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Commentary: RA Treatment Strategies, November 2023
Given the frequency of autoimmune conditions in women, the possible effects of estrogen and hormonal therapy exposure over the lifespan on the development of rheumatoid arthritis (RA) has long been of interest. Prior studies have identified a potential increase in RA risk in older women taking estrogen replacement. Hadizadeh and colleagues used the UK Biobank to identify cases of RA among over 236,000 women taking oral contraceptives and over 102,000 women taking hormone replacement therapy. Oral contraceptive use was associated with lower risk for RA (hazard ratio [HR] 0.89), whereas hormone replacement therapy was associated with higher risk for RA (HR 1.16) compared with women who had never used these therapies. Exogenous estrogen exposure may affect the development of RA, but the potential mechanisms (including the effect on systemic inflammation) remain unclear.
Among the multitude of studies on a treat-to-target (T2T) strategy in RA, a recent cluster randomized trial by Bessette and colleagues compared use of abatacept in 284 patients treated by 44 physicians. Patients assigned to both T2T and routine care had significant improvement in RA disease activity (as measured by the Clinical Disease Activity Index) with abatacept, with close to 40% in low disease activity at 12 months. Those treated with routine care experienced significant improvements in RA disease activity at 12 months of abatacept treatment. T2T was associated with slightly higher odds of low disease activity and a shorter time to Simplified Disease Activity Index remission (14 vs 19 months). With T2T being largely accepted as a standard of care on the basis of prior studies, this study raises the question of why little difference was seen between the two groups — perhaps it was related to the use of abatacept. It is unlikely to further change the standard of care to reduce use of disease activity measures.
To better understand refractory or difficult-to-treat (D2T) RA, Jung and colleagues used the KOBIO (KOrean College of Rheumatology BIOlogics) registry to compare characteristics of patients with D2T RA vs those who respond more readily to therapy. Of the 2321 patients included in the study, about 12% (271) had D2T RA. Patients with D2T RA tended to be younger and have longer disease duration, as well as a negative rheumatoid factor (RF); less use of conventional synthetic disease-modifying antirheumatic drugs (csDMARD); and, as expected, higher disease activity measures. Given that about 80% of patients were seropositive for RF and the fact that patients with D2T RA tended to have higher inflammatory markers (erythrocyte sedimentation rate and C-reactive protein), it is not likely that patients were misclassified with RA. The reason why patients with D2T RA had less csDMARD use is not clear, but prior studies have supported early and aggressive use of csDMARD for best outcomes. The study did suggest that patients with D2T RA stayed on Janus kinase (JAK) inhibitor therapy the longest, and perhaps similar studies in future will help outline the best treatment strategy for patients with D2T RA and persistently high disease activity.
Finally, in a post hoc analysis of the ORAL Start trial of the JAK inhibitor tofacitinib vs methotrexate, Ciurea and colleagues looked at paired joint pathology scores (PJPS) — swollen and tender joint counts with left and right pooled — over the course of the 12-month study. Patients receiving tofacitinib had overall improved PJPS, though patients receiving methotrexate had more improvement in the foot. These findings, generally supporting those of the initial study, are unlikely to further change therapy.
Given the frequency of autoimmune conditions in women, the possible effects of estrogen and hormonal therapy exposure over the lifespan on the development of rheumatoid arthritis (RA) has long been of interest. Prior studies have identified a potential increase in RA risk in older women taking estrogen replacement. Hadizadeh and colleagues used the UK Biobank to identify cases of RA among over 236,000 women taking oral contraceptives and over 102,000 women taking hormone replacement therapy. Oral contraceptive use was associated with lower risk for RA (hazard ratio [HR] 0.89), whereas hormone replacement therapy was associated with higher risk for RA (HR 1.16) compared with women who had never used these therapies. Exogenous estrogen exposure may affect the development of RA, but the potential mechanisms (including the effect on systemic inflammation) remain unclear.
Among the multitude of studies on a treat-to-target (T2T) strategy in RA, a recent cluster randomized trial by Bessette and colleagues compared use of abatacept in 284 patients treated by 44 physicians. Patients assigned to both T2T and routine care had significant improvement in RA disease activity (as measured by the Clinical Disease Activity Index) with abatacept, with close to 40% in low disease activity at 12 months. Those treated with routine care experienced significant improvements in RA disease activity at 12 months of abatacept treatment. T2T was associated with slightly higher odds of low disease activity and a shorter time to Simplified Disease Activity Index remission (14 vs 19 months). With T2T being largely accepted as a standard of care on the basis of prior studies, this study raises the question of why little difference was seen between the two groups — perhaps it was related to the use of abatacept. It is unlikely to further change the standard of care to reduce use of disease activity measures.
To better understand refractory or difficult-to-treat (D2T) RA, Jung and colleagues used the KOBIO (KOrean College of Rheumatology BIOlogics) registry to compare characteristics of patients with D2T RA vs those who respond more readily to therapy. Of the 2321 patients included in the study, about 12% (271) had D2T RA. Patients with D2T RA tended to be younger and have longer disease duration, as well as a negative rheumatoid factor (RF); less use of conventional synthetic disease-modifying antirheumatic drugs (csDMARD); and, as expected, higher disease activity measures. Given that about 80% of patients were seropositive for RF and the fact that patients with D2T RA tended to have higher inflammatory markers (erythrocyte sedimentation rate and C-reactive protein), it is not likely that patients were misclassified with RA. The reason why patients with D2T RA had less csDMARD use is not clear, but prior studies have supported early and aggressive use of csDMARD for best outcomes. The study did suggest that patients with D2T RA stayed on Janus kinase (JAK) inhibitor therapy the longest, and perhaps similar studies in future will help outline the best treatment strategy for patients with D2T RA and persistently high disease activity.
Finally, in a post hoc analysis of the ORAL Start trial of the JAK inhibitor tofacitinib vs methotrexate, Ciurea and colleagues looked at paired joint pathology scores (PJPS) — swollen and tender joint counts with left and right pooled — over the course of the 12-month study. Patients receiving tofacitinib had overall improved PJPS, though patients receiving methotrexate had more improvement in the foot. These findings, generally supporting those of the initial study, are unlikely to further change therapy.
Given the frequency of autoimmune conditions in women, the possible effects of estrogen and hormonal therapy exposure over the lifespan on the development of rheumatoid arthritis (RA) has long been of interest. Prior studies have identified a potential increase in RA risk in older women taking estrogen replacement. Hadizadeh and colleagues used the UK Biobank to identify cases of RA among over 236,000 women taking oral contraceptives and over 102,000 women taking hormone replacement therapy. Oral contraceptive use was associated with lower risk for RA (hazard ratio [HR] 0.89), whereas hormone replacement therapy was associated with higher risk for RA (HR 1.16) compared with women who had never used these therapies. Exogenous estrogen exposure may affect the development of RA, but the potential mechanisms (including the effect on systemic inflammation) remain unclear.
Among the multitude of studies on a treat-to-target (T2T) strategy in RA, a recent cluster randomized trial by Bessette and colleagues compared use of abatacept in 284 patients treated by 44 physicians. Patients assigned to both T2T and routine care had significant improvement in RA disease activity (as measured by the Clinical Disease Activity Index) with abatacept, with close to 40% in low disease activity at 12 months. Those treated with routine care experienced significant improvements in RA disease activity at 12 months of abatacept treatment. T2T was associated with slightly higher odds of low disease activity and a shorter time to Simplified Disease Activity Index remission (14 vs 19 months). With T2T being largely accepted as a standard of care on the basis of prior studies, this study raises the question of why little difference was seen between the two groups — perhaps it was related to the use of abatacept. It is unlikely to further change the standard of care to reduce use of disease activity measures.
To better understand refractory or difficult-to-treat (D2T) RA, Jung and colleagues used the KOBIO (KOrean College of Rheumatology BIOlogics) registry to compare characteristics of patients with D2T RA vs those who respond more readily to therapy. Of the 2321 patients included in the study, about 12% (271) had D2T RA. Patients with D2T RA tended to be younger and have longer disease duration, as well as a negative rheumatoid factor (RF); less use of conventional synthetic disease-modifying antirheumatic drugs (csDMARD); and, as expected, higher disease activity measures. Given that about 80% of patients were seropositive for RF and the fact that patients with D2T RA tended to have higher inflammatory markers (erythrocyte sedimentation rate and C-reactive protein), it is not likely that patients were misclassified with RA. The reason why patients with D2T RA had less csDMARD use is not clear, but prior studies have supported early and aggressive use of csDMARD for best outcomes. The study did suggest that patients with D2T RA stayed on Janus kinase (JAK) inhibitor therapy the longest, and perhaps similar studies in future will help outline the best treatment strategy for patients with D2T RA and persistently high disease activity.
Finally, in a post hoc analysis of the ORAL Start trial of the JAK inhibitor tofacitinib vs methotrexate, Ciurea and colleagues looked at paired joint pathology scores (PJPS) — swollen and tender joint counts with left and right pooled — over the course of the 12-month study. Patients receiving tofacitinib had overall improved PJPS, though patients receiving methotrexate had more improvement in the foot. These findings, generally supporting those of the initial study, are unlikely to further change therapy.
AI flagged skin cancer with near-perfect accuracy, in UK study
. AI detected more than 99% of all skin cancers.
The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.
Skin cancer is the most common cancer in the United States; one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.
Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.
The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.
“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.
Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.
The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.
Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.
Limitations
The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.
But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.
And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.
“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”
Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”
A version of this article appeared on Medscape.com.
. AI detected more than 99% of all skin cancers.
The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.
Skin cancer is the most common cancer in the United States; one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.
Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.
The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.
“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.
Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.
The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.
Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.
Limitations
The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.
But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.
And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.
“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”
Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”
A version of this article appeared on Medscape.com.
. AI detected more than 99% of all skin cancers.
The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.
Skin cancer is the most common cancer in the United States; one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.
Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.
The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.
“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.
Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.
The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.
Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.
Limitations
The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.
But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.
And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.
“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”
Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”
A version of this article appeared on Medscape.com.
FROM THE EADV CONGRESS
More evidence metformin may be neuroprotective
TOPLINE:
New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.
