NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – The evolving treatment of acute myeloid leukemia (AML) was highlighted at the Acute Leukemia Forum of Hemedicus.

In a video interview, Martin Tallman, MD, of Memorial Sloan Kettering Cancer Center in New York, discussed several meeting presentations on the treatment of AML.

In his presentation, Craig Jordan, PhD, of the University of Colorado at Denver, Aurora, explained how the combination of venetoclax and azacitidine appears to target leukemic stem cells in AML.

Courtney DiNardo, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented information on novel agents for AML, including antibody-drug conjugates; bispecific therapies; checkpoint inhibitors; and inhibitors of IDH1/2, MCL1, and MDM2.

Richard Larson, MD, of the University of Chicago, explored the possibility of an individualized approach to postremission therapy in AML.

Frederick Appelbaum, MD, of Fred Hutchinson Cancer Research Center in Seattle, showed that various maintenance therapies given after allogeneic hematopoietic stem cell transplant (HSCT) have not proven beneficial for AML patients.

Richard Jones, MD, of Johns Hopkins Medicine in Baltimore, presented data showing that post-HSCT cyclophosphamide has made haploidentical transplants safer and more effective for AML patients.

And James Ferrara, MD, of the Icahn School of Medicine at Mount Sinai, New York, detailed research showing that biomarkers of graft-versus-host disease can predict nonrelapse mortality after HSCT.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – The evolving treatment of acute myeloid leukemia (AML) was highlighted at the Acute Leukemia Forum of Hemedicus.

In a video interview, Martin Tallman, MD, of Memorial Sloan Kettering Cancer Center in New York, discussed several meeting presentations on the treatment of AML.

In his presentation, Craig Jordan, PhD, of the University of Colorado at Denver, Aurora, explained how the combination of venetoclax and azacitidine appears to target leukemic stem cells in AML.

Courtney DiNardo, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented information on novel agents for AML, including antibody-drug conjugates; bispecific therapies; checkpoint inhibitors; and inhibitors of IDH1/2, MCL1, and MDM2.

Richard Larson, MD, of the University of Chicago, explored the possibility of an individualized approach to postremission therapy in AML.

Frederick Appelbaum, MD, of Fred Hutchinson Cancer Research Center in Seattle, showed that various maintenance therapies given after allogeneic hematopoietic stem cell transplant (HSCT) have not proven beneficial for AML patients.

Richard Jones, MD, of Johns Hopkins Medicine in Baltimore, presented data showing that post-HSCT cyclophosphamide has made haploidentical transplants safer and more effective for AML patients.

And James Ferrara, MD, of the Icahn School of Medicine at Mount Sinai, New York, detailed research showing that biomarkers of graft-versus-host disease can predict nonrelapse mortality after HSCT.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – The evolving treatment of acute myeloid leukemia (AML) was highlighted at the Acute Leukemia Forum of Hemedicus.

In a video interview, Martin Tallman, MD, of Memorial Sloan Kettering Cancer Center in New York, discussed several meeting presentations on the treatment of AML.

In his presentation, Craig Jordan, PhD, of the University of Colorado at Denver, Aurora, explained how the combination of venetoclax and azacitidine appears to target leukemic stem cells in AML.

Courtney DiNardo, MD, of the University of Texas MD Anderson Cancer Center, Houston, presented information on novel agents for AML, including antibody-drug conjugates; bispecific therapies; checkpoint inhibitors; and inhibitors of IDH1/2, MCL1, and MDM2.

Richard Larson, MD, of the University of Chicago, explored the possibility of an individualized approach to postremission therapy in AML.

Frederick Appelbaum, MD, of Fred Hutchinson Cancer Research Center in Seattle, showed that various maintenance therapies given after allogeneic hematopoietic stem cell transplant (HSCT) have not proven beneficial for AML patients.

Richard Jones, MD, of Johns Hopkins Medicine in Baltimore, presented data showing that post-HSCT cyclophosphamide has made haploidentical transplants safer and more effective for AML patients.

And James Ferrara, MD, of the Icahn School of Medicine at Mount Sinai, New York, detailed research showing that biomarkers of graft-versus-host disease can predict nonrelapse mortality after HSCT.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

Major U.S. cardiology and heart-surgery societies seek to create an “integrated model of care for patients with valvular heart disease” based on a two-tiered system of hospital certification, according to a consensus plan released April 19.

