The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

The presence of chronic kidney disease (CKD) or end-stage renal disease (ESRD) is associated with worse in-hospital and short-term outcomes after left atrial appendage (LAA) closure, a nationwide study shows.

Patients with ESRD were particularly vulnerable, having about 6.5-fold higher odds of in-hospital mortality than those without CKD and about 11.5-fold higher odds than those with CKD, even after adjustment for potential confounders.

Patients with CKD had higher rates of stroke or transient ischemic attack (TIA) and more short-term readmissions for bleeding, Keerat Rai Ahuja, MD, Reading Hospital-Tower Health, West Reading, Pennsylvania, and colleagues reported August 16 in JACC: Cardiovascular Interventions.

CKD and ESRD are known to be associated with an increased risk for stroke and bleeding in patients with atrial fibrillation (AFib), yet data are limited on the safety and efficacy of LAA closure for stroke prevention in AFib patients with CKD or ESRD, they note.  

“It’s important to know about CKD and understand that there may be an association with worse levels of CKD and worse outcomes, but the data that strikes me is really that for end-stage renal disease,” Matthew Sherwood, MD, MHS, who was not involved with the study, said in an interview.

He noted that data have not been published for patients with CKD and ESRD enrolled in the pivotal PROTECT-AF and PREVAIL trials of Boston Scientific’s Watchman device or from large clinical registries such as EWOLUTION and the company’s continued access protocol registries.

Further, it’s not well understood what the best strategy is to prevent stroke in AFib patients with ESRD and whether they benefit from anticoagulation with warfarin or any of the newer agents. “Thus, it’s hard to then say: ‘Well they have worse outcomes with Watchman,’ which is true as shown in this study, but they may not have any other options based upon the lack of data for oral anticoagulants in end-stage kidney disease patients,” said Dr. Sherwood, from the Inova Heart and Vascular Institute, Falls Church, Virginia.

The lack of clarity is concerning, given rising atrial fibrillation cases and the prevalence of abnormal renal function in everyday practice. In the present study – involving 21,274 patients undergoing LAA closure between 2016 and 2017 in the Nationwide Readmissions Database – 18.6% of patients had CKD stages I to V and 2.7% had ESRD based on ICD-10 codes.

In-hospital mortality was increased only in patients with ESRD. In all, 3.3% of patients with ESRD and 0.4% of those with no CKD died in hospital (adjusted odds ratio [aOR], 6.48), as did 0.5% of patients with CKD (aOR, 11.43; both P <.001).

“These patients represent a sicker population at baseline and have an inherent greater risk for mortality in cardiac interventions, as noted in other studies of structural heart interventions,” Dr. Ahuja and colleagues write.

Patients with CKD had a higher risk for in-hospital stroke or TIA than patients with no CKD (1.8% vs. 1.3%; aOR, 1.35; P = .038) and this risk continued up to 90 days after discharge (1.7% vs. 1.0%; aOR, 1.67; P = .007).

The in-hospital stroke rate was numerically higher in patients with ESRD compared with no CKD (aOR, 1.18; P = .62).

The authors point out that previous LAA closure and CKD studies have reported no differences in in-hospital or subsequent stroke/TIA rates in patients with and without CKD. Possible explanations are that patients with CKD in the present study had higher CHA2DS2-VASc scores than those without CKD (4.18 vs. 3.62) and, second, patients with CKD and AFib are known to have higher risk for thromboembolic events than those with AFib without CKD.

CKD patients were also more likely than those without CKD to experience in-hospital acute kidney injury or hemodialysis (aOR, 5.02; P <.001).

CKD has been shown to be independently associated with acute kidney injury (AKI) after LAA closure. AKI may have long-term thromboembolic consequences, the authors suggest, with one study reporting higher stroke risk at midterm follow-up in patients with AKI.

“As with other cardiac interventions in patients with CKD, efforts should be made to optimize preoperative renal function, minimize contrast volume, and avoid abrupt hemodynamic changes such as hypotension during the procedure to prevent AKI,” Dr. Ahuja and colleagues write.

Patients with CKD and ESRD had longer index length of stay than those without CKD but had similar rates of other in-hospital complications, such as systemic embolization, bleeding/transfusion, vascular complications, and pericardial tamponade requiring intervention.

Among the short-term outcomes, 30- and 90-day all-cause readmissions were increased in patients with CKD and ESRD compared with those without CKD, and 30-day bleeding readmissions were increased within the CKD cohort.

“With Watchman and left atrial appendage closure, what we see is that they have higher rates of readmission and other problems,” Dr. Sherwood said. “I think we understand that that’s probably related not to the procedure itself, not because the Watchman doesn’t work for end-stage kidney disease, but because the patients themselves are likely higher risk.”

Commonly used risk scores for atrial fibrillation, however, don’t take into account advanced kidney disease, he added.

Besides the inherent limitations of observational studies, Dr. Sherwood and the authors point to the lack of laboratory variables and procedural variables in the database, the fact that CKD was defined using ICD-10 codes, that outcomes were not clinically adjudicated, that unmeasured confounders likely still exist, and that long-term follow-up is lacking.

Dr. Sherwood, who wrote an editorial accompanying the study, said that the release of outcomes data from CKD and ESRD patients in the major clinical trials would be helpful going forward, as would possible involvement with the Kidney Disease Improving Global Outcomes organization.

“One of the main points of this study is that we just need a lot more research diving into this patient population,” he said.