METHODOLOGY:
- Researchers evaluated the association between discontinuing metformin for reasons unrelated to kidney dysfunction and dementia incidence.
- The cohort included 12,220 Kaiser Permanente Northern California members who stopped metformin early (with normal kidney function) and 29,126 routine metformin users.
- The cohort of early terminators was 46% women with an average age of 59 years at the start of metformin prescription. The cohort continuing metformin was 47% women, with a start age of 61 years.
TAKEAWAY:
- Adults who stopped metformin early were 21% more likely to be diagnosed with dementia during follow up (hazard ratio, 1.21; 95% confidence interval, 1.12-1.30), compared with routine metformin users.
- This association was largely independent of changes in A1c level and insulin usage.
IN PRACTICE:
The findings “corroborate the largely consistent evidence from other observational studies showing an association between metformin use and lower dementia incidence [and] may have important implications for clinical treatment of adults with diabetes,” the authors write.
SOURCE:
The study, with first author Scott Zimmerman, MPH, University of California, San Francisco, was published online in JAMA Network Open.
LIMITATIONS:
Dementia diagnosis was obtained based on medical records. Factors such as race, ethnicity, or time on metformin were not evaluated. Information on the exact reason for stopping metformin was not available.
DISCLOSURES:
The study was funded by grants from the National Institutes of Health, National Institute on Aging. Mr. Zimmerman owns stock in AbbVie, Gilead Sciences, CRISPR Therapeutics, and Abbott Laboratories. Disclosure for the other study authors can be found with the original article.
A version of this article first appeared on Medscape.com.
TOPLINE:
New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.
METHODOLOGY:
- Researchers evaluated the association between discontinuing metformin for reasons unrelated to kidney dysfunction and dementia incidence.
- The cohort included 12,220 Kaiser Permanente Northern California members who stopped metformin early (with normal kidney function) and 29,126 routine metformin users.
- The cohort of early terminators was 46% women with an average age of 59 years at the start of metformin prescription. The cohort continuing metformin was 47% women, with a start age of 61 years.
TAKEAWAY:
- Adults who stopped metformin early were 21% more likely to be diagnosed with dementia during follow up (hazard ratio, 1.21; 95% confidence interval, 1.12-1.30), compared with routine metformin users.
- This association was largely independent of changes in A1c level and insulin usage.
IN PRACTICE:
The findings “corroborate the largely consistent evidence from other observational studies showing an association between metformin use and lower dementia incidence [and] may have important implications for clinical treatment of adults with diabetes,” the authors write.
SOURCE:
The study, with first author Scott Zimmerman, MPH, University of California, San Francisco, was published online in JAMA Network Open.
LIMITATIONS:
Dementia diagnosis was obtained based on medical records. Factors such as race, ethnicity, or time on metformin were not evaluated. Information on the exact reason for stopping metformin was not available.
DISCLOSURES:
The study was funded by grants from the National Institutes of Health, National Institute on Aging. Mr. Zimmerman owns stock in AbbVie, Gilead Sciences, CRISPR Therapeutics, and Abbott Laboratories. Disclosure for the other study authors can be found with the original article.
A version of this article first appeared on Medscape.com.
TOPLINE:
New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.
METHODOLOGY:
- Researchers evaluated the association between discontinuing metformin for reasons unrelated to kidney dysfunction and dementia incidence.
- The cohort included 12,220 Kaiser Permanente Northern California members who stopped metformin early (with normal kidney function) and 29,126 routine metformin users.
- The cohort of early terminators was 46% women with an average age of 59 years at the start of metformin prescription. The cohort continuing metformin was 47% women, with a start age of 61 years.
TAKEAWAY:
- Adults who stopped metformin early were 21% more likely to be diagnosed with dementia during follow up (hazard ratio, 1.21; 95% confidence interval, 1.12-1.30), compared with routine metformin users.
- This association was largely independent of changes in A1c level and insulin usage.
IN PRACTICE:
The findings “corroborate the largely consistent evidence from other observational studies showing an association between metformin use and lower dementia incidence [and] may have important implications for clinical treatment of adults with diabetes,” the authors write.
SOURCE:
The study, with first author Scott Zimmerman, MPH, University of California, San Francisco, was published online in JAMA Network Open.
LIMITATIONS:
Dementia diagnosis was obtained based on medical records. Factors such as race, ethnicity, or time on metformin were not evaluated. Information on the exact reason for stopping metformin was not available.
DISCLOSURES:
The study was funded by grants from the National Institutes of Health, National Institute on Aging. Mr. Zimmerman owns stock in AbbVie, Gilead Sciences, CRISPR Therapeutics, and Abbott Laboratories. Disclosure for the other study authors can be found with the original article.
A version of this article first appeared on Medscape.com.
FDA OKs first ustekinumab biosimilar
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved ustekinumab-auub (Wezlana) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the first approval for a ustekinumab biosimilar in the United States.
Ustekinumab-auub was also granted an interchangeability designation, meaning that, depending on state law, a pharmacist may substitute the biosimilar for the reference product without consulting the prescribing provider.
“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval can empower patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
Ustekinumab, manufactured by Johnson & Johnson, targets interleukin-12 and IL-23 and was first approved in 2009. Ustekinumab-auub was developed by Amgen.
Ustekinumab-auub is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. It is also approved for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
The approval was based on “comprehensive review of scientific evidence,” including “comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data,” the FDA said.
Some common side effects of ustekinumab-auub include nasopharyngitis, upper respiratory tract infection, headache, fatigue, and nausea. The most severe side effect of the biosimilar, as with the reference drug ustekinumab, is infection.
The product launch of ustekinumab-auub will be delayed as a part of a settlement of Johnson & Johnson’s lawsuit against Amgen, according to Reuters. The details of the settlement are confidential, but it was stated that the biosimilar would be available by Jan. 1, 2025.
A version of this article first appeared on Medscape.com.
Serious mental illness tied to 50% higher all-cause mortality risk after COVID
TOPLINE:
METHODOLOGY:
- Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
- The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
- Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
- Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).
TAKEAWAY:
- Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
- Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
- After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.
IN PRACTICE:
“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.
SOURCE:
Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.
LIMITATIONS:
COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.
DISCLOSURES:
One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
- The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
- Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
- Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).
TAKEAWAY:
- Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
- Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
- After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.
IN PRACTICE:
“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.
SOURCE:
Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.
LIMITATIONS:
COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.
DISCLOSURES:
One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
- The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
- Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
- Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).
TAKEAWAY:
- Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
- Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
- After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.
IN PRACTICE:
“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.
SOURCE:
Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.
LIMITATIONS:
COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.
DISCLOSURES:
One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
Early career considerations for gastroenterologists interested in diversity, equity, and inclusion roles
Highlighting the importance of DEI across all aspects of medicine is long overdue, and the field of gastroenterology is no exception. Diversity in the gastroenterology workforce still has significant room for improvement with only 12% of all gastroenterology fellows in 2018 identifying as Black, Latino/a/x, American Indian or Alaskan Native, or Native Hawaiian or Pacific Islander.1 Moreover, only 4.4% of practicing gastroenterologists identify as Black, 6.7% identify as Latino/a/x, 0.1% as American Indian or Alaskan Native, and 0.003% as Native Hawaiian or Pacific Islander.2
The intensified focus on diversity in GI is welcomed, but increasing physician workforce diversity is only one of the necessary steps. If our ultimate goal is to improve health outcomes and achieve health equity for historically marginalized racial, ethnic, and socioeconomically disadvantaged communities, we must critically evaluate the path beyond just enhancing workforce diversity.
Black and Latino/a/x physicians are more likely to care for historically marginalized communities,3 which has been shown to improve all-cause mortality and reduce racial disparities.4 Additionally, diverse work teams are more innovative and productive.5 Therefore, expanding diversity must include 1) providing equitable policies and access to opportunities and promotions; 2) building inclusive environments in our institutions and practices; and 3) providing space for all people to feel like they can belong, feel respected at work, and genuinely have their opinions and ideas valued. What diversity, equity, inclusion, and belonging provide for us and our patients are avenues to thrive, solve complex problems, and tackle prominent issues within our institutions, workplaces, and communities.
To this end, many academic centers, hospitals, and private practice entities have produced a flurry of new DEI initiatives coupled with titles and roles. Some of these roles have thankfully brought recognition and economic compensation to the people doing this work. Still, as an early career gastroenterologist, you may be offered or are considering taking on a DEI role during your early career. As two underrepresented minority women in medicine who took on DEI roles with their first jobs, we wanted to highlight a few aspects to think about during your early career:
Does the DEI role come with resources?
Historically, DEI efforts were treated as “extra work,” or an activity that was done using one’s own personal time. In addition, this work called upon the small number of physicians underrepresented in medicine, largely uncompensated and with an exorbitant minority tax during a critical moment in establishing their early careers. DEI should no longer be seen as an extracurricular activity but as a vital component of an institution’s success.
If you are considering a DEI role, the first question to ask is, “Does this role come with extra compensation or protected time?” We highly recommend not taking on the role if the answer is no. If your institution or employer is only offering increased minority tax, you are being set up to either fail, burn out, or both. Your employer or institution does not appear to value your time or effort in DEI, and you should interpret their lack of compensation or protected time as such.
If the answer is yes, then here are a few other things to consider: Is there institutional support for you to be successful in your new role? As DEI work challenges you to come up with solutions to combat years of historic marginalization for racial and ethnic minorities, this work can sometimes feel overwhelming and isolating. The importance of the DEI community and mentorship within and outside your institution is critical. You should consider joining DEI working groups or committees through GI national societies, the Association of American Medical Colleges, or the Accreditation Council for Graduate Medical Education. You can also connect with a fantastic network of people engaged in this work via social media and lean on friends and colleagues leading similar initiatives across the country.
Other critical logistical questions are if your role will come with administrative support, whether there is a budget for programs or events, and whether your institution/employer will support you in seeking continued professional development for your DEI role.6
Make sure to understand the “ask” from your division, department, or company.
Before confirming you are willing to take on this role, get a clear vision of what you are being asked to accomplish. There are so many opportunities to improve the DEI landscape. Therefore, knowing what you are specifically being asked to do will be critical to your success.
