

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

Sublingual immunotherapy (SLIT) with house dust mite (HDM) extract showed some benefit in improving the signs and symptoms of atopic dermatitis in mite-sensitized patients, but improvement in the primary outcome was not significant, new data show.

Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.

Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.

The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.

The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.

Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.

At baseline, the mean SCORAD was 46.9 (range, 17-87).

After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.

On the other hand, some secondary outcomes did show significant results.

At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).

There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.

Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.

Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.

She pointed out that even in the placebo group, more than half the patients met the primary endpoint.

However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.

With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.

It all comes down to risk and benefits, she said.

She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.

Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.

She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.

The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life. 

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

Sublingual immunotherapy (SLIT) with house dust mite (HDM) extract showed some benefit in improving the signs and symptoms of atopic dermatitis in mite-sensitized patients, but improvement in the primary outcome was not significant, new data show.

Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.

Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.

The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.

The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.

Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.

At baseline, the mean SCORAD was 46.9 (range, 17-87).

After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.

On the other hand, some secondary outcomes did show significant results.

At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).

There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.

Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.

Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.

She pointed out that even in the placebo group, more than half the patients met the primary endpoint.

However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.

With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.

It all comes down to risk and benefits, she said.

She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.

Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.

She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.

The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life. 

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

Sublingual immunotherapy (SLIT) with house dust mite (HDM) extract showed some benefit in improving the signs and symptoms of atopic dermatitis in mite-sensitized patients, but improvement in the primary outcome was not significant, new data show.

Results of the small, randomized, double-blind, placebo-controlled trial were published recently in The Journal of Allergy and Clinical Immunology: In Practice.

Lead author Sarah Sella Langer, MD, of the department of medicine, Ribeirão Preto (Brazil) Medical School, University of São Paulo, and colleagues said their results suggest HDM SLIT is safe and effective as an add-on treatment.

The dust mite extract therapy had no major side effects after 18 months of treatment, the authors reported.

The researchers included data from 66 patients who completed the study. The participants were at least 3 years old, registered at least 15 on the SCORing Atopic Dermatitis (SCORAD) measure, and had a skin prick test and/or immunoglobulin E (IgE) test for sensitization to dust mites.

Patients were grouped by age (younger than 12 years or 12 years and older) to receive HDM SLIT (n = 35) or placebo (n = 31) 3 days a week for the study period – between May 2018 and June 2020 – at the Clinical Research Unit of Ribeirão Preto Medical School Hospital.

At baseline, the mean SCORAD was 46.9 (range, 17-87).

After 18 months, 74.2% and 58% of patients in HDM SLIT and placebo groups, respectively, showed at least a15-point decrease in SCORAD (relative risk, 1.28; 95% confidence interval, 0.89-1.83). However, those primary outcome results did not reach statistical significance.

On the other hand, some secondary outcomes did show significant results.

At 95% CI, the researchers reported significant objective-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (average difference, 21.3). Significantly more patients had a score of 0 or 1 on the 5-point Investigator’s Global Assessment scale in the intervention group than in the placebo group (14/35 vs. 5/31; RR, 2.63).

There were no significant changes in the Eczema Area and Severity Index, the visual analogue scale for symptoms, the pruritus scale, or the Dermatology Life Quality Index.

Patients in the trial, most of whom had moderate to severe disease, continued to be treated with usual, individualized therapy for AD, in accordance with current guidelines and experts’ recommendations.

Tina Sindher, MD, an allergist with the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University, , told this news organization that the results are not robust enough to recommend the immunotherapy widely.

She pointed out that even in the placebo group, more than half the patients met the primary endpoint.

However, she did say HDM SLIT could be considered as an add-on treatment for the right patients, especially since risk for an allergic reaction or other adverse condition is small. The most common adverse effects were headache and abdominal pain, and they were reported in both the treatment and placebo groups.

With AD, she said, “there is no one drug that’s right for everyone,” because genetics and environment make the kind of symptoms and severity and duration different for each patient.

It all comes down to risk and benefits, she said.