The authors report no relevant financial relationships. Dr. Sherwood reports honoraria from Janssen and Medtronic. Editorial coauthor Sean Pokorney reports research grant support from Gilead, Boston Scientific, Pfizer, Bristol Myers Squibb, Janssen, and the Food and Drug Administration; and advisory board, consulting, and honoraria supports from Medtronic, Boston Scientific, Pfizer, Bristol Myers Squibb, Philips, and Zoll.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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

CT scans are used to diagnose, track, and screen for a variety of diseases. Even before the National Lung Screening Trial research team proved that an annual CT scan could reduce lung cancer mortality, physicians were ordering 62 million scans per year. At the same time, advances in technology have improved power and resolution. The CT scan has changed the way that health care is practiced, and that change has created challenges and opportunities. We’re now experiencing a modern pandemic of incidental findings. It falls to the clinician to decide when the dreaded “incidentaloma” is clinically relevant.

Pulmonologists are adept at managing pulmonary nodules found on scans performed for other reasons. Multiple risk-stratification models exist and guidelines provide algorithms that are easy to follow. Radiologists generally reference these guidelines in their reports and instruct the clinician on how to proceed. A less common but still prevalent incidental finding in the pulmonary parenchyma is an interstitial lung abnormality (ILA).

What is an ILA and how is it defined? Well, it’s tricky. A position paper from the Fleischner Society outlines specific radiographic findings that are consistent with an ILA: honeycombing, traction bronchiectasis, parenchymal distortions, and reticular abnormalities that take up more than 5% of a particular lung zone. To be called an ILA, the patient in whom these abnormalities are present must not yet be diagnosed with a clinical interstitial lung disease (ILD). In one sense, then, an ILA can be considered a subclinical ILD. Detecting fibrosing ILDs before they progress is of vital importance because lung function lost cannot be restored. ILAs detected on CT scan are associated with increased morbidity and mortality, and 50% will progress radiographically over a period of 5 years. Case closed then, right? ILAs represent subclinical ILD and they should be treated as such. Let’s throw antifibrotics at them and preserve lung function!

Not so fast. ILAs are identified in 2%-10% of adults and 7%-9% of patients with higher smoking rates and cardiovascular risk factors. They’re observed in up to 10% of CTs done for lung cancer screening. Their prevalence is far greater than that of all ILDs combined, so most will not progress to clinically important ILD. Furthermore, the elevated mortality rates may not be directly attributable to the ILAs, and some of the excess morbidity is of questionable clinical significance. The million-dollar question: How do we identify which ILAs are important?

A new paper published online in the CHEST journal tackled this difficult question. The authors designed an iterative survey which they provided to pulmonologists and thoracic radiologists with expertise in ILD. The survey assessed the experts’ views on how to diagnose and manage ILAs. They included a total of 44 experts, and greater than 75% agreement on a particular response constituted a consensus. Consensus was reached on proper annotation on reports and referral to pulmonologists for lung testing.

The short version: ILAs should be annotated on radiology reports and in most cases should trigger referral to a pulmonologist. In underresourced areas with few specialists, there are probably scenarios where high-resolution CT or lung function testing could be recommended without referral. In my opinion, though, you’re going to need a good pulmonologist to sort these out and avoid unnecessary testing, treatment, and anxiety. Recognition of ILAs is an important step forward in identifying ILD early; let’s just be careful not to diagnose disease when it doesn’t exist.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine. He disclosed receiving a research grant from Fisher-Paykel and income from the American College of Chest Physicians.

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

Adults aged 65 years and older who develop psychotic manifestations are significantly more likely than those without such manifestations to develop prodromal Parkinson’s disease, data from 925 individuals suggest.

“The presence of perceptual abnormalities and/or delusional ideation among community-dwelling elderly individuals is more widespread than considered in the past,” wrote Ioanna Pachi, MD, of National and Kapodistrian University of Athens Medical School and colleagues. However, those psychoses and their potential impact on prodromal Parkinson’s disease (PD) have not been well studied in community-dwelling populations, they noted in the study, published in Parkinsonism and Related Disorders.

In the study, Dr. Pachi and colleagues reviewed data from 914 participants in the Hellenic Longitudinal Investigation of Aging and Diet study (HELIAD), a cross-sectional, population-based cohort study of older adults in Greece. The average age of the participants was 76 years, and 41% were men. Participants had no delusional features at baseline; delusional features were assessed using the Neuropsychiatric Inventory scale and the Columbia University Scale for Psychopathology in Alzheimer’s disease. The researchers calculated the probability of prodromal PD (pPD) for each participant based on the 2019 International Parkinson and Movement Disorders Society research criteria for prodromal PD.

Over a 3-year follow-up period, 20 participants developed psychotic manifestations and were 1.3 times more likely to have pPD, compared with those without psychoses (P = .006). Those with new-onset psychotic features were categorized together as the NPSY group, regardless of symptom severity or frequency; those with no symptoms at either baseline or during follow-up were categorized as unaffected (UPSY). Most of the NPSY participants showed isolated delusional features, although some expressed hallucinations. Most symptoms were mild.

New-onset psychosis was associated with a fivefold increased risk of both subthreshold parkinsonism and depression (adjusted odds ratios, 4.5 and 5.0, respectively) and with a threefold increased risk of constipation (aOR 2.6). Other factors, including nonsmoking, global cognitive deficit, and anxiety were not significantly associated with new-onset psychotic symptoms after adjusting for confounding factors.

Although the mechanism behind the association remains unclear, “the parallel evolution of psychotic features and prodromal PD could be related to the spreading pattern of neuronal damage that occurs in PD,” the researchers wrote.

The study findings were limited by several factors, including the administration of neuropsychiatric questionnaires by nonpsychiatrists, and lack of detailed psychiatric history, including complete information on medication use, the researchers noted. The small size of the NPSY group also prevented evaluation of the potential associations between pPD and different modalities of hallucinations, they said.

