A 67-year-old man asks about what he can do to prevent dementia. He reports his mother had dementia, and he wants to do everything he can to prevent it. Which of the following has evidence of benefit?
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Dr. Douglas S. Paauw
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
A 67-year-old man asks about what he can do to prevent dementia. He reports his mother had dementia, and he wants to do everything he can to prevent it. Which of the following has evidence of benefit?
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Dr. Douglas S. Paauw
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
A 67-year-old man asks about what he can do to prevent dementia. He reports his mother had dementia, and he wants to do everything he can to prevent it. Which of the following has evidence of benefit?
A) Thiamine
B) Vitamin E
C) Multivitamin (MV)
D) Keto diet
E) Red wine
FDA-approved therapies for dementia
To date the actual therapies for dementia have been disappointing. Donepezil, the most prescribed medication for the treatment of dementia has a number-needed-to treat (NNT) over 17, and causes frequent side effects. Aducanumab was recently approved by the Food and Drug Administration for the treatment of Alzheimer’s disease (AD), but controversy has arisen, as the clinical results were modest, and the price tag will be large – estimated at $30,000-$50,000/year.
Preventive options that may decrease the likelihood of dementia
Patients often ask the question stated above. Regarding how to respond to that question, choice C, MV, has some recent evidence of benefit. Baker and colleagues studied the effect of cocoa extract and multivitamins on cognitive function in the COSMOS-Mind trial.1 A total of 2,262 people were enrolled, and over 90% completed baseline and at least one annual cognitive assessment. Cocoa extract had no impact on global cognition (confidence interval [CI], –.02-.08, P = .28), but MV supplementation did have a statistically significant impact on global cognition (CI, .02-.12, P less than .007).
Dr. Douglas S. Paauw
Vitamin E has been enthusiastically endorsed in the past as a treatment to prevent cognitive decline. The most recent Cochrane review on vitamin E concluded there was no evidence that the alpha-tocopherol form of vitamin E given to people with MCI prevents progression to dementia, or that it improves cognitive function in people with MCI or dementia due to AD.2
Exercise has long been a mainstay of our advice to patients as something they can do to help prevent dementia. Yu and colleagues did a meta-analysis of almost 400 randomized controlled trials and observational studies to grade the evidence on different interventions.3 They gave exercise a grade B for evidence of benefit.
A recent study addressed this issue, and I think it is helpful on quantifying how much exercise is needed. Del Pozo Cruz and colleagues did a prospective population-based cohort study of 78,000 adults aged 40-79, with an average of 6.9 years of follow up.4 The optimal step count was 9,826 steps (hazard ratio [HR], 0.49; 95% CI, 0.39-0.62) and the minimal step count for benefit was 3,826 steps (HR, 0.75; 95% CI, 0.67-0.83).
Modifiable factors
The other major modifiable factors to consider are problems with special senses. Both vision loss and hearing loss have been associated with cognitive impairment.
Shang and colleagues published a meta-analysis of 14 cohort studies addressing vision impairment and cognitive function involving more than 6 million individuals.5 They concluded that vision impairment is associated with an increased risk of both dementia and cognitive impairment in older adults.
Loughrey and colleagues performed a meta-analysis of 36 studies addressing hearing loss and cognitive decline.6 They reported that, among cross-sectional studies, a significant association was found for cognitive impairment (odds ratio [OR], 2.00; 95% CI, 1.39-2.89) and dementia (OR, 2.42; 95% CI, 1.24-4.72). A similar finding was present in prospective cohort studies with a significant association being found for cognitive impairment (OR, 1.22; 95% CI, 1.09-1.36) and dementia (OR, 1.28; 95% CI, 1.02-1.59).
A 25-year prospective, population-based study of patients with hearing loss revealed a difference in the rate of change in MMSE score over the 25-year follow-up between participants with hearing loss not using hearing aids matched with controls who didn’t have hearing loss. Those with untreated hearing loss had more cognitive decline than that of patients without hearing loss.7 The subjects with hearing loss using a hearing aid had no difference in cognitive decline from controls.