ChaNaWiT/iStock/Getty Images Plus

The centerpiece of the integrated model is a certification process that would designate appropriate hospitals as “Comprehensive (Level I)” or “Primary (Level II)” valve centers to serve as the designated U.S. sites for performing repair or replacement of aortic and mitral valves by transcatheter or open-surgery procedures.

The consensus document, written by a panel of mostly interventional cardiologists or heart surgeons and published in Journal of the American College of Cardiology, cited the success of similar accreditation and tiered systems that have become fixtures in United States for the delivery of care for trauma, stroke, cancer, bariatric surgery, and percutaneous coronary intervention for acute ST-segment elevation MI.


The focus of the consensus document is to “initiate a discussion regarding whether a regionalized, tiered system of care for patients with [valvular heart disease (VHD)] that accounts for the differences in valve center expertise, experience, and resources constitutes a more rational delivery model than one left to expand continuously without direction,” the panel wrote.

Under the proposal, a key component of every designated valve center would be a multidisciplinary clinical team, staffed at minimum with an interventional cardiologist, a cardiac surgeon, echocardiographic and radiographic imaging specialists, a specialist in heart failure, a person with valve expertise, nurse practitioners, a cardiovascular anesthesiologist, a program navigator, and a data manager. Valve centers also would need to enroll patients in registries, perform research, education, and training, and collect data using carefully selected performance metrics.

The document addresses case-volume minimums, a topic that’s been tricky for leaders in the heart-valve field to reconcile as they try to balance volume thresholds against having valve procedures readily available and convenient for rural or remote patients.

“The primary motivation behind volume recommendations is not to exclude centers but rather to serve as one metric in the identification of centers that are most capable of providing certain services,” the consensus statement explained. “Volumes alone are not necessarily the best surrogate for quality, but a volume-outcome association does exist for many cardiac procedures.”


Recent proof of this relationship for transcatheter aortic valve replacement appeared in an article published earlier in April; the article reviewed 30-day mortality outcomes for more than 113,000 U.S. patients who underwent this procedure and showed that centers with the lowest procedure volumes also had the highest mortality rate (New Engl J Med. 2019 April 3. doi: 10.1056/NEJMsa1901109).

But the document also qualified its support of and the role for volume minimums, highlighting that case volume is an inadequate surrogate for program quality, especially when considered in isolation. “The proposed concept of system care for VHD patients is not conceived to deny individuals and institutions the opportunity to provide services, nor should it be perceived to impede the ability of a committed center to achieve its strategic goals. Rather, it is intended to focus more on outcomes and not simply on procedural volumes.”

The launch by the Joint Commission of a Comprehensive Cardiac Advanced Certification program in January 2017, which included VHD care, is a step toward that goal, but “there is a great deal of detailed work ahead to realize the goal of this proposal,” according to the consensus document.

The consensus statement was issued by the American Association for Thoracic Surgery, the American College of Cardiology, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

[email protected]

SOURCE: Nishimura RA et al. J Amer Coll Cardiol. 2019 April 19. doi: 10.1016/j.jacc.2018.10.007.

Major U.S. cardiology and heart-surgery societies seek to create an “integrated model of care for patients with valvular heart disease” based on a two-tiered system of hospital certification, according to a consensus plan released April 19.

ChaNaWiT/iStock/Getty Images Plus

The centerpiece of the integrated model is a certification process that would designate appropriate hospitals as “Comprehensive (Level I)” or “Primary (Level II)” valve centers to serve as the designated U.S. sites for performing repair or replacement of aortic and mitral valves by transcatheter or open-surgery procedures.

The consensus document, written by a panel of mostly interventional cardiologists or heart surgeons and published in Journal of the American College of Cardiology, cited the success of similar accreditation and tiered systems that have become fixtures in United States for the delivery of care for trauma, stroke, cancer, bariatric surgery, and percutaneous coronary intervention for acute ST-segment elevation MI.


The focus of the consensus document is to “initiate a discussion regarding whether a regionalized, tiered system of care for patients with [valvular heart disease (VHD)] that accounts for the differences in valve center expertise, experience, and resources constitutes a more rational delivery model than one left to expand continuously without direction,” the panel wrote.