Are you being asked to work on diversity?
Does your institution want you to focus on and improve the recruitment and retention of trainees, physicians, or staff underrepresented in medicine? If so, you will need to have access to all the prior work and statistics. Capture the landscape before your interventions (% underrepresented in medicine [URiM] trainees, % URiM faculty at each level, % of URiM trainees retained as faculty, % of URiM faculty being promoted each year, etc.) This will allow you to determine the outcomes of your proposed improvements or programs.
Is your employer focused on equity?
Are you being asked to think about ways to operationalize improved patient health equity, or are you being asked to build equitable opportunities/programs for career advancement for URiMs at your institution? For either equity issue, you first need to understand the scope of the problem to ask for the necessary resources for a potential solution. Discuss timeline expectations, as equity work is a marathon and may take years to move the needle on any particular issue. This timeline is also critical for your employer to be aware of and support, as unrealistic timelines and expectations will also set you up for failure.
Or, are you being asked to concentrate on inclusion?
Does your institution need an assessment of how inclusive the climate is for trainees, staff, or physicians? Does this assessment align with your division or department’s impression, and how do you plan to work toward potential solutions for improvement?
Although diversity, equity, and inclusion are interconnected entities, they all have distinct objectives and solutions. It is essential to understand your vision and your employer’s vision for this role. If they are not aligned, having early and in-depth conversations about aligning your visions will set you on a path to success in your early career.
Know your why or more importantly, your who?
Early career physicians who are considering taking on DEI work do so for a reason. Being passionate about this type of work is usually born from a personal experience or your deep-rooted values. For us, experiencing and witnessing health disparities for our family members and people who look like us are what initially fueled our passion for this work. Additional experiences with trainees and patients keep us invigorated to continue highlighting the importance of DEI and encourage others to be passionate about DEI’s huge value added. As DEI work can come with challenges, remembering and re-centering on why you are passionate about this work or who you are engaging in this work for can keep you going.
There are several aspects to consider before taking on a DEI role, but overall, the work is rewarding and can be a great addition to the building blocks of your early career. In the short term, you build a DEI community network of peers, mentors, colleagues, and friends beyond your immediate institution and specialty. You also can demonstrate your leadership skills and potential early on in your career. In the long-term, engaging in these types of roles helps build a climate and culture that is conducive to enacting change for our patients and communities, including advancing healthcare equity and working toward recruitment, retention, and expansion efforts for our trainees and faculty. Overall, we think this type of work in your early career can be an integral part of your personal and professional development, while also having an impact that ripples beyond the walls of the endoscopy suite.
Dr. Fritz is an assistant professor of medicine in the division of gastroenterology at Washington University School of Medicine, St. Louis. Dr. Rodriguez is a gastroenterologist with Brigham and Women’s Hospital in Boston. Neither Dr. Rodriguez nor Dr. Fritz disclosed no conflicts of interest.
References
1. Santhosh L,Babik JM. Trends in racial and ethnic diversity in internal medicine subspecialty fellowships from 2006 to 2018. JAMA Network Open 2020;3:e1920482-e1920482.
2. Colleges AoAM. Physician Specialty Data Report/Active physicians who identified as Black or African-American, 2021. 2022.
3. Komaromy M et al. The role of black and Hispanic physicians in providing health care for underserved populations. New England Journal of Medicine 1996;334:1305-10.
4. Snyder JE et al. Black representation in the primary care physician workforce and its association with population life expectancy and mortality rates in the US. JAMA Network Open 2023;6:e236687-e236687.
5. Page S. Diversity bonuses and the business case. The Diversity Bonus: Princeton University Press, 2017:184-208.
6. Vela MB et al. Diversity, equity, and inclusion officer position available: Proceed with caution. Journal of Graduate Medical Education 2021;13:771-3.
Helpful resources
Diversity and Inclusion Toolkit Resources, AAMC
Blackinggastro.org, The Association of Black Gastroenterologists and Hepatologists (ABGH)
Podcast: Clinical Problem Solvers: Anti-Racism in Medicine
Highlighting the importance of DEI across all aspects of medicine is long overdue, and the field of gastroenterology is no exception. Diversity in the gastroenterology workforce still has significant room for improvement with only 12% of all gastroenterology fellows in 2018 identifying as Black, Latino/a/x, American Indian or Alaskan Native, or Native Hawaiian or Pacific Islander.1 Moreover, only 4.4% of practicing gastroenterologists identify as Black, 6.7% identify as Latino/a/x, 0.1% as American Indian or Alaskan Native, and 0.003% as Native Hawaiian or Pacific Islander.2
The intensified focus on diversity in GI is welcomed, but increasing physician workforce diversity is only one of the necessary steps. If our ultimate goal is to improve health outcomes and achieve health equity for historically marginalized racial, ethnic, and socioeconomically disadvantaged communities, we must critically evaluate the path beyond just enhancing workforce diversity.
Black and Latino/a/x physicians are more likely to care for historically marginalized communities,3 which has been shown to improve all-cause mortality and reduce racial disparities.4 Additionally, diverse work teams are more innovative and productive.5 Therefore, expanding diversity must include 1) providing equitable policies and access to opportunities and promotions; 2) building inclusive environments in our institutions and practices; and 3) providing space for all people to feel like they can belong, feel respected at work, and genuinely have their opinions and ideas valued. What diversity, equity, inclusion, and belonging provide for us and our patients are avenues to thrive, solve complex problems, and tackle prominent issues within our institutions, workplaces, and communities.
To this end, many academic centers, hospitals, and private practice entities have produced a flurry of new DEI initiatives coupled with titles and roles. Some of these roles have thankfully brought recognition and economic compensation to the people doing this work. Still, as an early career gastroenterologist, you may be offered or are considering taking on a DEI role during your early career. As two underrepresented minority women in medicine who took on DEI roles with their first jobs, we wanted to highlight a few aspects to think about during your early career:
Does the DEI role come with resources?
Historically, DEI efforts were treated as “extra work,” or an activity that was done using one’s own personal time. In addition, this work called upon the small number of physicians underrepresented in medicine, largely uncompensated and with an exorbitant minority tax during a critical moment in establishing their early careers. DEI should no longer be seen as an extracurricular activity but as a vital component of an institution’s success.
If you are considering a DEI role, the first question to ask is, “Does this role come with extra compensation or protected time?” We highly recommend not taking on the role if the answer is no. If your institution or employer is only offering increased minority tax, you are being set up to either fail, burn out, or both. Your employer or institution does not appear to value your time or effort in DEI, and you should interpret their lack of compensation or protected time as such.
If the answer is yes, then here are a few other things to consider: Is there institutional support for you to be successful in your new role? As DEI work challenges you to come up with solutions to combat years of historic marginalization for racial and ethnic minorities, this work can sometimes feel overwhelming and isolating. The importance of the DEI community and mentorship within and outside your institution is critical. You should consider joining DEI working groups or committees through GI national societies, the Association of American Medical Colleges, or the Accreditation Council for Graduate Medical Education. You can also connect with a fantastic network of people engaged in this work via social media and lean on friends and colleagues leading similar initiatives across the country.
Other critical logistical questions are if your role will come with administrative support, whether there is a budget for programs or events, and whether your institution/employer will support you in seeking continued professional development for your DEI role.6
Make sure to understand the “ask” from your division, department, or company.
Before confirming you are willing to take on this role, get a clear vision of what you are being asked to accomplish. There are so many opportunities to improve the DEI landscape. Therefore, knowing what you are specifically being asked to do will be critical to your success.
Are you being asked to work on diversity?
Does your institution want you to focus on and improve the recruitment and retention of trainees, physicians, or staff underrepresented in medicine? If so, you will need to have access to all the prior work and statistics. Capture the landscape before your interventions (% underrepresented in medicine [URiM] trainees, % URiM faculty at each level, % of URiM trainees retained as faculty, % of URiM faculty being promoted each year, etc.) This will allow you to determine the outcomes of your proposed improvements or programs.
Is your employer focused on equity?
Are you being asked to think about ways to operationalize improved patient health equity, or are you being asked to build equitable opportunities/programs for career advancement for URiMs at your institution? For either equity issue, you first need to understand the scope of the problem to ask for the necessary resources for a potential solution. Discuss timeline expectations, as equity work is a marathon and may take years to move the needle on any particular issue. This timeline is also critical for your employer to be aware of and support, as unrealistic timelines and expectations will also set you up for failure.
Or, are you being asked to concentrate on inclusion?
Does your institution need an assessment of how inclusive the climate is for trainees, staff, or physicians? Does this assessment align with your division or department’s impression, and how do you plan to work toward potential solutions for improvement?
Although diversity, equity, and inclusion are interconnected entities, they all have distinct objectives and solutions. It is essential to understand your vision and your employer’s vision for this role. If they are not aligned, having early and in-depth conversations about aligning your visions will set you on a path to success in your early career.
Know your why or more importantly, your who?
Early career physicians who are considering taking on DEI work do so for a reason. Being passionate about this type of work is usually born from a personal experience or your deep-rooted values. For us, experiencing and witnessing health disparities for our family members and people who look like us are what initially fueled our passion for this work. Additional experiences with trainees and patients keep us invigorated to continue highlighting the importance of DEI and encourage others to be passionate about DEI’s huge value added. As DEI work can come with challenges, remembering and re-centering on why you are passionate about this work or who you are engaging in this work for can keep you going.
There are several aspects to consider before taking on a DEI role, but overall, the work is rewarding and can be a great addition to the building blocks of your early career. In the short term, you build a DEI community network of peers, mentors, colleagues, and friends beyond your immediate institution and specialty. You also can demonstrate your leadership skills and potential early on in your career. In the long-term, engaging in these types of roles helps build a climate and culture that is conducive to enacting change for our patients and communities, including advancing healthcare equity and working toward recruitment, retention, and expansion efforts for our trainees and faculty. Overall, we think this type of work in your early career can be an integral part of your personal and professional development, while also having an impact that ripples beyond the walls of the endoscopy suite.
Dr. Fritz is an assistant professor of medicine in the division of gastroenterology at Washington University School of Medicine, St. Louis. Dr. Rodriguez is a gastroenterologist with Brigham and Women’s Hospital in Boston. Neither Dr. Rodriguez nor Dr. Fritz disclosed no conflicts of interest.
