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‘Overbasalization’ common in type 2 diabetes management
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
that impedes achievement of optimal glycemic control, new research suggests.
Such ‘overbasalization,’ defined as a hemoglobin A1c of greater than 8% despite use of more than 0.5 units/kg per day of basal insulin, was identified in about 40% of patients seen in a Florida primary care clinic during 2015-2018. The findings were published in the April 2021 issue of Clinical Diabetes by Kevin Cowart, PharmD, a diabetes care and education specialist at the University of South Florida, Tampa, and colleagues.
The literature suggests that once people with type 2 diabetes start basal insulin, the chance that they’ll achieve a given hemoglobin A1c target, i.e., less than 7%, diminishes significantly if that goal isn’t achieved within the first year of starting insulin, Dr. Cowart said in an interview.
“Our analysis suggests that overbasalization plays a role in patients with type 2 diabetes on basal insulin not achieving optimal glycemic control. Basal insulin is not designed to address postprandial hyperglycemia. I think there’s a clear need to address hesitancy in therapeutic progression beyond basal insulin. A lot of factors underlie the delays, with therapeutic inertia being one of them. It’s complex,” he said.
Overbasalization seen in large proportion of patients
The study comprised 655 adults diagnosed with type 2 diabetes for at least a year who received a prescription for a basal insulin (glargine U-100, glargine U-300, detemir, degludec U-100, degludec U-200, regular U-500, or NPH insulin).
The patients had a mean hemoglobin A1c of 8.4% and a mean basal insulin dose 0.4 units/kg per day. The prevalence of overbasalization was 38.1% for those with hemoglobin A1c above 8%, 42.7% for those with A1c of 9% or above, and 42% with A1c of 10% or greater.
Patient characteristics independently associated with overbasalization were age 35-54 years (odds ratio 1.89), age 65-80 years (0.44), A1c 9% or greater (13.97), and A1c 10% or greater (6.04). Having a prescription for insulin glargine U-100 was associated with a lower overbasalization risk (0.62). In multivariate analysis, only an A1c of 9% or greater remained significant.
Rozalina G. McCoy, MD, an endocrinologist and primary care clinician at the Mayo Clinic, Rochester, Minn., said in an interview that she sees [overbasalization] frequently in patients who are referred to her. “It’s kind of that wall that patients with type 2 diabetes hit because their A1c is high but their fasting blood sugars are normal. Sometimes it’s assumed that there’s a discrepancy, because people don’t always think about postprandial hyperglycemia.”
She also noted that there has been a push in recent years to simplify regimens, particularly in older patients.
“We really want to avoid rapid-acting insulin in older patients because we’re afraid of hypoglycemia, so we start them on basal and keep the noninsulins like metformin and sulfonylureas around. Initially those control the postprandial blood sugar but over time they’re no longer enough.”
Options exist for addressing postmeal blood sugar highs while minimizing lows
While in the past adding premeal insulin was the only option, today there are alternatives for addressing postmeal hyperglycemia, at least in the short term.
Dr. Cowart advised that the first step is to have patients self-monitor their blood glucose and titrate their basal insulin to address fasting hyperglycemia first. Once that appropriate dose is reached, if the patient’s hemoglobin A1c is still above target, the next step is to evaluate the need for postmeal control.
For patients who are at high cardiovascular risk, the next step might involve adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a glucagon-like peptide 1 receptor agonist (GLP-1RA) instead of premeal insulin. But for patients in whom overbasalization is the main concern, a GLP-1RA might be the better choice since it will have a greater impact on postprandial glucose levels, while an SGLT2i will have more effect on fasting blood sugar, he said.
Another option is to use a fixed-dose combination of basal insulin and a glucagon-like peptide 1 receptor agonist (GLP-1RA), provided there aren’t cost or formulary barriers. “We want to use the right combination of drugs and not use too much of one to lead to hypoglycemia,” Dr. Cowart said.
Dr. McCoy doesn’t use fixed-dose combinations because they don’t allow as much flexibility in dosing. To correct overbasalization, she also recommends adding either a GLP-1RA or SGLT2i instead of premeal insulin. However, she cautions, “you still have to monitor those patients because after a few years it still won’t be enough and you’ll have to add mealtime insulin.”
If cost or lack of coverage prevents a patient’s use of SLGT2i/GLP-1RAs, Dr. McCoy said that adding just one premeal injection of rapid-acting insulin before the largest meal of the day is one option. Another is to use twice-daily NPH insulin instead of analog basal insulin, since that does offer some postprandial coverage.
Dr. Cowart said his approach in cost barrier situations is to try to use patient assistance programs and to look into the patient’s formulary to see if there is step therapy or tier considerations, and maybe have a discussion with the insurance company. “We often have to navigate that, and it does take a significant amount of time and could potentially delay patients getting the right therapy when it’s warranted. That is an area where there is a particular role for pharmacists in helping to overcome that and get patients on the right drugs,” he explained.
Problem may be even more common; testing is key
Dr. McCoy said that the A1c cutoff of 8% used to define overbasalization in the study probably resulted in an underestimation of the problem, since many patients are experiencing nighttime hypoglycemia from the basal insulin. The lows bring down their A1c level, but they’re still experiencing postmeal highs.
“I think they’re missing a lot of people, to be honest. I see a lot of patients with A1cs that aren’t that bad, say 7.5%, and their fasting blood sugars are okay, but if you were to put a [continuous glucose monitor] on those patients, invariably there’s hypoglycemia at night that no one knew about.”
Of course, for insurance reasons, most people with type 2 diabetes don’t currently have access to continuous glucose monitors. And often those who are not taking multiple daily injections are limited to one fingerstick test strip a day.
Dr. McCoy says that if hypoglycemia is a concern she will write a prior authorization justifying more test strips.
“I state explicitly in my notes why I recommend frequent monitoring. If they’re on a sulfonylurea, they should be able to check more frequently because they can have hypoglycemia. Same thing with basal insulin.”
Dr. McCoy advises that patients test their blood sugar 2 hours after the largest meal on one day, and at other times on different days. “Blood glucose after a meal shouldn’t be more than 200 [mg/dL]. If it is, that’s not a failure of basal insulin. It’s doing its job. You just need a different agent.”
Dr. Cowart has no disclosures. Dr. McCoy receives funding from the National Institutes of Health.
FROM CLINICAL DIABETES
COVID-19 vaccination rate rising quickly among adolescents
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
With nearly half of all Americans having received at least one dose of a COVID-19 vaccine, the youngest eligible group is beginning to overcome its late start, according to data from the Centers for Disease Control and Prevention.
As of May 24, 49.4% of the U.S. population – that’s almost 164 million people – has received at least one dose of vaccine. The corresponding figure for children aged 12-15 years is 14.4%, but that’s up from only 0.6% just 3 weeks before. Among children aged 16-17, who’ve been getting vaccinated since early April in some states, the proportion receiving at least one dose went from 24.9% to 33.9% over those same 3 weeks, the CDC said on its COVID Data Tracker site.
The comparatively rapid increase among the younger group of eligible children can be seen over the last 14 days. To put that into perspective, only those aged 25-39 years were higher at 21.9%, while 18-24 (12.1%), 40-49 (13.4%), 50-64 (18.2%), 65-74 (5.3%), and ≥75 (2.9%) were all lower.