However, the results were strengthened by the overall large and population-based sample size, and the comprehensive evaluation of psychotic features, they wrote. More follow-up evaluations in the HELIAD cohort are planned to further explore the underlying mechanism of the association between late-life psychosis and pPD.

“Provided that these results are confirmed in other community cohorts of elderly subjects, psychotic features may be added to the list of manifestations of pPD,” they concluded.

The study was supported in part by grants from the Alzheimer’s Association, ARISTEIA, and the ESPA-EU program Excellence Grant. It was cofunded by the European Social Fund and Greek National resources, the Ministry for Health and Social Solidarity, Greece, and the Greek State Scholarships Foundation. Dr. Pachi had no disclosures.

Adults aged 65 years and older who develop psychotic manifestations are significantly more likely than those without such manifestations to develop prodromal Parkinson’s disease, data from 925 individuals suggest.

“The presence of perceptual abnormalities and/or delusional ideation among community-dwelling elderly individuals is more widespread than considered in the past,” wrote Ioanna Pachi, MD, of National and Kapodistrian University of Athens Medical School and colleagues. However, those psychoses and their potential impact on prodromal Parkinson’s disease (PD) have not been well studied in community-dwelling populations, they noted in the study, published in Parkinsonism and Related Disorders.

In the study, Dr. Pachi and colleagues reviewed data from 914 participants in the Hellenic Longitudinal Investigation of Aging and Diet study (HELIAD), a cross-sectional, population-based cohort study of older adults in Greece. The average age of the participants was 76 years, and 41% were men. Participants had no delusional features at baseline; delusional features were assessed using the Neuropsychiatric Inventory scale and the Columbia University Scale for Psychopathology in Alzheimer’s disease. The researchers calculated the probability of prodromal PD (pPD) for each participant based on the 2019 International Parkinson and Movement Disorders Society research criteria for prodromal PD.

Over a 3-year follow-up period, 20 participants developed psychotic manifestations and were 1.3 times more likely to have pPD, compared with those without psychoses (P = .006). Those with new-onset psychotic features were categorized together as the NPSY group, regardless of symptom severity or frequency; those with no symptoms at either baseline or during follow-up were categorized as unaffected (UPSY). Most of the NPSY participants showed isolated delusional features, although some expressed hallucinations. Most symptoms were mild.

New-onset psychosis was associated with a fivefold increased risk of both subthreshold parkinsonism and depression (adjusted odds ratios, 4.5 and 5.0, respectively) and with a threefold increased risk of constipation (aOR 2.6). Other factors, including nonsmoking, global cognitive deficit, and anxiety were not significantly associated with new-onset psychotic symptoms after adjusting for confounding factors.

Although the mechanism behind the association remains unclear, “the parallel evolution of psychotic features and prodromal PD could be related to the spreading pattern of neuronal damage that occurs in PD,” the researchers wrote.

The study findings were limited by several factors, including the administration of neuropsychiatric questionnaires by nonpsychiatrists, and lack of detailed psychiatric history, including complete information on medication use, the researchers noted. The small size of the NPSY group also prevented evaluation of the potential associations between pPD and different modalities of hallucinations, they said.

However, the results were strengthened by the overall large and population-based sample size, and the comprehensive evaluation of psychotic features, they wrote. More follow-up evaluations in the HELIAD cohort are planned to further explore the underlying mechanism of the association between late-life psychosis and pPD.

“Provided that these results are confirmed in other community cohorts of elderly subjects, psychotic features may be added to the list of manifestations of pPD,” they concluded.

The study was supported in part by grants from the Alzheimer’s Association, ARISTEIA, and the ESPA-EU program Excellence Grant. It was cofunded by the European Social Fund and Greek National resources, the Ministry for Health and Social Solidarity, Greece, and the Greek State Scholarships Foundation. Dr. Pachi had no disclosures.

Adults aged 65 years and older who develop psychotic manifestations are significantly more likely than those without such manifestations to develop prodromal Parkinson’s disease, data from 925 individuals suggest.

“The presence of perceptual abnormalities and/or delusional ideation among community-dwelling elderly individuals is more widespread than considered in the past,” wrote Ioanna Pachi, MD, of National and Kapodistrian University of Athens Medical School and colleagues. However, those psychoses and their potential impact on prodromal Parkinson’s disease (PD) have not been well studied in community-dwelling populations, they noted in the study, published in Parkinsonism and Related Disorders.

In the study, Dr. Pachi and colleagues reviewed data from 914 participants in the Hellenic Longitudinal Investigation of Aging and Diet study (HELIAD), a cross-sectional, population-based cohort study of older adults in Greece. The average age of the participants was 76 years, and 41% were men. Participants had no delusional features at baseline; delusional features were assessed using the Neuropsychiatric Inventory scale and the Columbia University Scale for Psychopathology in Alzheimer’s disease. The researchers calculated the probability of prodromal PD (pPD) for each participant based on the 2019 International Parkinson and Movement Disorders Society research criteria for prodromal PD.

Over a 3-year follow-up period, 20 participants developed psychotic manifestations and were 1.3 times more likely to have pPD, compared with those without psychoses (P = .006). Those with new-onset psychotic features were categorized together as the NPSY group, regardless of symptom severity or frequency; those with no symptoms at either baseline or during follow-up were categorized as unaffected (UPSY). Most of the NPSY participants showed isolated delusional features, although some expressed hallucinations. Most symptoms were mild.

