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Outcomes were mixed among ischemic stroke patients with large vessel occlusion who underwent thrombectomy by an interventional cardiologist as part of a multidisciplinary stroke team, in a single-center, prospective study from Poland.

Results from the 2-year experience show mechanical thrombectomy took longer when carried out by interventional cardiologists than by vascular surgeons and neuroradiologists (120 minutes vs. 105 minutes; P = .020).

The procedures were also less likely to achieve angiographic success, defined as a Thrombolysis in Cerebral Infarction (TICI) scale score of 2b or 3 (55.7% vs. 71.7%; P = .013), reported Krystian Wita, MD, PhD, Medical University of Silesia, Katowice, Poland, and colleagues.

The differences in duration and recanalization require further attention, they noted, and are related to a learning curve, more time dedicated to decision-making and, in some cases, needing a second opinion. Cardiologists performed 80 procedures compared with 116 for vascular surgeons and 52 for neuroradiologists, and treated twice as many patients with a previous stroke (13.9% vs. 6.5%).

Still, the interventional cardiologist- and noncardiologist-treated groups had similar functional independence at 3 months, defined by a modified Rankin Scale (mRS) score of 0 to 2 (44.4% vs. 54.8%; P = .275). Mortality was also similar at 3 months (31.3% vs. 28.0%; P = .595).

“This is the first analysis to prove the noninferiority of the cardiology services in the treatment of stroke with mechanical thrombectomy,” the authors reported in JACC: Cardiovascular Interventions.

But commenting for this news organization, J Mocco, MD, senior vice chair of neurosurgery and director of the Cerebrovascular Center at Mount Sinai Health System, New York, said this study isn’t designed as a noninferiority trial, is “grossly underpowered,” and the comparator cohort is not a gold standard comparator cohort.

“More importantly, they show that the cardiologists got significantly worse technical results and took longer, and we know that technical outcomes and the time to treatment are the two strongest predictors of outcome, which completely correlates with the fact that patients had 11% worse outcomes overall,” he said.

“It’s dumbfounding to me that this has been presented as evidence [that] an interventional cardiologist should be performing thrombectomy,” added Dr. Mocco, president-elect of the Society of NeuroInterventional Surgery.

Dr. Wita and coauthor Andrzej Kulach, MD, PhD, also with the Medical University of Silesia, told this news organization that timing is critical in mechanical thrombectomy (MT) and the sooner it’s performed, the better. But it cannot be performed by just any interventional cardiologist (IC).

“The IC must be trained in the procedure and cooperate with the neurologist to get good results,” they said. “We would like to stress that it is not a procedure for any cath lab and any cardiologist on duty. A network of cardiologists trained in MT must be organized and the stroke teams developed for the local unit to make the strategy reasonable and safe.”

The study was conducted from 2019 to 2020 and to participate, interventional cardiologists had to have performed a minimum of 700 angioplasties and 1,500 coronary angiographies and undergone complex training in thrombectomy, including 14-day training in a reference center and certified courses on a phantom and an animal model. They were also experienced in carotid angioplasty and participated as the second operators in neurointerventions.

“Considering the cardiologists are acting here in a multidisciplinary team led by neurologists, the findings are not surprising,” Dr. Wita and Dr. Kulach said. “What was surprising, is a certain level of skepticism among neurologists when cardiologists are to be involved in the procedure. We hope the quality of cardiology services will help to get over it.”

Major thrombectomy trials such as PRAGUE-16 have supported a role for interventional cardiologists to help meet demand for stroke thrombectomy. Dr. Wita and Dr. Kulach said there’s a lack of trained neuroradiologists and developed infrastructure for thrombectomy, whereas there’s a sufficient network of catheterization laboratories and trained cardiologists who could be involved.

The take-home message from the study, they said, is to “use the existing infrastructure to optimize the treatment of stroke. Building one from the very beginning is more time and resources-consuming.”

Dr. Mocco said a physician’s training is not a factor in the pathway to neurointerventional expertise, as long as they’re willing to put in the appropriate amount of specialization and training.

“There’s no way this represents a turf war or the neurology community somehow protecting its space, which is often used as a distraction, just like the idea that there’s not enough people,” he said. “It’s just not the case. Neurointervention is the most multispecialty space that I’m aware of.”

In the United States, at least, the problem isn’t a lack of resources or people to provide the service, but in getting patients to the correct hospitals, Dr. Mocco said. “We don’t have regionalized stroke care in the United States for the most part, so patients go to any hospital that says they provide stroke care rather than necessarily being triaged to capable centers that can provide the care.”

A 2021 Medicare analysis by Dr. Mocco and colleagues found that higher physician and hospital stroke thrombectomy volumes were associated with lower inpatient mortality and better outcomes.

Efforts are underway to regionalize care and delivery of patients in Los Angeles County and New York City, for example, where ambulances preferentially take patients with suspected large vessel occlusion to thrombectomy-capable stroke centers certified by independent organizations, Dr. Mocco said. In New York, “they’ve shown it has improved outcomes.”

Estêvão Carvalho de Campos Martins, MD, Hospital de Força Aérea do Galeão, Rio de Janeiro, and Fernando Luiz de Melo Bernardi, MD, Hospital Regional do Oeste, Chapecó, Brazil, noted in an accompanying editorial that the observational study is “hypothesis-generating only” and that the disconnect between technical and clinical outcomes is due to a type II error of low power.

They suggest that collaboration between specialties will be “essential for defining the optimal training program, so that ICs can reach solid procedural results.

“The accumulated experience with virtual simulation-based training for stroke could act as an educational accelerator but should be inserted in a prespecified program,” the editorialists said. “How to train and how to insert ICs into [an] MT interdisciplinary team is the current debate; meanwhile ICs are here, and many of them already contributing.”

Dr. Mocco is the principal investigator on research trials funded by Stryker Neurovascular, Microvention, and Penumbra; and is an investor in Cerebrotech, Imperative Care, Endostream, Viseon, BlinkTBI, Myra Medical, Serenity, Vastrax, NTI, RIST, Viz.ai , Synchron, Radical, and Truvic. He serves, or has recently served, as a consultant for: Cerebrotech, Viseon, Endostream, Vastrax, RIST, Synchron, Viz.ai , Perflow, and CVAid. Dr. Carvalho de Campos Martins and Dr. Luiz de Melo Bernardi have disclosed no relevant financial relationships.