She said if she had a patient with an environmental allergy who’s trying to manage nasal congestion and also happened to have eczema, “I think they’re a great candidate for sublingual dust mite therapy because then not only am I treating their nasal congestions, their other symptoms, it may also help their eczema,” Dr. Sindher said.

Without those concurrent conditions, she said, the benefits of dust mite immunotherapy would not outweigh the risks or the potential burden on the patient of having to take the SLIT.

She said she would present the choice to the patient, and if other treatments haven’t been successful and the patient wants to try it, she would be open to a trial period.

The study was supported by the Brazilian National Council for Scientific and Technological Development, the Institute of Investigation in Immunology, the National Institutes of Science and Technology, the Brazilian National Council for Scientific and Technological Development, and the São Paulo Research Foundation. The mite extract for immunotherapy was provided by the laboratory IPI-ASAC Brasil/ASAC Pharma Brasil. Dr. Langer received a doctoral scholarship from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Dr. Sindher reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Environmental triggers of atopic dermatitis (AD) may be difficult to assess, especially as children with AD commonly develop “overlap” conditions of allergic rhinitis, food allergy, and asthma. The place of immunotherapy in treatment of AD has been controversial over the years, with mixed results from studies on its effect on eczema in different subpopulations. However, a holistic view of allergy care makes consideration of environmental allergies reasonable. The study by Dr. Langer and colleagues was a well-designed double-blind placebo-controlled trial of house dust mite sublingual immunotherapy in mite-sensitized AD patients aged 3 and older with at least mild AD, though the mean eczema severity was severe. After 18 months, there was an impressive 74% decrease in eczema score (SCORAD), but also a 58% decrease in the placebo group. While the primary outcome measure wasn’t statistically significant, some secondary ones were. I agree with the commentary in the article that the data doesn’t support immunotherapy being advised to everyone, while its use as an add-on treatment for certain patients in whom the eczema may overlap with other allergic manifestations is reasonable. For several years at Rady Children’s Hospital, San Diego, we have run a multidisciplinary atopic dermatitis program where patients are comanaged by dermatology and allergy. We have learned to appreciate that a broad perspective on managing comorbid conditions in children with AD really helps the patients and families to understand the many effects of inflammatory and allergic conditions, with improved outcomes and quality of life. 

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

Online reviews and star ratings are the most important factor in choosing a new health care provider, according to a new survey from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.

m-imagephotography/Thinkstock.com

In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.

The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.

“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”

Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.

Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
 

How patients search online

In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.

The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.

According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)

Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.

When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.

Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.

The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
 

Factors in patient loyalty

The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.

Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).

The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.

According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
 

Online appointment booking is a must

To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.

Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.

“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”

Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.

Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”

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

Online reviews and star ratings are the most important factor in choosing a new health care provider, according to a new survey from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.

m-imagephotography/Thinkstock.com

In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.

The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.

“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”

Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.

Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
 

How patients search online

In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.

The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.

According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)

Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.

When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.

Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.

The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
 

Factors in patient loyalty

The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.

Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).

The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.

According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
 

Online appointment booking is a must

To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.

Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.

“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”

Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.

Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”

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

Online reviews and star ratings are the most important factor in choosing a new health care provider, according to a new survey from Press Ganey, a provider of patient satisfaction surveys. According to the data, this online information is more important to consumers in selecting a physician than another doctor’s referral and is more than twice as important when choosing a primary care physician.

m-imagephotography/Thinkstock.com

In fact, 83% of respondents said they went online to read reviews of a physician after receiving a referral from another provider.

The online research trend reflects not only the increased familiarity of all generations with the internet but also the growing consumerization of health care, Thomas Jeffrey, president of the Sullivan/Luallin Group, a patient experience consulting firm, told this news organization.

“According to patient satisfaction surveys, people are becoming health care consumers more than in the past,” he noted. “Historically, we didn’t look at health care as a consumer product. But, with high deductibles and copays, doctor visits can represent a pretty significant out-of-pocket expense. As it begins to hit folks’ pocketbooks, they become more savvy shoppers.”

Digital preferences for providers were gaining “positive momentum” even before the COVID-19 pandemic, but the crisis “drove upticks in some consumer digital behaviors,” the Press Ganey report pointed out.