New-onset psychosis was associated with a fivefold increased risk of both subthreshold parkinsonism and depression (adjusted odds ratios, 4.5 and 5.0, respectively) and with a threefold increased risk of constipation (aOR 2.6). Other factors, including nonsmoking, global cognitive deficit, and anxiety were not significantly associated with new-onset psychotic symptoms after adjusting for confounding factors.

Although the mechanism behind the association remains unclear, “the parallel evolution of psychotic features and prodromal PD could be related to the spreading pattern of neuronal damage that occurs in PD,” the researchers wrote.

The study findings were limited by several factors, including the administration of neuropsychiatric questionnaires by nonpsychiatrists, and lack of detailed psychiatric history, including complete information on medication use, the researchers noted. The small size of the NPSY group also prevented evaluation of the potential associations between pPD and different modalities of hallucinations, they said.

However, the results were strengthened by the overall large and population-based sample size, and the comprehensive evaluation of psychotic features, they wrote. More follow-up evaluations in the HELIAD cohort are planned to further explore the underlying mechanism of the association between late-life psychosis and pPD.

“Provided that these results are confirmed in other community cohorts of elderly subjects, psychotic features may be added to the list of manifestations of pPD,” they concluded.

The study was supported in part by grants from the Alzheimer’s Association, ARISTEIA, and the ESPA-EU program Excellence Grant. It was cofunded by the European Social Fund and Greek National resources, the Ministry for Health and Social Solidarity, Greece, and the Greek State Scholarships Foundation. Dr. Pachi had no disclosures.

Adding or switching biologics is a common practice in the treatment of patients with inflammatory bowel disease (IBD), but there is a dearth of clinical data on whether patients should receive their first or second biologic as monotherapy or combined with immunomodulatory therapies. It’s a clinical conundrum made more difficult by the increasing number of biologics and drugs available to treat IBD, and the fact that some first-line biologics may fail because of immune responses.

The authors of a new review by Roni Aoun, MD, published in the Journal of Clinical Gastroenterology sought to provide some much-needed advice on these issues, surveying the literature that does exist in order to offer evidence-based recommendations for how and when biologics should be used.
 

A confusing array of therapeutic choices

The review arrives at a moment when IBD treatments have hit a therapeutic plateau, producing remission rates of only around 30%-35%, despite new treatments and mechanisms of action. “That’s just not where we want to be [so] there’s a lot of interest in how we can make our therapies better,” said David Rubin, MD, a professor of medicine and the codirector of the Digestive Diseases Center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation.

Dr. Rubin, who did not participate in authoring the review, added that the field also faces questions of what patients should receive after their first has either failed to work entirely or the initial response has waned.

“Understanding sequencing is important,” he said. “The best way to assess that right now has been through claims data, which are notoriously missing important information like [disease activity].”

The landmark SONIC and SUCCESS studies concluded that combining antibodies with immunomodulatory drugs was the best approach, but times have changed since these results were published. One recent study showed that the patient’s HLA subtype can be associated with anti–tumor necrosis factor (TNF) immune responses.

“We now know that you can be much more specific and precise about this. You can predict the likelihood someone’s going to have antidrug antibodies against an anti-TNF [agent],” said Dr. Rubin.

Factors that go into the decision of whether or not to prescribe an immunomodulator include the class of biologic, whether it is a first or second biologic, the presence or absence of antidrug antibodies, patient preference, and any comorbid conditions.

Anti-TNF agents often lose efficacy, with one study finding an average 41% loss of response to certolizumab, 33% to infliximab, and 30% to adalimumab. Another problem is posed by the intrinsic risk of immunogenicity with biologics, with rates reported to be as high as 65.3% for infliximab and 38% for adalimumab.

Immunogenicity to one anti-TNF agent often predicts immunogenicity to other anti-TNF biologics. Some data suggest that, in patients who produced antibodies to an initial anti-TNF agent, combination therapy can provide benefit with a second anti-TNF biologic. However, there are some scenarios that call for monotherapy, such as when a patient can’t take immunomodulators or when over-suppression could be risky. According to Dr. Aoun and colleagues, limited data and lessons from clinical practice suggest that monotherapy anti-TNF biologics with proactive therapeutic drug monitoring is a reasonable approach in these cases. Monitoring may also reduce the risk of immunogenicity.
 

What the authors recommended

For those reasons, if the first biologic is an anti-TNF agent, the authors recommend an immunomodulator combined with anti-TNF agents for induction or maintenance treatment of either ulcerative colitis or Crohn’s disease. If immunogenicity is present after a loss of response, they recommend a second anti-TNF agent with an immunomodulator. If there is no immunogenicity and the failure is mechanistic, they recommend switching to vedolizumab monotherapy or ustekinumab monotherapy. Immunomodulators can be prescribed on an individualized basis.

When vedolizumab or ustekinumab are the patient’s first biologic, they should be used as monotherapy. Both have very low rates of immunogenicity, and an immunomodulator is unlikely to confer a meaningful benefit, according to the review authors, who nonetheless called for prospective trials to explore these questions further. If there is a loss of response, they recommend anti-TNF agents combined with an immunomodulator, or monotherapy if the second agent is ustekinumab or vedolizumab.

In severe IBD cases, when combining agents with different mechanisms of action, or in patients who have immunogenicity to more than one class of biologic, the authors don’t provide general recommendations. Instead, they noted that the risks and benefits to individual patients should be weighed for combinations with immunomodulators.

The authors declare that they have nothing to disclose. Dr. Rubin has consulted for Janssen, AbbVie, and Takeda.

Adding or switching biologics is a common practice in the treatment of patients with inflammatory bowel disease (IBD), but there is a dearth of clinical data on whether patients should receive their first or second biologic as monotherapy or combined with immunomodulatory therapies. It’s a clinical conundrum made more difficult by the increasing number of biologics and drugs available to treat IBD, and the fact that some first-line biologics may fail because of immune responses.

