Intravenous steroids were less effective in ulcerative colitis patients with older-onset disease, compared with younger-onset patients, according to data from nearly 500 individuals.

A combination of rising ulcerative colitis rates and an aging population has driven an increase in older-onset UC worldwide, Shinji Okabayashi, MD, of Kyoto University, and colleagues wrote in a study published in Alimentary Pharmacology & Therapeutics.

Data on differences in disease history between younger- and older-onset cases have been inconsistent, but one meta-analysis suggested a higher rate of surgery in older-onset cases, the authors of the current study wrote. “The higher risk of surgery may be due to the difference in effectiveness of intravenous steroid treatment, which is one of the important treatment options to avoid surgery for a severe course of UC,” but data on the effectiveness of IV steroids for older-onset UC are lacking.

The researchers reviewed data from 467 adults with ulcerative colitis at 27 centers in Japan. The participants were hospitalized and received their initial intravenous steroids between April 2014 and July 2019. The treatment was a daily dose of 40 mg or more of IV prednisolone or its equivalent, with dosing according to current guidelines. The primary outcome was clinical remission after 30 days.

The study population included 83 patients with older-onset UC and 384 with younger-onset UC. No cutoff currently exists to classify UC by age; the researchers defined younger onset as patients diagnosed at younger than 60 years and older onset as those diagnosed at age 60 years and older. The median age of onset was 32 years in the younger-onset patients and 68 in the older-onset group.

Overall, 51.8% of older-onset patients and 65.6% of younger-onset patients had clinical remission at 30 days (adjusted risk ratio, 0.74; P = .009). The incidence of colectomy at 30 days was significantly higher in older-onset patients, compared with younger-onset patients (15.7% vs. 1.8%; P < .001).

The researchers also assessed risk of surgery and adverse events at 90 days as secondary outcomes. The risk of surgery was significantly higher in older-onset patients compared with younger-onset patients (20.5% vs. 3.1%; ARR, 8.92) as was the risk of adverse events (25.3% vs. 9.1%, ARR, 2.19). A total of four deaths occurred during the study period, all in older-onset patients.

In addition, the researchers found that clinical remission rates at 30 days in older patients with younger-onset UC was similar to that of younger patients with younger-onset UC.

Potential contributors to the lower effectiveness of intravenous steroids in older-onset UC include genetic susceptibility, gut microbiota, and environmental factors, the researchers noted. The dysregulated immune response in older-onset UC also might play a role in limiting the effectiveness of intravenous steroids in these patients.

The study findings were limited by several factors including the lack of data on genetic susceptibility, environmental factors, and gut microbiota, as well as the inclusion only of patients with moderate to severe disease, which might have contributed to the higher risk of surgery in older patients, the researchers said. Other potential limitations include the potential confounders of concomitant drugs and nutritional status, and the use of symptom-based scoring to determine clinical remission.

However, the overall results reflect data from a recent meta-analysis, and the current study “clearly suggests that one of the reasons for the poor prognosis in patients with older-onset UC is the lower effectiveness of intravenous steroid treatment, which is one of the important treatment options for a severe course of UC,” the researchers wrote.

“Further research is warranted to establish the optimal treatment strategies for moderate to severe older-onset UC,” they concluded.
 

Findings have value for high-risk patients

The study is of interest to clinicians in practice, Hamed Khalili, MD, of Massachusetts General Hospital, Boston, said in an interview. “The findings are largely consistent with prior studies that have shown older-onset IBD patients have higher risk of surgery,” said Dr. Khalili, who was not involved with the study.

“This study focuses on a smaller subset of patients with IBD who present with acute severe UC,” Dr. Khalili noted. “Since this is a higher-risk patient population, the findings that older-onset UC is associated with lower response to intravenous steroids could have direct clinical implications.”

The study was supported by the Japanese Society for Inflammatory Bowel Disease. The researchers had no relevant financial conflicts to disclose. Dr. Khalili had no financial conflicts to disclose.

Intravenous steroids were less effective in ulcerative colitis patients with older-onset disease, compared with younger-onset patients, according to data from nearly 500 individuals.

A combination of rising ulcerative colitis rates and an aging population has driven an increase in older-onset UC worldwide, Shinji Okabayashi, MD, of Kyoto University, and colleagues wrote in a study published in Alimentary Pharmacology & Therapeutics.