Mr. Jeffrey agreed, noting that this finding matches what Sullivan/Luallin has discovered in its research. “I think the pandemic pushed people to engage more online,” he said. “The highest net promoter score [likelihood to recommend in market surveys] for a pharmacy is the Amazon pharmacy, which is an online-based delivery service. Then you have telehealth visits, which are more convenient in many ways.”
 

How patients search online

In choosing a new primary care doctor, 51.1% go on the web first, 23.8% seek a referral from another health care provider, and 4.4% get information from an insurer or a benefits manager, according to the survey.

The factors that matter most to consumers when they pick any provider, in order, are online ratings and reviews of the physician, referral from a current doctor, ratings and reviews of the facility, and the quality and completeness of a doctor’s profile on a website or online directory. The doctor’s online presence and the quality of their website are also important.

According to Press Ganey, search engines like Google are the most used digital resources, with 65.4% of consumers employing them to find a doctor. However, consumers now use an average of 2.7 sites in their search. The leading destinations are a hospital or a clinic site, WebMD, Healthgrades, and Facebook. (This news organization is owned by WebMD.)

Compared with 2019, the report said, there has been a 22.8% decline in the use of search engines for seeking a doctor and a 53.7% increase in the use of health care review sites such as Healthgrades and Vitals.

When reading provider reviews, consumers look for more recent reviews and want the reviews to be “authentic and informative.” They also value the star ratings. About 84%of respondents said they wouldn’t book an appointment with a referred provider that had a rating of less than four stars.

Overall, the top reasons why people are deterred from making an appointment are difficulty contacting the office, the poor quality of online reviews, and an average online rating of less than four stars.

The vast majority of respondents (77%) said they believe internet reviews reflect their own experience with a provider organization, and only 2.6% said the reviews were inaccurate. Another finding of the survey indicates that this attention of patients to reviews of their own provider doesn’t represent idle curiosity: About 57% of Baby Boomers and 45% of millennials/Gen Z’ers said they’d written online reviews of a doctor or a hospital.
 

Factors in patient loyalty

The Press Ganey survey asked which of several factors, besides excellent care, patients weighed when giving a five-star review to a health care provider.

Quality of customer service was rated first by 70.8% of respondents, followed by cleanliness of facilities (67.5%), communication (63.4%), the provider’s bedside manner (63%), ease of appointment booking (58.8%), ease of patient intake/registration (52.3%), quality and accuracy of information (40.1%), availability of telehealth services (21.7%), and waiting room amenities (21.8%).

The report explained that “quality of customer service” means “demeanor, attentiveness, and helpfulness of staff and practitioners.” “Communication” refers to things like follow-up appointment reminders and annual checkup reminders.

According to Mr. Jeffrey, these factors were considered more important than a doctor’s bedside manner because of the team care approach in most physician offices. “We see a lot more folks derive their notion of quality from continuity of care. And if they feel the physician they love is being supported by a less than competent team, that can impact significantly their sense of the quality of care,” he said.
 

Online appointment booking is a must

To win over the online consumer, Press Ganey emphasized, practices should ensure that provider listings are accurate and complete. In addition, offering online appointment booking can avoid the top challenge in making a new appointment, which is getting through to the office.

Mr. Jeffrey concurred, although he notes that practices have to be careful about how they enable patients to select appointment slots online. He suggests that an appointment request form on a patient portal first ask what the purpose of the visit is and that it offer five or so options. If the request fits into a routine visit category, the provider’s calendar pops up and the patient can select a convenient time slot. If it’s something else, an appointment scheduler calls the patient back.

“There needs to be greater access to standard appointments online,” he said. “While privacy is an issue, you can use the patient portal that most EHRs have to provide online booking. If you want to succeed going forward, that’s going to be a major plus.”

Of course, to do any of this, including reading provider reviews, a consumer needs a good internet connection and a mobile or desktop device. While broadband internet access is still not available in some communities, the breakdown of the survey respondents by demographics shows that low-income people were included.

Mr. Jeffrey doesn’t believe that a lack of internet access or digital devices prevents many Americans from going online today. “Even in poor communities, most people have internet access through their smartphones. Even baby boomers are familiar with smartphones. I haven’t seen internet access be a big barrier for low-income households, because they all have access to phones.”