The authors of a new review by Roni Aoun, MD, published in the Journal of Clinical Gastroenterology sought to provide some much-needed advice on these issues, surveying the literature that does exist in order to offer evidence-based recommendations for how and when biologics should be used.
 

A confusing array of therapeutic choices

The review arrives at a moment when IBD treatments have hit a therapeutic plateau, producing remission rates of only around 30%-35%, despite new treatments and mechanisms of action. “That’s just not where we want to be [so] there’s a lot of interest in how we can make our therapies better,” said David Rubin, MD, a professor of medicine and the codirector of the Digestive Diseases Center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation.

Dr. Rubin, who did not participate in authoring the review, added that the field also faces questions of what patients should receive after their first has either failed to work entirely or the initial response has waned.

“Understanding sequencing is important,” he said. “The best way to assess that right now has been through claims data, which are notoriously missing important information like [disease activity].”

The landmark SONIC and SUCCESS studies concluded that combining antibodies with immunomodulatory drugs was the best approach, but times have changed since these results were published. One recent study showed that the patient’s HLA subtype can be associated with anti–tumor necrosis factor (TNF) immune responses.

“We now know that you can be much more specific and precise about this. You can predict the likelihood someone’s going to have antidrug antibodies against an anti-TNF [agent],” said Dr. Rubin.

Factors that go into the decision of whether or not to prescribe an immunomodulator include the class of biologic, whether it is a first or second biologic, the presence or absence of antidrug antibodies, patient preference, and any comorbid conditions.

Anti-TNF agents often lose efficacy, with one study finding an average 41% loss of response to certolizumab, 33% to infliximab, and 30% to adalimumab. Another problem is posed by the intrinsic risk of immunogenicity with biologics, with rates reported to be as high as 65.3% for infliximab and 38% for adalimumab.

Immunogenicity to one anti-TNF agent often predicts immunogenicity to other anti-TNF biologics. Some data suggest that, in patients who produced antibodies to an initial anti-TNF agent, combination therapy can provide benefit with a second anti-TNF biologic. However, there are some scenarios that call for monotherapy, such as when a patient can’t take immunomodulators or when over-suppression could be risky. According to Dr. Aoun and colleagues, limited data and lessons from clinical practice suggest that monotherapy anti-TNF biologics with proactive therapeutic drug monitoring is a reasonable approach in these cases. Monitoring may also reduce the risk of immunogenicity.
 

What the authors recommended

For those reasons, if the first biologic is an anti-TNF agent, the authors recommend an immunomodulator combined with anti-TNF agents for induction or maintenance treatment of either ulcerative colitis or Crohn’s disease. If immunogenicity is present after a loss of response, they recommend a second anti-TNF agent with an immunomodulator. If there is no immunogenicity and the failure is mechanistic, they recommend switching to vedolizumab monotherapy or ustekinumab monotherapy. Immunomodulators can be prescribed on an individualized basis.

When vedolizumab or ustekinumab are the patient’s first biologic, they should be used as monotherapy. Both have very low rates of immunogenicity, and an immunomodulator is unlikely to confer a meaningful benefit, according to the review authors, who nonetheless called for prospective trials to explore these questions further. If there is a loss of response, they recommend anti-TNF agents combined with an immunomodulator, or monotherapy if the second agent is ustekinumab or vedolizumab.

In severe IBD cases, when combining agents with different mechanisms of action, or in patients who have immunogenicity to more than one class of biologic, the authors don’t provide general recommendations. Instead, they noted that the risks and benefits to individual patients should be weighed for combinations with immunomodulators.

The authors declare that they have nothing to disclose. Dr. Rubin has consulted for Janssen, AbbVie, and Takeda.

Adding or switching biologics is a common practice in the treatment of patients with inflammatory bowel disease (IBD), but there is a dearth of clinical data on whether patients should receive their first or second biologic as monotherapy or combined with immunomodulatory therapies. It’s a clinical conundrum made more difficult by the increasing number of biologics and drugs available to treat IBD, and the fact that some first-line biologics may fail because of immune responses.

The authors of a new review by Roni Aoun, MD, published in the Journal of Clinical Gastroenterology sought to provide some much-needed advice on these issues, surveying the literature that does exist in order to offer evidence-based recommendations for how and when biologics should be used.
 

A confusing array of therapeutic choices

The review arrives at a moment when IBD treatments have hit a therapeutic plateau, producing remission rates of only around 30%-35%, despite new treatments and mechanisms of action. “That’s just not where we want to be [so] there’s a lot of interest in how we can make our therapies better,” said David Rubin, MD, a professor of medicine and the codirector of the Digestive Diseases Center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation.

Dr. Rubin, who did not participate in authoring the review, added that the field also faces questions of what patients should receive after their first has either failed to work entirely or the initial response has waned.

“Understanding sequencing is important,” he said. “The best way to assess that right now has been through claims data, which are notoriously missing important information like [disease activity].”

The landmark SONIC and SUCCESS studies concluded that combining antibodies with immunomodulatory drugs was the best approach, but times have changed since these results were published. One recent study showed that the patient’s HLA subtype can be associated with anti–tumor necrosis factor (TNF) immune responses.

“We now know that you can be much more specific and precise about this. You can predict the likelihood someone’s going to have antidrug antibodies against an anti-TNF [agent],” said Dr. Rubin.

Factors that go into the decision of whether or not to prescribe an immunomodulator include the class of biologic, whether it is a first or second biologic, the presence or absence of antidrug antibodies, patient preference, and any comorbid conditions.