Data on differences in disease history between younger- and older-onset cases have been inconsistent, but one meta-analysis suggested a higher rate of surgery in older-onset cases, the authors of the current study wrote. “The higher risk of surgery may be due to the difference in effectiveness of intravenous steroid treatment, which is one of the important treatment options to avoid surgery for a severe course of UC,” but data on the effectiveness of IV steroids for older-onset UC are lacking.

The researchers reviewed data from 467 adults with ulcerative colitis at 27 centers in Japan. The participants were hospitalized and received their initial intravenous steroids between April 2014 and July 2019. The treatment was a daily dose of 40 mg or more of IV prednisolone or its equivalent, with dosing according to current guidelines. The primary outcome was clinical remission after 30 days.

The study population included 83 patients with older-onset UC and 384 with younger-onset UC. No cutoff currently exists to classify UC by age; the researchers defined younger onset as patients diagnosed at younger than 60 years and older onset as those diagnosed at age 60 years and older. The median age of onset was 32 years in the younger-onset patients and 68 in the older-onset group.

Overall, 51.8% of older-onset patients and 65.6% of younger-onset patients had clinical remission at 30 days (adjusted risk ratio, 0.74; P = .009). The incidence of colectomy at 30 days was significantly higher in older-onset patients, compared with younger-onset patients (15.7% vs. 1.8%; P < .001).

The researchers also assessed risk of surgery and adverse events at 90 days as secondary outcomes. The risk of surgery was significantly higher in older-onset patients compared with younger-onset patients (20.5% vs. 3.1%; ARR, 8.92) as was the risk of adverse events (25.3% vs. 9.1%, ARR, 2.19). A total of four deaths occurred during the study period, all in older-onset patients.

In addition, the researchers found that clinical remission rates at 30 days in older patients with younger-onset UC was similar to that of younger patients with younger-onset UC.

Potential contributors to the lower effectiveness of intravenous steroids in older-onset UC include genetic susceptibility, gut microbiota, and environmental factors, the researchers noted. The dysregulated immune response in older-onset UC also might play a role in limiting the effectiveness of intravenous steroids in these patients.

The study findings were limited by several factors including the lack of data on genetic susceptibility, environmental factors, and gut microbiota, as well as the inclusion only of patients with moderate to severe disease, which might have contributed to the higher risk of surgery in older patients, the researchers said. Other potential limitations include the potential confounders of concomitant drugs and nutritional status, and the use of symptom-based scoring to determine clinical remission.

However, the overall results reflect data from a recent meta-analysis, and the current study “clearly suggests that one of the reasons for the poor prognosis in patients with older-onset UC is the lower effectiveness of intravenous steroid treatment, which is one of the important treatment options for a severe course of UC,” the researchers wrote.

“Further research is warranted to establish the optimal treatment strategies for moderate to severe older-onset UC,” they concluded.
 

Findings have value for high-risk patients

The study is of interest to clinicians in practice, Hamed Khalili, MD, of Massachusetts General Hospital, Boston, said in an interview. “The findings are largely consistent with prior studies that have shown older-onset IBD patients have higher risk of surgery,” said Dr. Khalili, who was not involved with the study.

“This study focuses on a smaller subset of patients with IBD who present with acute severe UC,” Dr. Khalili noted. “Since this is a higher-risk patient population, the findings that older-onset UC is associated with lower response to intravenous steroids could have direct clinical implications.”

The study was supported by the Japanese Society for Inflammatory Bowel Disease. The researchers had no relevant financial conflicts to disclose. Dr. Khalili had no financial conflicts to disclose.

Intravenous steroids were less effective in ulcerative colitis patients with older-onset disease, compared with younger-onset patients, according to data from nearly 500 individuals.

A combination of rising ulcerative colitis rates and an aging population has driven an increase in older-onset UC worldwide, Shinji Okabayashi, MD, of Kyoto University, and colleagues wrote in a study published in Alimentary Pharmacology & Therapeutics.

Data on differences in disease history between younger- and older-onset cases have been inconsistent, but one meta-analysis suggested a higher rate of surgery in older-onset cases, the authors of the current study wrote. “The higher risk of surgery may be due to the difference in effectiveness of intravenous steroid treatment, which is one of the important treatment options to avoid surgery for a severe course of UC,” but data on the effectiveness of IV steroids for older-onset UC are lacking.

The researchers reviewed data from 467 adults with ulcerative colitis at 27 centers in Japan. The participants were hospitalized and received their initial intravenous steroids between April 2014 and July 2019. The treatment was a daily dose of 40 mg or more of IV prednisolone or its equivalent, with dosing according to current guidelines. The primary outcome was clinical remission after 30 days.