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

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

As the pandemic shows no signs of ending, primary care doctors may be reassured that delivering care via video teleconferencing can be as effective as usual in-person consultation for several common health conditions.

This was a finding of a new study published in Annals of Internal Medicine involving a review of literature on video teleconferencing (VTC) visits, which was authored by Jordan Albritton, PhD, MPH and his colleagues.

The authors found generally comparable patient outcomes as well as no differences in health care use, patient satisfaction, and quality of life when visits conducted using VTC were compared with usual care.

While VTC may work best for monitoring patients with chronic conditions, it can also be effective for acute care, said Dr. Albritton, who is a research public health analyst at RTI International in Research Triangle Park, N.C., in an interview.

The investigators analyzed 20 randomized controlled trials of at least 50 patients and acceptable risk of bias in which VTC was used either for main or adjunct care delivery. Published from 2013 to 2019, these studies looked at care for diabetes and pain management, as well as some respiratory, neurologic, and cardiovascular conditions. Studies comparing VTC with usual care that did not involve any added in-person care were more likely to favor the VTC group, the investigators found.

“We excluded conditions such as substance use disorders, maternal care, and weight management for which there was sufficient prior evidence of the benefit of VTC,” Dr. Albritton said in an interview. “But I don’t think our results would have been substantially different if we had included these other diseases. We found general evidence in the literature that VTC is effective for a broader range of conditions.”

In some cases, such as if changes in a patient’s condition triggered an automatic virtual visit, the author said he thinks VTC may lead to even greater effectiveness.

“The doctor and patient could figure out on the spot what’s going on and perhaps change the medication,” Dr. Albritton explained.

In general agreement is Julia L. Frydman, MD, assistant professor in the Brookdale Department of Geriatric and Palliative Medicine at Icahn School of Medicine at Mount Sinai in New York, who was not involved in the RTI research.

“Telemedicine has promise across many medical subspecialties, and what we need now are more studies to understand the perspectives of patients, caregivers, and clinicians as well as the impact of telemedicine on health outcomes and healthcare utilization.”

In acknowledgment of their utility, video visits are on the rise in the United States. A 2020 survey found that 22% of patients and 80% of physicians reported having participated in a video visit, three times the rate of the previous year. The authors noted that policy changes enacted to support telehealth strategies during the pandemic are expected to remain in place, and although patients are returning to in-person care, the virtual visit market will likely continue growing.
 

Increased telemedicine use by older adults

“We’ve seen an exciting expansion of telemedicine use among older adults, and we need to focus on continuing to meet their needs,” Dr. Frydman said.

In a recent study of televisits during the pandemic, Dr. Frydman’s group found a fivefold greater uptake of remote consultations by seniors – from 5% to 25%. Although in-person visits were far more common among older adults.

A specific advantage of video-based over audio-only telehealth, noted Dr. Albritton, is that physicians can directly observe patients in their home environment. Sharing that view is Deepa Iyengar, MBBS/MD,MPH, professor of family medicine at McGovern Medical School at The University of Texas Health Science Center at Houston, where, she said, “the pandemic has put VTC use into overdrive.”

According to Dr. Iyengar, who was not involved in the RTI research, the video component definitely represents value-added over phone calls. “You can pick up visual cues on video that you might not see if the patient came in and you can see what the home environment is like – whether there are a lot of loose rugs on the floor or broken or missing light bulbs,” she said in an interview.
 

‘VTC is here to stay’

In other parts of the country, doctors are finding virtual care useful – and more common. “VTC is here to stay, for sure – the horse is out of the barn,” said Cheryl L. Wilkes, MD, an internist at Northwestern Medicine and assistant professor of medicine at Northwestern University in Chicago. “The RTI study shows no harm from VTC and also shows it may even improve clinical outcomes.”

Video visits can also save patients high parking fees at clinics and spare the sick or elderly from having to hire caregivers to bring them into the office or from having to walk blocks in dangerous weather conditions, she added. “And I can do a virtual visit on the fly or at night when a relative or caregiver is home from work to be there with the patient.”