Anti-TNF agents often lose efficacy, with one study finding an average 41% loss of response to certolizumab, 33% to infliximab, and 30% to adalimumab. Another problem is posed by the intrinsic risk of immunogenicity with biologics, with rates reported to be as high as 65.3% for infliximab and 38% for adalimumab.

Immunogenicity to one anti-TNF agent often predicts immunogenicity to other anti-TNF biologics. Some data suggest that, in patients who produced antibodies to an initial anti-TNF agent, combination therapy can provide benefit with a second anti-TNF biologic. However, there are some scenarios that call for monotherapy, such as when a patient can’t take immunomodulators or when over-suppression could be risky. According to Dr. Aoun and colleagues, limited data and lessons from clinical practice suggest that monotherapy anti-TNF biologics with proactive therapeutic drug monitoring is a reasonable approach in these cases. Monitoring may also reduce the risk of immunogenicity.
 

What the authors recommended

For those reasons, if the first biologic is an anti-TNF agent, the authors recommend an immunomodulator combined with anti-TNF agents for induction or maintenance treatment of either ulcerative colitis or Crohn’s disease. If immunogenicity is present after a loss of response, they recommend a second anti-TNF agent with an immunomodulator. If there is no immunogenicity and the failure is mechanistic, they recommend switching to vedolizumab monotherapy or ustekinumab monotherapy. Immunomodulators can be prescribed on an individualized basis.

When vedolizumab or ustekinumab are the patient’s first biologic, they should be used as monotherapy. Both have very low rates of immunogenicity, and an immunomodulator is unlikely to confer a meaningful benefit, according to the review authors, who nonetheless called for prospective trials to explore these questions further. If there is a loss of response, they recommend anti-TNF agents combined with an immunomodulator, or monotherapy if the second agent is ustekinumab or vedolizumab.

In severe IBD cases, when combining agents with different mechanisms of action, or in patients who have immunogenicity to more than one class of biologic, the authors don’t provide general recommendations. Instead, they noted that the risks and benefits to individual patients should be weighed for combinations with immunomodulators.

The authors declare that they have nothing to disclose. Dr. Rubin has consulted for Janssen, AbbVie, and Takeda.

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

Another frustrated patient awaits transfer from the hospital to a nursing home. The do-not-resuscitate form must be signed by a physician. I – a physician assistant (PA) – am available, but the physician is with a medically unstable patient. Another patient in the ED waits for this hospital bed, lying uncomfortably on a stretcher in the hallway.

As a Florida PA who has practiced in other states with far fewer barriers to medical care, I applaud the advancement of HB 431. PAs can now sign certain documents, ensuring accelerated access to therapeutic interventions and honoring end-of-life wishes with timely do-not-resuscitate orders. Children now have improved access to psychiatric medications without a lengthy wait for an appointment with a psychiatrist, given the demand for mental health services and limited physician availability.

HB 431 expands medical care to patients in a state experiencing exponential growth in patient health care demands. HB 431 removes the following barriers to patient care as summarized by the Florida Academy of Physician Assistants. HB 431:

• Changes the physician:PA ratio from 1:4 to 1:10
• Allows PAs to authenticate documents such as death certificates and involuntary examinations; to order durable medical equipment, home health services, physical therapy, occupational therapy, and speech-language therapy
• Allows do-not-resuscitate orders, workers’ compensation claims, and school physical examinations with the exception of medical marijuana documents and maximum medical improvement/impairment rating documents for workman’s compensation
• Allows a fully licensed PA to procure medical devices and drugs
• Codifies that a PA can supervise a medical assistant
• Allows PAs to receive direct payment for services rendered
• Removes the long-standing restriction of PAs to prescribe any controlled psychiatric medication to patients aged under 18 years, and now allows PAs working with a pediatrician, family practice physician, internal medicine physician, or psychiatrist to prescribe a 14-day supply of schedule II psychiatric medications for those aged under 18 years
• Removes the requirement that a PA must inform a patient that they have the right to see the physician before a prescription is prescribed or dispensed
• Removes outdated language regarding prescriber number
• Improves the supervision data form submission process

Oregon HB 3036, also passed this year, significantly expands medical care provided by PAs. The Oregon legislation allows collaborative agreements with physicians at the practice level and removes the submission requirement for board approval. In contrast to Florida, Oregon completely eliminated PA ratios, improved PA prescriptive and dispensing regulations, and developed an environment that fosters team-based collaboration with accelerated patient access to quality care.

Many other states reduced these supervisory barriers during the pandemic. Even before the pandemic, federal systems such as the Veterans Affairs Medical Centers and the military had removed supervisory restrictions, which subsequently reduced the overall cost of care.

PAs are trained to be flexible and meet the needs of the patient through a medical rather than nursing model. By allowing PAs to determine how best to collaborate with their clinical teams, patients are provided more efficient, patient-centered health care. Team members rely on each other for operational and clinical support through a degree of autonomy that contributes to effective patient management. These skills are expanded with the modernization of PA clinical practice and the removal of legislative barriers. A benefit to physicians through collaborative practice agreements is the reduction of their own liability for the care that PAs provide. Unlike Oregon, the state of Florida has not approved collaborative practice agreements and has retained physician supervisory barriers.

There are misconceptions in the medical community regarding the PA profession’s legislative goals. These efforts are not aimed at replacing physicians and competing for employment. The goal is to expand access and reduce barriers to patient care. There are not enough providers available to support comprehensive patient care. This is a fact.

Gaps in medical care exist and have existed since the PA profession was developed in the 1970s. Our vision has been to expand medical care through collaboration with physicians and assist with recruitment and retention challenges in various medical disciplines, particularly primary care. This is why all PA programs are based on a primary care medical model to care for patients across the lifespan, from infant care to geriatrics.