Pearl
Several simple and safe interventions may protect our patients from cognitive decline. These include taking a daily multivitamin, walking more than 4,000 steps a day, and optimizing vision and hearing.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Baker LD et al. Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial. Alzheimer’s Dement. 2022 Sep 14. doi: 10.1002/alz.12767.
2. Farina N et al. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database Syst Rev. 2017 Apr 18;4(4):CD002854. doi: 10.1002/14651858.CD002854.pub5.
3. Yu JT et al. Evidence-based prevention of Alzheimer’s disease: Systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials. J Neurol Neurosurg Psychiatry. 2020 Nov;91(11):1201-9.
4. Del Pozo Cruz B et al. Association of daily step count and intensity with incident dementia in 78,430 adults living in the UK. JAMA Neurol. 2022 Oct 1;79(10):1059-63.
5. Shang X et al. The association between vision impairment and incidence of dementia and cognitive impairment: A systematic review and meta-analysis. Ophthalmology. 2021 Aug;128(8):1135-49.
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Dr. Siddharth Singh
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
FatCamera/Getty Images
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ashwin N. Ananthakrishnan
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Dr. Siddharth Singh
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
FatCamera/Getty Images
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ashwin N. Ananthakrishnan
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
Findings indicate that vedolizumab is associated with an increased risk for treatment failure in older patients with inflammatory bowel disease (IBD), as compared with tumor necrosis factor (TNF) antagonists, according to a new study published in JAMA Network Open.
Dr. Siddharth Singh
Although the incidence and prevalence of IBD among older adults are rapidly increasing, there is a lack of evidence-based treatment guidance for these patients, who represent less than 5% of participants in IBD-related clinical trials, wrote Siddharth Singh, MD, a gastroenterologist and assistant professor of medicine at the University of California, San Diego, and colleagues.
“Older patients are frequently undertreated and mismanaged with long-term corticosteroid use and limited use of steroid-sparing therapies owing to patients’ and clinicians’ concerns about the safety of immunosuppressive therapy,” the authors wrote. “There is considerable need for evidence-based treatment guidance for older patients with IBD.”
FatCamera/Getty Images
The researchers undertook an observational study of the comparative effectiveness of vedolizumab versus TNF antagonists (namely infliximab, adalimumab, and golimumab) among older patients with IBD in Denmark. Using the Danish National Patient Register, the authors included 754 patients aged 50 years and older who received treatment between 2005 and 2018.
The primary effectiveness outcome was treatment failure, defined as the composite 1-year risk of IBD-related hospitalization, IBD-related surgery, or a new corticosteroid prescription more than 6 weeks after initiation of treatment with a biologic. Secondary effectiveness outcomes included time to each component included in the composite score.
The primary safety outcome was the risk of serious infections, defined as those that required hospitalization. Secondary safety outcomes were risk of cancer and major adverse cardiovascular or venous thromboembolic events.
The researchers conducted a 1:1 propensity score-matched analysis, accounting for patient, disease, and treatment factors. The 754 patients included 377 incident users of vedolizumab, including 177 with Crohn’s disease; and 377 incident users of TNF antagonists, including 182 with Crohn’s disease. The average follow-up after treatment initiation occurred between 32 and 40 weeks.
Notably, patients treated with vedolizumab were more likely than those treated with TNF antagonists to have multimorbidity, at 16.2% versus 14.1%, and a higher burden of frailty, at 2.7% versus 1.9%. No significant differences were observed in the proportion of patients with recent immunomodulator and corticosteroid exposure.
Overall, vedolizumab was associated with a 31% increased risk of treatment failure (45.4%), compared with TNF antagonists (34.7%). This included an increased risk of IBD-related hospitalization (27.8% versus 16.3%) and IBD-related major abdominal surgery (21.3% versus 8%).