In addition to being beneficial for following up with patients with chronic diseases such as hypertension or diabetes, VTC may be able to replace some visits that have traditionally required hands-on care, said Dr. Wilkes.

She said she knows a cardiologist who has refined a process whereby a patient – say, one who may have edema – is asked to perform a maneuver via VTC and then display the result to the doctor: The doctor says, “put your leg up and press on it hard for 10 seconds and then show me what it looks like,” according to Dr. Wilkes.

The key now is to identify the best persons across specialties from neurology to rheumatology to videotape ways they’ve created to help their patients participate virtually in consults traditionally done at the office, Dr. Wilkes noted.

But some conditions will always require palpation and the use of a stethoscope, according Dr. Iyengar.

“If someone has an ulcer, I have to be able to feel it,” she said.

And while some maternity care can be given virtually – for instance, if a mother-to be develops a bad cold – hands-on obstetrical care to check the position and health of the baby obviously has to be done in person. “So VTC is definitely going to be a welcome addition but not a replacement,” Dr. Iyengar said.

Gaps in research on VTC visits

Many questions remain regarding the overall usefulness of VTC visits for certain patient groups, according to the authors.

They highlighted, for example, the dearth of data on subgroups or on underserved and vulnerable populations, with no head-to-head studies identified in their review. In addition, they found no studies examining VTC versus usual care for patients with concurrent conditions or on its effect on health equity and disparities.

“It’s now our job to understand the ongoing barriers to telemedicine access, including the digital divide and the usability of telemedicine platforms, and design interventions that overcome them,” Dr. Frydman said. “At the same time, we need to make sure we’re understanding and respecting the preferences of older adults in terms of how they access health care.”

This study was supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Albritton is employed by RTI International, the contractor responsible for conducting the research and developing the manuscript. Several coauthors disclosed support from or contracts with PCORI. One coauthor’s spouse holds stock in private health companies. Dr. Frydman, Dr. Iyengar, and Dr. Wilkes disclosed no competing interests relevant to their comments.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming, scientists and public health officials are debating when it will be time to change the definition of “fully vaccinated” to include a booster shot.

It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.

At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.

The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.

Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.

“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.

But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”

Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.

“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.

New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.

What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.

“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”

Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.

Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.

Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.

Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.

But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.

Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.

Kuzma/istockphoto

Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.

The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.

Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. Well-intentioned medical professionals may be tempted to promote the information and products featured on websites that advocate for unproven products and protocols. This can have serious legal consequences.
 

The crux of the issue

This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.

On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:

“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”

 

What are the legal consequences?

Medical malpractice

The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.

The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.

By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.

In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.

In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
 

Professional licensing action

Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.

This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.

In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.

The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.

The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.

Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.

Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.

In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
 

Peer review and affected privileges

Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.

The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
 

Criminal charges

Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.

Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
 

Breach of contract

Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.

Reputation/credibility damage and the attendant consequences

In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.

Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.

In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
 

Violation of the COVID-19 Consumer Protection Act of 2020

For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.

The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.

Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”

After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.

In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
 

Conclusion

It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.

Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

Children with severe cow’s milk allergy may be able to safely tolerate small amounts of baked milk after 12 months of oral immunotherapy, new research suggests.

The small, ongoing clinical trial has enabled some participants – all of whom reacted to less than a tablespoon of baked milk at baseline – to begin incorporating baked milk products into everyday diets and to eat in restaurants with less fear of allergic reactions, reported study author Jennifer Dantzer, MD, MHS, assistant professor of pediatrics in the division of pediatric allergy, immunology, and rheumatology at Johns Hopkins University in Baltimore.

Cow’s milk is the most common food allergy in young children, and “for many, it’s a constant stressor that’s always there,” Dr. Dantzer said in an interview. “For a lot of families, this impacts where they eat out, if they eat out, and sometimes where they vacation, or a lot of the social activities they do.

“This was a unique group of kids with a very severe milk phenotype who were reactive to teeny doses and may not have qualified or done well with other types of oral immunotherapy,” she added. “Using a modified allergen – baked milk – seems to work. But for now, we think this is something that still needs further research before it’s ready for a clinical setting.”