The 12- to 15-year-olds are further behind when it comes to full vaccination status, however, with just 0.6% having received both doses of a two-dose vaccine or one dose of the single-shot variety, compared with 21.6% for those aged 16-17 years. Children aged 12-15 make up 5% of the total U.S. population but just 0.1% of all those who have been fully vaccinated versus 2.5% and 1.4%, respectively, for those aged 16-17, the CDC reported.
Cardiologists’ pay increases, despite COVID-19 impacts
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
Despite the huge challenges of COVID-19, including a drop in patient visits, cardiologists reported an average increase in income in 2020 and remain among the top earners in medicine, according to the 2021 Medscape Cardiologist Compensation Report.
Although 46% of cardiologists reported some decline in compensation, average cardiologist income was $459,000 in 2020 – up from $438,000 in 2019.
Cardiologist pay is the third highest of all specialties in the overall 2021 Medscape Physician Compensation Report, which covers U.S. physicians as a whole and almost 18,000 physicians in 29 specialties.
Only plastic surgeons ($526,000) and orthopedists ($511,000) earned more than cardiologists in 2020.
On average among cardiologists, self-employment yields a somewhat higher paycheck than does being employed ($477,000 vs. $450,000).
Just like in last year’s report, nearly two-thirds (61%) of cardiologists overall say they feel fairly compensated.
The average incentive bonus payment for cardiologists in 2020 was 14% of total salary, about the same as last year. Two-thirds of cardiologists who earn an incentive bonus achieve more than three-quarters of their potential annual payment, up from 55% the prior year.
COVID challenges and the road back
The vast majority (92%) of cardiologists who saw a drop in income last year cited COVID-related issues such as job loss, working fewer hours, and seeing fewer patients.
Close to half (48%) of cardiologists who suffered financial or practice-related ill effects as a result of the pandemic expect their income to return to normal this year; 38% believe it will take 2 to 3 years. Notably, 45% of physicians overall said the pandemic did not cause them financial or practice-related harm.
Physician work hours generally declined for at least some time during the pandemic – and some physicians were furloughed – but most are now working about the same number of hours they did prior to COVID-19.
Cardiologists are back working an average of 57 hours per week. Perhaps not surprising, intensivists, infectious disease physicians, and public health/preventive medicine physicians are pulling longer hours now, about 6 or 7 more per week than before.
Although working about the same number of hours per week now as they did before the pandemic, physicians overall are typically seeing fewer patients because of time spent on medical office safety protocols, answering COVID-19–related questions and other factors.
Cardiologists are seeing an average decline in weekly patient visits of about 6% – from 77 to 72 patients. Pediatricians are experiencing the largest average declines – from 78 patients per week prior to 64 now, an 18% drop.
Among self-employed cardiologists, 43% believe that a drop in patient volume of up to one-quarter is permanent.
Most cardiologists remain happy at work
Despite COVID-19 and other professional challenges, most cardiologists (and physicians overall) continue to find their work rewarding.
Cardiologists say the most rewarding aspect of their profession is “being good at what I do/finding answers and diagnoses” (27%), followed by relationships with and gratitude from patients (26%), making the world a better place (23%) and making good money at a job they like (12%). A few cited pride in their profession (6%) and teaching (2%). These figures are in line with last year’s responses.
The most challenging part of practicing cardiology is having so many rules and regulations (22%), followed by having to work long hours (16%), working with electronic health records (13%), trouble getting fair reimbursement (11%), danger/risk associated with treating COVID-19 patients (11%), dealing with difficult patients (8%) and worry about being sued (7%).
Bureaucratic tasks continue to be a burden for physicians in all specialties. On average, cardiologists spend 17.4 hours per week on paperwork and administration, similar to last year (16.9 hours per week) and to physicians overall (16.3 hours).
Despite the challenges, 86% of cardiologists said they would choose medicine again, and 92% would choose cardiology again, about the same as last year.
Most cardiologists (83%) plan to keep Medicare and/or Medicaid patients; only 1% say they won’t take new Medicare or Medicaid patients; and 16% are undecided.
Thirty-nine percent of cardiologists plan to participate in the Merit-based Incentive Payment System (MIPS) in 2021.
“The stakes of the Quality Payment Program – the program that incorporates MIPS – are high, with a 9% penalty applied to all Medicare reimbursement for failure to participate,” said Elizabeth Woodcock, MBA, CPC, president of physician practice consulting firm Woodcock & Associates, Atlanta.
“With margins already slim, most physicians can’t afford this massive penalty. It makes sense to protect your revenue by complying with at least the bare minimum,” she noted.
A version of this article first appeared on Medscape.com.
Evolving strategies in sequencing for HER2+ MBC therapy
The landscape for therapies targeting HER2-positive metastatic breast cancer (MBC) has evolved rapidly in the past few years. In a 12-month window, the U.S. Food and Drug Administration approved four agents targeting human epidermal growth factor 2 (HER2)–positive MBC, starting with trastuzumab deruxtecan in December 2019, followed by neratinib and tucatinib a few months later, and margetuximab last December.
Although first-line therapy for the majority of patients continues to be the CLEOPATRA regimen — the monoclonal antibodies trastuzumab and pertuzumab plus a taxane, such as docetaxel or paclitaxel — .
“We have been really fortunate to see a number of highly effective new therapies approved for HER2-positive MBC in the past year, and this has given us even more options to offer our patients,” remarked Rita Nanda, MD, director of the Breast Oncology Program and associate professor of medicine at University of Chicago Medicine.
What considerations do experts weigh when sequencing HER2-positive MBC?
For Kelly McCann, MD, PhD, the order largely depends on balancing two factors: regimens that will provide the best efficacy in terms of patient survival and quality of life. “In the metastatic setting, I know I’m going to end up using all of the available medications one after the other, so the order that allows patients to continue living their best life for as long as possible is essential,” commented Dr. McCann, a hematologist/oncologist in the department of medicine at the David Geffen School of Medicine, University of California, Los Angeles.
A new second-line option?
Before the wave of drug approvals for metastatic HER2-positive disease last year, oncologists routinely looked to trastuzumab emtansine (T-DM1) as second-line therapy.
But tucatinib may also now be considered in the second-line setting, after results from the HER2CLIMB trial. The decision between tucatinib and T-DM1 largely comes down to the presence or absence of brain metastases.
“T-DM1 is well-tolerated, so it’s still my go-to in the second-line setting unless my patient has a brain metastasis, in which case I opt for tucatinib,” Dr. McCann noted, adding that the HER2-specific oral tyrosine kinase inhibitor (TKI) not only crosses the blood-brain barrier but is also effective in patients with untreated brain metastases.
In HER2CLIMB, tucatinib exhibited strong efficacy in patients with advanced HER2-positive disease, including those with previously treated or untreated brain metastases. The randomized controlled trial, which paired tucatinib with trastuzumab and capecitabine, showed median progression-free survival of 7.8 months in 410 patients with HER2-positive MBC compared with 5.6 months in the 202 patients receiving the placebo regimen. The tucatinib cohort showed an overall survival advantage compared with the placebo group (21.9 vs 17.4 months).