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

Outcomes were mixed among ischemic stroke patients with large vessel occlusion who underwent thrombectomy by an interventional cardiologist as part of a multidisciplinary stroke team, in a single-center, prospective study from Poland.

Results from the 2-year experience show mechanical thrombectomy took longer when carried out by interventional cardiologists than by vascular surgeons and neuroradiologists (120 minutes vs. 105 minutes; P = .020).

The procedures were also less likely to achieve angiographic success, defined as a Thrombolysis in Cerebral Infarction (TICI) scale score of 2b or 3 (55.7% vs. 71.7%; P = .013), reported Krystian Wita, MD, PhD, Medical University of Silesia, Katowice, Poland, and colleagues.

The differences in duration and recanalization require further attention, they noted, and are related to a learning curve, more time dedicated to decision-making and, in some cases, needing a second opinion. Cardiologists performed 80 procedures compared with 116 for vascular surgeons and 52 for neuroradiologists, and treated twice as many patients with a previous stroke (13.9% vs. 6.5%).

Still, the interventional cardiologist- and noncardiologist-treated groups had similar functional independence at 3 months, defined by a modified Rankin Scale (mRS) score of 0 to 2 (44.4% vs. 54.8%; P = .275). Mortality was also similar at 3 months (31.3% vs. 28.0%; P = .595).

“This is the first analysis to prove the noninferiority of the cardiology services in the treatment of stroke with mechanical thrombectomy,” the authors reported in JACC: Cardiovascular Interventions.

But commenting for this news organization, J Mocco, MD, senior vice chair of neurosurgery and director of the Cerebrovascular Center at Mount Sinai Health System, New York, said this study isn’t designed as a noninferiority trial, is “grossly underpowered,” and the comparator cohort is not a gold standard comparator cohort.

“More importantly, they show that the cardiologists got significantly worse technical results and took longer, and we know that technical outcomes and the time to treatment are the two strongest predictors of outcome, which completely correlates with the fact that patients had 11% worse outcomes overall,” he said.

“It’s dumbfounding to me that this has been presented as evidence [that] an interventional cardiologist should be performing thrombectomy,” added Dr. Mocco, president-elect of the Society of NeuroInterventional Surgery.

Dr. Wita and coauthor Andrzej Kulach, MD, PhD, also with the Medical University of Silesia, told this news organization that timing is critical in mechanical thrombectomy (MT) and the sooner it’s performed, the better. But it cannot be performed by just any interventional cardiologist (IC).

“The IC must be trained in the procedure and cooperate with the neurologist to get good results,” they said. “We would like to stress that it is not a procedure for any cath lab and any cardiologist on duty. A network of cardiologists trained in MT must be organized and the stroke teams developed for the local unit to make the strategy reasonable and safe.”

The study was conducted from 2019 to 2020 and to participate, interventional cardiologists had to have performed a minimum of 700 angioplasties and 1,500 coronary angiographies and undergone complex training in thrombectomy, including 14-day training in a reference center and certified courses on a phantom and an animal model. They were also experienced in carotid angioplasty and participated as the second operators in neurointerventions.

“Considering the cardiologists are acting here in a multidisciplinary team led by neurologists, the findings are not surprising,” Dr. Wita and Dr. Kulach said. “What was surprising, is a certain level of skepticism among neurologists when cardiologists are to be involved in the procedure. We hope the quality of cardiology services will help to get over it.”

Major thrombectomy trials such as PRAGUE-16 have supported a role for interventional cardiologists to help meet demand for stroke thrombectomy. Dr. Wita and Dr. Kulach said there’s a lack of trained neuroradiologists and developed infrastructure for thrombectomy, whereas there’s a sufficient network of catheterization laboratories and trained cardiologists who could be involved.

The take-home message from the study, they said, is to “use the existing infrastructure to optimize the treatment of stroke. Building one from the very beginning is more time and resources-consuming.”

Dr. Mocco said a physician’s training is not a factor in the pathway to neurointerventional expertise, as long as they’re willing to put in the appropriate amount of specialization and training.

“There’s no way this represents a turf war or the neurology community somehow protecting its space, which is often used as a distraction, just like the idea that there’s not enough people,” he said. “It’s just not the case. Neurointervention is the most multispecialty space that I’m aware of.”

In the United States, at least, the problem isn’t a lack of resources or people to provide the service, but in getting patients to the correct hospitals, Dr. Mocco said. “We don’t have regionalized stroke care in the United States for the most part, so patients go to any hospital that says they provide stroke care rather than necessarily being triaged to capable centers that can provide the care.”

A 2021 Medicare analysis by Dr. Mocco and colleagues found that higher physician and hospital stroke thrombectomy volumes were associated with lower inpatient mortality and better outcomes.

Efforts are underway to regionalize care and delivery of patients in Los Angeles County and New York City, for example, where ambulances preferentially take patients with suspected large vessel occlusion to thrombectomy-capable stroke centers certified by independent organizations, Dr. Mocco said. In New York, “they’ve shown it has improved outcomes.”

Estêvão Carvalho de Campos Martins, MD, Hospital de Força Aérea do Galeão, Rio de Janeiro, and Fernando Luiz de Melo Bernardi, MD, Hospital Regional do Oeste, Chapecó, Brazil, noted in an accompanying editorial that the observational study is “hypothesis-generating only” and that the disconnect between technical and clinical outcomes is due to a type II error of low power.

They suggest that collaboration between specialties will be “essential for defining the optimal training program, so that ICs can reach solid procedural results.

“The accumulated experience with virtual simulation-based training for stroke could act as an educational accelerator but should be inserted in a prespecified program,” the editorialists said. “How to train and how to insert ICs into [an] MT interdisciplinary team is the current debate; meanwhile ICs are here, and many of them already contributing.”

Dr. Mocco is the principal investigator on research trials funded by Stryker Neurovascular, Microvention, and Penumbra; and is an investor in Cerebrotech, Imperative Care, Endostream, Viseon, BlinkTBI, Myra Medical, Serenity, Vastrax, NTI, RIST, Viz.ai , Synchron, Radical, and Truvic. He serves, or has recently served, as a consultant for: Cerebrotech, Viseon, Endostream, Vastrax, RIST, Synchron, Viz.ai , Perflow, and CVAid. Dr. Carvalho de Campos Martins and Dr. Luiz de Melo Bernardi have disclosed no relevant financial relationships.