Under the proposal, a key component of every designated valve center would be a multidisciplinary clinical team, staffed at minimum with an interventional cardiologist, a cardiac surgeon, echocardiographic and radiographic imaging specialists, a specialist in heart failure, a person with valve expertise, nurse practitioners, a cardiovascular anesthesiologist, a program navigator, and a data manager. Valve centers also would need to enroll patients in registries, perform research, education, and training, and collect data using carefully selected performance metrics.

The document addresses case-volume minimums, a topic that’s been tricky for leaders in the heart-valve field to reconcile as they try to balance volume thresholds against having valve procedures readily available and convenient for rural or remote patients.

“The primary motivation behind volume recommendations is not to exclude centers but rather to serve as one metric in the identification of centers that are most capable of providing certain services,” the consensus statement explained. “Volumes alone are not necessarily the best surrogate for quality, but a volume-outcome association does exist for many cardiac procedures.”


Recent proof of this relationship for transcatheter aortic valve replacement appeared in an article published earlier in April; the article reviewed 30-day mortality outcomes for more than 113,000 U.S. patients who underwent this procedure and showed that centers with the lowest procedure volumes also had the highest mortality rate (New Engl J Med. 2019 April 3. doi: 10.1056/NEJMsa1901109).

But the document also qualified its support of and the role for volume minimums, highlighting that case volume is an inadequate surrogate for program quality, especially when considered in isolation. “The proposed concept of system care for VHD patients is not conceived to deny individuals and institutions the opportunity to provide services, nor should it be perceived to impede the ability of a committed center to achieve its strategic goals. Rather, it is intended to focus more on outcomes and not simply on procedural volumes.”

The launch by the Joint Commission of a Comprehensive Cardiac Advanced Certification program in January 2017, which included VHD care, is a step toward that goal, but “there is a great deal of detailed work ahead to realize the goal of this proposal,” according to the consensus document.

The consensus statement was issued by the American Association for Thoracic Surgery, the American College of Cardiology, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

[email protected]

SOURCE: Nishimura RA et al. J Amer Coll Cardiol. 2019 April 19. doi: 10.1016/j.jacc.2018.10.007.

Major U.S. cardiology and heart-surgery societies seek to create an “integrated model of care for patients with valvular heart disease” based on a two-tiered system of hospital certification, according to a consensus plan released April 19.

ChaNaWiT/iStock/Getty Images Plus

The centerpiece of the integrated model is a certification process that would designate appropriate hospitals as “Comprehensive (Level I)” or “Primary (Level II)” valve centers to serve as the designated U.S. sites for performing repair or replacement of aortic and mitral valves by transcatheter or open-surgery procedures.

The consensus document, written by a panel of mostly interventional cardiologists or heart surgeons and published in Journal of the American College of Cardiology, cited the success of similar accreditation and tiered systems that have become fixtures in United States for the delivery of care for trauma, stroke, cancer, bariatric surgery, and percutaneous coronary intervention for acute ST-segment elevation MI.


The focus of the consensus document is to “initiate a discussion regarding whether a regionalized, tiered system of care for patients with [valvular heart disease (VHD)] that accounts for the differences in valve center expertise, experience, and resources constitutes a more rational delivery model than one left to expand continuously without direction,” the panel wrote.

Under the proposal, a key component of every designated valve center would be a multidisciplinary clinical team, staffed at minimum with an interventional cardiologist, a cardiac surgeon, echocardiographic and radiographic imaging specialists, a specialist in heart failure, a person with valve expertise, nurse practitioners, a cardiovascular anesthesiologist, a program navigator, and a data manager. Valve centers also would need to enroll patients in registries, perform research, education, and training, and collect data using carefully selected performance metrics.

The document addresses case-volume minimums, a topic that’s been tricky for leaders in the heart-valve field to reconcile as they try to balance volume thresholds against having valve procedures readily available and convenient for rural or remote patients.

“The primary motivation behind volume recommendations is not to exclude centers but rather to serve as one metric in the identification of centers that are most capable of providing certain services,” the consensus statement explained. “Volumes alone are not necessarily the best surrogate for quality, but a volume-outcome association does exist for many cardiac procedures.”


Recent proof of this relationship for transcatheter aortic valve replacement appeared in an article published earlier in April; the article reviewed 30-day mortality outcomes for more than 113,000 U.S. patients who underwent this procedure and showed that centers with the lowest procedure volumes also had the highest mortality rate (New Engl J Med. 2019 April 3. doi: 10.1056/NEJMsa1901109).