The study population included 83 patients with older-onset UC and 384 with younger-onset UC. No cutoff currently exists to classify UC by age; the researchers defined younger onset as patients diagnosed at younger than 60 years and older onset as those diagnosed at age 60 years and older. The median age of onset was 32 years in the younger-onset patients and 68 in the older-onset group.

Overall, 51.8% of older-onset patients and 65.6% of younger-onset patients had clinical remission at 30 days (adjusted risk ratio, 0.74; P = .009). The incidence of colectomy at 30 days was significantly higher in older-onset patients, compared with younger-onset patients (15.7% vs. 1.8%; P < .001).

The researchers also assessed risk of surgery and adverse events at 90 days as secondary outcomes. The risk of surgery was significantly higher in older-onset patients compared with younger-onset patients (20.5% vs. 3.1%; ARR, 8.92) as was the risk of adverse events (25.3% vs. 9.1%, ARR, 2.19). A total of four deaths occurred during the study period, all in older-onset patients.

In addition, the researchers found that clinical remission rates at 30 days in older patients with younger-onset UC was similar to that of younger patients with younger-onset UC.

Potential contributors to the lower effectiveness of intravenous steroids in older-onset UC include genetic susceptibility, gut microbiota, and environmental factors, the researchers noted. The dysregulated immune response in older-onset UC also might play a role in limiting the effectiveness of intravenous steroids in these patients.

The study findings were limited by several factors including the lack of data on genetic susceptibility, environmental factors, and gut microbiota, as well as the inclusion only of patients with moderate to severe disease, which might have contributed to the higher risk of surgery in older patients, the researchers said. Other potential limitations include the potential confounders of concomitant drugs and nutritional status, and the use of symptom-based scoring to determine clinical remission.

However, the overall results reflect data from a recent meta-analysis, and the current study “clearly suggests that one of the reasons for the poor prognosis in patients with older-onset UC is the lower effectiveness of intravenous steroid treatment, which is one of the important treatment options for a severe course of UC,” the researchers wrote.

“Further research is warranted to establish the optimal treatment strategies for moderate to severe older-onset UC,” they concluded.
 

Findings have value for high-risk patients

The study is of interest to clinicians in practice, Hamed Khalili, MD, of Massachusetts General Hospital, Boston, said in an interview. “The findings are largely consistent with prior studies that have shown older-onset IBD patients have higher risk of surgery,” said Dr. Khalili, who was not involved with the study.

“This study focuses on a smaller subset of patients with IBD who present with acute severe UC,” Dr. Khalili noted. “Since this is a higher-risk patient population, the findings that older-onset UC is associated with lower response to intravenous steroids could have direct clinical implications.”

The study was supported by the Japanese Society for Inflammatory Bowel Disease. The researchers had no relevant financial conflicts to disclose. Dr. Khalili had no financial conflicts to disclose.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Following a vegan diet for at least 3 months helped people with overweight or type 2 diabetes shed the pounds, but had only a marginal effect on hemoglobin A1c levels, on average, new research indicates.

No effect was seen on blood pressure, triglycerides, or high-density lipoprotein cholesterol. HbA1c was reduced by a mean of –0.18 percentage points (P = .002), and there was a small reduction in total cholesterol and low-density lipoprotein cholesterol, on average, across all the studies examined in this meta-analysis.

The work, which compared a number of trials looking at vegan diets versus “normal” eating or other kinds of weight loss diets, “indicates with reasonable certainty that adhering to a vegan diet for at least 12 weeks may result in clinically meaningful weight loss [and] can be used in the management of overweight and type 2 diabetes,” said Anne-Ditte Termannsen, PhD, who reported the findings during a press conference at the European Congress on Obesity 2022, where the work was also presented as a poster.

A vegan diet most likely led to weight loss because it is “associated with a reduced calorie intake due to a lower content of fat and higher content of dietary fiber,” added Dr. Termannsen of the Steno Diabetes Center Copenhagen.

Asked to comment, Janet Cade, PhD, who leads the Nutritional Epidemiology Group at the University of Leeds (England) said the results are likely attributable to fewer calories in the vegan diet, compared with the “control” diets. “Of course, a vegan diet can be healthier in a range of ways, such as higher fruit and vegetables, more fiber and antioxidants; however, the same would be true of a vegetarian diet,” she noted.