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

Outcomes were mixed among ischemic stroke patients with large vessel occlusion who underwent thrombectomy by an interventional cardiologist as part of a multidisciplinary stroke team, in a single-center, prospective study from Poland.

Results from the 2-year experience show mechanical thrombectomy took longer when carried out by interventional cardiologists than by vascular surgeons and neuroradiologists (120 minutes vs. 105 minutes; P = .020).

The procedures were also less likely to achieve angiographic success, defined as a Thrombolysis in Cerebral Infarction (TICI) scale score of 2b or 3 (55.7% vs. 71.7%; P = .013), reported Krystian Wita, MD, PhD, Medical University of Silesia, Katowice, Poland, and colleagues.

The differences in duration and recanalization require further attention, they noted, and are related to a learning curve, more time dedicated to decision-making and, in some cases, needing a second opinion. Cardiologists performed 80 procedures compared with 116 for vascular surgeons and 52 for neuroradiologists, and treated twice as many patients with a previous stroke (13.9% vs. 6.5%).

Still, the interventional cardiologist- and noncardiologist-treated groups had similar functional independence at 3 months, defined by a modified Rankin Scale (mRS) score of 0 to 2 (44.4% vs. 54.8%; P = .275). Mortality was also similar at 3 months (31.3% vs. 28.0%; P = .595).

“This is the first analysis to prove the noninferiority of the cardiology services in the treatment of stroke with mechanical thrombectomy,” the authors reported in JACC: Cardiovascular Interventions.

But commenting for this news organization, J Mocco, MD, senior vice chair of neurosurgery and director of the Cerebrovascular Center at Mount Sinai Health System, New York, said this study isn’t designed as a noninferiority trial, is “grossly underpowered,” and the comparator cohort is not a gold standard comparator cohort.

“More importantly, they show that the cardiologists got significantly worse technical results and took longer, and we know that technical outcomes and the time to treatment are the two strongest predictors of outcome, which completely correlates with the fact that patients had 11% worse outcomes overall,” he said.

“It’s dumbfounding to me that this has been presented as evidence [that] an interventional cardiologist should be performing thrombectomy,” added Dr. Mocco, president-elect of the Society of NeuroInterventional Surgery.

Dr. Wita and coauthor Andrzej Kulach, MD, PhD, also with the Medical University of Silesia, told this news organization that timing is critical in mechanical thrombectomy (MT) and the sooner it’s performed, the better. But it cannot be performed by just any interventional cardiologist (IC).

“The IC must be trained in the procedure and cooperate with the neurologist to get good results,” they said. “We would like to stress that it is not a procedure for any cath lab and any cardiologist on duty. A network of cardiologists trained in MT must be organized and the stroke teams developed for the local unit to make the strategy reasonable and safe.”

The study was conducted from 2019 to 2020 and to participate, interventional cardiologists had to have performed a minimum of 700 angioplasties and 1,500 coronary angiographies and undergone complex training in thrombectomy, including 14-day training in a reference center and certified courses on a phantom and an animal model. They were also experienced in carotid angioplasty and participated as the second operators in neurointerventions.

“Considering the cardiologists are acting here in a multidisciplinary team led by neurologists, the findings are not surprising,” Dr. Wita and Dr. Kulach said. “What was surprising, is a certain level of skepticism among neurologists when cardiologists are to be involved in the procedure. We hope the quality of cardiology services will help to get over it.”

Major thrombectomy trials such as PRAGUE-16 have supported a role for interventional cardiologists to help meet demand for stroke thrombectomy. Dr. Wita and Dr. Kulach said there’s a lack of trained neuroradiologists and developed infrastructure for thrombectomy, whereas there’s a sufficient network of catheterization laboratories and trained cardiologists who could be involved.

The take-home message from the study, they said, is to “use the existing infrastructure to optimize the treatment of stroke. Building one from the very beginning is more time and resources-consuming.”

Dr. Mocco said a physician’s training is not a factor in the pathway to neurointerventional expertise, as long as they’re willing to put in the appropriate amount of specialization and training.

“There’s no way this represents a turf war or the neurology community somehow protecting its space, which is often used as a distraction, just like the idea that there’s not enough people,” he said. “It’s just not the case. Neurointervention is the most multispecialty space that I’m aware of.”

In the United States, at least, the problem isn’t a lack of resources or people to provide the service, but in getting patients to the correct hospitals, Dr. Mocco said. “We don’t have regionalized stroke care in the United States for the most part, so patients go to any hospital that says they provide stroke care rather than necessarily being triaged to capable centers that can provide the care.”

A 2021 Medicare analysis by Dr. Mocco and colleagues found that higher physician and hospital stroke thrombectomy volumes were associated with lower inpatient mortality and better outcomes.

Efforts are underway to regionalize care and delivery of patients in Los Angeles County and New York City, for example, where ambulances preferentially take patients with suspected large vessel occlusion to thrombectomy-capable stroke centers certified by independent organizations, Dr. Mocco said. In New York, “they’ve shown it has improved outcomes.”

Estêvão Carvalho de Campos Martins, MD, Hospital de Força Aérea do Galeão, Rio de Janeiro, and Fernando Luiz de Melo Bernardi, MD, Hospital Regional do Oeste, Chapecó, Brazil, noted in an accompanying editorial that the observational study is “hypothesis-generating only” and that the disconnect between technical and clinical outcomes is due to a type II error of low power.

They suggest that collaboration between specialties will be “essential for defining the optimal training program, so that ICs can reach solid procedural results.

“The accumulated experience with virtual simulation-based training for stroke could act as an educational accelerator but should be inserted in a prespecified program,” the editorialists said. “How to train and how to insert ICs into [an] MT interdisciplinary team is the current debate; meanwhile ICs are here, and many of them already contributing.”

Dr. Mocco is the principal investigator on research trials funded by Stryker Neurovascular, Microvention, and Penumbra; and is an investor in Cerebrotech, Imperative Care, Endostream, Viseon, BlinkTBI, Myra Medical, Serenity, Vastrax, NTI, RIST, Viz.ai , Synchron, Radical, and Truvic. He serves, or has recently served, as a consultant for: Cerebrotech, Viseon, Endostream, Vastrax, RIST, Synchron, Viz.ai , Perflow, and CVAid. Dr. Carvalho de Campos Martins and Dr. Luiz de Melo Bernardi have disclosed no relevant financial relationships.