Among patients with Crohn’s disease, vedolizumab was associated with a 77% increased risk of treatment failure, as well as a greater need for corticosteroids. There was no significant difference in the risk of treatment failure or need for corticosteroids in patients with ulcerative colitis
No significant differences were seen in the risk of serious infections between patients treated with vedolizumab or TNF antagonists, at 8.2% versus 8.7%. This didn’t change by IBD phenotype, age at time of biologic therapy initiation, or treatment with biologic monotherapy versus combination therapy with immunomodulators.
The overall incidence of major adverse cardiovascular or venous thromboembolic events was similar among the groups. Rates of new malignant neoplasms were low, with fewer than five events.
In a subgroup analysis based on the Charlson Comorbidity Index, vedolizumab was associated with a 63% increased risk of treatment failure for patients without comorbidities but not for patients with comorbidities.
“This study adds to the body of literature comparing vedolizumab and anti-TNF in older adults. The findings have been mixed, in some part due to differences in study designs,” said Ashwin N. Ananthakrishnan, MBBS, MPH, associate professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston.
Dr. Ashwin N. Ananthakrishnan
Dr. Ananthakrishnan, who wasn’t involved with this study, has previously researched the two treatments and found that they are comparably safe in older adults. In fact, among patients with significant comorbidity, vedolizumab may be safer. However, the Danish study wasn’t powered to describe that, he said. Moreover, patient characteristics and treatment approaches likely differ between the United States and Denmark.
“Overall, the findings are reassuring. Often when we treat older adults, the emphasis is on safety,” he said. “But by highlighting the difference in clinical response rates – their findings being consistent with a study we published a few years ago – it highlights the importance of also considering efficacy and onset of action for specific disease phenotypes in treatment selection.”
Dr. Ananthakrishnan and colleagues are currently developing clinical tools for risk stratification and prognostication in older adults with IBD, including functional and frailty assessments. “Biologically, older adults may be particularly vulnerable to specific treatment risks such as infections and cancer, but they are also vulnerable to the consequences of untreated disease, including loss of functional independence and frailty,” he explained. “Thus, arriving at the right risk to benefit balance is critically important when making treatment decisions for older adults.”
The study by Dr. Singh and colleagues was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and the Danish National Research Foundation. Dr. Singh reported receiving grants from pharmaceutical companies unrelated to the study, as well as support from the International Organization for the Study of Inflammatory Bowel Disease Operating Grant and Litwin Pioneers in IBD. No other disclosures were reported. Dr. Ananthakrishnan reported no relevant disclosures.
Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
Suicide as a way out or solution to an insoluble problem.
Suicide as the final act in a long road of suffering.
Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
University of Rochester Medical Center
Dr. Yeates Conwell
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
Suicide as a way out or solution to an insoluble problem.
Suicide as the final act in a long road of suffering.
Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
University of Rochester Medical Center
Dr. Yeates Conwell
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.
A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.
“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.
“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.
The study was published online in The American Journal of Geriatric Psychiatry.
Opportunity for intervention
Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.
Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.
The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.
Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.
In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.
The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).
The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).
Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
Common themes
Four major themes emerged in the analysis of the suicide notes.
Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).
The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:
Suicide as a way out or solution to an insoluble problem.
Suicide as the final act in a long road of suffering.
Suicide as the logical culmination of life (the person “lived a good life”).
“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.
“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.
“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
Untangling suicide drivers
Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”
University of Rochester Medical Center
Dr. Yeates Conwell
Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.
However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.
“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.
No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.
Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.
The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.
In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.
At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.
No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.
In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.
“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.
In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.
Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.
Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.
Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.
The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”
Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.
The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.
The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.
Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.
In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.
The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”
Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.
During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”
In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.
It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.
Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.
“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.
The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.
In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.
“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.
In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.
Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.
In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.
The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.
Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.
Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.
The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.
A version of this article first appeared on Medscape.com.