But the document also qualified its support of and the role for volume minimums, highlighting that case volume is an inadequate surrogate for program quality, especially when considered in isolation. “The proposed concept of system care for VHD patients is not conceived to deny individuals and institutions the opportunity to provide services, nor should it be perceived to impede the ability of a committed center to achieve its strategic goals. Rather, it is intended to focus more on outcomes and not simply on procedural volumes.”

The launch by the Joint Commission of a Comprehensive Cardiac Advanced Certification program in January 2017, which included VHD care, is a step toward that goal, but “there is a great deal of detailed work ahead to realize the goal of this proposal,” according to the consensus document.

The consensus statement was issued by the American Association for Thoracic Surgery, the American College of Cardiology, the American Society of Echocardiography, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

[email protected]

SOURCE: Nishimura RA et al. J Amer Coll Cardiol. 2019 April 19. doi: 10.1016/j.jacc.2018.10.007.

SAN FRANCISCO – Low-dose subcutaneous recombinant human interleukin-2 is effective, well tolerated, and safe for the treatment of systemic lupus erythematosus (SLE), according to the first randomized, double-blind, placebo-controlled clinical trial of the novel therapy.

Bruce Jancin/MDedge News

Of note, more than half of the study participants with lupus nephritis experienced complete remission of their renal impairment, and another quarter had partial remission, Jing He, MD, PhD, reported at an international congress on systemic lupus erythematosus.

The mechanism of benefit appears to be the same as previously shown for low-dose interleukin-2 in patients with chronic graft versus host disease refractory to glucocorticoids (N Engl J Med. 2011 Dec 1;365[22]:2055-66): expansion of the deficient population of T regulatory cells, which is a hallmark of both inflammatory diseases.

“Low-dose IL-2 can reinstate the imbalance of T regulatory/T effector cells and improve immune homeostasis, which is critical in clinical remission of SLE,” said Dr. He of Peking University People’s Hospital in Beijing.


For nearly 20 years it has been known that SLE is characterized by very low levels of endogenous IL-2. Dr. He was lead author of the first proof-of-concept study, which showed low-dose subcutaneous IL-2 therapy resulted in markedly reduced SLE disease activity accompanied by expansion of the T regulatory cell population and suppression of follicular helper T cells and IL-17–producing helper T cells (Nat Med. 2016 Sep;22[9]:991-3). However, that was a small, single-center, uncontrolled study, so she and her coworkers have now carried out a 60-patient, double-blind, placebo-controlled randomized trial. In addition to hydroxychloroquine and other standard background medications, the patients in the active treatment arm received 1 million IU of IL-2 every other day for 2 weeks, followed by a 2-week hiatus, for a total of three courses.

At week 24 – 12 weeks after the last injection – the IL-2 recipients showed significantly greater improvement on numerous endpoints.

For example, the median SLE Disease Activity Index (SLEDAI) in the IL-2 group improved from 12 at baseline to 6 at week 12 and to 4 at week 24.

The marked improvement in renal impairment in the IL-2 recipients with lupus nephritis at baseline was accompanied by a significant increase in serum albumin and reduced 24-hour urinary protein, compared with controls.

The treatment was safe, with no increase in infections, severe or otherwise, and indeed with no serious adverse events of any kind, although nine patients in the IL-2 group experienced mild injection site reactions and three developed flu-like symptoms.

Dr. He reported having no financial conflicts regarding her study.

[email protected]

SAN FRANCISCO – Low-dose subcutaneous recombinant human interleukin-2 is effective, well tolerated, and safe for the treatment of systemic lupus erythematosus (SLE), according to the first randomized, double-blind, placebo-controlled clinical trial of the novel therapy.

Bruce Jancin/MDedge News

Of note, more than half of the study participants with lupus nephritis experienced complete remission of their renal impairment, and another quarter had partial remission, Jing He, MD, PhD, reported at an international congress on systemic lupus erythematosus.

The mechanism of benefit appears to be the same as previously shown for low-dose interleukin-2 in patients with chronic graft versus host disease refractory to glucocorticoids (N Engl J Med. 2011 Dec 1;365[22]:2055-66): expansion of the deficient population of T regulatory cells, which is a hallmark of both inflammatory diseases.