References
1. Santhosh L,Babik JM. Trends in racial and ethnic diversity in internal medicine subspecialty fellowships from 2006 to 2018. JAMA Network Open 2020;3:e1920482-e1920482.
2. Colleges AoAM. Physician Specialty Data Report/Active physicians who identified as Black or African-American, 2021. 2022.
3. Komaromy M et al. The role of black and Hispanic physicians in providing health care for underserved populations. New England Journal of Medicine 1996;334:1305-10.
4. Snyder JE et al. Black representation in the primary care physician workforce and its association with population life expectancy and mortality rates in the US. JAMA Network Open 2023;6:e236687-e236687.
5. Page S. Diversity bonuses and the business case. The Diversity Bonus: Princeton University Press, 2017:184-208.
6. Vela MB et al. Diversity, equity, and inclusion officer position available: Proceed with caution. Journal of Graduate Medical Education 2021;13:771-3.
Helpful resources
Diversity and Inclusion Toolkit Resources, AAMC
Blackinggastro.org, The Association of Black Gastroenterologists and Hepatologists (ABGH)
Podcast: Clinical Problem Solvers: Anti-Racism in Medicine
Highlighting the importance of DEI across all aspects of medicine is long overdue, and the field of gastroenterology is no exception. Diversity in the gastroenterology workforce still has significant room for improvement with only 12% of all gastroenterology fellows in 2018 identifying as Black, Latino/a/x, American Indian or Alaskan Native, or Native Hawaiian or Pacific Islander.1 Moreover, only 4.4% of practicing gastroenterologists identify as Black, 6.7% identify as Latino/a/x, 0.1% as American Indian or Alaskan Native, and 0.003% as Native Hawaiian or Pacific Islander.2
The intensified focus on diversity in GI is welcomed, but increasing physician workforce diversity is only one of the necessary steps. If our ultimate goal is to improve health outcomes and achieve health equity for historically marginalized racial, ethnic, and socioeconomically disadvantaged communities, we must critically evaluate the path beyond just enhancing workforce diversity.
Black and Latino/a/x physicians are more likely to care for historically marginalized communities,3 which has been shown to improve all-cause mortality and reduce racial disparities.4 Additionally, diverse work teams are more innovative and productive.5 Therefore, expanding diversity must include 1) providing equitable policies and access to opportunities and promotions; 2) building inclusive environments in our institutions and practices; and 3) providing space for all people to feel like they can belong, feel respected at work, and genuinely have their opinions and ideas valued. What diversity, equity, inclusion, and belonging provide for us and our patients are avenues to thrive, solve complex problems, and tackle prominent issues within our institutions, workplaces, and communities.
To this end, many academic centers, hospitals, and private practice entities have produced a flurry of new DEI initiatives coupled with titles and roles. Some of these roles have thankfully brought recognition and economic compensation to the people doing this work. Still, as an early career gastroenterologist, you may be offered or are considering taking on a DEI role during your early career. As two underrepresented minority women in medicine who took on DEI roles with their first jobs, we wanted to highlight a few aspects to think about during your early career:
Does the DEI role come with resources?
Historically, DEI efforts were treated as “extra work,” or an activity that was done using one’s own personal time. In addition, this work called upon the small number of physicians underrepresented in medicine, largely uncompensated and with an exorbitant minority tax during a critical moment in establishing their early careers. DEI should no longer be seen as an extracurricular activity but as a vital component of an institution’s success.
If you are considering a DEI role, the first question to ask is, “Does this role come with extra compensation or protected time?” We highly recommend not taking on the role if the answer is no. If your institution or employer is only offering increased minority tax, you are being set up to either fail, burn out, or both. Your employer or institution does not appear to value your time or effort in DEI, and you should interpret their lack of compensation or protected time as such.
If the answer is yes, then here are a few other things to consider: Is there institutional support for you to be successful in your new role? As DEI work challenges you to come up with solutions to combat years of historic marginalization for racial and ethnic minorities, this work can sometimes feel overwhelming and isolating. The importance of the DEI community and mentorship within and outside your institution is critical. You should consider joining DEI working groups or committees through GI national societies, the Association of American Medical Colleges, or the Accreditation Council for Graduate Medical Education. You can also connect with a fantastic network of people engaged in this work via social media and lean on friends and colleagues leading similar initiatives across the country.
Other critical logistical questions are if your role will come with administrative support, whether there is a budget for programs or events, and whether your institution/employer will support you in seeking continued professional development for your DEI role.6
Make sure to understand the “ask” from your division, department, or company.
Before confirming you are willing to take on this role, get a clear vision of what you are being asked to accomplish. There are so many opportunities to improve the DEI landscape. Therefore, knowing what you are specifically being asked to do will be critical to your success.
Are you being asked to work on diversity?
Does your institution want you to focus on and improve the recruitment and retention of trainees, physicians, or staff underrepresented in medicine? If so, you will need to have access to all the prior work and statistics. Capture the landscape before your interventions (% underrepresented in medicine [URiM] trainees, % URiM faculty at each level, % of URiM trainees retained as faculty, % of URiM faculty being promoted each year, etc.) This will allow you to determine the outcomes of your proposed improvements or programs.
Is your employer focused on equity?
Are you being asked to think about ways to operationalize improved patient health equity, or are you being asked to build equitable opportunities/programs for career advancement for URiMs at your institution? For either equity issue, you first need to understand the scope of the problem to ask for the necessary resources for a potential solution. Discuss timeline expectations, as equity work is a marathon and may take years to move the needle on any particular issue. This timeline is also critical for your employer to be aware of and support, as unrealistic timelines and expectations will also set you up for failure.
Or, are you being asked to concentrate on inclusion?
Does your institution need an assessment of how inclusive the climate is for trainees, staff, or physicians? Does this assessment align with your division or department’s impression, and how do you plan to work toward potential solutions for improvement?
Although diversity, equity, and inclusion are interconnected entities, they all have distinct objectives and solutions. It is essential to understand your vision and your employer’s vision for this role. If they are not aligned, having early and in-depth conversations about aligning your visions will set you on a path to success in your early career.
Know your why or more importantly, your who?
Early career physicians who are considering taking on DEI work do so for a reason. Being passionate about this type of work is usually born from a personal experience or your deep-rooted values. For us, experiencing and witnessing health disparities for our family members and people who look like us are what initially fueled our passion for this work. Additional experiences with trainees and patients keep us invigorated to continue highlighting the importance of DEI and encourage others to be passionate about DEI’s huge value added. As DEI work can come with challenges, remembering and re-centering on why you are passionate about this work or who you are engaging in this work for can keep you going.
There are several aspects to consider before taking on a DEI role, but overall, the work is rewarding and can be a great addition to the building blocks of your early career. In the short term, you build a DEI community network of peers, mentors, colleagues, and friends beyond your immediate institution and specialty. You also can demonstrate your leadership skills and potential early on in your career. In the long-term, engaging in these types of roles helps build a climate and culture that is conducive to enacting change for our patients and communities, including advancing healthcare equity and working toward recruitment, retention, and expansion efforts for our trainees and faculty. Overall, we think this type of work in your early career can be an integral part of your personal and professional development, while also having an impact that ripples beyond the walls of the endoscopy suite.
Dr. Fritz is an assistant professor of medicine in the division of gastroenterology at Washington University School of Medicine, St. Louis. Dr. Rodriguez is a gastroenterologist with Brigham and Women’s Hospital in Boston. Neither Dr. Rodriguez nor Dr. Fritz disclosed no conflicts of interest.
References
1. Santhosh L,Babik JM. Trends in racial and ethnic diversity in internal medicine subspecialty fellowships from 2006 to 2018. JAMA Network Open 2020;3:e1920482-e1920482.
2. Colleges AoAM. Physician Specialty Data Report/Active physicians who identified as Black or African-American, 2021. 2022.
3. Komaromy M et al. The role of black and Hispanic physicians in providing health care for underserved populations. New England Journal of Medicine 1996;334:1305-10.
4. Snyder JE et al. Black representation in the primary care physician workforce and its association with population life expectancy and mortality rates in the US. JAMA Network Open 2023;6:e236687-e236687.
5. Page S. Diversity bonuses and the business case. The Diversity Bonus: Princeton University Press, 2017:184-208.
6. Vela MB et al. Diversity, equity, and inclusion officer position available: Proceed with caution. Journal of Graduate Medical Education 2021;13:771-3.
Helpful resources
Diversity and Inclusion Toolkit Resources, AAMC
Blackinggastro.org, The Association of Black Gastroenterologists and Hepatologists (ABGH)
Podcast: Clinical Problem Solvers: Anti-Racism in Medicine
Later-line tisotumab vedotin shows survival benefit in metastatic cervical CA
which was presented at the European Society of Medical Oncology (ESMO) Congress 2023.
Median overall survival (OS) was 11.5 months among 253 women randomized to tisotumab vedotin (TV) monotherapy versus 9.5 months among 249 randomized to investigators’ choice of chemotherapy, a 30% reduction in the risk of death (P = .0038).
Median progression-free survival (PFS) was 4.2 months with TV versus 2.9 months with chemotherapy (P < .0001), but survival benefits were not statistically significant in a number of subgroups.
Nonetheless, “tisotumab vedotin should be considered as a potential new standard of care for patients who have progressed after first-line systemic therapy,” said lead investigator Ignace Vergote, MD, PhD, a gynecologic oncologist and researcher at the Catholic University of Leuven, Belgium, who presented the findings.
New and emerging options
The trial serves as the confirmation the Food and Drug Administration required when it gave TV accelerated approval in 2021 for recurrent or metastatic cervical cancer (r/m CC) that’s progressed during or after first-line treatment, an approval based on response rates in an earlier phase 2 trial, the InnovaTV 204 study.
TV is the only antibody-drug conjugate approved for the indication, but another agent is also under investigation, the anti-PD-1 cemiplimab. It’s not yet approved for r/m CC, but it is approved in the United States for locally advanced/metastatic basal cell carcinoma, cutaneous squamous cell carcinoma, and non–small cell lung cancer.