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? Vaccinate the elderly (and some middle-aged too, if possible) and the frail as soon as possible with any version of the booster you have available, if you want to keep hospital pressure to the minimum and save a fair number of complications and deaths over the next months. This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? Vaccinate the elderly (and some middle-aged too, if possible) and the frail as soon as possible with any version of the booster you have available, if you want to keep hospital pressure to the minimum and save a fair number of complications and deaths over the next months. This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Many countries around the globe are starting to roll out another booster of the COVID-19 vaccine but, with public interest waning and a sense of normalcy firmly installed in our minds, this may prove an ill-fated effort, unless authorities can provide a coherent answer to the question “Is another jab really needed?” (The short answer is a firm “yes,” of course.)
In what we could call the “chronic” phase of the pandemic, most countries have now settled for a certain number of daily cases and a (relatively low) number of complications and deaths. It’s the vaccines that have afforded us this peace of mind, lest we forget. But they are different to other vaccines that we are more familiar with, such as the MMR that we get as kids and then forget about for the rest of our lives. As good as the different COVID-19 vaccines are, they never came with the promise of generating lifelong antibodies. We knew early on that the immunity they provide slowly wanes with time. That doesn’t mean that those who have their vaccination records up to date (which included a booster probably earlier in 2022) are suddenly exposed. Data suggest that although people several months past their last booster would now be more prone to getting reinfected, the protection against severe disease still hangs around 85%. In other words, their chances of ending up in the hospital are low.
Why worry, then, about further boosting the immune system? The same studies show that an additional jab would increase this percentage up to 99%. Is this roughly 10% improvement really worth another worldwide vaccination campaign? Well, this is a numbers game, after all. The current form of the virus is extremely infectious, and the Northern Hemisphere is heading toward the cold months of the year, which we have seen in past years increases COVID-19 contagions, as you would expect from any airborne virus. Thus, it’s easy to expect a new peak in the number of cases, especially considering that we are not going to apply any of the usual restrictions to prevent this. In these conditions, extending the safety net to a further 10% of the population would substantially reduce the total number of victims. It seems like a good investment of resources.
We can be more surgical about it and direct this new vaccination campaign to the population most likely to end up in the hospital. People with concomitant pathologies are at the top of the list, but it’s also an age issue. On the basis of different studies of the most common ages of admission, the cutoff point for the booster varies from country to country, with the lowest being 50 and in other cases hovering around 65 years of age. Given the safety of these vaccines, if we can afford it, the wider we cast the net, the better, but at least we should make every effort to fully vaccinate the higher age brackets.
The final question is which vaccine to give. There are confounding studies about the importance of switching to Omicron-specific jabs, which are finally available. Although this seems like a good idea, since Omicron infections elicit a more effective range of antibodies and new variants seem to better escape our defenses, recent studies suggest that there actually may not be so much difference with the old formula.
The conclusion? Vaccinate the elderly (and some middle-aged too, if possible) and the frail as soon as possible with any version of the booster you have available, if you want to keep hospital pressure to the minimum and save a fair number of complications and deaths over the next months. This regimen of yearly boosters for some may be the scenario for the upcoming years, similar to what we already do for the flu, so we should get used to it.
Dr. Macip is associate professor, department of molecular and cellular biology, University of Leicester (England). He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Lecanemab (Eisai/Biogen), an investigational amyloid-clearing monoclonal antibody, reduced cognitive decline by 27%, compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
Lecanemab (Eisai/Biogen), an investigational amyloid-clearing monoclonal antibody, reduced cognitive decline by 27%, compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
Lecanemab (Eisai/Biogen), an investigational amyloid-clearing monoclonal antibody, reduced cognitive decline by 27%, compared with placebo and decreased amyloid levels in the brain of adults enrolled in a phase 3 trial.
The Clarity AD trial included 1,795 adults with early AD and confirmed amyloid pathology in the brain. Treatment consisted of lecanemab 10 mg/kg biweekly or matching placebo.