The study, for which 24-month unblinded results are being tallied, was recently published in the Journal of Allergy and Clinical Immunology .

About 2%-3% of preschool-age children are affected by cow’s milk allergy. Children often outgrow it, but for about 20% of children, it persists into adolescence and adulthood. The only current management approaches are avoidance and emergency medications to treat reactions.

But for those with severe milk allergy who react to even trace amounts of milk in any form, the now-routine clinical practice of introducing baked milk isn’t an option, Dr. Dantzer said. The new trial stood out from prior research by using lower starting doses and a more gradual dose escalation of extensively heated milk to determine if oral immunotherapy could be safer but still effective.

Dr. Dantzer and her team randomly assigned 30 participants (aged 3-18 years) into two blinded groups. For 12 months, one group received baked milk oral immunotherapy (BMOIT), and the other a placebo consisting of tapioca flour. At baseline, for all participants, the milk skin prick test wheal diameter was ≥ 3 mm, and the cow’s milk immunoglobulin E (IgE) level was > 5 kU/L. All the children experienced positive dose-limiting reactions to < 1 tablespoon of baked milk protein but could tolerate at least 3 mg on initial dose escalation.

Measured doses of baked milk and placebo powders were supplied to participants for all doses consumed at home. Participants were given instructions on how to prepare it in cupcake or muffin batter. Over 12 months, doses were gradually increased to a maximum cumulative dose of 4,044 mg baked milk protein, or approximately a half tablespoon.

Researchers collected blood samples for immune studies, and participants or their parents completed quality-of-life questionnaires that asked about food anxiety, social and dietary limitations, emotional impact, risk for accidental ingestion, and allergen avoidance.

Fourteen of 15 participants (93%) in the BMOIT group reached the goal-maintenance dose of 2,000 mg of baked milk protein (about a quarter tablespoon). Of those who completed the 12-month challenge, 11 of 14 (79%) in the BMOIT group tolerated 4,000 mg of baked milk protein, compared to none in the placebo group.

“We anticipated that by starting with really small amounts, we would be able to build up the amount of baked milk these kids could tolerate,” Dr. Dantzer said. “We were very pleased by how many could reach the maximal dose at the end of the first year. Once we get the results of the second year, that will provide a lot of additional detail about how this translates into unheated milk amounts they can tolerate and introduce into their diet at home.”

No significant changes were found in IgE levels over time in either study group. Most in the BMOIT group reported improvement in at least one quality-of-life domain, while more in the placebo group reported improvements in only the emotional impact domain.

Adverse events such as gastrointestinal side effects occurred in both groups of participants, but the vast majority of events were mild, Dr. Dantzer said. Fewer than 1% of dosing-related reactions were severe. Four participants required epinephrine.

“This highlights how this needs to be done by someone comfortable and trained, and not by a family at home on their own,” Dr. Dantzer said. “But potentially in the future, this concept of using a modified allergen could be applied to more kids with milk allergy.”

A Montreal-based pediatric allergy specialist who was not involved in the study said the results weren’t surprising. “We’ve known for a good while that the allergenic proteins found in certain foods, or caused by milk in this context, are influenced by the way in which food is processed,” said Christine McCusker, MD, associate professor of pediatrics and director of the division of pediatric allergy, immunology, and dermatology at Montreal Children’s Hospital at McGill University Health Center.

But “having this relatively definitive data that supports what you’re suggesting to patients is obviously the way to optimize your management,” Dr. McCusker said in an interview. “These types of studies are important steps, especially in this age of increased food allergies where many of these things can be dealt with in very young children before their immune systems are fixed.”

Dr. Dantzer and Dr. McCusker agreed that the small size of the study was a limitation, though “waiting for more participants means you don’t always get information out there in a timely manner,” Dr. McCusker said.

She said additional research should focus on preidentifying which children may be prone to severe, lasting food allergies. “If you have a milk allergy that will stay with you the rest of your life and we could maybe modify that outcome with early, targeted intervention, that would be the nirvana of the field,” Dr. McCusker said.

Dr. Dantzer said her research “showed us that oral immunotherapy is an option, but not a perfect option.

