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Statins beneficial in elderly, guidelines should be strengthened
Contrary to historical evidence, two new studies show.
“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.
“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.
“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).
The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.
“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.
“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
No RCTs have included patients older than 70
For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.
However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.
Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.
As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
Primary prevention: CV events increase with elevated LDL cholesterol in older age
Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.
Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.
Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.
In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).
Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.
Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).
The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.
“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.
With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.
With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.
“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”
“These robust findings are novel,” he and his colleagues stressed.
Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.
The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
Unequivocal reductions in events in elderly, comparable with younger patients
In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.
The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.
The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.
The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).
Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).
“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.
“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.
“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”
The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”
The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.
A version of this article originally appeared on Medscape.com.
Contrary to historical evidence, two new studies show.
“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.
“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.
“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).
The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.
“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.
“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
No RCTs have included patients older than 70
For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.
However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.
Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.
As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
Primary prevention: CV events increase with elevated LDL cholesterol in older age
Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.
Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.
Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.
In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).
Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.
Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).
The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.
“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.
With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.
With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.
“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”
“These robust findings are novel,” he and his colleagues stressed.
Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.
The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
Unequivocal reductions in events in elderly, comparable with younger patients
In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.
The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.
The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.
The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).
Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).
“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.
“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.
“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”
The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”
The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.
A version of this article originally appeared on Medscape.com.
Contrary to historical evidence, two new studies show.
“By contrast with previous historical studies, our data show that LDL cholesterol is an important risk factor for myocardial infarction and atherosclerotic cardiovascular disease in a contemporary primary prevention cohort of individuals aged 70 to 100 years,” Borge Nordestgaard, MD, of the University of Copenhagen, and colleagues noted in the first of the two studies, published this week in the Lancet.
“By lowering LDL cholesterol in healthy individuals aged 70-100 years, the potential for preventing myocardial infarctions and atherosclerotic cardiovascular disease is huge, and at a substantially lower number needed to treat when compared with those aged 20-69 years,” they added.
“These findings support the concept of the cumulative burden of LDL cholesterol over one’s lifetime and the progressive increase in risk for atherosclerotic cardiovascular disease, including myocardial infarction, with age,” added Frederick J. Raal, PhD, and Farzahna Mohamed, MB BCh, of the University of the Witwatersrand, Johannesburg, South Africa, in an editorial published with both new studies in the Lancet (2020 Nov 10. doi: 10.1016/S0140-6736[20]32333-3).
The studies underscore the need for clinicians to consider continued risks associated with elevated LDL cholesterol in older age, they stressed, adding that statins are also beneficial for younger persons at risk to prevent conditions from worsening.
“The average age of patients in all the trials analyzed was older than 60 years, an age when atherosclerotic cardiovascular disease is already well established,” the editorialists wrote.
“Lipid-lowering therapy should be initiated at a younger age, preferably before age 40 years, in those at risk to delay the onset of atherosclerosis, rather than try to manage the condition once fully established or advanced,” they stressed.
No RCTs have included patients older than 70
For persons aged 40-75 years, elevated LDL cholesterol levels are a known risk factor for MI and atherosclerotic cardiovascular disease, and there is consensus in guidelines regarding treatment with statins.
However, the risk for people older than 70 is controversial. Some studies show little or no association between elevated LDL cholesterol levels and an increased risk for MI.
Contributing to the uncertainty is that few of the randomized, controlled trials that have investigated the question have included patients aged older than 70 years.
As a consequence, many practice guidelines have noted that the level of evidence in older patients is low, and some organizations have lowered the strength of recommendations regarding the treatment for older patients in comparison with younger patients.
Primary prevention: CV events increase with elevated LDL cholesterol in older age
Dr. Nordestgaard and colleagues studied data on 91,131 people living in Copenhagen who did not have atherosclerotic cardiovascular disease or diabetes at baseline and were not taking statins.
Of the participants, 10,592 were aged 70-79 years, and 3,188 participants were aged 80-100 years.
Over an average follow-up period of 7.7 years, 1,515 participants had a first MI, and 3,389 developed atherosclerotic cardiovascular disease.
In the primary-prevention cohort, after multivariate adjustment, the risk of having a heart attack per 1.0 mmol/L increase in LDL cholesterol was increased in the group overall (hazard ratio, 1.34). The increased risk was observed for all age groups, including those aged 80-100 years (HR, 1.28), 70-79 (HR, 1.25), 60-69 (HR, 1.29), 50-59 (HR, 1.28), and 20-49 (HR, 1.68).
Risk for atherosclerotic cardiovascular disease was also raised per 1.0 mmol/L increase in LDL cholesterol overall (HR, 1.16) and in all age groups, particularly those aged 70-100 years.
Greater elevations in LDL cholesterol (5.0 mmol/L or higher, indicative of possible familial hypercholesterolemia) were associated with a notably higher risk for heart attack after multivariate adjustment in people aged 80-100 (HR, 2.99). Risk was also higher among those aged 70-79 (HR, 1.82).