Treatment with lecanemab met the primary endpoint, reducing clinical decline on the global cognitive and functional scale, the Clinical Dementia Rating–Sum of Boxes (CDR-SB), at 18 months by 27%, compared with placebo, with a treatment difference in the score change of –0.45 (P = .00005), the companies reported.
Starting as early as 6 months, across all time points, treatment with lecanemab yielded highly statistically significant changes in CDR-SB from baseline, compared with placebo (all P < .01).
The study also met all key secondary endpoints with highly statistically significant results, compared with placebo (P < .01).
Key secondary endpoints, in comparison with placebo, were change from baseline at 18 months in amyloid levels in the brain measured by amyloid PET, the AD Assessment Scale–cognitive subscale14 (ADAS-cog14), the AD Composite Score (ADCOMS), and the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
Imaging abnormalities within expectations
Overall, rates of amyloid-related imaging abnormalities (ARIA) related to lecanemab were “within expectations,” the companies said.
The incidence of ARIA related to edema (ARIA-E) was 12.5% in the lecanemab group and 1.7% in the placebo group.
The incidence of symptomatic ARIA-E was 2.8% and 0.0%, respectively, and the rate of cerebral hemorrhage (ARIA-H) was 17.0% and 8.7%. The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group.
Full results of the Clarity AD trial will be presented in November at the Clinical Trials on Alzheimer’s Congress.
Incremental benefit
Responding to the findings, the Alzheimer’s Association said in a statement that it “enthusiastically welcomes” the positive findings. It noted that these are “the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanemab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions,” the Alzheimer’s Association added.
Also weighing in, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a release that “the combination of the biomarker change – reduced amyloid – plus slowing of cognitive decline in this study is encouraging news for the 57 million patients around the world living with Alzheimer’s.
“However, amyloid-clearing drugs will provide an incremental benefit at best, and there is still a pressing need for the next generation of drugs focused on other targets based on our knowledge of the biology of aging,” Dr. Fillit cautioned.
“We are optimistic about the future as many of these drugs are in development, with 75% of drugs in the pipeline now targeting nonamyloid pathways of neurodegeneration,” he added.
In July 2022, the Food and Drug Administration accepted Eisai’s biologics license application for lecanemab under the accelerated approval pathway and granted priority review. Lecanemab has a prescription Drugs User Fee Act action date of Jan. 6, 2023.
A version of this article first appeared on Medscape.com.
LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.
Within weeks, the Four Seasons brand may be finished.
Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.
Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.
In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.
“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”
What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
Residents as ‘revenue streams’
As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.
But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”
A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”
In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.
“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.
Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.
Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.
Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
The financial shuffle
At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.
Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”
Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.
“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.
Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.
Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”
As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.
How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.
Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.
From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
Beyond government control
British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.
“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”
She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”
In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.
And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.
Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.
Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”
“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.
Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.
Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”
Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.
Within weeks, the Four Seasons brand may be finished.
Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.
Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.
In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.
“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”
What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
Residents as ‘revenue streams’
As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.
But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”
A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”
In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.
“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.
Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.
Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.
Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
The financial shuffle
At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.
Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”
Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.
“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.
Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.
Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”
As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.
How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.
Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.
From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
Beyond government control
British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.
“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”
She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”
In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.
And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.
Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.
Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”
“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.
Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.
Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”
Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.
Within weeks, the Four Seasons brand may be finished.
Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.
Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.
In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.
“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”
What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
Residents as ‘revenue streams’
As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.
But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”
A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”
In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.
“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.
Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.
Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.
Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
The financial shuffle
At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.
Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”
Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.
“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.
Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.
Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”
As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.
How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.
Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.
From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
Beyond government control
British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.
“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”
She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”
In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.
And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.
Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.
Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”
“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.
Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.
Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”
Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
An athletic coach stands in front of a packed gym full of high school students.
“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”
Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.
National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.
Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.
“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.
Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
Changing the status quo
A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.
Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.
The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.
The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.
“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”
Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.
Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
Conquering social media
Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”
Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.
“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”
Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.
Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
Promoting pleasure
While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.
“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”
Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.
Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”
She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
Speaking of adult students – An older generation learns new tricks
While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.
The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.
Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”
In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”
Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.
“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
A big subject requires a big mission
For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.
Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.
“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”
A version of this article first appeared on Medscape.com.
An athletic coach stands in front of a packed gym full of high school students.
“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”
Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.
National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.
Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.
“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.
Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
Changing the status quo
A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.
Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.
The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.
The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.
“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”
Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.
Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
Conquering social media
Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”
Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.
“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”
Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.
Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
Promoting pleasure
While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.
“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”
Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.
Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”
She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
Speaking of adult students – An older generation learns new tricks
While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.
The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.
Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”
In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”
Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.
“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
A big subject requires a big mission
For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.
Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.
“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”
A version of this article first appeared on Medscape.com.
An athletic coach stands in front of a packed gym full of high school students.
“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”
Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.
National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.
Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.
“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.
Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
Changing the status quo
A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.
Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.
The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.
The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.
“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”
Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.
Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
Conquering social media
Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”
Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.
“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”
Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.
Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
Promoting pleasure
While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.
“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”
Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.
Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”
She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
Speaking of adult students – An older generation learns new tricks
While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.
The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.
Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”
In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”
Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.
“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
A big subject requires a big mission
For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.
Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.
“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”
A version of this article first appeared on Medscape.com.
Older age is associated with many health conditions that could potentially benefit from psychedelic-assisted therapy, yet very few older adults have been included in clinical trials of psychedelics, new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
University of Arizona
Dr. C. Bree Johnston
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
courtesy McLean Hospital
Dr. Ipsit Vahia
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Older age is associated with many health conditions that could potentially benefit from psychedelic-assisted therapy, yet very few older adults have been included in clinical trials of psychedelics, new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
University of Arizona
Dr. C. Bree Johnston
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
courtesy McLean Hospital
Dr. Ipsit Vahia
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Older age is associated with many health conditions that could potentially benefit from psychedelic-assisted therapy, yet very few older adults have been included in clinical trials of psychedelics, new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
University of Arizona
Dr. C. Bree Johnston
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
courtesy McLean Hospital
Dr. Ipsit Vahia
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
BARCELONA – Increased frailty of patients with heart failure with preserved ejection fraction (HFpEF) should have no bearing on whether those patients receive sacubitril/valsartan (Entresto), according to results of a post hoc analysis of data from a pivotal trial.
Plus, a recently reported prespecified analysis of data from a different pivotal trial shows that the same rule applies to patients with HFpEF who receive treatment with dapagliflozin (Farxiga). A pair of earlier reports showed similar findings for dapagliflozin and sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF).
Dr. Jawad H. Butt
“There appears to be a greater reduction in the primary outcome and in hospitalizations for heart failure with sacubitril/valsartan compared with valsartan with increasing frailty, and sacubitril/valsartan was safe and well tolerated regardless of frailty status” in post hoc analysis of data from the PARAGON-HF trial, Jawad H. Butt, MD, reported at the annual congress of the European Society of Cardiology.
Analysis of the treatment effect by sacubitril/valsartan compared with valsartan in patients with HFpEF in PARAGON-HF showed that sacubitril/valsartan actually benefited patients more as their frailty increased when researchers applied frailty severity as a continuous variable. When they analyzed frailty’s effect by dividing the study cohort into three subgroups based on frailty severity – not frail, more frail, and most frail – the statistical analysis showed no significant heterogeneity of effect, although the point estimates for each subgroup showed by far the biggest benefit among the most frail patients. A safety analysis showed consistent safety of sacubitril/valsartan compared with valsartan across all three frailty subgroups, Dr. Butt reported.
Simultaneously with his report at the congress the results appeared online in the Journal of the American College of Cardiology.