Perhaps the most notable finding occurred in patients with brain or central nervous system (CNS) involvement, which develops in as many as half of patients with HER-positive MBC and is associated with shorter survival. In the HER2CLIMB trial, median progression-free survival was 7.6 months in patients with brain metastases compared with 5.4 months in the placebo group.
A follow-up exploratory analysis, which focused on 291 patients with brain metastases, found that adding tucatinib reduced the risk for intracranial progression by two thirds and death by almost half. In patients with active brain metastases, median progression-free survival reached 9.5 months vs 4.1 months in the placebo group. Those with stable metastases also benefited from tucatinib, with median progression-free survival of 13.9 vs 5.6 months in the placebo group.
On the basis of the results, the authors concluded that this randomized trial was the first to demonstrate improvements in both CNS progression–free survival and overall survival in patients with HER2-positive MBC and brain metastases.
Evolving options in the third-line setting and after
For third-line therapy and beyond, oncologists have an array of newer agents to choose from alongside longer-standing options — which include trastuzumab plus lapatinib, trastuzumab or lapatinib plus capecitabine, as well as T-DM1, if not given as second-line therapy.
According to Dr. McCann, the antibody-drug conjugate trastuzumab deruxtecan has been a particularly exciting addition to third-line treatment. In the phase 2 DESTINY-01 trial, more than 60% of a heavily pretreated population showed an objective response to trastuzumab deruxtecan, with a median response duration of almost 15 months and a median progression-free survival of 16.4 months. Longer-term follow-up results, presented in December at the 2020 San Antonio Breast Cancer Symposium, revealed progression-free survival of 19.4 months and preliminary median overall survival of 24.6 months.
Neratinib, the second TKI to bridge the blood-brain barrier in HER2-positive disease, was also approved for third-line use; however, Sayeh Lavasani, MD, MS, said she is more likely to consider this agent later in the sequence, potentially in the fourth-line setting and beyond, given the more robust outcomes observed in the HER2CLIMB tucatinib trial.
“Neratinib improved progression-free survival and time to intervention for CNS metastasis but, unlike tucatinib, did not demonstrate an overall survival benefit,” remarked Dr. Lavasani, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
More specifically, the phase 3 NALA trial, which randomly assigned patients to receive neratinib plus capecitabine or lapatinib plus capecitabine, reported progression-free survival of 8.8 months in the neratinib group compared with 6.6 months in the control arm but no significant gains in overall survival (hazard ratio, 0.88; P = .2098).
The fourth recently approved drug, margetuximab, has not yet made a significant mark on sequencing decisions for Dr. McCann.
“Margetuximab could have been a potential game changer, but clinical trial results were underwhelming,” she said.
In the phase 3 randomized clinical SOPHIA trial, margetuximab plus chemotherapy prolonged median progression-free survival by just over 1 month compared with trastuzumab plus chemotherapy. Preliminary overall survival data showed a slight, but not significant, benefit in the margetuximab group (21.6 vs 19.8 months).
For Dr. Lavasani, the presence of brain metastases is the most important consideration when weighing sequencing options. “For some of my patients with HER2-positive MBC, it’s ultimately disease progression in the brain that takes their life,” she said.
Aside from CNS metastases, specific sequencing choices may vary on the basis of drug-related tolerance as well as patient preferences. “It is critical to get a patient’s input in treatment selection,” Dr. Nanda remarked. “Given the number of effective treatments for HER2-positive MBC and the lack of data to guide how to sequence these regimens, it is important to ask patients what their preferences are.”
Dr. McCann agreed, noting that “a patient with HER2-positive MBC typically has a life expectancy measured in years, which is also why sequencing should be influenced by quality of life considerations.”
Convenience, side-effect profile, and financial toxicity should factor into clinical decision-making, according to Dr. Nanda. Some patients may, for instance, prefer a combination of tucatinib, capecitabine, and trastuzumab over trastuzumab deruxtecan to avoid hair loss and the risk for interstitial lung disease, which has been reported in more than 13% of patients, whereas others may prefer trastuzumab deruxtecan to avoid the possibility of diarrhea.
Taxanes come with a high risk for infusion reactions — which occur in about 30% of patients — and can cause neuropathy as well as hair loss and severe gastrointestinal side effects. In first-line care, Dr. McCann typically stops the taxane at some point for toxicity reasons and continues with trastuzumab plus pertuzumab until disease progression.
Even with an array of new options for treating metastatic HER2-positive disease, ultimately drug resistance does occur, Dr. Lavasani cautioned. Several ongoing trials are exploring new combinations of existing drugs to see whether those variations move the needle on survival outcomes. The HER2CLIMB-04 trial, for instance, is pairing tucatinib with trastuzumab deruxtecan, whereas HER2CLIMB-02 is pairing tucatinib with T-DM1.
But given progress in drug development in just the past few years, Lisa A. Carey, MD, deputy director of Clinical Sciences at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, sees a promising future for treating metastatic HER2-positive disease. “There is so much going on in the HER2-positive MBC therapeutics space that almost every 6 months, oncologists have to regroup and reevaluate treatment and sequencing, which is a great position to be in,” Dr. Carey noted.
A version of this article first appeared on Medscape.com .
The landscape for therapies targeting HER2-positive metastatic breast cancer (MBC) has evolved rapidly in the past few years. In a 12-month window, the U.S. Food and Drug Administration approved four agents targeting human epidermal growth factor 2 (HER2)–positive MBC, starting with trastuzumab deruxtecan in December 2019, followed by neratinib and tucatinib a few months later, and margetuximab last December.
Although first-line therapy for the majority of patients continues to be the CLEOPATRA regimen — the monoclonal antibodies trastuzumab and pertuzumab plus a taxane, such as docetaxel or paclitaxel — .
“We have been really fortunate to see a number of highly effective new therapies approved for HER2-positive MBC in the past year, and this has given us even more options to offer our patients,” remarked Rita Nanda, MD, director of the Breast Oncology Program and associate professor of medicine at University of Chicago Medicine.
What considerations do experts weigh when sequencing HER2-positive MBC?
For Kelly McCann, MD, PhD, the order largely depends on balancing two factors: regimens that will provide the best efficacy in terms of patient survival and quality of life. “In the metastatic setting, I know I’m going to end up using all of the available medications one after the other, so the order that allows patients to continue living their best life for as long as possible is essential,” commented Dr. McCann, a hematologist/oncologist in the department of medicine at the David Geffen School of Medicine, University of California, Los Angeles.
A new second-line option?
Before the wave of drug approvals for metastatic HER2-positive disease last year, oncologists routinely looked to trastuzumab emtansine (T-DM1) as second-line therapy.
But tucatinib may also now be considered in the second-line setting, after results from the HER2CLIMB trial. The decision between tucatinib and T-DM1 largely comes down to the presence or absence of brain metastases.
“T-DM1 is well-tolerated, so it’s still my go-to in the second-line setting unless my patient has a brain metastasis, in which case I opt for tucatinib,” Dr. McCann noted, adding that the HER2-specific oral tyrosine kinase inhibitor (TKI) not only crosses the blood-brain barrier but is also effective in patients with untreated brain metastases.