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

A high percentage of people with type 2 diabetes also have atherosclerotic cardiovascular disease (ASCVD), but fewer than 1 in 20 get the triumvirate of evidence-based medications – drugs to lower cholesterol, blood pressure, and glucose levels – that can mitigate the dominant health risks they face, a large multicenter cohort study reported.

The cohort consisted of 324,706 patients with diabetes and ASCVD in the National Patient-Centered Clinical Research Network in 2018.

Senior study author Christopher B. Granger, MD, said in an interview that the findings represent “a shocking underuse of treatments proven to improve outcomes in this high-risk population.” For example, he noted that high-intensity statins are “inexpensive, well tolerated, and highly effective, but the fact that they’re only used in 26.8% of this population is really an indictment and embarrassment for our health-care system.”

The study analyzed prescriptions of high-intensity statins to lower cholesterol, ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure, and SGLT2 inhibitors or GLP-1 receptor agonists for hyperglycemia in a population with both diabetes and ASCVD.

This study amplifies the perceived treatment gap in cardiovascular risk reduction in persons with diabetes,” Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “The unfortunate treatment deficiency documented among 325,000 patients in 12 health systems is carefully quantitated and the message is loud, clear, and simple: There is gross underutilization of agents – ACE inhibitors and ARBs, SGLT-2 inhibitors, GLP-1 receptor agonists, and high-intensity statins – with definitively proven ASCVD benefit.”

Overcoming barriers to prescriptions

The study noted that more work needs to be done to overcome the barriers to more widespread use of these therapies in patients with both diabetes and ASCVD.

Specifically with SGLT2 inhibitors and GLP-1 receptor agonists, cost was more likely to be a barrier than with the other drug groups, but that didn’t explain the low levels of high-intensity statin prescriptions, said Dr. Granger of Duke University, Durham, N.C.

The first barrier he mentioned is what he called “clinical inertia.” He said: “I’m a cardiologist who cares for these patients in my clinic each week, and there are so many different things that we need to be trying to achieve with the brief time we have with each patient in our clinic setting that people tend to miss the opportunity.”

The cost barrier, especially with the glucose-lowering therapies, can be overcome with clinic and health care system programs that aid patients in getting discounted drugs, he noted.

Other barriers Dr. Granger pointed out are lack of education – “So many people think that people with previous muscle aches can’t take a high-intensity statin, and we know that’s not true” – and misinformation, which he called “the more nefarious issue.”

He said, “Part of the problem is that misinformation travels much faster than accurate information. There’s so much out there about statins being toxic, which is just not true.”

Fragmentation of the U.S. health care system and the lack of feedback on quality measures, and physicians deferring decisions on glucose-lowering therapy to endocrinologists also pose barriers to more widespread use of evidence-based therapies in patients with diabetes and ASCVD, Dr. Granger said.

“This is a call to action,” Dr. Granger said. “By clearly describing these gaps, we hope that people will see this as an important opportunity to improve care not only at the level of individual providers, but even more importantly at the level of health systems.”

Dr. Jellinger said the “dismal results” of the study serve as a “wake-up call,” adding that “my own perception among my colleagues, along with the data referred to in this article, point to definitely higher usage among commercially insured patients. However, even in more enriched populations the message is not having its full impact. We have remarkable agents for our patients with diabetes that can make a real impact in diabetes-related morbidity and mortality. Our twofold goal should be to aggressively educate a broad slate of health care professionals and, of course, make patient access easy and affordable without ‘prior authorization.’ ”

The study noted the need to bring the prescribing patterns for patients with both diabetes and ASCVD more in line with evidence-based guidelines. To that end, said Dr. Granger, the researchers are moving ahead on a randomized study of a quality improvement project involving about 45 U.S. cardiology clinics using a feedback loop to apply more consistent prescribing patterns for the three therapy groups. “Hopefully a year from now we’ll have a lot more information about this problem,” Dr. Granger added.

Boehringer Ingelheim and Lilly funded the study. Dr. Granger reported financial relationships with Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, Medtronic, Akros Pharma, Apple, AstraZeneca, Daichi-Sankyo, Novartis, AbbVie, Bayer, Boston Scientific, CeleCor, Correvio, Espero, Merck, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Jellinger is on speaker’s bureaus for Esperion and Amgen.
 

A high percentage of people with type 2 diabetes also have atherosclerotic cardiovascular disease (ASCVD), but fewer than 1 in 20 get the triumvirate of evidence-based medications – drugs to lower cholesterol, blood pressure, and glucose levels – that can mitigate the dominant health risks they face, a large multicenter cohort study reported.

The cohort consisted of 324,706 patients with diabetes and ASCVD in the National Patient-Centered Clinical Research Network in 2018.

Senior study author Christopher B. Granger, MD, said in an interview that the findings represent “a shocking underuse of treatments proven to improve outcomes in this high-risk population.” For example, he noted that high-intensity statins are “inexpensive, well tolerated, and highly effective, but the fact that they’re only used in 26.8% of this population is really an indictment and embarrassment for our health-care system.”

The study analyzed prescriptions of high-intensity statins to lower cholesterol, ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure, and SGLT2 inhibitors or GLP-1 receptor agonists for hyperglycemia in a population with both diabetes and ASCVD.

This study amplifies the perceived treatment gap in cardiovascular risk reduction in persons with diabetes,” Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “The unfortunate treatment deficiency documented among 325,000 patients in 12 health systems is carefully quantitated and the message is loud, clear, and simple: There is gross underutilization of agents – ACE inhibitors and ARBs, SGLT-2 inhibitors, GLP-1 receptor agonists, and high-intensity statins – with definitively proven ASCVD benefit.”

Overcoming barriers to prescriptions

The study noted that more work needs to be done to overcome the barriers to more widespread use of these therapies in patients with both diabetes and ASCVD.

Specifically with SGLT2 inhibitors and GLP-1 receptor agonists, cost was more likely to be a barrier than with the other drug groups, but that didn’t explain the low levels of high-intensity statin prescriptions, said Dr. Granger of Duke University, Durham, N.C.

The first barrier he mentioned is what he called “clinical inertia.” He said: “I’m a cardiologist who cares for these patients in my clinic each week, and there are so many different things that we need to be trying to achieve with the brief time we have with each patient in our clinic setting that people tend to miss the opportunity.”

The cost barrier, especially with the glucose-lowering therapies, can be overcome with clinic and health care system programs that aid patients in getting discounted drugs, he noted.

Other barriers Dr. Granger pointed out are lack of education – “So many people think that people with previous muscle aches can’t take a high-intensity statin, and we know that’s not true” – and misinformation, which he called “the more nefarious issue.”