And she warned that longer-term data are needed on health outcomes associated with vegan diets, noting, “there have been links to poorer bone health and osteoporosis in people consuming a vegan diet.”

Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading (England) told the UK Science Media Centre: “The authors conducted a systematic review of intervention studies and found that, compared with no dietary interventions, vegan diets showed the strongest association with body-weight reduction.”

However, “When comparing vegan diets with other dietary interventions – such as the Mediterranean diet – the association was much weaker,” he noted.
 

Vegan, habitual, or a range of weight-loss diets

Dr. Termannsen and colleagues set out to look at the effect of a plant-based diet on cardiometabolic risk factors in people with overweight or type 2 diabetes. They searched the literature for randomized controlled trials with adult participants with overweight (body mass index ≥ 25 kg/m²), prediabetes, or type 2 diabetes.

Participants followed a vegan diet that lasted at least 12 weeks; habitual diets without any changes or energy restriction; a Mediterranean diet; a host of different “diabetes” diets; a low-fat diet; or portion-controlled diets.

“The vegan diets were nearly all low-fat vegan diets but vary substantially regarding the protein, fat, carbohydrate content. All but one study was ad libitum fat, and there were no energy restrictions,” Dr. Termannsen said.

Control diets were more varied. “Some continued their habitual diet, and about half were energy restricted and the others were not,” she acknowledged.

Outcomes comprised body weight, BMI, HbA1c, systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, which were assessed across studies.

A total of 11 trials were included in the meta-analysis, and studies were a mean duration of 19 weeks. A total of 796 participants were included.

Compared with control diets, those on vegan diets lost on average –4.1 kg (–9 lb) (P < .001), with a range of –5.9 kg to –2.4 kg.

BMI dropped by –1.38 kg/m² (P < .001). Total cholesterol dropped by –0.30 mmol/L (–11.6 mg/dL; P = .007) and LDL cholesterol by –0.24 mmol/L (–9.28 mg/dL; P = .005).

Further analyses found even greater reductions in body weight and BMI when vegan diets were compared with continuing a normal diet without dietary changes, on average, at –7.4 kg (–16.3 lb) (P < .001) and –2.78 kg/m² (P < .001) respectively.

When compared with other intervention diets, however, body weight dropped by –2.7 kg (–6 lb; P < .001) and BMI by –0.87 kg/m² (P < .001).

Commenting on limitations of studies compared to the real world, Dr. Termannsen said: “Some studies reported high adherence to their diet, usually due to a high level of support, suggesting that providing continued face-to-face contact with participants may partly explain the adherence differences.”

“This also questions the long-term feasibility of the diet and the applicability of this as long-term care,” she added.

Following a vegan diet requires good planning to ensure adequate nutrition and avoid any deficiencies, she urged. “We need to remember that the menu plans in the studies were created by dietitians.”

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

Stanford Health Care’s resident physicians voted May 2 in favor of joining the Committee of Interns and Residents (CIR-SEIU), part of a growing trend in unionization within the medical profession.

More than 81% of the health system’s resident physicians voted to join the union; the decision garnered 835 yes votes and 214 no votes, according to a CIR-SEIU announcement. The largest housestaff union in the United States and a local of the Service Employees International Union (SEIU), CIR-SEIU represents more than 20,000 resident physicians and fellows.

“With its successful representation with the Committee of Interns and Residents, Stanford housestaff now join the strong community of allied unions and fellow health care workers such as the Committee for Recognition of Nursing Achievement (CRONA), an independent union of Stanford nurses,” according to CIR-SEIU.

“We are organizing not only for a new economic contract that enables all potential housestaff and their families to afford living in the Bay Area but also for a new social contract that redefines how we are valued by the hospital system,” Ben Solomon, MD, PhD, a third-year resident physician in pediatrics at Stanford Medicine and a member of CIR-SEIU, said in an interview.

“This includes advocating for more humane working hours, reasonable parental leave, and childcare support, as well as resources to combat burnout in young physicians,” he added.

Lisa Kim, a spokesperson for Stanford Health Care, told this news organization that “a majority of residents and fellows at Stanford Health Care voted in favor of unionization. Of 1,478 total residents and fellows, 835 voted in favor. CIR/SEIU will be certified as the exclusive bargaining representative for all residents and fellows. Stanford Health Care does not plan to contest the election results.”