In HER2CLIMB, tucatinib exhibited strong efficacy in patients with advanced HER2-positive disease, including those with previously treated or untreated brain metastases. The randomized controlled trial, which paired tucatinib with trastuzumab and capecitabine, showed median progression-free survival of 7.8 months in 410 patients with HER2-positive MBC compared with 5.6 months in the 202 patients receiving the placebo regimen. The tucatinib cohort showed an overall survival advantage compared with the placebo group (21.9 vs 17.4 months).
Perhaps the most notable finding occurred in patients with brain or central nervous system (CNS) involvement, which develops in as many as half of patients with HER-positive MBC and is associated with shorter survival. In the HER2CLIMB trial, median progression-free survival was 7.6 months in patients with brain metastases compared with 5.4 months in the placebo group.
A follow-up exploratory analysis, which focused on 291 patients with brain metastases, found that adding tucatinib reduced the risk for intracranial progression by two thirds and death by almost half. In patients with active brain metastases, median progression-free survival reached 9.5 months vs 4.1 months in the placebo group. Those with stable metastases also benefited from tucatinib, with median progression-free survival of 13.9 vs 5.6 months in the placebo group.
On the basis of the results, the authors concluded that this randomized trial was the first to demonstrate improvements in both CNS progression–free survival and overall survival in patients with HER2-positive MBC and brain metastases.
Evolving options in the third-line setting and after
For third-line therapy and beyond, oncologists have an array of newer agents to choose from alongside longer-standing options — which include trastuzumab plus lapatinib, trastuzumab or lapatinib plus capecitabine, as well as T-DM1, if not given as second-line therapy.
According to Dr. McCann, the antibody-drug conjugate trastuzumab deruxtecan has been a particularly exciting addition to third-line treatment. In the phase 2 DESTINY-01 trial, more than 60% of a heavily pretreated population showed an objective response to trastuzumab deruxtecan, with a median response duration of almost 15 months and a median progression-free survival of 16.4 months. Longer-term follow-up results, presented in December at the 2020 San Antonio Breast Cancer Symposium, revealed progression-free survival of 19.4 months and preliminary median overall survival of 24.6 months.
Neratinib, the second TKI to bridge the blood-brain barrier in HER2-positive disease, was also approved for third-line use; however, Sayeh Lavasani, MD, MS, said she is more likely to consider this agent later in the sequence, potentially in the fourth-line setting and beyond, given the more robust outcomes observed in the HER2CLIMB tucatinib trial.
“Neratinib improved progression-free survival and time to intervention for CNS metastasis but, unlike tucatinib, did not demonstrate an overall survival benefit,” remarked Dr. Lavasani, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
More specifically, the phase 3 NALA trial, which randomly assigned patients to receive neratinib plus capecitabine or lapatinib plus capecitabine, reported progression-free survival of 8.8 months in the neratinib group compared with 6.6 months in the control arm but no significant gains in overall survival (hazard ratio, 0.88; P = .2098).
The fourth recently approved drug, margetuximab, has not yet made a significant mark on sequencing decisions for Dr. McCann.
“Margetuximab could have been a potential game changer, but clinical trial results were underwhelming,” she said.
In the phase 3 randomized clinical SOPHIA trial, margetuximab plus chemotherapy prolonged median progression-free survival by just over 1 month compared with trastuzumab plus chemotherapy. Preliminary overall survival data showed a slight, but not significant, benefit in the margetuximab group (21.6 vs 19.8 months).
For Dr. Lavasani, the presence of brain metastases is the most important consideration when weighing sequencing options. “For some of my patients with HER2-positive MBC, it’s ultimately disease progression in the brain that takes their life,” she said.
Aside from CNS metastases, specific sequencing choices may vary on the basis of drug-related tolerance as well as patient preferences. “It is critical to get a patient’s input in treatment selection,” Dr. Nanda remarked. “Given the number of effective treatments for HER2-positive MBC and the lack of data to guide how to sequence these regimens, it is important to ask patients what their preferences are.”
Dr. McCann agreed, noting that “a patient with HER2-positive MBC typically has a life expectancy measured in years, which is also why sequencing should be influenced by quality of life considerations.”
Convenience, side-effect profile, and financial toxicity should factor into clinical decision-making, according to Dr. Nanda. Some patients may, for instance, prefer a combination of tucatinib, capecitabine, and trastuzumab over trastuzumab deruxtecan to avoid hair loss and the risk for interstitial lung disease, which has been reported in more than 13% of patients, whereas others may prefer trastuzumab deruxtecan to avoid the possibility of diarrhea.
Taxanes come with a high risk for infusion reactions — which occur in about 30% of patients — and can cause neuropathy as well as hair loss and severe gastrointestinal side effects. In first-line care, Dr. McCann typically stops the taxane at some point for toxicity reasons and continues with trastuzumab plus pertuzumab until disease progression.
Even with an array of new options for treating metastatic HER2-positive disease, ultimately drug resistance does occur, Dr. Lavasani cautioned. Several ongoing trials are exploring new combinations of existing drugs to see whether those variations move the needle on survival outcomes. The HER2CLIMB-04 trial, for instance, is pairing tucatinib with trastuzumab deruxtecan, whereas HER2CLIMB-02 is pairing tucatinib with T-DM1.
But given progress in drug development in just the past few years, Lisa A. Carey, MD, deputy director of Clinical Sciences at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, sees a promising future for treating metastatic HER2-positive disease. “There is so much going on in the HER2-positive MBC therapeutics space that almost every 6 months, oncologists have to regroup and reevaluate treatment and sequencing, which is a great position to be in,” Dr. Carey noted.
A version of this article first appeared on Medscape.com .
The landscape for therapies targeting HER2-positive metastatic breast cancer (MBC) has evolved rapidly in the past few years. In a 12-month window, the U.S. Food and Drug Administration approved four agents targeting human epidermal growth factor 2 (HER2)–positive MBC, starting with trastuzumab deruxtecan in December 2019, followed by neratinib and tucatinib a few months later, and margetuximab last December.
Although first-line therapy for the majority of patients continues to be the CLEOPATRA regimen — the monoclonal antibodies trastuzumab and pertuzumab plus a taxane, such as docetaxel or paclitaxel — .
“We have been really fortunate to see a number of highly effective new therapies approved for HER2-positive MBC in the past year, and this has given us even more options to offer our patients,” remarked Rita Nanda, MD, director of the Breast Oncology Program and associate professor of medicine at University of Chicago Medicine.
What considerations do experts weigh when sequencing HER2-positive MBC?
For Kelly McCann, MD, PhD, the order largely depends on balancing two factors: regimens that will provide the best efficacy in terms of patient survival and quality of life. “In the metastatic setting, I know I’m going to end up using all of the available medications one after the other, so the order that allows patients to continue living their best life for as long as possible is essential,” commented Dr. McCann, a hematologist/oncologist in the department of medicine at the David Geffen School of Medicine, University of California, Los Angeles.
A new second-line option?
Before the wave of drug approvals for metastatic HER2-positive disease last year, oncologists routinely looked to trastuzumab emtansine (T-DM1) as second-line therapy.
But tucatinib may also now be considered in the second-line setting, after results from the HER2CLIMB trial. The decision between tucatinib and T-DM1 largely comes down to the presence or absence of brain metastases.