He said, “Part of the problem is that misinformation travels much faster than accurate information. There’s so much out there about statins being toxic, which is just not true.”

Fragmentation of the U.S. health care system and the lack of feedback on quality measures, and physicians deferring decisions on glucose-lowering therapy to endocrinologists also pose barriers to more widespread use of evidence-based therapies in patients with diabetes and ASCVD, Dr. Granger said.

“This is a call to action,” Dr. Granger said. “By clearly describing these gaps, we hope that people will see this as an important opportunity to improve care not only at the level of individual providers, but even more importantly at the level of health systems.”

Dr. Jellinger said the “dismal results” of the study serve as a “wake-up call,” adding that “my own perception among my colleagues, along with the data referred to in this article, point to definitely higher usage among commercially insured patients. However, even in more enriched populations the message is not having its full impact. We have remarkable agents for our patients with diabetes that can make a real impact in diabetes-related morbidity and mortality. Our twofold goal should be to aggressively educate a broad slate of health care professionals and, of course, make patient access easy and affordable without ‘prior authorization.’ ”

The study noted the need to bring the prescribing patterns for patients with both diabetes and ASCVD more in line with evidence-based guidelines. To that end, said Dr. Granger, the researchers are moving ahead on a randomized study of a quality improvement project involving about 45 U.S. cardiology clinics using a feedback loop to apply more consistent prescribing patterns for the three therapy groups. “Hopefully a year from now we’ll have a lot more information about this problem,” Dr. Granger added.

Boehringer Ingelheim and Lilly funded the study. Dr. Granger reported financial relationships with Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, Medtronic, Akros Pharma, Apple, AstraZeneca, Daichi-Sankyo, Novartis, AbbVie, Bayer, Boston Scientific, CeleCor, Correvio, Espero, Merck, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Jellinger is on speaker’s bureaus for Esperion and Amgen.
 

A high percentage of people with type 2 diabetes also have atherosclerotic cardiovascular disease (ASCVD), but fewer than 1 in 20 get the triumvirate of evidence-based medications – drugs to lower cholesterol, blood pressure, and glucose levels – that can mitigate the dominant health risks they face, a large multicenter cohort study reported.

The cohort consisted of 324,706 patients with diabetes and ASCVD in the National Patient-Centered Clinical Research Network in 2018.

Senior study author Christopher B. Granger, MD, said in an interview that the findings represent “a shocking underuse of treatments proven to improve outcomes in this high-risk population.” For example, he noted that high-intensity statins are “inexpensive, well tolerated, and highly effective, but the fact that they’re only used in 26.8% of this population is really an indictment and embarrassment for our health-care system.”

The study analyzed prescriptions of high-intensity statins to lower cholesterol, ACE inhibitors or angiotensin-receptor blockers (ARBs) for blood pressure, and SGLT2 inhibitors or GLP-1 receptor agonists for hyperglycemia in a population with both diabetes and ASCVD.

This study amplifies the perceived treatment gap in cardiovascular risk reduction in persons with diabetes,” Paul S. Jellinger, MD, of the Center for Diabetes and Endocrine Care in Hollywood, Fla., said in an interview. “The unfortunate treatment deficiency documented among 325,000 patients in 12 health systems is carefully quantitated and the message is loud, clear, and simple: There is gross underutilization of agents – ACE inhibitors and ARBs, SGLT-2 inhibitors, GLP-1 receptor agonists, and high-intensity statins – with definitively proven ASCVD benefit.”

Overcoming barriers to prescriptions

The study noted that more work needs to be done to overcome the barriers to more widespread use of these therapies in patients with both diabetes and ASCVD.

Specifically with SGLT2 inhibitors and GLP-1 receptor agonists, cost was more likely to be a barrier than with the other drug groups, but that didn’t explain the low levels of high-intensity statin prescriptions, said Dr. Granger of Duke University, Durham, N.C.

The first barrier he mentioned is what he called “clinical inertia.” He said: “I’m a cardiologist who cares for these patients in my clinic each week, and there are so many different things that we need to be trying to achieve with the brief time we have with each patient in our clinic setting that people tend to miss the opportunity.”

The cost barrier, especially with the glucose-lowering therapies, can be overcome with clinic and health care system programs that aid patients in getting discounted drugs, he noted.

Other barriers Dr. Granger pointed out are lack of education – “So many people think that people with previous muscle aches can’t take a high-intensity statin, and we know that’s not true” – and misinformation, which he called “the more nefarious issue.”

He said, “Part of the problem is that misinformation travels much faster than accurate information. There’s so much out there about statins being toxic, which is just not true.”

Fragmentation of the U.S. health care system and the lack of feedback on quality measures, and physicians deferring decisions on glucose-lowering therapy to endocrinologists also pose barriers to more widespread use of evidence-based therapies in patients with diabetes and ASCVD, Dr. Granger said.

“This is a call to action,” Dr. Granger said. “By clearly describing these gaps, we hope that people will see this as an important opportunity to improve care not only at the level of individual providers, but even more importantly at the level of health systems.”

Dr. Jellinger said the “dismal results” of the study serve as a “wake-up call,” adding that “my own perception among my colleagues, along with the data referred to in this article, point to definitely higher usage among commercially insured patients. However, even in more enriched populations the message is not having its full impact. We have remarkable agents for our patients with diabetes that can make a real impact in diabetes-related morbidity and mortality. Our twofold goal should be to aggressively educate a broad slate of health care professionals and, of course, make patient access easy and affordable without ‘prior authorization.’ ”

The study noted the need to bring the prescribing patterns for patients with both diabetes and ASCVD more in line with evidence-based guidelines. To that end, said Dr. Granger, the researchers are moving ahead on a randomized study of a quality improvement project involving about 45 U.S. cardiology clinics using a feedback loop to apply more consistent prescribing patterns for the three therapy groups. “Hopefully a year from now we’ll have a lot more information about this problem,” Dr. Granger added.

Boehringer Ingelheim and Lilly funded the study. Dr. Granger reported financial relationships with Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Pfizer, Medtronic, Akros Pharma, Apple, AstraZeneca, Daichi-Sankyo, Novartis, AbbVie, Bayer, Boston Scientific, CeleCor, Correvio, Espero, Merck, Novo Nordisk, Rhoshan Pharmaceuticals, and Roche Diagnostics. Dr. Jellinger is on speaker’s bureaus for Esperion and Amgen.
 