“We still need to keep working on other alternatives that can be even safer and potentially work better,” she added.

The study was supported by the Myra Reinhard Family Foundation. Dr. Dantzer and Dr. McCusker report no relevant financial relationships.

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

In March 2021, Prime Minister Boris Johnson proposed a 1% pay rise for National Health Service (NHS) workers in the United Kingdom — a move many deemed inadequate after a full year of fighting the COVID-19 pandemic. The next day, James Cowe, a 23-year-old healthcare assistant who had been working in dementia care for 6 years, decided to create a profile on the content subscription site OnlyFans.

The London-based site allows subscribers, or “fans,” to request content, making its name distributing nude pictures, videos, and other sexually explicit content. It garnered mainstream attention in 2020 when housebound individuals and even celebrities began using it to generate income. Back in August, OnlyFans released a statement stating that it would ban “sexually explicit” content beginning in October. Days later, the company recanted the statement after uproar from creators.

“Because of the one-percent pay rise, I’ve started OnlyFans and I’m making more money in three days than I make in a month at work,” Mr. Cowe said in a now-deleted TikTok post. “Sorry Boris, but I’m done with healthcare and now I’m an online whore.”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans.

Mr. Cowe is one of many healthcare workers in the United Kingdom who have supplemented or replaced their health work with sex work. Stories like his have multiplied during the pandemic, at a time when healthcare professionals have been particularly overworked and particularly essential. Meanwhile, the pandemic has exacerbated challenges for many sex workers across the globe.

“[There have been] many, many reports over history that transactional sex is used as a sort of emergency livelihood strategy in all kinds of emergencies,” says Joanne Csete, PhD, associate professor of population and family health at Columbia University, New York, “and I suppose this is an emergency in that sense, like any other.”
 

The relationship between sex work and healthcare

A 2015 study by Leeds University found that 70% of sex workers in the United Kingdom previously worked in healthcare, charities, or education and that more than a third held university degrees.

The relationship between sex workers and healthcare workers has historically been disconnected. Sex workers are at higher risk of experiencing violence, sexually transmitted infections, and substance abuse and mental health problems than the general population, as noted by the American College of Obstetricians and Gynecologists. But according to the UN Population Fund, 63% of sex workers will not seek health services alone because they are distrustful and fearful of healthcare workers. A 2014 study by UNAIDS found that stigmatization also makes sex workers less likely to seek assistance from social services.

“I think it’s almost universally hard for sex workers to get respectful healthcare without judgment, and in some cases actual hostility, because of the stigma of their work,” Dr. Csete says. “Health workers are not always trained to see sex work as anything but either a criminal act or an immoral act.”

In August 2021, U.K. medical students called for the British Medical Association to protect students from being penalized by or expelled from their universities for engaging in sex work. BMA Medical Students Committee chair Becky Bates cited high medical school fees and a lack of financial support as motivations for student sex workers. She told this news organization that sex work often allows for flexible hours that might make it easier for students to balance the demands of medical school than other part-time jobs would.

At the annual BMA conference in September, two thirds of the association’s doctors voted in favor of the motion, while others criticized it as potential encouragement for students to get involved in sex work. “The motion isn’t about the morality of sex work,” Ms. Bates said. “[It’s] about the fact that it’s happening and what we can do to support students.”
 

Healthcare workers on OnlyFans

The rising pressures placed on individuals in the health field have coincided with the rise of online platforms that host pornographic content. During the pandemic, professionals worn down by their healthcare work have embraced sites like OnlyFans as lower-risk, lower-stress, and potentially higher-paying additions or alternatives.

“It’s quite exploitative to work for such low pay in harsh conditions,” Mr. Cowe told this news organizaation of his experience as a dementia care assistant. “It’s soul-destroying. You feel like, ‘It doesn’t matter how many hours I work, it doesn’t matter what I do, I’m still going to be in this same financial position.’ ”

Mr. Cowe earned the equivalent of a year’s salary from his healthcare assistant job in his first 22 days on OnlyFans. Within 8 months, he had earned £150,000, or approximately $205,000.