“T-DM1 is well-tolerated, so it’s still my go-to in the second-line setting unless my patient has a brain metastasis, in which case I opt for tucatinib,” Dr. McCann noted, adding that the HER2-specific oral tyrosine kinase inhibitor (TKI) not only crosses the blood-brain barrier but is also effective in patients with untreated brain metastases.
In HER2CLIMB, tucatinib exhibited strong efficacy in patients with advanced HER2-positive disease, including those with previously treated or untreated brain metastases. The randomized controlled trial, which paired tucatinib with trastuzumab and capecitabine, showed median progression-free survival of 7.8 months in 410 patients with HER2-positive MBC compared with 5.6 months in the 202 patients receiving the placebo regimen. The tucatinib cohort showed an overall survival advantage compared with the placebo group (21.9 vs 17.4 months).
Perhaps the most notable finding occurred in patients with brain or central nervous system (CNS) involvement, which develops in as many as half of patients with HER-positive MBC and is associated with shorter survival. In the HER2CLIMB trial, median progression-free survival was 7.6 months in patients with brain metastases compared with 5.4 months in the placebo group.
A follow-up exploratory analysis, which focused on 291 patients with brain metastases, found that adding tucatinib reduced the risk for intracranial progression by two thirds and death by almost half. In patients with active brain metastases, median progression-free survival reached 9.5 months vs 4.1 months in the placebo group. Those with stable metastases also benefited from tucatinib, with median progression-free survival of 13.9 vs 5.6 months in the placebo group.
On the basis of the results, the authors concluded that this randomized trial was the first to demonstrate improvements in both CNS progression–free survival and overall survival in patients with HER2-positive MBC and brain metastases.
Evolving options in the third-line setting and after
For third-line therapy and beyond, oncologists have an array of newer agents to choose from alongside longer-standing options — which include trastuzumab plus lapatinib, trastuzumab or lapatinib plus capecitabine, as well as T-DM1, if not given as second-line therapy.
According to Dr. McCann, the antibody-drug conjugate trastuzumab deruxtecan has been a particularly exciting addition to third-line treatment. In the phase 2 DESTINY-01 trial, more than 60% of a heavily pretreated population showed an objective response to trastuzumab deruxtecan, with a median response duration of almost 15 months and a median progression-free survival of 16.4 months. Longer-term follow-up results, presented in December at the 2020 San Antonio Breast Cancer Symposium, revealed progression-free survival of 19.4 months and preliminary median overall survival of 24.6 months.
Neratinib, the second TKI to bridge the blood-brain barrier in HER2-positive disease, was also approved for third-line use; however, Sayeh Lavasani, MD, MS, said she is more likely to consider this agent later in the sequence, potentially in the fourth-line setting and beyond, given the more robust outcomes observed in the HER2CLIMB tucatinib trial.
“Neratinib improved progression-free survival and time to intervention for CNS metastasis but, unlike tucatinib, did not demonstrate an overall survival benefit,” remarked Dr. Lavasani, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
More specifically, the phase 3 NALA trial, which randomly assigned patients to receive neratinib plus capecitabine or lapatinib plus capecitabine, reported progression-free survival of 8.8 months in the neratinib group compared with 6.6 months in the control arm but no significant gains in overall survival (hazard ratio, 0.88; P = .2098).
The fourth recently approved drug, margetuximab, has not yet made a significant mark on sequencing decisions for Dr. McCann.
“Margetuximab could have been a potential game changer, but clinical trial results were underwhelming,” she said.
In the phase 3 randomized clinical SOPHIA trial, margetuximab plus chemotherapy prolonged median progression-free survival by just over 1 month compared with trastuzumab plus chemotherapy. Preliminary overall survival data showed a slight, but not significant, benefit in the margetuximab group (21.6 vs 19.8 months).
For Dr. Lavasani, the presence of brain metastases is the most important consideration when weighing sequencing options. “For some of my patients with HER2-positive MBC, it’s ultimately disease progression in the brain that takes their life,” she said.
Aside from CNS metastases, specific sequencing choices may vary on the basis of drug-related tolerance as well as patient preferences. “It is critical to get a patient’s input in treatment selection,” Dr. Nanda remarked. “Given the number of effective treatments for HER2-positive MBC and the lack of data to guide how to sequence these regimens, it is important to ask patients what their preferences are.”
Dr. McCann agreed, noting that “a patient with HER2-positive MBC typically has a life expectancy measured in years, which is also why sequencing should be influenced by quality of life considerations.”
Convenience, side-effect profile, and financial toxicity should factor into clinical decision-making, according to Dr. Nanda. Some patients may, for instance, prefer a combination of tucatinib, capecitabine, and trastuzumab over trastuzumab deruxtecan to avoid hair loss and the risk for interstitial lung disease, which has been reported in more than 13% of patients, whereas others may prefer trastuzumab deruxtecan to avoid the possibility of diarrhea.
Taxanes come with a high risk for infusion reactions — which occur in about 30% of patients — and can cause neuropathy as well as hair loss and severe gastrointestinal side effects. In first-line care, Dr. McCann typically stops the taxane at some point for toxicity reasons and continues with trastuzumab plus pertuzumab until disease progression.
Even with an array of new options for treating metastatic HER2-positive disease, ultimately drug resistance does occur, Dr. Lavasani cautioned. Several ongoing trials are exploring new combinations of existing drugs to see whether those variations move the needle on survival outcomes. The HER2CLIMB-04 trial, for instance, is pairing tucatinib with trastuzumab deruxtecan, whereas HER2CLIMB-02 is pairing tucatinib with T-DM1.
But given progress in drug development in just the past few years, Lisa A. Carey, MD, deputy director of Clinical Sciences at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, sees a promising future for treating metastatic HER2-positive disease. “There is so much going on in the HER2-positive MBC therapeutics space that almost every 6 months, oncologists have to regroup and reevaluate treatment and sequencing, which is a great position to be in,” Dr. Carey noted.
A version of this article first appeared on Medscape.com .
The end of happy hour? No safe level of alcohol for the brain
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
There is no safe amount of alcohol consumption for the brain; even moderate drinking adversely affects brain structure and function, according a British study of more 25,000 adults.
“This is one of the largest studies of alcohol and brain health to date,” Anya Topiwala, DPhil, University of Oxford (England), told this news organization.
“There have been previous claims the relationship between alcohol and brain health are J-shaped (ie., small amounts are protective), but we formally tested this and did not find it to be the case. In fact, we found that any level of alcohol was associated with poorer brain health, compared to no alcohol,” Dr. Topiwala added.
The study, which has not yet been peer reviewed, was published online May 12 in MedRxiv.
Global impact on the brain
Participants provided detailed information on their alcohol intake. The cohort included 691 never-drinkers, 617 former drinkers, and 24,069 current drinkers.
Median alcohol intake was 13.5 units (102 g) weekly. Almost half of the sample (48.2%) were drinking above current UK low-risk guidelines (14 units, 112 g weekly), but few were heavy drinkers (>50 units, 400 g weekly).
After adjusting for all known potential confounders and multiple comparisons, a higher volume of alcohol consumed per week was associated with lower gray matter in “almost all areas of the brain,” Dr. Topiwala said in an interview.