“As we begin the collective bargaining process, our goal remains unchanged: providing our residents and fellows with a world-class training experience. We will bring this same focus to negotiations as we strive to support their development as physician leaders,” she added.

The National Labor Relations Board (NLRB) must certify the election results before they are considered final, per CIR-SEIU. An independent federal agency, the NLRB safeguards employees’ rights to organize and determines whether union participation is appropriate while also preventing and remedying unfair labor practices committed by private sector employers and unions.
 

Concerns date back to initial COVID-19 vaccine rollout

The residents delivered a formal demand to Stanford Health Care to recognize the union in February; their request was not accepted by the health system. The residents’ concerns date as far back as the availability of the COVID-19 vaccines at the end of 2020.

Of the health system’s 5,000 doses, only seven residents and fellows were included in the initial round.

Niraj Sehgal, MD, chief medical officer for Stanford Health Care, apologized in a letter to the graduate medical education community, posted by Palo Alto Weekly, which revealed the root causes to be an algorithm used by the hospital and the age of the residents.

The vote by Stanford Health Care’s residents comes a day after nurses at Stanford and Lucile Packard Children’s hospitals ratified a new contract with their union after a strike for better working conditions and higher pay stretched on for a week, reported Palo Alto Online.
 

Part of a growing trend

Dr. Solomon got involved in the unionization effort at Stanford Health Care “to have a say in working conditions for residents and fellows,” he said. “As individuals, it’s virtually impossible to make demands to our hospital without risking our careers, but together we can demand improvements on the job and in patient care.”

The health system’s inability to extend COVID-19 vaccines during the initial rollout, “despite our role working with COVID patients on the frontlines,” spurred his involvement in the union effort, said Dr. Solomon.

In the short term, the union will be involved in negotiating its first contract, he said. “However, in the long term, we are committed to supporting the unionization efforts of residents and fellows across the country, including partnering with many housestaff unions here in California.”

Stanford Health Care’s residents are participating in a growing trend. In Worcester, Mass., UMass Medical School’s 613 residents and fellow physicians, who are also represented by CIR-SEIU, had their union certified by the Massachusetts Department of Labor Relations in March 2021, reported the (Worcester) Telegram & Gazette.

Other unionization efforts across the country include a supermajority of 85 interns, residents, and fellows employed by Keck School of Medicine of University of Southern California , who requested that Los Angeles County+USC Medical Center recognize their union, per an announcement. That’s in addition to residents at University of Vermont Medical Center, who announced their intention to unionize in March, reported VTDigger.org.

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

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

In an updated clinical practice guideline, the American Society of Clinical Oncology has named the Breast Cancer Index (BCI) as the only genomic test that should be used to guide extended endocrine therapy decisions for women with early-stage, hormone receptor–positive breast cancer. The update applies to women who are node negative or have one to three positive nodes treated with 5 years of endocrine therapy and no sign of recurrence.

The update was published in the Journal of Clinical Oncology. It also gives more specific details on how to apply other, previously recommended, genomic tests to guide treatment choices.

More than half of breast cancer deaths occur after 5 years of tamoxifen therapy. The National Surgical Adjuvant Breast and Bowel Project (NSABP)- B14 trial, published in 2001, showed no benefit to extending tamoxifen therapy to 10 years, but other studies have produced mixed results.

Extended endocrine therapy may reduce the risk of recurrence, but significant side effects can impact quality of life, including osteoporosis, bone fractures, and joint pain. The uncertain benefits of extended endocrine therapy, combined with its side effects and impact on quality of life, has generated interest in genomic tests to identify patients most likely to benefit.

The BCI analyzes 11 genes from the tumor and delivers two results: the likelihood of recurrence 5-10 years after diagnosis, and whether a total of 10 years of endocrine therapy are likely to provide a survival benefit.

The 21-gene prognostic and predictive assay Oncotype DX Breast Recurrence Score, the 70-gene signature test Mammaprint, the 12-gene risk score EndoPredict, levels of Ki67 expression, and immunohistochemistry are also recommended for guiding decisions on endocrine therapy. The update included additional guidance on specific situations that each can be used. However, their usefulness for predicting recurrence at 5-10 years is unproven.

“The clinical decision to either extend or end adjuvant endocrine therapy after 5 years is a challenging decision for healthcare providers and their patients,” Mark Pegram, MD, said in a press release. He is chief medical consultant for breast oncology at Biotheranostics, a subsidiary of Hologic. “There is an extensive body of clinical evidence consistently proving the utility of BCI, and its addition to major oncology clinical guidelines like those from ASCO further underscores the test’s potential in clinical decision-making regarding extended adjuvant endocrine therapy.”