As an emergency medical services (EMS) worker in New York City, 23-year-old Lauren Kwei lifted obese bariatric patients, administered cardiopulmonary resuscitation to unresponsive recipients, and transported elderly patients and children with terminal illnesses to hospice. She earned $25 an hour, which she says was insufficient for life in one of the world’s most expensive cities. So, in addition to her paramedic work, Ms. Kwei posted photos and videos on OnlyFans to help pay for rent and groceries during the pandemic.

Ms. Kwei started her OnlyFans as a means of paying for necessities like rent and groceries, which her wage as an emergency medical services worker couldn’t cover entirely.

In December 2020, Ms. Kwei got a call from a New York Post reporter who informed her he was writing an article outing her OnlyFans side gig. Ms. Kwei immediately deleted her account on the site for fear of being penalized by her employer, SeniorCare.

“Leave her alone,” U.S. Representative Alexandria Ocasio-Cortez wrote on Twitter in response to the New York Post article. “The actual scandalous headline here is ‘Medics in the United States need two jobs to survive.’ ”

The article quoted an anonymous male paramedic who said Ms. Kwei should have been “pulling extra shifts, instead of pulling off [her] clothes” to earn more money. Ms. Kwei says such advice fails to acknowledge the intensity of the job. “Why would I pick up overtime shifts doing manual labor,” she says, “when I could be doing [OnlyFans] from the comfort of my own home?”
 

The future of the healthcare/sex work relationship

Ms. Kwei is young enough to receive health insurance through her parents, and Mr. Cowe has access to free healthcare through the NHS. But many sex workers — particularly full-service sex workers, who carry out their work in person — have limited access to services such as healthcare and unemployment benefits. Pandemic restrictions have concurrently driven full-service sex work further underground and therefore deepened the health and safety risks associated with its criminalization.

As health workers become increasingly involved in sex work, advocates in both fields are pushing for healthcare systems to involve sex workers.

“Just as we would do with supporting any group, it’s about understanding any specific barriers or specific problems that they’re encountering, and understanding what they think would help, and working together on that solution,” Ms. Bates says of supporting medical students who engage in sex work.

Tlaleng Mofokeng, MD, UN Special Rapporteur on the right to health, says it is crucial for healthcare organizations to partner with sex worker organizations when it comes to planning the resourcing and budgeting of the public health system in order to meet sex workers’ needs. “While we wait for national policy to change and while we wait for decriminalization,” she says, “tangible things can be done to ensure the provision of equitable services that are aligned with the respect of [sex workers’] rights and the restoration of their dignity.”

Today, healthcare professionals can expect to work with classmates, colleagues, and patients who are involved in sex work and who do not fit the socioeconomic stereotypes associated with sex workers. The number of medical students and healthcare workers engaging in sex work is likely to continue to rise as these individuals struggle to find financial and emotional support within the health sector. Ultimately, many health workers and sex workers share a common goal: to be involved in healthcare systems that respect their work and meet their basic needs.

Mr. Cowe doubts he will ever return to the healthcare industry, owing in part to the stigma against sex workers. “I would feel quite unwelcome,” he says. “[The publicity I received] probably made it not possible for me to go back, but even so, I wouldn’t have a desire to because I was just so burnt out in the end.”

Ms. Kwei is taking a break from her EMS work because of the emotional and financial toll it took, but she plans to return in the future. In the meantime, she is back on OnlyFans and advocating for higher wages for EMS workers as a member of the Emergency Medical Services Public Advocacy Council (EMSPAC). “In order to be a good paramedic, my mental health needs to be on point,” she says. “Hopefully down the line, when I decide to pick up EMS [work] again, I can find a job that pays me enough.”

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

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

One Montana hospital went into lockdown and called police after a woman threatened violence because her relative was denied her request to be treated with ivermectin.

Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.

And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.

These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.

“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”

Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.

Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.

Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.

Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.

In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.

“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.

Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.

The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.

“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”

An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.

That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.

“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.

“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.

A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.

Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.

Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.

The report did not offer any conclusions or allegations of wrongdoing.

Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.

“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.

“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.

The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.

Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.

“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”

He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.

Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.

“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.

Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.

“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.