Alcohol consumption accounted for up to 0.8% of gray matter volume variance. “The size of the effect is small, albeit greater than any other modifiable risk factor. These brain changes have been previously linked to aging, poorer performance on memory changes, and dementia,” Dr. Topiwala said.
Widespread negative associations were also found between drinking alcohol and all the measures of white matter integrity that were assessed. There was a significant positive association between alcohol consumption and resting-state functional connectivity.
Higher blood pressure and body mass index “steepened” the negative associations between alcohol and brain health, and binge drinking had additive negative effects on brain structure beyond the absolute volume consumed.
There was no evidence that the risk for alcohol-related brain harm differs according to the type of alcohol consumed (wine, beer, or spirits).
A key limitation of the study is that the study population from the UK Biobank represents a sample that is healthier, better educated, and less deprived and is characterized by less ethnic diversity than the general population. “As with any observational study, we cannot infer causality from association,” the authors note.
What remains unclear, they say, is the duration of drinking needed to cause an effect on the brain. It may be that vulnerability is increased during periods of life in which dynamic brain changes occur, such as adolescence and older age.
They also note that some studies of alcohol-dependent individuals have suggested that at least some brain damage is reversible upon abstinence. Whether that is true for moderate drinkers is unknown.
On the basis of their findings, there is “no safe dose of alcohol for the brain,” Dr. Topiwala and colleagues conclude. They suggest that current low-risk drinking guidelines be revisited to take account of brain effects.
Experts weigh in
Several experts weighed in on the study in a statement from the nonprofit UK Science Media Center.
Paul Matthews, MD, head of the department of brain sciences, Imperial College London, noted that this “carefully performed preliminary report extends our earlier UK Dementia Research Institute study of a smaller group from same UK Biobank population also showing that even moderate drinking is associated with greater atrophy of the brain, as well as injury to the heart and liver.”
Dr. Matthews said the investigators’ conclusion that there is no safe threshold below which alcohol consumption has no toxic effects “echoes our own. We join with them in suggesting that current public health guidelines concerning alcohol consumption may need to be revisited.”
Rebecca Dewey, PhD, research fellow in neuroimaging, University of Nottingham (England), cautioned that “the degree to which very small changes in brain volume are harmful” is unknown.
“While there was no threshold under which alcohol consumption did not cause changes in the brain, there may a degree of brain volume difference that is irrelevant to brain health. We don’t know what these people’s brains looked like before they drank alcohol, so the brain may have learned to cope/compensate,” Dewey said.
Sadie Boniface, PhD, head of research at the Institute of Alcohol Studies and visiting researcher at King’s College London, said, “While we can’t yet say for sure whether there is ‘no safe level’ of alcohol regarding brain health at the moment, it has been known for decades that heavy drinking is bad for brain health.
“We also shouldn’t forget alcohol affects all parts of the body and there are multiple health risks. For example, it is already known there is ‘no safe level’ of alcohol consumption for the seven types of cancer caused by alcohol, as identified by the UK chief medical officers,” Dr. Boniface said.
The study was supported in part by the Wellcome Trust, Li Ka Shing Center for Health Information and Discovery, the National Institutes of Health, and the UK Medical Research Council. Dr. Topiwala, Dr. Boniface, Dr. Dewey, and Dr. Matthews have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physicians’ trust in health care leadership drops in pandemic
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a survey conducted by NORC at the University of Chicago on behalf of the American Board of Internal Medicine Foundation.
Survey results, released May 21, indicate that 30% of physicians say their trust in the U.S. health care system and health care leadership has decreased during the pandemic. Only 18% reported an increase in trust.
Physicians, however, have great trust in their fellow clinicians.
In the survey of 600 physicians, 94% said they trust doctors within their practice; 85% trusted doctors outside of their practice; and 89% trusted nurses. That trust increased during the pandemic, with 41% saying their trust in fellow physicians rose and 37% saying their trust in nurses did.
In a separate survey, NORC asked patients about their trust in various aspects of health care. Among 2,069 respondents, a wide majority reported that they trust doctors (84%) and nurses (85%), but only 64% trusted the health care system as a whole. One in three consumers (32%) said their trust in the health care system decreased during the pandemic, compared with 11% who said their trust increased.
The ABIM Foundation released the research findings on May 21 as part of Building Trust, a national campaign that aims to boost trust among patients, clinicians, system leaders, researchers, and others.
Richard J. Baron, MD, president and chief executive officer of the ABIM Foundation, said in an interview, “Clearly there’s lower trust in health care organization leaders and executives, and that’s troubling.
“Science by itself is not enough,” he said. “Becoming trustworthy has to be a core project of everybody in health care.”
Deterioration in physicians’ trust during the pandemic comes in part from failed promises of adequate personal protective equipment and some physicians’ loss of income as a result of the crisis, Dr. Baron said.
He added that the vaccine rollout was very uneven and that policies as to which elective procedures could be performed were handled differently in different parts of the country.
He also noted that, early on, transparency was lacking as to how many COVID patients hospitals were treating, which may have contributed to the decrease in trust in the system.
Fear of being known as ‘the COVID hospital’
Hospitals were afraid of being known as “the COVID hospital” and losing patients who were afraid to come there, Dr. Baron said.
He said the COVID-19 epidemic exacerbated problems regarding trust, but that trust has been declining for some time. The Building Trust campaign will focus on solutions in breaches of trust as physicians move increasingly toward being employees of huge systems, according to Dr. Baron.
However, trust works both ways, Dr. Baron notes. Physicians can be champions for their health care system or “throw the system under the bus,” he said.
For example, if a patient complains about the appointment system, clinicians who trust their institutions may say the system usually works and that they will try to make sure the patient has a better experience next time. Clinicians without trust may say they agree that the health care system doesn’t know what it is doing, and patients may further lose confidence when physicians validate their complaint, and patients may then go elsewhere.
78% of patients trust primary care doctor
When asked whether they trust their primary care physician, 78% of patients said yes. However, trust in doctors was higher among people who were older (90%), White (82%), or had high income (89%). Among people reporting lower trust, 25% said their physician spends too little time with them, and 14% said their doctor does not know or listen to them.
The survey shows that government agencies have work to do to earn trust. Responses indicate that 43% of physicians said they have “complete trust” in government health care agencies, such as the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which is substantially higher than other parts of the health care system. However, trust in agencies declined for 43% of physician respondents and increased for 21%.
Dhruv Khullar, MD, MPP, of the department of health policy and economics at Weill Cornell Medical College in New York, told this news organization the survey results match what he sees anecdotally in medicine – that physicians have been losing trust in the system but not in their colleagues.
He said the sample size of 600 is enough to be influential, though he said he would like to know the response rate, which was not calculated for this survey.
He added that, in large part, physicians’ lack of trust in their systems may come from generally being asked to see more patients and to meet more metrics during the same or shorter periods.
Physicians’ lack of trust in the system can have significant consequences, he said. It can lead to burnout, which has been linked with poorer quality of care and physician turnover, he noted.
COVID-19 led some physicians to wonder whether their system had their best interests at heart, insofar as access to adequate medicines and supplies as well as emotional support were inconsistent, Dr. Khullar said.