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Radioactive iodine treatment of children and young adults with differentiated thyroid cancer appears to heighten the future risk of leukemia and a range of solid tumors, including breast cancer, according to a new analysis of the United States SEER cancer registries.

The study included data from 36,311 patients between 1975 and 2017. Among 5-year differentiated thyroid cancer survivors, over a median follow-up of 15.6 years, radioactive iodine treatment was linked to a 23% increased risk of solid tumors. Among 20-year survivors, there was a 47% increased risk in solid tumors and a 46% increased risk of breast cancer. Two-year survivors had a 51% increased risk of hematologic malignancies, including a 92% increased risk of leukemia. The researchers estimate that 6% of all solid tumors, 5% of breast tumors, and 14% of hematologic malignancies among differentiated thyroid cancer patients who have survived at least 1 year are attributable to radioactive iodine (RAI).

“Our study is not the first to show an increased risk of leukemia or solid cancer after RAI therapy, although some may be surprised about the increased risk of breast cancer, which was not observed in some earlier studies on this topic. The large size of our study, our focus on younger patients (who are more susceptible to the late effects of radiation therapy than older patients), and more than 40 years of follow-up, enabled us to provide more precise estimates of these risks. Our findings were not surprising given current understanding of the long-term, carcinogenic effects of radiation exposure,” said lead author Cari Kitahara, PhD, senior investigator in the division of cancer epidemiology and genetics at National Cancer Institute. The risk estimates also are similar to previous studies of exposure to medial and nonmedical radiation sources, she added.

Although radioactive iodine has seen an increase in use for treatment of differentiated thyroid cancer, there is little evidence that it improves outcomes in localized differentiated thyroid cancer, and the American Thyroid Association guidelines recommend against radioactive iodine therapy for low-risk differentiated thyroid cancers smaller than 1 cm, and lower radiation levels for larger tumors. The pediatric guideline suggests a similar approach, except that it doesn’t discourage use of RAI in low-risk differentiated thyroid cancers.

“Physicians should discuss the overall balance of risks and benefits of RAI therapy with their patients. Although RAI has been used in the management of thyroid cancer for many decades, clinical practice guidelines have changed over time and now encourage avoidance of unnecessary or excessive use of RAI therapy for low-risk tumors. Our results suggest that even greater caution and more consideration of the late effects of RAI therapy are needed for younger patients, who are more vulnerable to the carcinogenic effects of radiation exposure and are more likely to experience these long-term effects than older adults,” Dr. Kitahara said.

The study was funded by the National Cancer Institute. Dr. Kitahara has no relevant financial disclosures.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

Statin intolerance is far less common than previously reported, according to a new meta-analysis, with data on more than 4 million adults from around the world, looking at reported statin adverse effects.

The study puts the prevalence of statin intolerance at 6% to 10%, meaning that statin intolerance is “overestimated and overdiagnosed” in most cases, Maciej Banach, MD, PhD, from the Medical University of Lodz and the University of Zielona Góra, Poland, said in a news release.

It also means that “around 93% of patients on statin therapy can be treated effectively, with very good tolerability and without any safety issues,” Dr. Banach added.

The study, conducted on behalf of the Lipid and Blood Pressure Meta-Analysis Collaboration and the International Lipid Expert Panel, was published online Feb. 16 in the European Heart Journal.
 

Reassuring data

In a statement from the British nonprofit Science Media Center, Sir Nilesh J. Samani, MBChB, MD, medical director of the British Heart Foundation, said: “Decades of evidence have proven that statins save lives. This latest analysis, showing that the risk of side effects from statins are less than previously thought, should provide reassurance to those who are recommended this medicine to reduce their risk of a heart attack or stroke.”

The reported prevalence of statin intolerance varies widely, from 2% to 3% to as high as 50%, chiefly because “there is still a lack of a clear and easy way to apply the definition of statin intolerance,” Dr. Banach told this news organization.

“The ones we use in lipid clinics – by National Lipid Association (NLA), European Atherosclerosis Society (EAS), and International Lipid Expert Panel (ILEP) – are not used or are rarely used in everyday clinical practice by GPs and other specialists,” Dr. Banach explained.

He also blames “physician inertia: When they listen to a patient complain of muscle pain, or see elevated alanine aminotransferase (ALT), in most of the cases, they will immediately discontinue statins, without any further investigations. One should remember that there are many secondary causes of statin intolerance,” Dr. Banach said.

To get a better handle on the true prevalence of statin intolerance, the study team did a meta-analysis of 4,143,517 patients worldwide from 176 studies: 112 randomized controlled trials and 64 cohort studies.

The overall prevalence of statin intolerance was 9.1% (95% confidence interval, 8.0%-10.0%).

The prevalence of statin intolerance was even lower when assessed with diagnostic criteria from the NLA (7.0%; 95% CI, 6.0%-8.0%), the ILEP (6.7%; 95% CI, 5.0%-8.0%), and the EAS (5.9%; 95% CI, 4.0%-7.0%).

The main factors associated with an increased risk for statin intolerance are female gender, hypothyroidism, high statin dose, advanced age, concomitant use of anti-arrhythmic drugs, and obesity. Other factors include race (being Asian or African American), type 2 diabetes, alcohol use, and chronic liver and renal diseases.

“Our findings mean that we should evaluate patients’ symptoms very carefully, firstly to see whether symptoms are indeed caused by statins, and secondly to evaluate whether it might be patients’ perceptions that statins are harmful – so called nocebo or drucebo effect – which could be responsible for more than 50% of all symptoms, rather than the drug itself,” Dr. Banach said.

He encourages use of the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) to assess the likelihood that a patient’s muscle symptoms are caused or worsened by statin use.

Substantial analysis, valid results

“This is a substantial analysis [and], based on what we know about statin side effects to date, the results are likely to be broadly valid and indicate that we should not overestimate statin side effects or be too quick to stop statins without due consideration,” Riyaz Patel, MBBS, professor of cardiology, University College London, told the Science Media Center.

“Some patients do experience real side effects, and we do our best to help them with alternative therapies, as with any other medicine. However, for the vast majority of people experiencing statin side effects, we can usually work with the patient to understand the symptoms, use proven strategies to manage these, and ensure they do not miss out on the well-established benefits of statins,” Mr. Patel said.

“This is especially important for people who have already had a heart attack or stroke, where statin therapy is really important in preventing further events,” Mr. Patel added.