Cemiplimab outcomes were similar to TV’s in a phase 3 trial following progression on first-line treatment without anti-PD-1 therapy, with a median OS of 12 months with cemiplimab versus 8.5 months with investigators’ choice of chemotherapy.
Pembrolizumab is also approved as monotherapy for r/m CC for PD-L1 positive women after progression on or during first-line treatment based on response outcomes, not survival.
The question now is how to pick among the various options, said Krishnansu Tewari, MD, a gynecologic oncologist and researcher at the University of California, Irvine, who discussed InnovaTV 301 at the meeting.
In the second line for r/m CC, “we can hypothetically consider” TV monotherapy; pembrolizumab in PD-L1-positive women not previously exposed to a checkpoint inhibitor (CPI); cemiplimab in women not previously exposed to a CPI, and perhaps TV plus pembrolizumab, also in women new to CPIs.
It remains particularly unclear at the moment how to select between TV and cemiplimab monotherapy, if cemiplimab is approved for the indication.
One difference is that unlike in the cemiplimab trial, 28.1% of women treated with TV in the phase 3 trial had been on an anti-PD-(L)1 in the first line. However, although PFS benefits were statistically significant for TV after checkpoint inhibitor exposure, OS benefit was not.
Regarding cost, TV was administered at 2 mg/kg every 3 weeks in Innova; 40 mg costs around $7,000.
Cemiplimab was dosed at 350 mg every 3 weeks in its trial; a single dose costs over $10,000.
Subgroups fall short of statistical significance
In InnovaTV 301, 12-month OS was about 48.7% with TV versus 35% with chemotherapy; 6-month PFS was 30.4% with TV versus 18.9%.
The PFS benefit with TV did not reach statistical significance among the 35.2% of women who had not been treated with bevacizumab in the first-line, and there was no OS benefit or trend to benefit (HR 1.0) for them.
In addition to women previously treated with an anti-PD-1, OS benefits with TV were not statistically significant among the 54.2% of women with baseline performance scores of 0; the 36.8% with adeno or adenosquamous carcinoma, and the 62.8% who had been on one prior systemic regimen instead two.
Women in the trial were a median of 50 years old, and fewer than 7% were from the United States. Investigator choice of chemotherapy included topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.
The rate of grade 3 or higher adverse events was 29.2% with TV and 45.2% with chemotherapy.
The known side effects of TV were all higher than in the chemotherapy arm, including grade 3 or worse peripheral neuropathy (5.2%), ocular events (3.2%), and bleeding (0.8%).
The study was funded in part by Genmab and SeaGen, the companies co-developing TV. Dr. Vergote is an adviser to both companies and many others. Dr. Tewari is an adviser/consultant, researcher, and speaker for SeaGen and Genmab as well as for Merck, AstraZeneca, and other companies.
which was presented at the European Society of Medical Oncology (ESMO) Congress 2023.
Median overall survival (OS) was 11.5 months among 253 women randomized to tisotumab vedotin (TV) monotherapy versus 9.5 months among 249 randomized to investigators’ choice of chemotherapy, a 30% reduction in the risk of death (P = .0038).
Median progression-free survival (PFS) was 4.2 months with TV versus 2.9 months with chemotherapy (P < .0001), but survival benefits were not statistically significant in a number of subgroups.
Nonetheless, “tisotumab vedotin should be considered as a potential new standard of care for patients who have progressed after first-line systemic therapy,” said lead investigator Ignace Vergote, MD, PhD, a gynecologic oncologist and researcher at the Catholic University of Leuven, Belgium, who presented the findings.
New and emerging options
The trial serves as the confirmation the Food and Drug Administration required when it gave TV accelerated approval in 2021 for recurrent or metastatic cervical cancer (r/m CC) that’s progressed during or after first-line treatment, an approval based on response rates in an earlier phase 2 trial, the InnovaTV 204 study.
TV is the only antibody-drug conjugate approved for the indication, but another agent is also under investigation, the anti-PD-1 cemiplimab. It’s not yet approved for r/m CC, but it is approved in the United States for locally advanced/metastatic basal cell carcinoma, cutaneous squamous cell carcinoma, and non–small cell lung cancer.
Cemiplimab outcomes were similar to TV’s in a phase 3 trial following progression on first-line treatment without anti-PD-1 therapy, with a median OS of 12 months with cemiplimab versus 8.5 months with investigators’ choice of chemotherapy.
Pembrolizumab is also approved as monotherapy for r/m CC for PD-L1 positive women after progression on or during first-line treatment based on response outcomes, not survival.
The question now is how to pick among the various options, said Krishnansu Tewari, MD, a gynecologic oncologist and researcher at the University of California, Irvine, who discussed InnovaTV 301 at the meeting.
In the second line for r/m CC, “we can hypothetically consider” TV monotherapy; pembrolizumab in PD-L1-positive women not previously exposed to a checkpoint inhibitor (CPI); cemiplimab in women not previously exposed to a CPI, and perhaps TV plus pembrolizumab, also in women new to CPIs.
It remains particularly unclear at the moment how to select between TV and cemiplimab monotherapy, if cemiplimab is approved for the indication.
One difference is that unlike in the cemiplimab trial, 28.1% of women treated with TV in the phase 3 trial had been on an anti-PD-(L)1 in the first line. However, although PFS benefits were statistically significant for TV after checkpoint inhibitor exposure, OS benefit was not.
Regarding cost, TV was administered at 2 mg/kg every 3 weeks in Innova; 40 mg costs around $7,000.
Cemiplimab was dosed at 350 mg every 3 weeks in its trial; a single dose costs over $10,000.
Subgroups fall short of statistical significance
In InnovaTV 301, 12-month OS was about 48.7% with TV versus 35% with chemotherapy; 6-month PFS was 30.4% with TV versus 18.9%.
The PFS benefit with TV did not reach statistical significance among the 35.2% of women who had not been treated with bevacizumab in the first-line, and there was no OS benefit or trend to benefit (HR 1.0) for them.
In addition to women previously treated with an anti-PD-1, OS benefits with TV were not statistically significant among the 54.2% of women with baseline performance scores of 0; the 36.8% with adeno or adenosquamous carcinoma, and the 62.8% who had been on one prior systemic regimen instead two.
Women in the trial were a median of 50 years old, and fewer than 7% were from the United States. Investigator choice of chemotherapy included topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.
The rate of grade 3 or higher adverse events was 29.2% with TV and 45.2% with chemotherapy.
The known side effects of TV were all higher than in the chemotherapy arm, including grade 3 or worse peripheral neuropathy (5.2%), ocular events (3.2%), and bleeding (0.8%).
The study was funded in part by Genmab and SeaGen, the companies co-developing TV. Dr. Vergote is an adviser to both companies and many others. Dr. Tewari is an adviser/consultant, researcher, and speaker for SeaGen and Genmab as well as for Merck, AstraZeneca, and other companies.
which was presented at the European Society of Medical Oncology (ESMO) Congress 2023.
Median overall survival (OS) was 11.5 months among 253 women randomized to tisotumab vedotin (TV) monotherapy versus 9.5 months among 249 randomized to investigators’ choice of chemotherapy, a 30% reduction in the risk of death (P = .0038).
Median progression-free survival (PFS) was 4.2 months with TV versus 2.9 months with chemotherapy (P < .0001), but survival benefits were not statistically significant in a number of subgroups.
Nonetheless, “tisotumab vedotin should be considered as a potential new standard of care for patients who have progressed after first-line systemic therapy,” said lead investigator Ignace Vergote, MD, PhD, a gynecologic oncologist and researcher at the Catholic University of Leuven, Belgium, who presented the findings.
New and emerging options
The trial serves as the confirmation the Food and Drug Administration required when it gave TV accelerated approval in 2021 for recurrent or metastatic cervical cancer (r/m CC) that’s progressed during or after first-line treatment, an approval based on response rates in an earlier phase 2 trial, the InnovaTV 204 study.
TV is the only antibody-drug conjugate approved for the indication, but another agent is also under investigation, the anti-PD-1 cemiplimab. It’s not yet approved for r/m CC, but it is approved in the United States for locally advanced/metastatic basal cell carcinoma, cutaneous squamous cell carcinoma, and non–small cell lung cancer.
Cemiplimab outcomes were similar to TV’s in a phase 3 trial following progression on first-line treatment without anti-PD-1 therapy, with a median OS of 12 months with cemiplimab versus 8.5 months with investigators’ choice of chemotherapy.
Pembrolizumab is also approved as monotherapy for r/m CC for PD-L1 positive women after progression on or during first-line treatment based on response outcomes, not survival.
The question now is how to pick among the various options, said Krishnansu Tewari, MD, a gynecologic oncologist and researcher at the University of California, Irvine, who discussed InnovaTV 301 at the meeting.
In the second line for r/m CC, “we can hypothetically consider” TV monotherapy; pembrolizumab in PD-L1-positive women not previously exposed to a checkpoint inhibitor (CPI); cemiplimab in women not previously exposed to a CPI, and perhaps TV plus pembrolizumab, also in women new to CPIs.
It remains particularly unclear at the moment how to select between TV and cemiplimab monotherapy, if cemiplimab is approved for the indication.
One difference is that unlike in the cemiplimab trial, 28.1% of women treated with TV in the phase 3 trial had been on an anti-PD-(L)1 in the first line. However, although PFS benefits were statistically significant for TV after checkpoint inhibitor exposure, OS benefit was not.
Regarding cost, TV was administered at 2 mg/kg every 3 weeks in Innova; 40 mg costs around $7,000.
Cemiplimab was dosed at 350 mg every 3 weeks in its trial; a single dose costs over $10,000.
Subgroups fall short of statistical significance
In InnovaTV 301, 12-month OS was about 48.7% with TV versus 35% with chemotherapy; 6-month PFS was 30.4% with TV versus 18.9%.
The PFS benefit with TV did not reach statistical significance among the 35.2% of women who had not been treated with bevacizumab in the first-line, and there was no OS benefit or trend to benefit (HR 1.0) for them.