“Low-dose IL-2 can reinstate the imbalance of T regulatory/T effector cells and improve immune homeostasis, which is critical in clinical remission of SLE,” said Dr. He of Peking University People’s Hospital in Beijing.


For nearly 20 years it has been known that SLE is characterized by very low levels of endogenous IL-2. Dr. He was lead author of the first proof-of-concept study, which showed low-dose subcutaneous IL-2 therapy resulted in markedly reduced SLE disease activity accompanied by expansion of the T regulatory cell population and suppression of follicular helper T cells and IL-17–producing helper T cells (Nat Med. 2016 Sep;22[9]:991-3). However, that was a small, single-center, uncontrolled study, so she and her coworkers have now carried out a 60-patient, double-blind, placebo-controlled randomized trial. In addition to hydroxychloroquine and other standard background medications, the patients in the active treatment arm received 1 million IU of IL-2 every other day for 2 weeks, followed by a 2-week hiatus, for a total of three courses.

At week 24 – 12 weeks after the last injection – the IL-2 recipients showed significantly greater improvement on numerous endpoints.

For example, the median SLE Disease Activity Index (SLEDAI) in the IL-2 group improved from 12 at baseline to 6 at week 12 and to 4 at week 24.

The marked improvement in renal impairment in the IL-2 recipients with lupus nephritis at baseline was accompanied by a significant increase in serum albumin and reduced 24-hour urinary protein, compared with controls.

The treatment was safe, with no increase in infections, severe or otherwise, and indeed with no serious adverse events of any kind, although nine patients in the IL-2 group experienced mild injection site reactions and three developed flu-like symptoms.

Dr. He reported having no financial conflicts regarding her study.

[email protected]

SAN FRANCISCO – Low-dose subcutaneous recombinant human interleukin-2 is effective, well tolerated, and safe for the treatment of systemic lupus erythematosus (SLE), according to the first randomized, double-blind, placebo-controlled clinical trial of the novel therapy.

Bruce Jancin/MDedge News

Of note, more than half of the study participants with lupus nephritis experienced complete remission of their renal impairment, and another quarter had partial remission, Jing He, MD, PhD, reported at an international congress on systemic lupus erythematosus.

The mechanism of benefit appears to be the same as previously shown for low-dose interleukin-2 in patients with chronic graft versus host disease refractory to glucocorticoids (N Engl J Med. 2011 Dec 1;365[22]:2055-66): expansion of the deficient population of T regulatory cells, which is a hallmark of both inflammatory diseases.

“Low-dose IL-2 can reinstate the imbalance of T regulatory/T effector cells and improve immune homeostasis, which is critical in clinical remission of SLE,” said Dr. He of Peking University People’s Hospital in Beijing.


For nearly 20 years it has been known that SLE is characterized by very low levels of endogenous IL-2. Dr. He was lead author of the first proof-of-concept study, which showed low-dose subcutaneous IL-2 therapy resulted in markedly reduced SLE disease activity accompanied by expansion of the T regulatory cell population and suppression of follicular helper T cells and IL-17–producing helper T cells (Nat Med. 2016 Sep;22[9]:991-3). However, that was a small, single-center, uncontrolled study, so she and her coworkers have now carried out a 60-patient, double-blind, placebo-controlled randomized trial. In addition to hydroxychloroquine and other standard background medications, the patients in the active treatment arm received 1 million IU of IL-2 every other day for 2 weeks, followed by a 2-week hiatus, for a total of three courses.

At week 24 – 12 weeks after the last injection – the IL-2 recipients showed significantly greater improvement on numerous endpoints.

For example, the median SLE Disease Activity Index (SLEDAI) in the IL-2 group improved from 12 at baseline to 6 at week 12 and to 4 at week 24.

The marked improvement in renal impairment in the IL-2 recipients with lupus nephritis at baseline was accompanied by a significant increase in serum albumin and reduced 24-hour urinary protein, compared with controls.

The treatment was safe, with no increase in infections, severe or otherwise, and indeed with no serious adverse events of any kind, although nine patients in the IL-2 group experienced mild injection site reactions and three developed flu-like symptoms.

Dr. He reported having no financial conflicts regarding her study.