Also weighing in on the results, Peter Sever, MB BChir, professor of clinical pharmacology and therapeutics, Imperial College London, said: “The importance for clinicians and patients is to realize that commonly reported symptoms, such as muscle aches and pains and lethargy, are not due to the chemistry of the drug.”

“These ‘nocebo’ symptoms may be psychological in origin, but they are no less real than pharmacological symptoms in how they affect quality of life,” Mr. Sever told the Science Media Center.

“However, it’s important to note that as they are not directly caused by the drug, they should not override the decision to prescribe and take statins on account of their proven benefit in reducing death and disability from heart attacks, strokes, and other cardiovascular conditions,” he added.

This meta-analysis was conducted independently; no company or institution supported it financially. Dr. Banach is on the speakers bureau for Amgen, Herbapol, Kogen, KRKA, Polpharma, Mylan/Viatris, Novartis, Novo Nordisk, Sanofi-Aventis, Teva, and Zentiva; is a consultant to Abbott Vascular, Amgen, Daichii Sankyo, Esperion, FreiaPharmaceuticals, Novartis, Polfarmex, and Sanofi-Aventis; has received grants from Amgen, Mylan/Viatris, Sanofi, and Valeant; and serves as CMO for Nomi Biotech Corporation. Dr. Samani has no relevant disclosures. Mr. Patel has received past honoraria and consulting fees from drug companies manufacturing new cholesterol-lowering drugs and currently works with NICE as a topic advisor for CVD prevention. Mr. Sever has received research grants and consultancy from Pfizer and Amgen.

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

Statin intolerance is far less common than previously reported, according to a new meta-analysis, with data on more than 4 million adults from around the world, looking at reported statin adverse effects.

The study puts the prevalence of statin intolerance at 6% to 10%, meaning that statin intolerance is “overestimated and overdiagnosed” in most cases, Maciej Banach, MD, PhD, from the Medical University of Lodz and the University of Zielona Góra, Poland, said in a news release.

It also means that “around 93% of patients on statin therapy can be treated effectively, with very good tolerability and without any safety issues,” Dr. Banach added.

The study, conducted on behalf of the Lipid and Blood Pressure Meta-Analysis Collaboration and the International Lipid Expert Panel, was published online Feb. 16 in the European Heart Journal.
 

Reassuring data

In a statement from the British nonprofit Science Media Center, Sir Nilesh J. Samani, MBChB, MD, medical director of the British Heart Foundation, said: “Decades of evidence have proven that statins save lives. This latest analysis, showing that the risk of side effects from statins are less than previously thought, should provide reassurance to those who are recommended this medicine to reduce their risk of a heart attack or stroke.”

The reported prevalence of statin intolerance varies widely, from 2% to 3% to as high as 50%, chiefly because “there is still a lack of a clear and easy way to apply the definition of statin intolerance,” Dr. Banach told this news organization.

“The ones we use in lipid clinics – by National Lipid Association (NLA), European Atherosclerosis Society (EAS), and International Lipid Expert Panel (ILEP) – are not used or are rarely used in everyday clinical practice by GPs and other specialists,” Dr. Banach explained.

He also blames “physician inertia: When they listen to a patient complain of muscle pain, or see elevated alanine aminotransferase (ALT), in most of the cases, they will immediately discontinue statins, without any further investigations. One should remember that there are many secondary causes of statin intolerance,” Dr. Banach said.

To get a better handle on the true prevalence of statin intolerance, the study team did a meta-analysis of 4,143,517 patients worldwide from 176 studies: 112 randomized controlled trials and 64 cohort studies.

The overall prevalence of statin intolerance was 9.1% (95% confidence interval, 8.0%-10.0%).

The prevalence of statin intolerance was even lower when assessed with diagnostic criteria from the NLA (7.0%; 95% CI, 6.0%-8.0%), the ILEP (6.7%; 95% CI, 5.0%-8.0%), and the EAS (5.9%; 95% CI, 4.0%-7.0%).

The main factors associated with an increased risk for statin intolerance are female gender, hypothyroidism, high statin dose, advanced age, concomitant use of anti-arrhythmic drugs, and obesity. Other factors include race (being Asian or African American), type 2 diabetes, alcohol use, and chronic liver and renal diseases.

“Our findings mean that we should evaluate patients’ symptoms very carefully, firstly to see whether symptoms are indeed caused by statins, and secondly to evaluate whether it might be patients’ perceptions that statins are harmful – so called nocebo or drucebo effect – which could be responsible for more than 50% of all symptoms, rather than the drug itself,” Dr. Banach said.

He encourages use of the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) to assess the likelihood that a patient’s muscle symptoms are caused or worsened by statin use.

Substantial analysis, valid results

“This is a substantial analysis [and], based on what we know about statin side effects to date, the results are likely to be broadly valid and indicate that we should not overestimate statin side effects or be too quick to stop statins without due consideration,” Riyaz Patel, MBBS, professor of cardiology, University College London, told the Science Media Center.

“Some patients do experience real side effects, and we do our best to help them with alternative therapies, as with any other medicine. However, for the vast majority of people experiencing statin side effects, we can usually work with the patient to understand the symptoms, use proven strategies to manage these, and ensure they do not miss out on the well-established benefits of statins,” Mr. Patel said.

“This is especially important for people who have already had a heart attack or stroke, where statin therapy is really important in preventing further events,” Mr. Patel added.

Also weighing in on the results, Peter Sever, MB BChir, professor of clinical pharmacology and therapeutics, Imperial College London, said: “The importance for clinicians and patients is to realize that commonly reported symptoms, such as muscle aches and pains and lethargy, are not due to the chemistry of the drug.”

“These ‘nocebo’ symptoms may be psychological in origin, but they are no less real than pharmacological symptoms in how they affect quality of life,” Mr. Sever told the Science Media Center.

“However, it’s important to note that as they are not directly caused by the drug, they should not override the decision to prescribe and take statins on account of their proven benefit in reducing death and disability from heart attacks, strokes, and other cardiovascular conditions,” he added.