The spirit of collaboration in a team-based environment is challenged by these misconceptions and compounded by supervisory legislative and outdated practice requirements. PAs not only collaborate but also consult with and refer patients to other health care providers whenever the patient›s condition falls outside the PA’s education, training, and experience.

The changes in Florida’s HB 431 do not remove the requirement to clearly identify our roles. PAs still continue to identify themselves as physician assistants, and should a patient refuse to see a PA, they have the right to see any other provider they choose. Finally, patients are safe in the hands of a PA, as supported by numerous patient studies comparing PA clinical skills with other providers, including nurse practitioners, medical students, residents, fellows, and physicians.

Nonetheless, Florida is still behind other states in providing patients access to collaborative, team-based medical care with skilled PAs practicing as trained. Removing the remaining legislative barriers, hospital credentialing barriers, and health care perspectives will successfully provide patients superior medical care and improve the health outcomes of Florida residents.

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucie, Fla., a member of the Hospitalist’s editorial advisory board, and also serves as a physician assistant program director at South University in West Palm Beach, Fla.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

I was rounding at the nursing home and my day began as it often did. I reviewed the doctor communication book at the nursing station to see which patients I needed to visit and checked in with the floor nurse for any important updates. I had about a dozen patients who needed to be seen. But by day’s end, four of my patients would stand out in my mind for the one thing they had in common – and the many things they did not.

A mother waiting for her son to visit

The first patient on my list was Rose. She had become increasingly withdrawn and less mobile. She used to walk the corridors asking when her son, Billy, would visit. We would all remind her that Billy visited her two or three times a week, but she never remembered the visits and blamed him for moving her out of her comfortable home in New Jersey where she’d lived with her husband before his death several years earlier.

Rose was declining, and we were trying to optimize her function and quality of life. She fell frequently while trying to get up at night to use the bathroom. None of our fall-reduction strategies had worked, and she had broken her hip a year prior. She’d fully recovered, but the combination of mental and physical frailty was becoming obvious to everyone, including her son. She had lost another five pounds and was approaching the end of her life.

“Good morning, Rose.” (She had demanded that I use her first name.) “How are you doing today?”

“I am doing okay, doctor. Have you seen Billy? When is he going to visit me?”

“I really can’t say when he’ll visit next, but I saw in a note that he was here yesterday.”

“No, he didn’t come to see me,” she said. “He doesn’t care about me. He spends more time with his wife and family than with his own mother.”

“Well, is there anything special that I can do for you?”

“Yes. Please tell Billy to visit his mother,” she said.

I completed her evaluation and made my way down the hall.
 

A wife ready to rejoin her husband

Next on my list was a widow named Violet. She reminded me of Whistler’s mother. As was her custom, she was sitting up in her chair reading her Bible when I came in. Her husband had been a minister, and she enjoyed reading the Bible or meditating for several hours each morning. Her bedside table had the most recent devotional and a picture of her husband in his vestments.

Violet was quiet and direct, and she had steely blue eyes that could communicate with your soul. Her nun-like quality was not overpowering; her manner was warm and welcoming.

“Good morning!” I said. “I hope I’m not bothering you.”

“Good morning, doctor. It’s always nice to see you.”

“I haven’t been by in a while, and I wanted to check your heart and lungs and make sure everything is going okay for you.”

“Of course; help yourself,” she said. “I feel fine. And as you know, I am ready to join my husband whenever the Lord calls me. I have lived a blessed life and do not wish to prolong it unless it is God’s will.”

“You certainly have made your wishes clear to me, and you are still in excellent health,” I said.

She really was in good health, and I made a quick note to call her daughter – who lived on the other side of the country – with an update.
 

A beauty queen ready for her close-up

Gabby was next on my list. She was a former beauty queen who had competed in local and state beauty contests. Her looks were the cornerstone of her identity, and she had done a truly remarkable job of maintaining her physical appearance.

Gabby had three attentive daughters who lived locally and supplied her with the latest makeup, beauty creams, and anti-aging nostrums. She always managed to look natural (and not like a caricature) with her face made up and her blond wig in place. Over the years, she’d made good use of the services offered by the local plastic surgeons and dermatologists. And to her credit – and theirs – she looked 30 years younger than her chronological age. In fairness, she had also taken good care of her overall health.

Gabby’s nickname was appropriate as she was chatty, to the extreme. She enjoyed being the center of attention.

When I entered her room, she was putting on her makeup. She was seated near her bedside table, which looked like it belonged in the backstage dressing room of a Broadway star. Lined up on the table were various bottles, brushes, and a mirror surrounded by lights.

“Oh, doctor, you can’t come in now. I’m a dreadful mess,” she said. “Please come back in 10 minutes. I am so embarrassed that you are seeing me this way. I just have a few things to fix, and then I will be presentable. My daughters are taking me out for lunch at the club, and I do not want to look like an old lady.”

“Gabby,” I said, “I have seen you before without your makeup. Do you remember last year when you developed pneumonia? You were really sick, and frankly, we were not sure you were going to pull through. One of the clues that you were getting ill was your smeared mascara and lipstick.”

I pressed on, and she let me examine her while she continued to apply her eyeliner.

“Everything sounds good. And I like your fresh pedicure,” I said. “Is there anything I can do for you?”

“No, thank you. Have a nice day, doctor!”
 