[email protected]

Join us at #MDedgeChats on Tuesday, April 23, 2019, at 7:00 pm EST, for a Twitter discussion in Rheumatology on some of the top studies reported at the LUPUS 2019 Congress in San Francisco, April 5-8. Our special guests are two rheumatologists with expertise in lupus who attended the congress, Jinoos Yazdany, MD, and Gabriela Schmajuk, MD, both with the University of California, San Francisco. They will discuss the ins and outs of the study results presented.

We hope you can join us and invite a colleague, too.

We will discuss the results of the EMBRACE trial, which looks at the efficacy and safety of belimumab (Benlysta) in black patients with systemic lupus erythematosus (SLE); these patients have a higher prevalence of SLE and often higher disease severity but have been poorly represented in past belimumab studies.

We will also chat about the results of a phase 2 trial of baricitinib (Olumiant) in SLE patients.

Finally, we will look at the clinical utility of monitoring hydroxychloroquine levels in SLE patients and how well levels of the drug correlate with disease activity through the results of a meta-analysis of studies that examined these questions.
 

Topics of conversation

Q1: How does the methodology of the EMBRACE trial differ from past phase 3 belimumab trials?

Q2: How does the EMBRACE trial affect the way you prescribe belimumab?

Q3: Does the hydroxychloroquine level meta-analysis provide persuasive enough evidence to begin measuring it?

Q4: What kinds of interventions show the best evidence for improving hydroxychloroquine adherence?

Q5: Were concerns about the safety of baricitinib in SLE patients reduced by the trial results?

Resources

EMBRACE trial: Efficacy and Safety of Belimumab in Black Race Patients with Systemic Lupus Erythematosus.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Phase 2 trial of baricitinib in SLE.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Meta-analysis examining the clinical significance of monitoring of hydroxychloroquine levels in SLE.

LUPUS 2019 abstract
 

From LUPUS 2019:

Belimumab a bust for black SLE patients.

Here’s a top strategy for immunosuppressant discontinuation in SLE.
 

From EULAR 2018:

Baricitinib shows potential as lupus treatment.
 

About Dr. Yazdany

Dr. Yazdany is an associate professor in the division of rheumatology, department of medicine at UCSF (@UCSFMedicine). She is a rheumatologist and clinical researcher with expertise in systemic lupus erythematosus and health care quality measurement and improvement. Her clinical activities include seeing patients in the UCSF Lupus Clinic, where she serves as codirector, as well as at San Francisco General Hospital. Dr. Yazdany codirects the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She also leads ongoing, longitudinal studies of lupus that are investigating health disparities and outcomes in the condition.
 

About Dr. Schmajuk

Dr. Schmajuk is an Associate Professor in the Division of Rheumatology, Department of Medicine at UCSF (@UCSFMedicine) and the San Francisco VA Medical Center. She is a rheumatologist and clinical researcher with expertise in systemic #lupus erythematosus, quality of care, and patient safety. Dr. Schmajuk also co-directs the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She leads studies to develop patient-facing disease dashboards with the goal of improving patient-provider communication for patients with RA and SLE.


Are you new to Twitter chats? We have included simple steps below to help you join and participate in the conversation.

Join us at #MDedgeChats on Tuesday, April 23, 2019, at 7:00 pm EST, for a Twitter discussion in Rheumatology on some of the top studies reported at the LUPUS 2019 Congress in San Francisco, April 5-8. Our special guests are two rheumatologists with expertise in lupus who attended the congress, Jinoos Yazdany, MD, and Gabriela Schmajuk, MD, both with the University of California, San Francisco. They will discuss the ins and outs of the study results presented.

We hope you can join us and invite a colleague, too.

We will discuss the results of the EMBRACE trial, which looks at the efficacy and safety of belimumab (Benlysta) in black patients with systemic lupus erythematosus (SLE); these patients have a higher prevalence of SLE and often higher disease severity but have been poorly represented in past belimumab studies.

We will also chat about the results of a phase 2 trial of baricitinib (Olumiant) in SLE patients.

Finally, we will look at the clinical utility of monitoring hydroxychloroquine levels in SLE patients and how well levels of the drug correlate with disease activity through the results of a meta-analysis of studies that examined these questions.
 

Topics of conversation

Q1: How does the methodology of the EMBRACE trial differ from past phase 3 belimumab trials?

Q2: How does the EMBRACE trial affect the way you prescribe belimumab?

Q3: Does the hydroxychloroquine level meta-analysis provide persuasive enough evidence to begin measuring it?