This meta-analysis was conducted independently; no company or institution supported it financially. Dr. Banach is on the speakers bureau for Amgen, Herbapol, Kogen, KRKA, Polpharma, Mylan/Viatris, Novartis, Novo Nordisk, Sanofi-Aventis, Teva, and Zentiva; is a consultant to Abbott Vascular, Amgen, Daichii Sankyo, Esperion, FreiaPharmaceuticals, Novartis, Polfarmex, and Sanofi-Aventis; has received grants from Amgen, Mylan/Viatris, Sanofi, and Valeant; and serves as CMO for Nomi Biotech Corporation. Dr. Samani has no relevant disclosures. Mr. Patel has received past honoraria and consulting fees from drug companies manufacturing new cholesterol-lowering drugs and currently works with NICE as a topic advisor for CVD prevention. Mr. Sever has received research grants and consultancy from Pfizer and Amgen.

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

Statin intolerance is far less common than previously reported, according to a new meta-analysis, with data on more than 4 million adults from around the world, looking at reported statin adverse effects.

The study puts the prevalence of statin intolerance at 6% to 10%, meaning that statin intolerance is “overestimated and overdiagnosed” in most cases, Maciej Banach, MD, PhD, from the Medical University of Lodz and the University of Zielona Góra, Poland, said in a news release.

It also means that “around 93% of patients on statin therapy can be treated effectively, with very good tolerability and without any safety issues,” Dr. Banach added.

The study, conducted on behalf of the Lipid and Blood Pressure Meta-Analysis Collaboration and the International Lipid Expert Panel, was published online Feb. 16 in the European Heart Journal.
 

Reassuring data

In a statement from the British nonprofit Science Media Center, Sir Nilesh J. Samani, MBChB, MD, medical director of the British Heart Foundation, said: “Decades of evidence have proven that statins save lives. This latest analysis, showing that the risk of side effects from statins are less than previously thought, should provide reassurance to those who are recommended this medicine to reduce their risk of a heart attack or stroke.”

The reported prevalence of statin intolerance varies widely, from 2% to 3% to as high as 50%, chiefly because “there is still a lack of a clear and easy way to apply the definition of statin intolerance,” Dr. Banach told this news organization.

“The ones we use in lipid clinics – by National Lipid Association (NLA), European Atherosclerosis Society (EAS), and International Lipid Expert Panel (ILEP) – are not used or are rarely used in everyday clinical practice by GPs and other specialists,” Dr. Banach explained.

He also blames “physician inertia: When they listen to a patient complain of muscle pain, or see elevated alanine aminotransferase (ALT), in most of the cases, they will immediately discontinue statins, without any further investigations. One should remember that there are many secondary causes of statin intolerance,” Dr. Banach said.

To get a better handle on the true prevalence of statin intolerance, the study team did a meta-analysis of 4,143,517 patients worldwide from 176 studies: 112 randomized controlled trials and 64 cohort studies.

The overall prevalence of statin intolerance was 9.1% (95% confidence interval, 8.0%-10.0%).

The prevalence of statin intolerance was even lower when assessed with diagnostic criteria from the NLA (7.0%; 95% CI, 6.0%-8.0%), the ILEP (6.7%; 95% CI, 5.0%-8.0%), and the EAS (5.9%; 95% CI, 4.0%-7.0%).

The main factors associated with an increased risk for statin intolerance are female gender, hypothyroidism, high statin dose, advanced age, concomitant use of anti-arrhythmic drugs, and obesity. Other factors include race (being Asian or African American), type 2 diabetes, alcohol use, and chronic liver and renal diseases.

“Our findings mean that we should evaluate patients’ symptoms very carefully, firstly to see whether symptoms are indeed caused by statins, and secondly to evaluate whether it might be patients’ perceptions that statins are harmful – so called nocebo or drucebo effect – which could be responsible for more than 50% of all symptoms, rather than the drug itself,” Dr. Banach said.

He encourages use of the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) to assess the likelihood that a patient’s muscle symptoms are caused or worsened by statin use.

Substantial analysis, valid results

“This is a substantial analysis [and], based on what we know about statin side effects to date, the results are likely to be broadly valid and indicate that we should not overestimate statin side effects or be too quick to stop statins without due consideration,” Riyaz Patel, MBBS, professor of cardiology, University College London, told the Science Media Center.

“Some patients do experience real side effects, and we do our best to help them with alternative therapies, as with any other medicine. However, for the vast majority of people experiencing statin side effects, we can usually work with the patient to understand the symptoms, use proven strategies to manage these, and ensure they do not miss out on the well-established benefits of statins,” Mr. Patel said.

“This is especially important for people who have already had a heart attack or stroke, where statin therapy is really important in preventing further events,” Mr. Patel added.

Also weighing in on the results, Peter Sever, MB BChir, professor of clinical pharmacology and therapeutics, Imperial College London, said: “The importance for clinicians and patients is to realize that commonly reported symptoms, such as muscle aches and pains and lethargy, are not due to the chemistry of the drug.”

“These ‘nocebo’ symptoms may be psychological in origin, but they are no less real than pharmacological symptoms in how they affect quality of life,” Mr. Sever told the Science Media Center.

“However, it’s important to note that as they are not directly caused by the drug, they should not override the decision to prescribe and take statins on account of their proven benefit in reducing death and disability from heart attacks, strokes, and other cardiovascular conditions,” he added.

This meta-analysis was conducted independently; no company or institution supported it financially. Dr. Banach is on the speakers bureau for Amgen, Herbapol, Kogen, KRKA, Polpharma, Mylan/Viatris, Novartis, Novo Nordisk, Sanofi-Aventis, Teva, and Zentiva; is a consultant to Abbott Vascular, Amgen, Daichii Sankyo, Esperion, FreiaPharmaceuticals, Novartis, Polfarmex, and Sanofi-Aventis; has received grants from Amgen, Mylan/Viatris, Sanofi, and Valeant; and serves as CMO for Nomi Biotech Corporation. Dr. Samani has no relevant disclosures. Mr. Patel has received past honoraria and consulting fees from drug companies manufacturing new cholesterol-lowering drugs and currently works with NICE as a topic advisor for CVD prevention. Mr. Sever has received research grants and consultancy from Pfizer and Amgen.

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

About four in 10 COVID patients have some sort of taste loss, according to a new study.

Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.

But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”

Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.

“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.

Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.

The information came from self-reports and direct reports.

“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”

Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.

“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.

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

About four in 10 COVID patients have some sort of taste loss, according to a new study.

Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.

But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”

Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.

“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.

Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.

The information came from self-reports and direct reports.

“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”

Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.

“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.

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

About four in 10 COVID patients have some sort of taste loss, according to a new study.

Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.

But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”

Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.

“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.

Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.

The information came from self-reports and direct reports.

“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”

Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.

“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.

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