In addition to women previously treated with an anti-PD-1, OS benefits with TV were not statistically significant among the 54.2% of women with baseline performance scores of 0; the 36.8% with adeno or adenosquamous carcinoma, and the 62.8% who had been on one prior systemic regimen instead two.
Women in the trial were a median of 50 years old, and fewer than 7% were from the United States. Investigator choice of chemotherapy included topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed.
The rate of grade 3 or higher adverse events was 29.2% with TV and 45.2% with chemotherapy.
The known side effects of TV were all higher than in the chemotherapy arm, including grade 3 or worse peripheral neuropathy (5.2%), ocular events (3.2%), and bleeding (0.8%).
The study was funded in part by Genmab and SeaGen, the companies co-developing TV. Dr. Vergote is an adviser to both companies and many others. Dr. Tewari is an adviser/consultant, researcher, and speaker for SeaGen and Genmab as well as for Merck, AstraZeneca, and other companies.
FROM ESMO 2023
No more hot flashes? AI device could stop menopause symptom
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.
Vasomotor symptoms the sudden rises in body temperature that affect about 75% of menopausal women, have drawn interest after the approval of a new oral drug and research linking hot flashes to Alzheimer’s, heart disease, and stroke.
Now entering the discussion are researchers from the University of Massachusetts, Amherst, and Embr Labs (a Massachusetts Institute of Technology spinoff) who say they’ve developed a machine-learning algorithm that can predict a hot flash.
The device, which sells for $299, is already touted as a way to manage menopausal hot flashes.
But once the algorithm is added, the device will be able to “continuously monitor physiological signals – skin temperature, body temperature, sweating, activity level, or heart rate – and identify early indicators that a hot flash is building,” said Michael Busa, PhD, director of the Center for Human Health and Performance at UMass Amherst, who led the team that developed the algorithm.
That data would be sent to a computing platform in the cloud, where the algorithm can flag signs of an impending hot flash, Dr. Busa said. The device would automatically prompt cooling in less than a second, which could effectively stop the hot flash in its tracks or at least help to take the edge off.
Exploring cooling therapy for hot flashes
“There is always tremendous interest in anything that is nonhormonal and effective in treatment of hot flashes,” said Karen Adams, MD, an ob.gyn. and director of the menopause and healthy aging program at Stanford (Calif.) University. (Dr. Adams was not involved in developing this technology.)
Hormone therapy is the primary treatment, easing hot flashes in 3-4 weeks, Dr. Adams said. “But some women do not want to take estrogen, or should not due to medical contraindications.”
Hormone therapy is generally not recommended for people with a history of breast cancer, blood clots, or diseases of their heart or blood vessels. Recent research presented at the annual meeting of the Menopause Society found that hormone therapy may not work as well in women with obesity.
For nonhormonal treatments, the Food and Drug Administration cleared the oral med fezolinetant (Veozah) in May. Antidepressant medications can also be used as a first-line treatment in those who can’t take estrogen. Another oral drug, elinzanetant, is in late-stage clinical trials.
But there has been little clinical investigation – only two small studies, Dr. Adams said – examining cooling therapy as a treatment for hot flashes. That’s something the makers of this device hope to change.
“Despite the fact that seeking cooling relief is a woman’s immediate natural response to the onset of a hot flash, there is limited work done to understand the benefits of this natural therapy,” said Matthew Smith, PhD, chief technology officer at Embr Labs. “This is in part because the technology didn’t exist to deliver cooling in an immediate, reproducible manner.”
The algorithm’s performance has been benchmarked using data from women having hot flashes, Dr. Smith said. Results have been submitted for publication.
The Embr Wave has been shown to help menopausal women with hot flashes sleep better. It has also been tested as a therapy for hot flashes related to cancer treatment.
But to truly evaluate the device as a treatment for hot flashes, it should be tested in randomized trials including a “sham treatment arm” – where some people get the real treatment while others get the sham treatment, Dr. Adams said.
“Device studies tend to have high placebo response rates that can only be truly evaluated when there is a sham treatment in the study,” she said. “If such a device were shown to be safe and effective, we would absolutely recommend it. But we’re a long way from that.”
A version of this article appeared on WebMD.com.
Semaglutide prescribing surged in the past year
Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.
Before December 2022, prescribing for both semaglutide drug formulations had been relatively flat. Ozempic was approved in the United States for treating type 2 diabetes in 2017, and Wegovy for weight loss in 2021. Prescribing of oral type 2 diabetes drugs also rose during the study period but to a lesser degree.
General and family practice providers were the most frequent semaglutide providers, accounting for 30% of the total, followed by internists at 15%, endocrinologists at 4%, ob.gyns. at 2%, and pediatricians at 1%. Other specialists writing less than 1% of the prescriptions included cardiologists, emergency medicine physicians, hospitalists, psychiatrists, and surgeons.
“What I think is interesting is that in a relatively short period of time, primary care providers got comfortable with writing [prescriptions] for a drug that’s relatively new ... That isn’t always the case ... To me, it’s actually pretty telling that within a year or year and a half, the primary care field got very comfortable writing [prescriptions] for these [glucagon-like peptide 1 receptor agonists],” DrFirst chief medical officer Colin Banas, MD, said in an interview.
Asked to comment, S. Sethu K. Reddy, MD, president of the American Association of Clinical Endocrinologists, noted, “It is to be expected when there is an agent that not only lowers blood sugar levels but also may result in weight loss. These medications are packaged conveniently for a primary care physician to prescribe. There is enough awareness amongst the public in that the patients themselves often ask their physician about the medication.”
Moreover, Dr. Reddy noted, “there is clinical evidence that these medications not only improve diabetes control but also reduce the risk of cardiovascular events. The lack of cardiovascular safety data was a missing piece of the puzzle in the past. So, currently, if someone has type 2 diabetes and is at greater risk of cardiovascular disease, there is little controversy for the patient to receive GLP-1 analogs.”
Are patients actually getting the prescribed medications?
However, Sharon W. Lahiri, MD, of Wayne State University School of Medicine and Henry Ford Hospital, Detroit, pointed out that prescription data don’t equate to actual drug use. “It depends what type of insurance a person has. ... We write prescriptions on a daily basis for semaglutide. At least five or more come into our inbox every day saying it’s denied.”
Earlier this year, Dr. Lahiri co-authored results from a survey of 125 health care providers between February 9 and March 14, 2022, seeking to identify factors influencing medication choices and barriers to prescribing both GLP-1 agonists and sodium-glucose cotransporter 2 inhibitors. High cost and the need for prior authorizations were reported as the main barriers to prescribing drugs in these two classes, along with a lack of experience among some specialists.
Dr. Lahiri told this news organization that many insurers don’t cover Wegovy at all, or they mandate stepped-care paradigms in which the patient must enroll in behavior modification programs for a period of time or first try older, less expensive weight loss drugs such as phentermine, topiramate, or orlistat before they authorize coverage for Wegovy or even for the older weight-loss GLP-1 agonist drug Saxenda. “And then, they require you to document why the prior drugs didn’t work or couldn’t be tolerated.”
Moreover, Wegovy coverage is often time-limited, varying anywhere from 3 months to 2 years, and some insurers require a visit where the patient must have lost at least 5% of their body weight for coverage to continue.
Dr. Lahiri said recently she’s also encountered such “step” requirements when she’s tried to prescribe the “twincretin” Mounjaro for treating type 2 diabetes, where insurers will require trials of other GLP-1 agonists first. “So, it’s very complicated. I would say the barriers are definitely worse now. I don’t think the number of written prescriptions reflects that at all.”
Indeed, Dr. Banas noted, “more patients are going to pay out of pocket for Wegovy than for Ozempic if they have a diabetes indication.” And he added, “In my clinical observation, insurance coverage for obesity medication appears to be holding steady. I haven’t seen a massive increase in these drugs being covered for obesity per se, but I definitely see more coverage for diabetes use cases.”
The study was funded by DrFirst. Dr. Banas is an employee of DrFirst. Dr. Reddy and Dr. Lahiri have no disclosures.
A version of this article appeared on Medscape.com.
Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.
Before December 2022, prescribing for both semaglutide drug formulations had been relatively flat. Ozempic was approved in the United States for treating type 2 diabetes in 2017, and Wegovy for weight loss in 2021. Prescribing of oral type 2 diabetes drugs also rose during the study period but to a lesser degree.
General and family practice providers were the most frequent semaglutide providers, accounting for 30% of the total, followed by internists at 15%, endocrinologists at 4%, ob.gyns. at 2%, and pediatricians at 1%. Other specialists writing less than 1% of the prescriptions included cardiologists, emergency medicine physicians, hospitalists, psychiatrists, and surgeons.
“What I think is interesting is that in a relatively short period of time, primary care providers got comfortable with writing [prescriptions] for a drug that’s relatively new ... That isn’t always the case ... To me, it’s actually pretty telling that within a year or year and a half, the primary care field got very comfortable writing [prescriptions] for these [glucagon-like peptide 1 receptor agonists],” DrFirst chief medical officer Colin Banas, MD, said in an interview.
Asked to comment, S. Sethu K. Reddy, MD, president of the American Association of Clinical Endocrinologists, noted, “It is to be expected when there is an agent that not only lowers blood sugar levels but also may result in weight loss. These medications are packaged conveniently for a primary care physician to prescribe. There is enough awareness amongst the public in that the patients themselves often ask their physician about the medication.”
Moreover, Dr. Reddy noted, “there is clinical evidence that these medications not only improve diabetes control but also reduce the risk of cardiovascular events. The lack of cardiovascular safety data was a missing piece of the puzzle in the past. So, currently, if someone has type 2 diabetes and is at greater risk of cardiovascular disease, there is little controversy for the patient to receive GLP-1 analogs.”
Are patients actually getting the prescribed medications?
However, Sharon W. Lahiri, MD, of Wayne State University School of Medicine and Henry Ford Hospital, Detroit, pointed out that prescription data don’t equate to actual drug use. “It depends what type of insurance a person has. ... We write prescriptions on a daily basis for semaglutide. At least five or more come into our inbox every day saying it’s denied.”