A mother devoted to her daughter’s care

Unlike my other patients, Mabel shared a room with a family member – her daughter, Hope. Mabel’s daughter had a congenital illness with significant physical, functional, and cognitive deficits. Mabel had considerable guilt regarding her daughter’s condition. Mabel’s husband had divorced her decades earlier, and she had devoted her life to caring for Hope. When Mabel’s health began to decline and she realized she could no longer care for Hope alone, the two moved into the facility together. Mabel told me that she simply couldn’t die before her daughter, because no one could oversee her care like she could.

Mabel was frail physically but sharp and vigilant mentally. Hope had had numerous hospitalizations, and Mabel had been with her through each experience. Hope could not communicate with others, but Mabel could express Hope’s concerns.

“How are you doing today?” I asked.

“Not well. I am concerned about Hope. She has not had a bowel movement in two days and does not want to eat breakfast.”

I checked out Hope, and her examination was reassuring. She looked up at me with her distorted features and managed a broad smile. I went back over to Mabel.

“She likes you, doctor. She thinks you smell good.”

I turned to Hope and thanked her for the compliment.

“I will check with the nurse and see if we can give you something simple to help your bowels.”

“Warm prune juice often works,” said Mabel. “Please come by again tomorrow to check on her. I don’t want this to progress. She is miserable.”

“I will be back tomorrow, and I will make a special trip to see you both.”
 

Upon reflection ...

When I sat down to write my clinical notes for the day, I realized that Rose, Violet, Gabby, and Mabel were each over 100 years old. I had seen four centenarians in a single day! Each of them manifested a fundamental principle of geriatrics: The older we are, the more unique and differentiated we become. A one-size approach to geriatric care does not fit all. Our care must be personalized to the unique individual in front of us.

Patients’ names and some details have been changed to protect their privacy. Dr. Williams is the Emeritus Ward K. Ensminger Distinguished Professor of Geriatric Medicine, University of Virginia, Charlottesville and attending physician, internal medicine and geriatrics, New Hanover Regional Medical Center, Wilmington, N.C. He disclosed no relevant financial disclosures.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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

With the approval by the Food and Drug Administration of the calcineurin inhibitor voclosporin (Lupkynis) in January and belimumab (Benlysta) a month before that, clinicians now have new options for treating lupus nephritis in combination with a background immunosuppressive agent, such as mycophenolate mofetil.

But which combination should clinicians choose?

Brad Rovin, MD, a nephrologist with the Ohio State University Wexner Medical Center, Columbus, who worked on the phase 3 voclosprin trial, pointed to that drug’s fast reduction in proteinuria in a session of the Pan American League of Associations for Rheumatology (PANLAR) 2021 Annual Meeting. That effect on proteinuria is likely due to its effect on podocytes, special epithelial cells that cover the outside of capillaries in the kidney, he said.

These crucial cells have an elaborate cytoskeleton that is stabilized by the protein synaptopodin, which can be subject to harm from calcineurin. But because voclosporin blocks calcineurin, synaptopodin is protected, which consequently protects podocytes and the kidney, Dr. Rovin said.

“There’s a lot of data in the nephrology literature that suggests as you lose podocytes, you actually can develop glomerular sclerosis and loss of renal function,” he said. “In fact, if you lose a critical number of podocytes, then no matter what you do, the kidney is likely to progress to end-stage kidney disease.

“The way I think about it now is, what else do these drugs add? And this idea of preserving the histology of the kidney is really important, and this can be done with voclosporin,” Dr. Rovin said.

Belimumab is also hailed as an effective tool, particularly for the prevention of flares. In the trial leading to its approval), just under 16% of patients experienced a renal-related event or death over 2 years, compared with 28% of the group that received placebo. Those receiving belimumab had a 50% greater chance of reaching the primary efficacy renal response, which was defined as a ratio of urinary protein to creatinine of 0.7 or less, an estimated glomerular filtration rate that was no worse than 20% below the pre-flare value or at least 60 mL/min per 1.73 m², and no use of rescue therapy for treatment failure.

The endpoints in the belimumab lupus nephritis trial were “quite rigorous,” Richard A. Furie, MD, said in the same session at the meeting. Patients with class V lupus nephritis were included in the trial, although disease of this severity is known to be particularly difficult to treat, he noted.

“There’s little question that our patients with lupus nephritis will benefit from such a therapeutic approach” with belimumab and mycophenolate, said Dr. Furie, professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, in Hempstead, N.Y. “But regardless of which combination clinicians use, we are making advances, and that means better outcomes for our patients with lupus and lupus nephritis.”

Graciela Alarcon, MD, MPH, professor emeritus of medicine at the University of Alabama at Birmingham, who moderated the discussion, said there is no sure answer regarding the best choice for clinicians.

“As long as there’s no head-to-head comparison between the two new compounds, I don’t think that the question can be answered,” she said.

Indeed, the answer for many clinicians might be that for certain patients, dual therapy isn’t necessary, Dr. Furie said.

“The fundamental question, before we choose the second drug, is whether a second drug should be chosen,” he said. “There’s a lot of people in the community who are just sticking to the old-fashioned algorithm and that is just choosing one drug, like mycophenolate. ... Others might pick a second drug, but not until they see that mycophenolate is not doing an effective job.”

All agreed that the response rates are still not optimal for patients with lupus nephritis, even with these new combinations – they are still only in the 30%-40% range.

“We haven’t really boosted the response rate to where we want it to be, at least as measured by our current measurements and composite renal response,” Dr. Rovin said.

With voclosporin’s protective effects and belimumab’s flare prevention, the two could potentially be used together at some point, he suggested.

“I think these two drugs show us the possibility that we might use them together and get rid of the older drugs, and really minimize the older drugs and then use them on a longer-term basis to preserve kidney function, as well as keep the lupus in check,” he said.

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