The practice update cited five previous studies showing the ability of BCI to predict benefit from extending endocrine therapy: From 5 years of tamoxifen to 5 more years of tamoxifen; from 5 years of tamoxifen to 5 years of an aromatase inhibitor, and from 5 years of an AI to another 5 years of a drug from the same class. Most of the trials included patients who were node negative or had one to three positive nodes, so there is limited evidence supporting BCI in patients with more than three positive lymph nodes. The recommendation also applies only to postmenopausal women, as the trials included fewer premenopausal and perimenopausal women.

Several of the guideline authors reported conflicts of interest with numerous sources.

In an updated clinical practice guideline, the American Society of Clinical Oncology has named the Breast Cancer Index (BCI) as the only genomic test that should be used to guide extended endocrine therapy decisions for women with early-stage, hormone receptor–positive breast cancer. The update applies to women who are node negative or have one to three positive nodes treated with 5 years of endocrine therapy and no sign of recurrence.

The update was published in the Journal of Clinical Oncology. It also gives more specific details on how to apply other, previously recommended, genomic tests to guide treatment choices.

More than half of breast cancer deaths occur after 5 years of tamoxifen therapy. The National Surgical Adjuvant Breast and Bowel Project (NSABP)- B14 trial, published in 2001, showed no benefit to extending tamoxifen therapy to 10 years, but other studies have produced mixed results.

Extended endocrine therapy may reduce the risk of recurrence, but significant side effects can impact quality of life, including osteoporosis, bone fractures, and joint pain. The uncertain benefits of extended endocrine therapy, combined with its side effects and impact on quality of life, has generated interest in genomic tests to identify patients most likely to benefit.

The BCI analyzes 11 genes from the tumor and delivers two results: the likelihood of recurrence 5-10 years after diagnosis, and whether a total of 10 years of endocrine therapy are likely to provide a survival benefit.

The 21-gene prognostic and predictive assay Oncotype DX Breast Recurrence Score, the 70-gene signature test Mammaprint, the 12-gene risk score EndoPredict, levels of Ki67 expression, and immunohistochemistry are also recommended for guiding decisions on endocrine therapy. The update included additional guidance on specific situations that each can be used. However, their usefulness for predicting recurrence at 5-10 years is unproven.

“The clinical decision to either extend or end adjuvant endocrine therapy after 5 years is a challenging decision for healthcare providers and their patients,” Mark Pegram, MD, said in a press release. He is chief medical consultant for breast oncology at Biotheranostics, a subsidiary of Hologic. “There is an extensive body of clinical evidence consistently proving the utility of BCI, and its addition to major oncology clinical guidelines like those from ASCO further underscores the test’s potential in clinical decision-making regarding extended adjuvant endocrine therapy.”

The practice update cited five previous studies showing the ability of BCI to predict benefit from extending endocrine therapy: From 5 years of tamoxifen to 5 more years of tamoxifen; from 5 years of tamoxifen to 5 years of an aromatase inhibitor, and from 5 years of an AI to another 5 years of a drug from the same class. Most of the trials included patients who were node negative or had one to three positive nodes, so there is limited evidence supporting BCI in patients with more than three positive lymph nodes. The recommendation also applies only to postmenopausal women, as the trials included fewer premenopausal and perimenopausal women.

Several of the guideline authors reported conflicts of interest with numerous sources.

In an updated clinical practice guideline, the American Society of Clinical Oncology has named the Breast Cancer Index (BCI) as the only genomic test that should be used to guide extended endocrine therapy decisions for women with early-stage, hormone receptor–positive breast cancer. The update applies to women who are node negative or have one to three positive nodes treated with 5 years of endocrine therapy and no sign of recurrence.

The update was published in the Journal of Clinical Oncology. It also gives more specific details on how to apply other, previously recommended, genomic tests to guide treatment choices.

More than half of breast cancer deaths occur after 5 years of tamoxifen therapy. The National Surgical Adjuvant Breast and Bowel Project (NSABP)- B14 trial, published in 2001, showed no benefit to extending tamoxifen therapy to 10 years, but other studies have produced mixed results.

Extended endocrine therapy may reduce the risk of recurrence, but significant side effects can impact quality of life, including osteoporosis, bone fractures, and joint pain. The uncertain benefits of extended endocrine therapy, combined with its side effects and impact on quality of life, has generated interest in genomic tests to identify patients most likely to benefit.