Earlier this year, Dr. Lahiri co-authored results from a survey of 125 health care providers between February 9 and March 14, 2022, seeking to identify factors influencing medication choices and barriers to prescribing both GLP-1 agonists and sodium-glucose cotransporter 2 inhibitors. High cost and the need for prior authorizations were reported as the main barriers to prescribing drugs in these two classes, along with a lack of experience among some specialists.
Dr. Lahiri told this news organization that many insurers don’t cover Wegovy at all, or they mandate stepped-care paradigms in which the patient must enroll in behavior modification programs for a period of time or first try older, less expensive weight loss drugs such as phentermine, topiramate, or orlistat before they authorize coverage for Wegovy or even for the older weight-loss GLP-1 agonist drug Saxenda. “And then, they require you to document why the prior drugs didn’t work or couldn’t be tolerated.”
Moreover, Wegovy coverage is often time-limited, varying anywhere from 3 months to 2 years, and some insurers require a visit where the patient must have lost at least 5% of their body weight for coverage to continue.
Dr. Lahiri said recently she’s also encountered such “step” requirements when she’s tried to prescribe the “twincretin” Mounjaro for treating type 2 diabetes, where insurers will require trials of other GLP-1 agonists first. “So, it’s very complicated. I would say the barriers are definitely worse now. I don’t think the number of written prescriptions reflects that at all.”
Indeed, Dr. Banas noted, “more patients are going to pay out of pocket for Wegovy than for Ozempic if they have a diabetes indication.” And he added, “In my clinical observation, insurance coverage for obesity medication appears to be holding steady. I haven’t seen a massive increase in these drugs being covered for obesity per se, but I definitely see more coverage for diabetes use cases.”
The study was funded by DrFirst. Dr. Banas is an employee of DrFirst. Dr. Reddy and Dr. Lahiri have no disclosures.
A version of this article appeared on Medscape.com.
Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.
Before December 2022, prescribing for both semaglutide drug formulations had been relatively flat. Ozempic was approved in the United States for treating type 2 diabetes in 2017, and Wegovy for weight loss in 2021. Prescribing of oral type 2 diabetes drugs also rose during the study period but to a lesser degree.
General and family practice providers were the most frequent semaglutide providers, accounting for 30% of the total, followed by internists at 15%, endocrinologists at 4%, ob.gyns. at 2%, and pediatricians at 1%. Other specialists writing less than 1% of the prescriptions included cardiologists, emergency medicine physicians, hospitalists, psychiatrists, and surgeons.
“What I think is interesting is that in a relatively short period of time, primary care providers got comfortable with writing [prescriptions] for a drug that’s relatively new ... That isn’t always the case ... To me, it’s actually pretty telling that within a year or year and a half, the primary care field got very comfortable writing [prescriptions] for these [glucagon-like peptide 1 receptor agonists],” DrFirst chief medical officer Colin Banas, MD, said in an interview.
Asked to comment, S. Sethu K. Reddy, MD, president of the American Association of Clinical Endocrinologists, noted, “It is to be expected when there is an agent that not only lowers blood sugar levels but also may result in weight loss. These medications are packaged conveniently for a primary care physician to prescribe. There is enough awareness amongst the public in that the patients themselves often ask their physician about the medication.”
Moreover, Dr. Reddy noted, “there is clinical evidence that these medications not only improve diabetes control but also reduce the risk of cardiovascular events. The lack of cardiovascular safety data was a missing piece of the puzzle in the past. So, currently, if someone has type 2 diabetes and is at greater risk of cardiovascular disease, there is little controversy for the patient to receive GLP-1 analogs.”
Are patients actually getting the prescribed medications?
However, Sharon W. Lahiri, MD, of Wayne State University School of Medicine and Henry Ford Hospital, Detroit, pointed out that prescription data don’t equate to actual drug use. “It depends what type of insurance a person has. ... We write prescriptions on a daily basis for semaglutide. At least five or more come into our inbox every day saying it’s denied.”
Earlier this year, Dr. Lahiri co-authored results from a survey of 125 health care providers between February 9 and March 14, 2022, seeking to identify factors influencing medication choices and barriers to prescribing both GLP-1 agonists and sodium-glucose cotransporter 2 inhibitors. High cost and the need for prior authorizations were reported as the main barriers to prescribing drugs in these two classes, along with a lack of experience among some specialists.
Dr. Lahiri told this news organization that many insurers don’t cover Wegovy at all, or they mandate stepped-care paradigms in which the patient must enroll in behavior modification programs for a period of time or first try older, less expensive weight loss drugs such as phentermine, topiramate, or orlistat before they authorize coverage for Wegovy or even for the older weight-loss GLP-1 agonist drug Saxenda. “And then, they require you to document why the prior drugs didn’t work or couldn’t be tolerated.”
Moreover, Wegovy coverage is often time-limited, varying anywhere from 3 months to 2 years, and some insurers require a visit where the patient must have lost at least 5% of their body weight for coverage to continue.
Dr. Lahiri said recently she’s also encountered such “step” requirements when she’s tried to prescribe the “twincretin” Mounjaro for treating type 2 diabetes, where insurers will require trials of other GLP-1 agonists first. “So, it’s very complicated. I would say the barriers are definitely worse now. I don’t think the number of written prescriptions reflects that at all.”
Indeed, Dr. Banas noted, “more patients are going to pay out of pocket for Wegovy than for Ozempic if they have a diabetes indication.” And he added, “In my clinical observation, insurance coverage for obesity medication appears to be holding steady. I haven’t seen a massive increase in these drugs being covered for obesity per se, but I definitely see more coverage for diabetes use cases.”
The study was funded by DrFirst. Dr. Banas is an employee of DrFirst. Dr. Reddy and Dr. Lahiri have no disclosures.
A version of this article appeared on Medscape.com.
84-year-old MD contests employer’s mandatory cognitive tests for older docs
Lylas G. Mogk, MD, recently sued Henry Ford Health and Henry Ford Medical Group in federal court, alleging that the mandatory cognitive test violates the Americans with Disabilities Act, the Age Discrimination in Employment Act, and two Michigan laws.
Dr. Mogk’s lawsuit follows a widely watched 2020 case in which the U.S. Equal Employment Opportunity Commission sued Yale New Haven Hospital, the teaching hospital of Yale University, for age discrimination. According to the lawsuit, the hospital illegally required neuropsychological and eye examinations of physicians aged 70 or older who sought to gain or renew staff privileges.
According to the lawsuit, Dr. Mogk is a member of Henry Ford Medical Group, which in 2017 required all members aged 70 and older to undergo cognitive screening tests. The tests would be repeated every 5 years thereafter, the lawsuit said, and anyone who refused would have to resign or be fired.
Dr. Mogk completed the screening, although no information about the results or outcome was mentioned in the lawsuit. It’s not clear whether Henry Ford’s cognitive test mandate remains in place; a spokesperson for Henry Ford Health and attorneys for Dr. Mogk declined to comment.
The number of practicing physicians in their 70s and beyond is rising. A 2021 report found that 12% of U.S. licensed physicians in 2020 were least 70 years old, up from 9% in 2010 and an increase from 75,627 to 120,510. The percentage of doctors aged 60-69 grew to 19% from 16% in 2010.
The number of health systems requiring testing of older physicians isn’t known, although various reports suggest at least a dozen have had mandates.
The University of California, San Diego, offers a physical and mental screening program that health organizations can use to evaluate “late-career physicians,” and a 2021 report noted that “Nebraska’s Children’s Hospital requires physicians aged 70 years and older to undergo an assessment by several peers, a complete physical, and unspecified cognitive screening.” Another system, Hartford HealthCare, mandated an annual reappointment process for clinicians aged 70 or older, requiring them to undergo various exams.
There’s evidence that physician performance declines with age. However, age-based cognitive testing can run afoul of federal and state laws against age discrimination, said Sharona Hoffman, JD, professor of law and bioethics at Case Western Reserve University, Cleveland, in an interview.
Federal law prohibits age-related restrictions on employment but allows exceptions in areas like public safety, said Ms. Hoffman, who’s written about age discrimination and testing requirements. Pilots, law enforcement officers, firefighters, and air controllers, for example, can be forced to retire at specific ages.
It’s not clear how many physicians took the cognitive tests required by Henry Ford Medical Group.
However, details are available about the policy at Yale New Haven Hospital: According to the EEOC lawsuit, from 2016 to 2019, 145 physicians aged 70 or older took the mandatory test. Of those, seven individuals failed either or both of the exams, 14 were listed as “borderline deficient,” and one was listed as “deficient.” Another five refused testing and either resigned or changed their status. The EEOC case against the hospital is still pending.
“You can make an argument that health care is like a public safety job because people put their lives in the hands of doctors,” Ms. Hoffman said.
In defending mandatory cognitive tests, she said, health care systems could say, “it’s not really discrimination; we’re not forcing them to retire, we’re not limiting their work in any way. We’re just doing testing to make sure they perform competently, and the ADA allows us to conduct testing that is job-related.”
Indeed, a Yale New Haven Hospital spokesman made an argument along these lines in a statement regarding the 2020 lawsuit: The “policy is designed to protect our patients from potential harm while including safeguards to ensure that our physicians are treated fairly. The policy is modeled on similar standards in other industries, and we are confident that no discrimination has occurred and will vigorously defend ourselves in this matter.”
However, Ms. Hoffman herself doesn’t buy these arguments. Requiring tests only for older physicians does appear to be discrimination based on age, she said. As an alternative, “employers can do close supervision of people. As soon as there are performance problems or patient complaints, you need to see a doctor or get testing done.”
Another option is to mandate tests at specific ages via licensing boards. “I don’t think that would be legally problematic,” Ms. Hoffman said.
What else can be done to protect patients from clinicians whose skills have significantly declined as they’ve aged? The 2021 report in Neurology Clinical Practice notes that there are disadvantages to several strategies.
One common approach, waiting to evaluate a clinician until an error occurs, can lead to patient harm, the report’s authors wrote. Relying on reporting by peers is problematic because “physicians have been very resistant to reporting colleagues who are impaired” and the “medical apprenticeship model discourages physicians from reporting on senior colleagues.”
Physician self-assessment is yet another option, but “loss of insight may be a component of an individual’s impairment,” the authors wrote.