He said that to regain trust health care systems need to ask themselves questions in three areas. The first is whether their goals are focused on the best interest of the organization or the best interest of the patient.
“Next is competency,” Dr. Khullar said. “Maybe your motives are right, but are you able to deliver? Are you delivering a good product, whether clinical services or something else?”
The third area is transparency, he said. “Are you going to be honest and forthright in what we’re doing and where we’re going?”
Caroline Pearson, senior vice president of health care strategy for NORC, said the emailed survey was conducted between Dec. 29, 2020, and Feb. 5, 2021, with a health care survey partner that maintains a nationwide panel of physicians across specialties.
She said this report is fairly novel insofar as surveys are more typically conducted regarding patients’ trust of their doctors or of the health care system.
Ms. Pearson said because health care is delivered in teams, understanding the level of trust among the entities helps ensure that care will be delivered effectively and seamlessly with high quality.
“We want our patients to trust our doctors, but we really want doctors to trust each other and trust the hospitals and systems in which they’re working,” she said.
Dr. Baron, Ms. Pearson, and Dr. Khullar report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
First issue vs. April 2021 issue: Much has changed since 1971
For the first readers of Family Practice News, it started with this: “How safe is the pill? An extensive epidemiologic study being carried out in the United Kingdom by the Royal College of General Practitioners is expected to provide definitive answers to this question within the next few years.”
That was the first paragraph of the lead article on the front page of our very first issue, published in October 1971. The report on oral contraceptives, coming from the annual meeting of the British Medical Association in Leicester, largely focused on recruiting – noting that “all women in the study are married” – and data-gathering methods.
That first issue also covered such topics as the effect of “early and frequent coitus” on cervical dysplasia incidence (p. 4), breast cancer in men (p. 13), and treatment of prostate inflammation in patients with impotence (p. 34).
Our April 2021 issue included five articles related to the COVID-19 pandemic, starting on the front page and featuring a photo – a physician sitting at a computer, wearing a mask – and a topic – vaccine-hesitant patients.
Business of medicine today vs. in 1971
At the time of publication of our first issue the United States was in the midst of a 90-day freeze on wages and prices ordered by President Richard Nixon. Two articles in that first issue discussed the subject: “Freeze clouds future of health insurance plans” and “Freeze lets physicians ‘stabilize’ office fees.”
Besides COVID-19, here are some other topics covered in April 2021 but not in 1971: lessons learned from an electronic health records conversion, competition for physicians in the form of a “virtual primary care service” offered by United Healthcare, and the sleep effects of smartphone “addiction.”
Technology, clearly, plays a much larger role in physicians’ lives these days.
Similarities between issues
Not everything has changed, of course. We were informing physicians about heart disease in 1971 with “Primary MD can treat most vascular cases” and “Job satisfaction can help prevent heart disease.”
A look at the latest issue uncovered “Link clinched between high-glycemic index diets and cardiovascular disease events” and “Ultraprocessed ‘healthy’ foods raise cardiovascular disease events risk.” Diabetes is another topic that we have began covering since day one and continue to consider to be relevant to practicing family medicine. “Family attitude key to diabetic’s state” was published in our first issue and “Type 1 diabetes prevention moves toward reality as studies published” ran in our April 2021 issue.
The photos in that first issue, however, present a somewhat jarring counterpoint to our latest issue. The faces that look back from 50 years ago are men’s faces: 29 men, to be exact. There were no photos of women physicians in that issue.
That was not the case in April of 2021. Of the 26 physicians or research scientists who appeared in photos in that issue, 8 were women. Plus, three of those women appeared on the cover.
Among the photos from 1971 were 6 of the 14 founding members of our editorial advisory board, who were, again, all men. Our current board consists of 13 men and 8 women.
Times have changed.
This article was updated 5/27/21.
For the first readers of Family Practice News, it started with this: “How safe is the pill? An extensive epidemiologic study being carried out in the United Kingdom by the Royal College of General Practitioners is expected to provide definitive answers to this question within the next few years.”
That was the first paragraph of the lead article on the front page of our very first issue, published in October 1971. The report on oral contraceptives, coming from the annual meeting of the British Medical Association in Leicester, largely focused on recruiting – noting that “all women in the study are married” – and data-gathering methods.
That first issue also covered such topics as the effect of “early and frequent coitus” on cervical dysplasia incidence (p. 4), breast cancer in men (p. 13), and treatment of prostate inflammation in patients with impotence (p. 34).
Our April 2021 issue included five articles related to the COVID-19 pandemic, starting on the front page and featuring a photo – a physician sitting at a computer, wearing a mask – and a topic – vaccine-hesitant patients.
Business of medicine today vs. in 1971
At the time of publication of our first issue the United States was in the midst of a 90-day freeze on wages and prices ordered by President Richard Nixon. Two articles in that first issue discussed the subject: “Freeze clouds future of health insurance plans” and “Freeze lets physicians ‘stabilize’ office fees.”
Besides COVID-19, here are some other topics covered in April 2021 but not in 1971: lessons learned from an electronic health records conversion, competition for physicians in the form of a “virtual primary care service” offered by United Healthcare, and the sleep effects of smartphone “addiction.”
Technology, clearly, plays a much larger role in physicians’ lives these days.
Similarities between issues
Not everything has changed, of course. We were informing physicians about heart disease in 1971 with “Primary MD can treat most vascular cases” and “Job satisfaction can help prevent heart disease.”
A look at the latest issue uncovered “Link clinched between high-glycemic index diets and cardiovascular disease events” and “Ultraprocessed ‘healthy’ foods raise cardiovascular disease events risk.” Diabetes is another topic that we have began covering since day one and continue to consider to be relevant to practicing family medicine. “Family attitude key to diabetic’s state” was published in our first issue and “Type 1 diabetes prevention moves toward reality as studies published” ran in our April 2021 issue.
The photos in that first issue, however, present a somewhat jarring counterpoint to our latest issue. The faces that look back from 50 years ago are men’s faces: 29 men, to be exact. There were no photos of women physicians in that issue.
That was not the case in April of 2021. Of the 26 physicians or research scientists who appeared in photos in that issue, 8 were women. Plus, three of those women appeared on the cover.
Among the photos from 1971 were 6 of the 14 founding members of our editorial advisory board, who were, again, all men. Our current board consists of 13 men and 8 women.
Times have changed.
This article was updated 5/27/21.
For the first readers of Family Practice News, it started with this: “How safe is the pill? An extensive epidemiologic study being carried out in the United Kingdom by the Royal College of General Practitioners is expected to provide definitive answers to this question within the next few years.”
That was the first paragraph of the lead article on the front page of our very first issue, published in October 1971. The report on oral contraceptives, coming from the annual meeting of the British Medical Association in Leicester, largely focused on recruiting – noting that “all women in the study are married” – and data-gathering methods.
That first issue also covered such topics as the effect of “early and frequent coitus” on cervical dysplasia incidence (p. 4), breast cancer in men (p. 13), and treatment of prostate inflammation in patients with impotence (p. 34).
Our April 2021 issue included five articles related to the COVID-19 pandemic, starting on the front page and featuring a photo – a physician sitting at a computer, wearing a mask – and a topic – vaccine-hesitant patients.