The BCI analyzes 11 genes from the tumor and delivers two results: the likelihood of recurrence 5-10 years after diagnosis, and whether a total of 10 years of endocrine therapy are likely to provide a survival benefit.

The 21-gene prognostic and predictive assay Oncotype DX Breast Recurrence Score, the 70-gene signature test Mammaprint, the 12-gene risk score EndoPredict, levels of Ki67 expression, and immunohistochemistry are also recommended for guiding decisions on endocrine therapy. The update included additional guidance on specific situations that each can be used. However, their usefulness for predicting recurrence at 5-10 years is unproven.

“The clinical decision to either extend or end adjuvant endocrine therapy after 5 years is a challenging decision for healthcare providers and their patients,” Mark Pegram, MD, said in a press release. He is chief medical consultant for breast oncology at Biotheranostics, a subsidiary of Hologic. “There is an extensive body of clinical evidence consistently proving the utility of BCI, and its addition to major oncology clinical guidelines like those from ASCO further underscores the test’s potential in clinical decision-making regarding extended adjuvant endocrine therapy.”

The practice update cited five previous studies showing the ability of BCI to predict benefit from extending endocrine therapy: From 5 years of tamoxifen to 5 more years of tamoxifen; from 5 years of tamoxifen to 5 years of an aromatase inhibitor, and from 5 years of an AI to another 5 years of a drug from the same class. Most of the trials included patients who were node negative or had one to three positive nodes, so there is limited evidence supporting BCI in patients with more than three positive lymph nodes. The recommendation also applies only to postmenopausal women, as the trials included fewer premenopausal and perimenopausal women.

Several of the guideline authors reported conflicts of interest with numerous sources.

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

A few weeks ago I talked about my evening practice of doing jigsaw puzzles to relax, as a pleasant alternative to surfing the Internet.

Last week my daughter moved home from college for the summer. It’s been several years since she and I last did puzzles together, and I’d forgotten how much she likes them.

So now each night we sit there, either side by side or across the table from each other, each quietly working on some little portion of the same jigsaw. Very little is said, but it’s still the same bonding time I’ve always cherished.

But I notice things I’d never thought of.

I always start a puzzle like I thought most people do: Pick out the flat edge pieces to build the outside frame, then work inward from there.

But she doesn’t. Once the box is opened and pieces dumped out, she starts sorting them by patterns and colors, and begins there. The edges don’t get her attention at all as she begins. She assembles like-pieces and gradually expands from there.

Why?

I mean, I’m a neurologist. Brains are my business. So why are our thought patterns on the same task so different?

I have no clue.

This is part of the mystery of the brain. Why different ones, although anatomically similar, can function so differently in how they approach and solve the same problem.

I can’t blame this on who she learned from. We’ve been doing puzzles together since she was little. Think about it – do you even remember someone teaching you to do jigsaw puzzles at some point? Neither do I. I assume a family member or schoolteacher showed me a basic one at some point, and how the pieces fit together, but that’s a guess.

So I sit there working on my section and watch her doing hers, and the neurologist turns the whole thing over. Does she have more neurons and/or glia in whatever the “puzzle solving” portion of her brain (I assume part of visual memory and spatial relationships) is? Or do I? Like so much of neurology this should have a structural answer – I think.

It reminds me of how little we still know. And it bugs me.

Has anyone done PET scans while people work on jigsaw puzzles? I checked PubMed and couldn’t find anything. I doubt it due to the logistics of having someone do one inside a scanner. Searching Google with the same question only gets me ads for customized jigsaws of pets.

So I made the leap to doing a jigsaw puzzle on an iPad while in a PET machine. But even then, how do I know I’d be testing the same functions? The touchscreen is similar, but not the same, as doing a real jigsaw. (In my opinion real puzzles are preferable to iPad ones, except when traveling).

At the end of the day it’s a mystery I don’t know the answer to, probably never will, and realistically shouldn’t think too much about.

Because this summer the real meaning of the puzzle isn’t the jigsaw itself. It’s the young woman sitting next to me working on it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A few weeks ago I talked about my evening practice of doing jigsaw puzzles to relax, as a pleasant alternative to surfing the Internet.

Last week my daughter moved home from college for the summer. It’s been several years since she and I last did puzzles together, and I’d forgotten how much she likes them.