The highest incidence was in those older than 70. The rate was 8.5 heart attacks per 1,000 people per year among those aged 80-100 and 5.2 heart attacks per 1,000 in those aged 70-79. The rates were 2.5 per 1,000 among those 60-69, 1.8 for those aged 50-59, and 0.8 for those aged 20-49.
“The absolute risk [of cardiovascular events] is of course much higher in the elderly than those under the age of 75, but what was a surprise was how clear our results were on a relative risk scale, that the risk associated with elevated LDL [cholesterol] was as high in people aged 80-100 as the younger patients,” Dr. Nordestgaard said in an interview.
With regard to the benefits of cholesterol-lowering drugs, the study showed that the number needed to prevent one heart attack over 5 years was 80 among those aged 80-100; the number was 439 for people aged 50-59.
With regard to stronger statins, when moderate-intensity statins were used, the number needed to treat to prevent one cardiovascular disease event of any type dropped to 42 for patients aged 80-100. It was 88 for those aged 70-79, 164 for those aged 60-69, 345 for those aged 50-59, and 769 for those aged 20-49.
“The clinical significance of this is that it appears those in older age groups indeed benefit from cholesterol-lowering therapy,” Dr. Nordestgaard said. “I think many people have this idea that LDL [cholesterol] is not important over the age of about 70-75, but that’s not the case.”
“These robust findings are novel,” he and his colleagues stressed.
Despite these observational findings, the South African editorialists noted that “whether lipid-lowering therapy should be initiated for primary prevention in people aged 75 years or older is unclear,” owing to the host of risks and benefits that need to be balanced.
The findings of an ongoing randomized, placebo-controlled trial (STAREE) may answer this question, they wrote. It is investigating primary prevention in 18,000 older patients (≥70 years) who are being randomly assigned to receive atorvastatin 40 mg/d or placebo. The study is seeking to determine whether statin treatment extends the length of a disability-free life, which will be assessed on the basis of survival outside permanent residential care. Results are expected in 2022-2023.
Unequivocal reductions in events in elderly, comparable with younger patients
In the second study (Lancet. 2020 Nov 10. doi: 10.1016/S0140-6736[20]32332-1), Baris Gencer, MD, of Brigham and Women’s Hospital, Boston, =and colleagues evaluated the effects of statins and other cholesterol-lowering drugs, including ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors, in older versus younger patients.
The systematic review and meta-analysis of 29 randomized controlled trials, also published in the Lancet, were presented virtually as a poster as part of the 2020 American Heart Association scientific session. It included data on 244,090 patients, including 21,492 aged 75 years and older.
The meta-analysis included studies of cardiovascular outcomes of a guideline-recommended LDL cholesterol–lowering drug, with a median follow-up of at least 2 years and inclusion of data on patients aged 75 years and older.
The results showed that over a median follow-up of 2.2 to 6 years, statin use by older patients was associated with a relative risk reduction of major vascular events of 26% per 1 mmol/L reduction in LDL cholesterol (P = .0019), which was comparable with a risk reduction of 15% per 1 mmol/L reduction in LDL cholesterol for patients younger than 75 years (P = .37, compared with older patients).
Treatment of older patients with LDL cholesterol–lowering drugs was also associated with significantly improved outcomes in cardiovascular death (risk ratio, 0.85), MI (RR, 0.80), stroke (RR, 0.73), and coronary revascularization (RR, 0.80).
“We found an unequivocal reduction in the risk of major vascular events with both statin and nonstatin LDL cholesterol-lowering treatments, which was similar to that seen in younger patients,” the authors wrote.
“Cholesterol-lowering medications are affordable drugs that have reduced risk of heart disease for millions of people worldwide, but until now, their benefits for older people have remained less certain,” said lead author Marc Sabatine, MD, also of Brigham and Women’s Hospital, in a Lancet press release.
“Our analysis indicates that these therapies are as effective in reducing cardiovascular events and deaths in people aged 75 years and over as they are in younger people. We found no offsetting safety concerns, and together, these results should strengthen guideline recommendations for the use of cholesterol-lowering medications, including statin and nonstatin therapy, in elderly people.”
The editorialists agreed: “More than 80% of fatal cardiovascular events occur in individuals older than 65 years, and the incidence of cardiovascular events is increasing in those older than 80 years; therefore, the findings of Gencer and colleagues’ study should encourage the use of lipid-lowering therapy in older patients.”
The authors of the two studies have disclosed no relevant financial relationships. Dr. Raal has received research grants, honoraria, or consulting fees for advisory board membership, professional input, and lectures on lipid-lowering drug therapy from Amgen, Regeneron, Sanofi, Novartis, and the Medicines Company.
A version of this article originally appeared on Medscape.com.
COVID-19 cases in children continue to set records
As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.
In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.
The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.
Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.
Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.
As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.
In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.
The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.
Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.
Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.