Don’t withhold sacubitril/valsartan because of frailty
“We should not withhold [sacubitril/valsartan] treatment in patients perceived to be frail,” Dr. Butt declared in an interview. “There are no safety concerns, and no efficacy concerns,” although he cautioned that sacubitril/valsartan is not indicated for all patients with HFpEF. “If you believe that sacubitril/valsartan is indicated for a patient with HFpEF, do not withhold it just because of frailty,” said Dr. Butt, a cardiologist at Copenhagen University Hospital.
Dr. Butt went a step further and stressed, “I don’t think we should measure frailty” when considering patients with heart failure for treatment with sacubitril/valsartan, or with dapagliflozin, which had shown safety and maintained efficacy in a prespecified analysis he recently reported for patients with HFpEF, and in a separate recent report on a post hoc analysis of dapagliflozin use in patients with HFrEF in the DAPA-HF trial.
A published report also showed no evidence for an interaction between frailty and efficacy for sacubitril/valsartan compared with valsartan in the PARADIGM-HF pivotal trial, which enrolled people with HFrEF.
The issue of treatment safety and efficacy for patients considered frail is especially notable because “clinicians may be more reluctant to initiate new therapies due to doubt about the benefit of treatments in frail patients and apprehensions about predisposing them to potential new adverse effects,” said Dr. Butt.
“We should not defer these treatments on account of patient frailty,” said Maja Cikes, MD, a cardiologist at the University Hospital Center Zagreb, Croatia. The report by Dr. Butt “shows the safety” of using sacubitril/valsartan in most patients with HFpEF regardless of their frailty status, Dr. Cikes added in an interview.
Mitchel L. Zoler/MDedge News
Dr. Maja Cikes
‘Benefits without increasing the risk of frailty’
The data reported by Dr. Butt “suggest that although frail older persons with HFpEF are at greater risk for adverse outcomes overall, the prescription of sacubitril/valsartan seems to confer benefits without increasing the risk of frailty-related adverse events,” George A. Heckman, MD, a geriatrician at the University of Waterloo (Canada), and Kenneth Rockwood, MD, professor of geriatric medicine at Dalhousie University in Halifax, N.S., wrote in an editorial that accompanied the published version of Dr. Butt’s report.
The PARADIGM-HF trial enrolled 4,822 patients with heart failure and a left ventricular ejection fraction of at least 45% at 848 centers in 43 countries during 2014-2016, and followed them for a median of 35 months, with a primary endpoint of the combined rate of hospitalization for heart failure or cardiovascular death. Treatment with sacubitril/valsartan reduced the incidence of the primary endpoint by 13% compared with the control patients who received valsartan, a difference that missed narrowly missed significance (P = .06).
Despite this statistically neutral result, the Food and Drug Administration subsequently, based on these results, modified the indicationfor using sacubitril/valsartan from exclusively patients with HFrEF to patients with higher left ventricular ejection fractions, including at least some patients diagnosed with HFpEF.
To run the frailty analysis, Dr. Butt and his associates devised a 41-item frailty index, which identified 45% of the study cohort as not frail, 44% as more frail, and 11% as most frail. Their analyses also showed that frailty severity had no significant relationship to the effect of treatment with sacubitril valsartan on improving quality of life, or on improving functional status. Frailty also played no apparent role in the impact of sacubitril/valsartan compared with valsartan on treatment discontinuations or adverse effects.
PARAGON-HF and PARADIGM-HF were sponsored by Novartis, the company that markets sacubitril/valsartan (Entresto). Dr. Butt has been an adviser to Bayer. Dr. Cikes has received travel support or honoraria from Novartis as well as from Amicus, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Krka, LivaNova, Pfizer, Sanofi, and Teva, and research support or contracts from Novartis as well as from Abbott, Corvia, and Pfizer. Dr. Heckman had no disclosures. Dr. Rockwood is a cofounder of Ardea Outcomes, an adviser to Nutricia, and he holds a copyright through Dalhousie University on the Clinical Frailty Scale (which allows free use for educational, research, and not-for-profit health care purposes).
Mitchel L. Zoler/MDedge News