So now each night we sit there, either side by side or across the table from each other, each quietly working on some little portion of the same jigsaw. Very little is said, but it’s still the same bonding time I’ve always cherished.

But I notice things I’d never thought of.

I always start a puzzle like I thought most people do: Pick out the flat edge pieces to build the outside frame, then work inward from there.

But she doesn’t. Once the box is opened and pieces dumped out, she starts sorting them by patterns and colors, and begins there. The edges don’t get her attention at all as she begins. She assembles like-pieces and gradually expands from there.

Why?

I mean, I’m a neurologist. Brains are my business. So why are our thought patterns on the same task so different?

I have no clue.

This is part of the mystery of the brain. Why different ones, although anatomically similar, can function so differently in how they approach and solve the same problem.

I can’t blame this on who she learned from. We’ve been doing puzzles together since she was little. Think about it – do you even remember someone teaching you to do jigsaw puzzles at some point? Neither do I. I assume a family member or schoolteacher showed me a basic one at some point, and how the pieces fit together, but that’s a guess.

So I sit there working on my section and watch her doing hers, and the neurologist turns the whole thing over. Does she have more neurons and/or glia in whatever the “puzzle solving” portion of her brain (I assume part of visual memory and spatial relationships) is? Or do I? Like so much of neurology this should have a structural answer – I think.

It reminds me of how little we still know. And it bugs me.

Has anyone done PET scans while people work on jigsaw puzzles? I checked PubMed and couldn’t find anything. I doubt it due to the logistics of having someone do one inside a scanner. Searching Google with the same question only gets me ads for customized jigsaws of pets.

So I made the leap to doing a jigsaw puzzle on an iPad while in a PET machine. But even then, how do I know I’d be testing the same functions? The touchscreen is similar, but not the same, as doing a real jigsaw. (In my opinion real puzzles are preferable to iPad ones, except when traveling).

At the end of the day it’s a mystery I don’t know the answer to, probably never will, and realistically shouldn’t think too much about.

Because this summer the real meaning of the puzzle isn’t the jigsaw itself. It’s the young woman sitting next to me working on it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A few weeks ago I talked about my evening practice of doing jigsaw puzzles to relax, as a pleasant alternative to surfing the Internet.

Last week my daughter moved home from college for the summer. It’s been several years since she and I last did puzzles together, and I’d forgotten how much she likes them.

So now each night we sit there, either side by side or across the table from each other, each quietly working on some little portion of the same jigsaw. Very little is said, but it’s still the same bonding time I’ve always cherished.

But I notice things I’d never thought of.

I always start a puzzle like I thought most people do: Pick out the flat edge pieces to build the outside frame, then work inward from there.

But she doesn’t. Once the box is opened and pieces dumped out, she starts sorting them by patterns and colors, and begins there. The edges don’t get her attention at all as she begins. She assembles like-pieces and gradually expands from there.

Why?

I mean, I’m a neurologist. Brains are my business. So why are our thought patterns on the same task so different?

I have no clue.

This is part of the mystery of the brain. Why different ones, although anatomically similar, can function so differently in how they approach and solve the same problem.

I can’t blame this on who she learned from. We’ve been doing puzzles together since she was little. Think about it – do you even remember someone teaching you to do jigsaw puzzles at some point? Neither do I. I assume a family member or schoolteacher showed me a basic one at some point, and how the pieces fit together, but that’s a guess.

So I sit there working on my section and watch her doing hers, and the neurologist turns the whole thing over. Does she have more neurons and/or glia in whatever the “puzzle solving” portion of her brain (I assume part of visual memory and spatial relationships) is? Or do I? Like so much of neurology this should have a structural answer – I think.

It reminds me of how little we still know. And it bugs me.

Has anyone done PET scans while people work on jigsaw puzzles? I checked PubMed and couldn’t find anything. I doubt it due to the logistics of having someone do one inside a scanner. Searching Google with the same question only gets me ads for customized jigsaws of pets.

So I made the leap to doing a jigsaw puzzle on an iPad while in a PET machine. But even then, how do I know I’d be testing the same functions? The touchscreen is similar, but not the same, as doing a real jigsaw. (In my opinion real puzzles are preferable to iPad ones, except when traveling).

At the end of the day it’s a mystery I don’t know the answer to, probably never will, and realistically shouldn’t think too much about.

Because this summer the real meaning of the puzzle isn’t the jigsaw itself. It’s the young woman sitting next to me working on it.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.