As far as the pandemic is concerned, it seems like a pretty small thing. A difference of just 0.3%. Children now represent 11.8% of all COVID-19 cases that have occurred since the beginning of the pandemic, compared with 11.5% 1 week ago, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Hiding behind that 0.3%, however, is a much larger number: 144,145. That is the number of new child cases that occurred during the week that ended Nov. 19, and it’s the highest weekly figure yet, eclipsing the previous high of 111,946 from the week of Nov. 12, the AAP and the CHA said in their latest COVID-19 report. For the week ending Nov. 19, children represented 14.1% of all new cases, up from 14.0% the week before.
In the United States, more than 1.18 million children have been infected by the coronavirus since the beginning of the pandemic, with the total among all ages topping 10 million in 49 states (New York is not providing age distribution), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP/CHA data show. That works out to 11.8% of all cases.
The overall rate of child COVID-19 cases is now up to 1,573 per 100,000 children nationally, with considerable variation seen among the states. The lowest rates can be found in Vermont (344 per 100,000), Maine (452), and Hawaii (675), and the highest in North Dakota (5,589), South Dakota (3,993), and Wisconsin (3,727), the AAP and CHA said in the report.
Comparisons between states are somewhat problematic, though, because “each state makes different decisions about how to report the age distribution of COVID-19 cases, and as a result the age range for reported cases varies by state. … It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states at this time,” the two organizations noted.
Five more COVID-19–related deaths in children were reported during the week of Nov. 19, bringing the count to 138 and holding at just 0.06% of the total for all ages, based on data from 43 states and New York City. Children’s share of hospitalizations increased slightly in the last week, rising from 1.7% to 1.8% in the 24 states (and NYC) that are reporting such data. The total number of child hospitalizations in those jurisdictions is just over 6,700, the AAP and CHA said.
Finerenone’s heart benefits hold up in T2D patients without CVD
Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.
“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.
In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.
Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
CVD history produced heterogeneity for the primary endpoint
In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.
In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.
“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.
Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”
Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”
In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.
Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.
Finerenone looks better for safety
Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.
For treating patients with T2D and CKD ,finerenone overall “looks like a major advance,” Dr. Bhatt said in an interview.
In addition to the positive efficacy results, several experts also focused on what they saw as superior safety of finerenone in the trial, compared with the historical safety of the steroidal mineralocorticoid receptor antagonists (MRAs) now in use: spironolactone and eplerenone.
“I’m a big believer in spironolactone, but it has issues with side effects, and eplerenone never seemed to catch on,” said Dr. Bhatt, who is also executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston.
“A lot of physicians like these MRAs, but acknowledge that side effects have kept these drugs from being used to the extent they should.” The existing MRAs, especially spironolactone, have become a key drug class for treating heart failure with reduced ejection fraction (and, some claim, for also treating heart failure with preserved ejection fraction), as well as treatment-resistant hypertension and primary aldosteronism. By design, FIDELIO-DKD did not enroll patients with heart failure because treatment with an MRA is indicated for those with heart failure with reduced ejection fraction.
The spironolactone adverse effect that generates the greatest concern is hyperkalemia. During his discussion of FIDELIO-DKD as designated discussant, Christoph Wanner, MD, noted a recent study in which the incidence of hyperkalemia severe enough to cause study discontinuation was 23% among patients treated with spironolactone for heart failure, which contrasts with the 2.3% rate in FIDELIO-DKD among finerenone recipients. This hyperkalemia incidence from finerenone also improved on the historical performance of other drugs, like aliskiren (Tekturna), said Dr. Wanner, professor and head of nephrology at the University of Würzburg (Germany).
The FIDELIO-DKD results place finerenone alongside the RAS- and SGLT2-inhibitor drug classes as appropriate treatments for most patients with T2D and CKD. “We have entered a new era of effective treatment for diabetic kidney disease,” Dr. Wanner declared.
“The overall safety profile of finerenone looked better, including hyperkalemia,” said Dr. Bhatt. “Hyperkalemia with spironolactone is not necessarily as bad as the perception. With careful monitoring of spironolactone, the hyperkalemia is manageable. But the perception is that it’s bad, and along with gynecomastia it’s a real killer.”
While some dismiss gynecomastia as a major concern (for men) with spironolactone treatment, “if medical students learn one thing about spironolactone, it’s that it can cause gynecomastia,” adding to the negative image that the approved MRAs carry, Dr. Bhatt said.
“The hyperkalemia was manageable. This is very important because of past problems with potassium when using spironolactone,” Dr. Filippatos said. Finerenone also looks “more cardiorenal protective” than the steroidal MRAs, exerting renal benefits in FIDELIO-DKD never previously described for a steroidal MRA.
Some of the uncertainty about the efficacy of finerenone in patients with a history of cardiovascular disease will lift when results are available in about another year from the FIGARO-DKD pivotal trial of finerenone, which enrolled more than 7,000 patients with T2D and CKD (entry criteria very similar to FIDELIO-CKD). A big difference is that FIGARO-DKD has a composite CVD event metric as its primary endpoint, and includes hospitalization for heart failure as one facet of the composite.