So what’s the best solution? The authors recommended “a relatively brief cognitive screening followed by more extensive testing for the most impaired individuals.” This approach “appears most reliable in confidentially identifying truly impaired physicians while minimizing the chance of a falsely flagging unimpaired individuals. This strategy allows aging physicians to continue working while safeguarding both their reputations and their patients’ health.”
Ms. Hoffman has no disclosures.
A version of this article first appeared on Medscape.com.
Lylas G. Mogk, MD, recently sued Henry Ford Health and Henry Ford Medical Group in federal court, alleging that the mandatory cognitive test violates the Americans with Disabilities Act, the Age Discrimination in Employment Act, and two Michigan laws.
Dr. Mogk’s lawsuit follows a widely watched 2020 case in which the U.S. Equal Employment Opportunity Commission sued Yale New Haven Hospital, the teaching hospital of Yale University, for age discrimination. According to the lawsuit, the hospital illegally required neuropsychological and eye examinations of physicians aged 70 or older who sought to gain or renew staff privileges.
According to the lawsuit, Dr. Mogk is a member of Henry Ford Medical Group, which in 2017 required all members aged 70 and older to undergo cognitive screening tests. The tests would be repeated every 5 years thereafter, the lawsuit said, and anyone who refused would have to resign or be fired.
Dr. Mogk completed the screening, although no information about the results or outcome was mentioned in the lawsuit. It’s not clear whether Henry Ford’s cognitive test mandate remains in place; a spokesperson for Henry Ford Health and attorneys for Dr. Mogk declined to comment.
The number of practicing physicians in their 70s and beyond is rising. A 2021 report found that 12% of U.S. licensed physicians in 2020 were least 70 years old, up from 9% in 2010 and an increase from 75,627 to 120,510. The percentage of doctors aged 60-69 grew to 19% from 16% in 2010.
The number of health systems requiring testing of older physicians isn’t known, although various reports suggest at least a dozen have had mandates.
The University of California, San Diego, offers a physical and mental screening program that health organizations can use to evaluate “late-career physicians,” and a 2021 report noted that “Nebraska’s Children’s Hospital requires physicians aged 70 years and older to undergo an assessment by several peers, a complete physical, and unspecified cognitive screening.” Another system, Hartford HealthCare, mandated an annual reappointment process for clinicians aged 70 or older, requiring them to undergo various exams.
There’s evidence that physician performance declines with age. However, age-based cognitive testing can run afoul of federal and state laws against age discrimination, said Sharona Hoffman, JD, professor of law and bioethics at Case Western Reserve University, Cleveland, in an interview.
Federal law prohibits age-related restrictions on employment but allows exceptions in areas like public safety, said Ms. Hoffman, who’s written about age discrimination and testing requirements. Pilots, law enforcement officers, firefighters, and air controllers, for example, can be forced to retire at specific ages.
It’s not clear how many physicians took the cognitive tests required by Henry Ford Medical Group.
However, details are available about the policy at Yale New Haven Hospital: According to the EEOC lawsuit, from 2016 to 2019, 145 physicians aged 70 or older took the mandatory test. Of those, seven individuals failed either or both of the exams, 14 were listed as “borderline deficient,” and one was listed as “deficient.” Another five refused testing and either resigned or changed their status. The EEOC case against the hospital is still pending.
“You can make an argument that health care is like a public safety job because people put their lives in the hands of doctors,” Ms. Hoffman said.
In defending mandatory cognitive tests, she said, health care systems could say, “it’s not really discrimination; we’re not forcing them to retire, we’re not limiting their work in any way. We’re just doing testing to make sure they perform competently, and the ADA allows us to conduct testing that is job-related.”
Indeed, a Yale New Haven Hospital spokesman made an argument along these lines in a statement regarding the 2020 lawsuit: The “policy is designed to protect our patients from potential harm while including safeguards to ensure that our physicians are treated fairly. The policy is modeled on similar standards in other industries, and we are confident that no discrimination has occurred and will vigorously defend ourselves in this matter.”
However, Ms. Hoffman herself doesn’t buy these arguments. Requiring tests only for older physicians does appear to be discrimination based on age, she said. As an alternative, “employers can do close supervision of people. As soon as there are performance problems or patient complaints, you need to see a doctor or get testing done.”
Another option is to mandate tests at specific ages via licensing boards. “I don’t think that would be legally problematic,” Ms. Hoffman said.
What else can be done to protect patients from clinicians whose skills have significantly declined as they’ve aged? The 2021 report in Neurology Clinical Practice notes that there are disadvantages to several strategies.
One common approach, waiting to evaluate a clinician until an error occurs, can lead to patient harm, the report’s authors wrote. Relying on reporting by peers is problematic because “physicians have been very resistant to reporting colleagues who are impaired” and the “medical apprenticeship model discourages physicians from reporting on senior colleagues.”
Physician self-assessment is yet another option, but “loss of insight may be a component of an individual’s impairment,” the authors wrote.
So what’s the best solution? The authors recommended “a relatively brief cognitive screening followed by more extensive testing for the most impaired individuals.” This approach “appears most reliable in confidentially identifying truly impaired physicians while minimizing the chance of a falsely flagging unimpaired individuals. This strategy allows aging physicians to continue working while safeguarding both their reputations and their patients’ health.”
Ms. Hoffman has no disclosures.
A version of this article first appeared on Medscape.com.
Lylas G. Mogk, MD, recently sued Henry Ford Health and Henry Ford Medical Group in federal court, alleging that the mandatory cognitive test violates the Americans with Disabilities Act, the Age Discrimination in Employment Act, and two Michigan laws.
Dr. Mogk’s lawsuit follows a widely watched 2020 case in which the U.S. Equal Employment Opportunity Commission sued Yale New Haven Hospital, the teaching hospital of Yale University, for age discrimination. According to the lawsuit, the hospital illegally required neuropsychological and eye examinations of physicians aged 70 or older who sought to gain or renew staff privileges.
According to the lawsuit, Dr. Mogk is a member of Henry Ford Medical Group, which in 2017 required all members aged 70 and older to undergo cognitive screening tests. The tests would be repeated every 5 years thereafter, the lawsuit said, and anyone who refused would have to resign or be fired.
Dr. Mogk completed the screening, although no information about the results or outcome was mentioned in the lawsuit. It’s not clear whether Henry Ford’s cognitive test mandate remains in place; a spokesperson for Henry Ford Health and attorneys for Dr. Mogk declined to comment.
The number of practicing physicians in their 70s and beyond is rising. A 2021 report found that 12% of U.S. licensed physicians in 2020 were least 70 years old, up from 9% in 2010 and an increase from 75,627 to 120,510. The percentage of doctors aged 60-69 grew to 19% from 16% in 2010.
The number of health systems requiring testing of older physicians isn’t known, although various reports suggest at least a dozen have had mandates.
The University of California, San Diego, offers a physical and mental screening program that health organizations can use to evaluate “late-career physicians,” and a 2021 report noted that “Nebraska’s Children’s Hospital requires physicians aged 70 years and older to undergo an assessment by several peers, a complete physical, and unspecified cognitive screening.” Another system, Hartford HealthCare, mandated an annual reappointment process for clinicians aged 70 or older, requiring them to undergo various exams.
There’s evidence that physician performance declines with age. However, age-based cognitive testing can run afoul of federal and state laws against age discrimination, said Sharona Hoffman, JD, professor of law and bioethics at Case Western Reserve University, Cleveland, in an interview.
Federal law prohibits age-related restrictions on employment but allows exceptions in areas like public safety, said Ms. Hoffman, who’s written about age discrimination and testing requirements. Pilots, law enforcement officers, firefighters, and air controllers, for example, can be forced to retire at specific ages.
It’s not clear how many physicians took the cognitive tests required by Henry Ford Medical Group.
However, details are available about the policy at Yale New Haven Hospital: According to the EEOC lawsuit, from 2016 to 2019, 145 physicians aged 70 or older took the mandatory test. Of those, seven individuals failed either or both of the exams, 14 were listed as “borderline deficient,” and one was listed as “deficient.” Another five refused testing and either resigned or changed their status. The EEOC case against the hospital is still pending.
“You can make an argument that health care is like a public safety job because people put their lives in the hands of doctors,” Ms. Hoffman said.
In defending mandatory cognitive tests, she said, health care systems could say, “it’s not really discrimination; we’re not forcing them to retire, we’re not limiting their work in any way. We’re just doing testing to make sure they perform competently, and the ADA allows us to conduct testing that is job-related.”
Indeed, a Yale New Haven Hospital spokesman made an argument along these lines in a statement regarding the 2020 lawsuit: The “policy is designed to protect our patients from potential harm while including safeguards to ensure that our physicians are treated fairly. The policy is modeled on similar standards in other industries, and we are confident that no discrimination has occurred and will vigorously defend ourselves in this matter.”
However, Ms. Hoffman herself doesn’t buy these arguments. Requiring tests only for older physicians does appear to be discrimination based on age, she said. As an alternative, “employers can do close supervision of people. As soon as there are performance problems or patient complaints, you need to see a doctor or get testing done.”
Another option is to mandate tests at specific ages via licensing boards. “I don’t think that would be legally problematic,” Ms. Hoffman said.
What else can be done to protect patients from clinicians whose skills have significantly declined as they’ve aged? The 2021 report in Neurology Clinical Practice notes that there are disadvantages to several strategies.
One common approach, waiting to evaluate a clinician until an error occurs, can lead to patient harm, the report’s authors wrote. Relying on reporting by peers is problematic because “physicians have been very resistant to reporting colleagues who are impaired” and the “medical apprenticeship model discourages physicians from reporting on senior colleagues.”
Physician self-assessment is yet another option, but “loss of insight may be a component of an individual’s impairment,” the authors wrote.
So what’s the best solution? The authors recommended “a relatively brief cognitive screening followed by more extensive testing for the most impaired individuals.” This approach “appears most reliable in confidentially identifying truly impaired physicians while minimizing the chance of a falsely flagging unimpaired individuals. This strategy allows aging physicians to continue working while safeguarding both their reputations and their patients’ health.”
Ms. Hoffman has no disclosures.
A version of this article first appeared on Medscape.com.