Business of medicine today vs. in 1971
At the time of publication of our first issue the United States was in the midst of a 90-day freeze on wages and prices ordered by President Richard Nixon. Two articles in that first issue discussed the subject: “Freeze clouds future of health insurance plans” and “Freeze lets physicians ‘stabilize’ office fees.”
Besides COVID-19, here are some other topics covered in April 2021 but not in 1971: lessons learned from an electronic health records conversion, competition for physicians in the form of a “virtual primary care service” offered by United Healthcare, and the sleep effects of smartphone “addiction.”
Technology, clearly, plays a much larger role in physicians’ lives these days.
Similarities between issues
Not everything has changed, of course. We were informing physicians about heart disease in 1971 with “Primary MD can treat most vascular cases” and “Job satisfaction can help prevent heart disease.”
A look at the latest issue uncovered “Link clinched between high-glycemic index diets and cardiovascular disease events” and “Ultraprocessed ‘healthy’ foods raise cardiovascular disease events risk.” Diabetes is another topic that we have began covering since day one and continue to consider to be relevant to practicing family medicine. “Family attitude key to diabetic’s state” was published in our first issue and “Type 1 diabetes prevention moves toward reality as studies published” ran in our April 2021 issue.
The photos in that first issue, however, present a somewhat jarring counterpoint to our latest issue. The faces that look back from 50 years ago are men’s faces: 29 men, to be exact. There were no photos of women physicians in that issue.
That was not the case in April of 2021. Of the 26 physicians or research scientists who appeared in photos in that issue, 8 were women. Plus, three of those women appeared on the cover.
Among the photos from 1971 were 6 of the 14 founding members of our editorial advisory board, who were, again, all men. Our current board consists of 13 men and 8 women.
Times have changed.
This article was updated 5/27/21.
ID experts dole out practical advice to help with mask confusion
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.
The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).
The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.
That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.
Among their practical tips on how to interpret the guidance:
To mask or not?
To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said. And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.
Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.
“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.
If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.
The CDC also continues to recommend masks on mass transit for all.
One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.
“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.
“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.
Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.
Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”
In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
How to protect toddlers and infants
With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”
Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
J & J vaccine recipients
With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly?
“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”
Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.
A version of this article first appeared on Medscape.com.
Final SPRINT data confirm lower BP is better
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results include data on some outcome events from the trial that had yet to be adjudicated when the primary analysis was released in 2015, as well as posttrial observational follow-up data collected through July 2016.
The data confirm and enhance the earlier findings and show that “lower is better” when it comes to blood pressure, primary investigator Cora E. Lewis, MD, professor and chair, department of epidemiology, University of Alabama at Birmingham, said in an interview.
Final results of the Systolic Blood Pressure Intervention Trial (SPRINT) were published in the May 20 issue of the New England Journal of Medicine.
For the trial, researchers enrolled 9,361 adults 50 years and older with a SBP between 130 and 180 mm Hg who were at increased risk for cardiovascular disease (CVD) but did not have a history of diabetes or stroke. Patients were randomly assigned to an intensive treatment target (SBP < 120 mm Hg) or a standard treatment target (SBP < 140 mm Hg).
In the final analysis, the rate of the primary outcome was 1.77% per year in the intensive-treatment group and 2.40% per year in the standard-treatment group (hazard ratio [HR], 0.73; 95% confidence interval [CR], 0.63-0.86; P < .001), similar to the earlier SPRINT findings.
All-cause mortality was 1.06% per year in the intensive-treatment group and 1.41% per year in the standard-treatment group (HR, 0.75; 95% CI, 0.61-0.92; P = .006), again similar to the previous findings.
“These results were highly statistically significant. It is remarkable in a trial powered for a composite CVD outcome to obtain a significant benefit for total mortality,” Dr. Lewis said.
She noted that one criticism of the initial SPRINT results was that, for the components of the primary outcome, only heart failure and death due to CVD were significantly lower in the intensively treated group.
“Heart failure can be difficult to diagnose from records in a clinical trial, and the critiques were that this was shaky evidence, given that more participants treated to less than 120 were on diuretics, which could decrease swelling, a key symptom of heart failure,” she explained.
“In these final results, SPRINT found that risk of myocardial infarction, heart failure, and death from CVD were significantly lower in the group treated to less than 120, and risk of the primary outcome, excluding heart failure, was still significantly lower in the more intensively treated group,” she noted.
After the trial phase ended, blood pressure treatment was returned to the participants’ usual source of medical care and the trial treatment goals were no longer pursued. SPRINT continued to collect data on the outcomes through July 2016. During this time, SBP rose 6.9 mm Hg in the intensive-treatment group and 2.6 mm Hg in the standard-treatment group.
“Putting all the data together from the trial phase and the phase after randomized interventions had been stopped, there was still a significant benefit for the more intensive treatment on the primary outcome and on death from all causes,” Dr. Lewis said.
In addition, a separate new analysis based on all the data showed significantly fewer first and recurrent primary outcome events with intensive treatment than with standard treatment (435 vs. 552; HR, 0.78; 95% CI, 0.69-0.89; P < .001).
Manageable risk
The pattern of safety events in the final analysis was similar to the 2015 report. In the intervention period, rates of serious adverse events overall did not differ significantly between the groups. However, rates of hypotension, electrolyte abnormalities, syncope (none leading to injurious falls), and acute kidney injury were higher in the intensive-treatment group.
As in other SPRINT reports, “acute kidney injury safety events were generally mild and there was nearly complete recovery of kidney function within 1 year,” Dr. Lewis said. “This and other analyses we have published indicate this is probably a hemodynamic effect.”
“Intensive treatment can be well tolerated and is generally safe with proper patient selection and monitoring. There are advantages to intensive therapy, and some risks, but I don’t think the risks are such that we should just throw the idea of more intensive treatment out the window,” Dr. Lewis said.
Reached for comment, Carlos G. Santos-Gallego, MD, from the Icahn School of Medicine at Mount Sinai in New York, said there has been “controversy” over whether intensive blood pressure control targeting systolic to below 120 mm Hg is beneficial.
“The original SPRINT trial is incredibly important, in that it conclusively demonstrated that among patients with hypertension and increased cardiovascular risk, targeting systolic blood pressure to below 120 mm Hg resulted in lower rates of adverse cardiovascular events and, importantly, all-cause mortality," compared with the conventional target of 140 mm Hg, he said in an interview.
“This final report of the SPRINT trial basically consolidates, confirms, and corroborates the original SPRINT data,” he noted. However, the final data are “more robust, with additional primary outcome events and all events having been adjudicated by a central committee, and there is an additional observation period of 1 extra year in which the treatment has been discontinued,” he said.
“Over time, we are becoming more and more certain that lower is better with blood pressure. We still have a long way to go, but the cardiology community is slowly becoming more intense in our treatment of blood pressure for our patients,” Dr. Santos-Gallego said.
The potential adverse effects of intensive blood pressure control are “very manageable,” he added.
Support for SPRINT was provided by the National Institutes of Health. Full disclosures for authors are available in the original article. Dr. Santos-Gallego has no relevant disclosures.
A version of this article first appeared on Medscape.com.
HHS to inject billions into mental health, substance use disorders
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.