FIDELIO-DKD was sponsored by Bayer. Dr. Filippatos has been a lecturer on behalf of, served as a researcher for, or both for Bayer and also for Amgen, Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor. Dr. Bhatt has received research funding from Bayer and also from several other companies, and he also is an adviser to several companies. Dr. Wanner has received honoraria from Bayer, and also from AstraZeneca, Boehringer Ingelheim, FMC, Gilead, GlaxoSmithKline, Lilly, and Merck.
Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.
“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.
In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.
Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
CVD history produced heterogeneity for the primary endpoint
In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.
In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.
“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.
Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”
Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”
In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.
Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.
Finerenone looks better for safety
Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.
For treating patients with T2D and CKD ,finerenone overall “looks like a major advance,” Dr. Bhatt said in an interview.
In addition to the positive efficacy results, several experts also focused on what they saw as superior safety of finerenone in the trial, compared with the historical safety of the steroidal mineralocorticoid receptor antagonists (MRAs) now in use: spironolactone and eplerenone.
“I’m a big believer in spironolactone, but it has issues with side effects, and eplerenone never seemed to catch on,” said Dr. Bhatt, who is also executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston.
“A lot of physicians like these MRAs, but acknowledge that side effects have kept these drugs from being used to the extent they should.” The existing MRAs, especially spironolactone, have become a key drug class for treating heart failure with reduced ejection fraction (and, some claim, for also treating heart failure with preserved ejection fraction), as well as treatment-resistant hypertension and primary aldosteronism. By design, FIDELIO-DKD did not enroll patients with heart failure because treatment with an MRA is indicated for those with heart failure with reduced ejection fraction.
The spironolactone adverse effect that generates the greatest concern is hyperkalemia. During his discussion of FIDELIO-DKD as designated discussant, Christoph Wanner, MD, noted a recent study in which the incidence of hyperkalemia severe enough to cause study discontinuation was 23% among patients treated with spironolactone for heart failure, which contrasts with the 2.3% rate in FIDELIO-DKD among finerenone recipients. This hyperkalemia incidence from finerenone also improved on the historical performance of other drugs, like aliskiren (Tekturna), said Dr. Wanner, professor and head of nephrology at the University of Würzburg (Germany).
The FIDELIO-DKD results place finerenone alongside the RAS- and SGLT2-inhibitor drug classes as appropriate treatments for most patients with T2D and CKD. “We have entered a new era of effective treatment for diabetic kidney disease,” Dr. Wanner declared.
“The overall safety profile of finerenone looked better, including hyperkalemia,” said Dr. Bhatt. “Hyperkalemia with spironolactone is not necessarily as bad as the perception. With careful monitoring of spironolactone, the hyperkalemia is manageable. But the perception is that it’s bad, and along with gynecomastia it’s a real killer.”
While some dismiss gynecomastia as a major concern (for men) with spironolactone treatment, “if medical students learn one thing about spironolactone, it’s that it can cause gynecomastia,” adding to the negative image that the approved MRAs carry, Dr. Bhatt said.
“The hyperkalemia was manageable. This is very important because of past problems with potassium when using spironolactone,” Dr. Filippatos said. Finerenone also looks “more cardiorenal protective” than the steroidal MRAs, exerting renal benefits in FIDELIO-DKD never previously described for a steroidal MRA.
Some of the uncertainty about the efficacy of finerenone in patients with a history of cardiovascular disease will lift when results are available in about another year from the FIGARO-DKD pivotal trial of finerenone, which enrolled more than 7,000 patients with T2D and CKD (entry criteria very similar to FIDELIO-CKD). A big difference is that FIGARO-DKD has a composite CVD event metric as its primary endpoint, and includes hospitalization for heart failure as one facet of the composite.
FIDELIO-DKD was sponsored by Bayer. Dr. Filippatos has been a lecturer on behalf of, served as a researcher for, or both for Bayer and also for Amgen, Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor. Dr. Bhatt has received research funding from Bayer and also from several other companies, and he also is an adviser to several companies. Dr. Wanner has received honoraria from Bayer, and also from AstraZeneca, Boehringer Ingelheim, FMC, Gilead, GlaxoSmithKline, Lilly, and Merck.
Finerenone, the first nonsteroidal mineralocorticoid receptor antagonist to complete a phase 3 trial, showed cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease, regardless of whether they entered the study with a history of cardiovascular disease, in follow-up analyses of the FIDELIO-DKD trial, which included 5,674 patients.
“Finerenone demonstrated benefits for primary and secondary cardiovascular disease protection,” said Gerasimos Filippatos, MD, at the American Heart Association scientific sessions. Finerenone treatment cut the rate of cardiovascular death, nonfatal MI or stroke, or heart failure hospitalization, when compared with placebo, by a relative 15% among patients with a history of cardiovascular disease (CVD), and by a relative 14% in patients without this history, differences that met a statistical test for consistency. But the absolute, drug-associated increments in benefit over placebo differed between the two CVD subgroups because of a sharp underlying difference in event rates.
In contrast, the analyses reported by Dr. Filippatos and associates from the FIDELIO-DKD study showed significant heterogeneity based on the presence or absence of CVD for the study’s primary endpoint, a composite renal metric that tallied the combined rate of death from renal causes, renal failure, or a sustained drop in estimated glomerular filtration rate of at least 40%. Researchers enrolled patients into FIDELIO-DKD based on having type 2 diabetes (T2D) and chronic kidney disease (CKD). The prevalence of a history of CVD was 46%.
Among patients with a history of CVD, the composite adverse CVD outcome occurred at a rate of 8.5/100 patient-years in patients on placebo and in 7.18/100 patients years among those on finerenone during a median of 2.6 years of follow-up, a 1.32/100–patient-year absolute between-group difference. Among patients in a primary prevention setting, incident CVD event rates during follow-up were roughly half that in the secondary prevention patients. The upshot was that, in the placebo group, the rate was 3.92/100 patient- years, and in those on finerenone was 3.43/100 patient-years, a 0.49/100–patient-year absolute difference.
CVD history produced heterogeneity for the primary endpoint
In the analysis that focused on the study’s primary, renal endpoint, among patients identified as having CVD at study entry, the outcome occurred at a rate of 9.06/100 patient-years in the placebo subgroup and at a rate of 6.6/100 patient years in those who received finerenone, a significant 30% relative risk reduction and an absolute between-group difference of 2.46/100 patient-years.
In contrast, among patients without a CVD history, the composite renal endpoint occurred at a rate of 9.1/100 patient-years in the placebo patients and 8.42/100 patient-years in those on finerenone, a 6% relative risk reduction that was not significant, and a 0.68/100–patient-year absolute difference. This disparity in the primary event rate between the two treatment arms reached statistical significance (P = .016), the investigators reported in the published version of the report in Circulation that simultaneously appeared online.
“The totality of evidence suggests that finerenone could be used in patients with T2D with or without a history of CVD,” explained Dr. Filippatos in an interview. “The P-interaction for the composite kidney outcome is significant, but it is not corrected for multiple testing; therefore, it might be a false-chance finding and must be interpreted cautiously.
Furthermore, in another prespecified kidney composite outcome the results were consistent in patients with and without a history of CVD. In sum, all the FIDELIO-DKD analyses so far are “suggestive of a beneficial effect in patients without a history of CVD.”
Despite these patients receiving guideline directed therapies, “there remains a high unmet medical need in patients with T2D and CKD,” added Dr. Filippatos, professor of cardiology at the University of Athens. “We use multiple treatments for patients with heart failure, and we should use the same mindset for treating patients with T2D and CKD. The costs of dialysis and kidney transplant are very high, so it is important to consider options that slow progression of CKD in these patients.”
In FIDELIO-DKD, virtually all patients were on background therapy with a renin-angiotensin-system (RAS) inhibitor, so the trial’s results suggest that treatment should at least involve dual therapy with finerenone and a RAS inhibitor. Fewer than 5% were on background therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a drug class recently established as another key agent for treating CKD in patients with T2D, setting up the prospect for triple therapy, although this approach has not yet undergone prospective testing.
Combining RAS inhibition, finerenone, and an SGLT2 inhibitor is “potentially a marriage made in diabetes heaven,” commented Deepak L. Bhatt, MD, a professor of medicine at Harvard Medical School, Boston, who has not participated in finerenone studies.
Finerenone looks better for safety
Regardless of subgroup analyses based on history of CVD, the findings from all patients enrolled in FIDELIO-DKD were positive for the both the primary renal outcome and key secondary outcome of composite CVD events. In the total randomized cohort, treatment with finerenone on top of optimized treatment with an ACE inhibitor or angiotensin receptor blocker (RAS inhibition) led to a significant 18% relative risk reduction, compared with placebo, for the primary renal endpoint, and a significant 14% relative drop in the key secondary CVD outcome. Those results were published in October in the New England Journal of Medicine.
For treating patients with T2D and CKD ,finerenone overall “looks like a major advance,” Dr. Bhatt said in an interview.
In addition to the positive efficacy results, several experts also focused on what they saw as superior safety of finerenone in the trial, compared with the historical safety of the steroidal mineralocorticoid receptor antagonists (MRAs) now in use: spironolactone and eplerenone.
“I’m a big believer in spironolactone, but it has issues with side effects, and eplerenone never seemed to catch on,” said Dr. Bhatt, who is also executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston.
“A lot of physicians like these MRAs, but acknowledge that side effects have kept these drugs from being used to the extent they should.” The existing MRAs, especially spironolactone, have become a key drug class for treating heart failure with reduced ejection fraction (and, some claim, for also treating heart failure with preserved ejection fraction), as well as treatment-resistant hypertension and primary aldosteronism. By design, FIDELIO-DKD did not enroll patients with heart failure because treatment with an MRA is indicated for those with heart failure with reduced ejection fraction.
The spironolactone adverse effect that generates the greatest concern is hyperkalemia. During his discussion of FIDELIO-DKD as designated discussant, Christoph Wanner, MD, noted a recent study in which the incidence of hyperkalemia severe enough to cause study discontinuation was 23% among patients treated with spironolactone for heart failure, which contrasts with the 2.3% rate in FIDELIO-DKD among finerenone recipients. This hyperkalemia incidence from finerenone also improved on the historical performance of other drugs, like aliskiren (Tekturna), said Dr. Wanner, professor and head of nephrology at the University of Würzburg (Germany).
The FIDELIO-DKD results place finerenone alongside the RAS- and SGLT2-inhibitor drug classes as appropriate treatments for most patients with T2D and CKD. “We have entered a new era of effective treatment for diabetic kidney disease,” Dr. Wanner declared.
“The overall safety profile of finerenone looked better, including hyperkalemia,” said Dr. Bhatt. “Hyperkalemia with spironolactone is not necessarily as bad as the perception. With careful monitoring of spironolactone, the hyperkalemia is manageable. But the perception is that it’s bad, and along with gynecomastia it’s a real killer.”
While some dismiss gynecomastia as a major concern (for men) with spironolactone treatment, “if medical students learn one thing about spironolactone, it’s that it can cause gynecomastia,” adding to the negative image that the approved MRAs carry, Dr. Bhatt said.
“The hyperkalemia was manageable. This is very important because of past problems with potassium when using spironolactone,” Dr. Filippatos said. Finerenone also looks “more cardiorenal protective” than the steroidal MRAs, exerting renal benefits in FIDELIO-DKD never previously described for a steroidal MRA.
Some of the uncertainty about the efficacy of finerenone in patients with a history of cardiovascular disease will lift when results are available in about another year from the FIGARO-DKD pivotal trial of finerenone, which enrolled more than 7,000 patients with T2D and CKD (entry criteria very similar to FIDELIO-CKD). A big difference is that FIGARO-DKD has a composite CVD event metric as its primary endpoint, and includes hospitalization for heart failure as one facet of the composite.
FIDELIO-DKD was sponsored by Bayer. Dr. Filippatos has been a lecturer on behalf of, served as a researcher for, or both for Bayer and also for Amgen, Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor. Dr. Bhatt has received research funding from Bayer and also from several other companies, and he also is an adviser to several companies. Dr. Wanner has received honoraria from Bayer, and also from AstraZeneca, Boehringer Ingelheim, FMC, Gilead, GlaxoSmithKline, Lilly, and Merck.
FROM AHA 2020
AMA takes on vaccine misinformation, physician vaccines, racism
The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.
Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.
Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.
This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.
Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.
“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.
Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.
A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.
“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
Physician, immunize thyself
The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.
The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”
Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.
According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.
The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
Combating systemic racism
In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.
“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.
The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.
According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”
Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.
“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”
The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.
A version of this article originally appeared on Medscape.com.
The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.
Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.
Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.
This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.
Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.
“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.
Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.
A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.
“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
Physician, immunize thyself
The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.
The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”
Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.
According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.
The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
Combating systemic racism
In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.
“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.
The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.
According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”
Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.
“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”
The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.
A version of this article originally appeared on Medscape.com.
The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.
Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.
Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.
This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.
Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.
“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.
Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.
A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.
“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
Physician, immunize thyself
The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.
The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”
Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.
According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.
The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
Combating systemic racism
In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.
“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.
The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.
According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”
Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.
“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”
The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.
A version of this article originally appeared on Medscape.com.
Dangers of a medical board investigation: How to protect yourself
Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.
The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.
“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.
Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.
“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.
Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
Reprimands to revocations
Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.
According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.
Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.
Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.
Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.
“The gravity of this is something that many physicians don’t understand,” he said.
You can be the subject of anonymous complaints and investigations
Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.
Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.
“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.
Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.
All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.
“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.
In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
Don’t do anything wrong
That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.
“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.
Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.
But what if a physician becomes the subject of an investigation? What should they do?
Take any complaint seriously
Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.
Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.
“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.
Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.
Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.
At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.
Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.
Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.
About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
Don’t try to fix it yourself
Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.
It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
Hire a lawyer
Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.
They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.
Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.
Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.
Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
Get help before it’s too late
Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.
The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”
In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.
The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”
As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.
“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”
A version of this article originally appeared on Medscape.com.
Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.
The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.
“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.
Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.
“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.
Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
Reprimands to revocations
Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.
According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.
Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.
Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.
Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.
“The gravity of this is something that many physicians don’t understand,” he said.
You can be the subject of anonymous complaints and investigations
Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.
Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.
“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.
Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.
All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.
“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.
In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
Don’t do anything wrong
That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.
“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.
Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.
But what if a physician becomes the subject of an investigation? What should they do?
Take any complaint seriously
Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.
Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.
“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.
Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.
Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.
At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.
Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.
Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.
About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
Don’t try to fix it yourself
Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.
It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
Hire a lawyer
Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.
They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.
Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.
Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.
Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
Get help before it’s too late
Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.
The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”
In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.
The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”
As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.
“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”
A version of this article originally appeared on Medscape.com.
Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.
The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.
“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.
Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.
“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.
Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
Reprimands to revocations
Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.
According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.
Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.
Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.
Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.
“The gravity of this is something that many physicians don’t understand,” he said.
You can be the subject of anonymous complaints and investigations
Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.
Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.
“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.
Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.
All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.
“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.
In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
Don’t do anything wrong
That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.
“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.
Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.
But what if a physician becomes the subject of an investigation? What should they do?
Take any complaint seriously
Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.
Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.
“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.
Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.
Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.
At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.
Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.
Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.
About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
Don’t try to fix it yourself
Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.
It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
Hire a lawyer
Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.
They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.
Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.
Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.
Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
Get help before it’s too late
Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.
The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”
In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.
The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”
As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.
“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”
A version of this article originally appeared on Medscape.com.
Would it be smart to sell your medical practice now?
The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.
Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.
“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.
“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
Many doctors have been contemplating closing
The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.
In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.
“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.
“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.
Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
Will your practice be hard to sell?
With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.
“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”
In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.
“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
Practice values have (temporarily) fallen
Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.
COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”
Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”
Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.
“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
How long will it take to sell your practice?
Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.
Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.
The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
What’s the right price for your practice?
For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.
An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.
Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.
COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.
Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
Using valuations to set the price
A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.
Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”
A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.
Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.
This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.
For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”
Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
Buyers’ valuations
Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.
Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”
When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.
Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.
Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.
Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
A primer on valuations
As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”
Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”
The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.
With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.
“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”
The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.
The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.
“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
Will the buyer pay for goodwill?
Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.
“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”
One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.
Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.
Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
Selling to other doctors
Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.
“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”
A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.
The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.
COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”
He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
Selling to or merging with other practices
The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”
Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”
One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
Hospitals as buyers
Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.
Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”
Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.
Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
Selling to private-equity firms
Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.
The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.
Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.
Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.
Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”
The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.
“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.
When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
Do you really want to sell?
“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.
“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.
“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.
Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.
“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.
“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
Many doctors have been contemplating closing
The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.
In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.
“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.
“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.
Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
Will your practice be hard to sell?
With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.
“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”
In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.
“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
Practice values have (temporarily) fallen
Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.
COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”
Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”
Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.
“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
How long will it take to sell your practice?
Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.
Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.
The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
What’s the right price for your practice?
For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.
An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.
Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.
COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.
Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
Using valuations to set the price
A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.
Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”
A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.
Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.
This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.
For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”
Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
Buyers’ valuations
Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.
Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”
When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.
Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.
Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.
Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
A primer on valuations
As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”
Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”
The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.
With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.
“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”
The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.
The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.
“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
Will the buyer pay for goodwill?
Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.
“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”
One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.
Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.
Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
Selling to other doctors
Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.
“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”
A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.
The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.
COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”
He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
Selling to or merging with other practices
The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”
Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”
One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
Hospitals as buyers
Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.
Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”
Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.
Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
Selling to private-equity firms
Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.
The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.
Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.
Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.
Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”
The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.
“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.
When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
Do you really want to sell?
“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.
“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.
“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.
Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.
“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.
“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
Many doctors have been contemplating closing
The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.
In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.
“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.
“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.
Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
Will your practice be hard to sell?
With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.
“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”
In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.
“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
Practice values have (temporarily) fallen
Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.
COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”
Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”
Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.
“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
How long will it take to sell your practice?
Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.
Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.
The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
What’s the right price for your practice?
For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.
An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.
Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.
COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.
Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
Using valuations to set the price
A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.
Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”
A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.
Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.
This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.
For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”
Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
Buyers’ valuations
Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.
Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”
When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.
Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.
Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.
Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
A primer on valuations
As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”
Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”
The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.
With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.
“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”
The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.
The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.
“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
Will the buyer pay for goodwill?
Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.
“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”
One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.
Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.
Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
Selling to other doctors
Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.
“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”
A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.
The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.
COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”
He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
Selling to or merging with other practices
The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”
Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”
One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
Hospitals as buyers
Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.
Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”
Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.
Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
Selling to private-equity firms
Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.
The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.
Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.
Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.
Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”
The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.
“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.
When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
Do you really want to sell?
“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.
“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.
“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”
A version of this article originally appeared on Medscape.com.
Pfizer files for FDA emergency use authorization of COVID vaccine
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
Pfizer and its German partner BioNTech have filed an application with the US Food and Drug Administration (FDA) for an emergency use authorization of its vaccine against COVID-19, the disease caused by SARS-CoV-2, according to a company news release.
It is the latest step in what has been an extraordinarily fast-paced development and testing process, with the companies having reported interim results of phase 3 trials on November 9 and final results this past Wednesday, as reported by Medscape Medical News. The vaccine, BNT162b2, which uses a messenger RNA-based platform, was ultimately found to have 95% efficacy and more than 94% efficacy in individuals over age 65.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at a White House press briefing yesterday.
“We need to put to rest any concept that this was rushed in an inappropriate way,” he said. “This is really solid.”
Pfizer and BioNTech said they believe they have met the FDA’s safety data requirements for emergency use authorization (EUA). The agency in October outlined its expectations for safety and efficacy to secure an EUA.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, MD, Pfizer’s chairman and CEO, in its release.
The FDA is expected to hold a meeting of its Vaccines and Related Biological Products Advisory Committee sometime in December to review the safety and efficacy data in the companies’ application. The committee will review:
- Efficacy data from a total 170 confirmed cases of COVID-19 in the phase 3 study.
- Safety data from a randomly assigned subset of 8000 participants 18 years and older.
- Data on 19,000 enrollees who have been followed for a median of 2 months after the second and final dose.
- Data on the manufacturing processes.
According to Pfizer, the companies plan to submit the efficacy and safety data to a peer-reviewed journal once they have completed their analysis.
Vaccine logistics
The companies — which funded their own trials — signed an agreement with the US government’s Operation Warp Speed program in July to provide 100 million doses of its vaccine following FDA authorization or approval in exchange for $1.95 billion. The US government has the option to acquire up to 500 million more doses.
Pfizer and BioNTech said they will be able to supply 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. The vaccine must be given in two doses, spaced 21 days apart. Pfizer expects to be ready to distribute the vaccine within hours after FDA authorization.
The US government is still on track to deliver the Pfizer vaccine within 24 hours of an FDA authorization, said Operation Warp Speed’s Chief Operating Officer Gen. Gustave F. Perna at yesterday’s White House briefing.
Vice President Mike Pence emphasized that point at the briefing: “The moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours shipping that vaccine to hospitals, healthcare facilities and, 24 hours after that, literally injecting that vaccine into Americans,” he said.
The vaccine will be pushed out through 64 jurisdictions already part of the Centers for Disease Control and Prevention’s vaccines for children distribution program, and will likely be divided up according to population, said Perna.
Pfizer’s vaccine must be shipped and stored at –70°C (–94°F), which has presented logistical and storage issues. The company is testing out delivery methods, including a pilot delivery program in New Mexico, Rhode Island, Tennessee, and Texas that will be active after an FDA authorization. States, hospitals, and pharmacy chains are also buying special freezers.
The National Academies of Sciences, Engineering, and Medicine issued recommendations in October that healthcare workers, first responders, older Americans living in congregate settings (eg, nursing homes), and people with underlying health conditions be the first to receive a coronavirus vaccine. The CDC’s Advisory Committee on Immunization Practices will also be issuing recommendations as soon as the FDA authorizes a vaccine.
Pfizer and BioNTech are also seeking approval for the vaccine with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
This article first appeared on Medscape.com.
Tips for physicians, patients to make the most of the holidays amid COVID
“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.
This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.
Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.
Here are a few tips to help all of us and our patients make the most of this holiday season.
- Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
- Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
- Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.
Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.
For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.
- Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.
Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.
You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.
- Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?
Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?
We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.
I am proud to be a physician during this pandemic, and I hope you are, too!
- Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?
Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.
- Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein
Wishing you health and happiness in this holiday season and beyond.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.
“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.
This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.
Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.
Here are a few tips to help all of us and our patients make the most of this holiday season.
- Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
- Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
- Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.
Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.
For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.
- Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.
Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.
You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.
- Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?
Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?
We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.
I am proud to be a physician during this pandemic, and I hope you are, too!
- Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?
Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.
- Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein
Wishing you health and happiness in this holiday season and beyond.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.
“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.
This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.
Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.
Here are a few tips to help all of us and our patients make the most of this holiday season.
- Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
- Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
- Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.
Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.
For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.
- Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.
Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.
You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.
- Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?
Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?
We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.
I am proud to be a physician during this pandemic, and I hope you are, too!
- Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?
Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.
- Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein
Wishing you health and happiness in this holiday season and beyond.
Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.
FDA authorizes baricitinib combo for COVID-19
The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.
The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.
The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.
The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.
The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.
As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.
The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).
The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.
The FDA emphasizes that an EUA is not a full FDA approval.
In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.
The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.
The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.
The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.
The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.
As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.
The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).
The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.
The FDA emphasizes that an EUA is not a full FDA approval.
In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.
The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.
The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.
The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.
The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.
As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.
The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).
The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.
The FDA emphasizes that an EUA is not a full FDA approval.
In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
This article first appeared on Medscape.com.
‘Smart’ insulin pen with CGM first to launch in emerging field
Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.
Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.
Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.
The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.
InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.
Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”
Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”
Smart pens: How large is the market?
Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.
She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.
Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”
But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”
Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.
Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”
As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”
In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
Emerging field: “I think they’re here to stay”
The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.
The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.
Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.
Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.
For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.
Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.
Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.
“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”
Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
A version of this article originally appeared on Medscape.com.
Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.
Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.
Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.
The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.
InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.
Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”
Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”
Smart pens: How large is the market?
Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.
She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.
Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”
But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”
Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.
Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”
As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”
In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
Emerging field: “I think they’re here to stay”
The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.
The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.
Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.
Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.
For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.
Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.
Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.
“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”
Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
A version of this article originally appeared on Medscape.com.
Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.
Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.
Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.
The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.
InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.
Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”
Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”
Smart pens: How large is the market?
Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.
She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.
Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”
But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”
Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.
Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”
As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”
In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
Emerging field: “I think they’re here to stay”
The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.
The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.
Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.
Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.
For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.
Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.
Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.
“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”
Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
A version of this article originally appeared on Medscape.com.