Q4: What kinds of interventions show the best evidence for improving hydroxychloroquine adherence?

Q5: Were concerns about the safety of baricitinib in SLE patients reduced by the trial results?

Resources

EMBRACE trial: Efficacy and Safety of Belimumab in Black Race Patients with Systemic Lupus Erythematosus.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Phase 2 trial of baricitinib in SLE.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Meta-analysis examining the clinical significance of monitoring of hydroxychloroquine levels in SLE.

LUPUS 2019 abstract
 

From LUPUS 2019:

Belimumab a bust for black SLE patients.

Here’s a top strategy for immunosuppressant discontinuation in SLE.
 

From EULAR 2018:

Baricitinib shows potential as lupus treatment.
 

About Dr. Yazdany

Dr. Yazdany is an associate professor in the division of rheumatology, department of medicine at UCSF (@UCSFMedicine). She is a rheumatologist and clinical researcher with expertise in systemic lupus erythematosus and health care quality measurement and improvement. Her clinical activities include seeing patients in the UCSF Lupus Clinic, where she serves as codirector, as well as at San Francisco General Hospital. Dr. Yazdany codirects the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She also leads ongoing, longitudinal studies of lupus that are investigating health disparities and outcomes in the condition.
 

About Dr. Schmajuk

Dr. Schmajuk is an Associate Professor in the Division of Rheumatology, Department of Medicine at UCSF (@UCSFMedicine) and the San Francisco VA Medical Center. She is a rheumatologist and clinical researcher with expertise in systemic #lupus erythematosus, quality of care, and patient safety. Dr. Schmajuk also co-directs the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She leads studies to develop patient-facing disease dashboards with the goal of improving patient-provider communication for patients with RA and SLE.


Are you new to Twitter chats? We have included simple steps below to help you join and participate in the conversation.

Join us at #MDedgeChats on Tuesday, April 23, 2019, at 7:00 pm EST, for a Twitter discussion in Rheumatology on some of the top studies reported at the LUPUS 2019 Congress in San Francisco, April 5-8. Our special guests are two rheumatologists with expertise in lupus who attended the congress, Jinoos Yazdany, MD, and Gabriela Schmajuk, MD, both with the University of California, San Francisco. They will discuss the ins and outs of the study results presented.

We hope you can join us and invite a colleague, too.

We will discuss the results of the EMBRACE trial, which looks at the efficacy and safety of belimumab (Benlysta) in black patients with systemic lupus erythematosus (SLE); these patients have a higher prevalence of SLE and often higher disease severity but have been poorly represented in past belimumab studies.

We will also chat about the results of a phase 2 trial of baricitinib (Olumiant) in SLE patients.

Finally, we will look at the clinical utility of monitoring hydroxychloroquine levels in SLE patients and how well levels of the drug correlate with disease activity through the results of a meta-analysis of studies that examined these questions.
 

Topics of conversation

Q1: How does the methodology of the EMBRACE trial differ from past phase 3 belimumab trials?

Q2: How does the EMBRACE trial affect the way you prescribe belimumab?

Q3: Does the hydroxychloroquine level meta-analysis provide persuasive enough evidence to begin measuring it?

Q4: What kinds of interventions show the best evidence for improving hydroxychloroquine adherence?

Q5: Were concerns about the safety of baricitinib in SLE patients reduced by the trial results?

Resources

EMBRACE trial: Efficacy and Safety of Belimumab in Black Race Patients with Systemic Lupus Erythematosus.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Phase 2 trial of baricitinib in SLE.

LUPUS 2019 abstract | ClinicalTrials.gov listing



Meta-analysis examining the clinical significance of monitoring of hydroxychloroquine levels in SLE.

LUPUS 2019 abstract
 

From LUPUS 2019:

Belimumab a bust for black SLE patients.

Here’s a top strategy for immunosuppressant discontinuation in SLE.
 

From EULAR 2018:

Baricitinib shows potential as lupus treatment.
 

About Dr. Yazdany

Dr. Yazdany is an associate professor in the division of rheumatology, department of medicine at UCSF (@UCSFMedicine). She is a rheumatologist and clinical researcher with expertise in systemic lupus erythematosus and health care quality measurement and improvement. Her clinical activities include seeing patients in the UCSF Lupus Clinic, where she serves as codirector, as well as at San Francisco General Hospital. Dr. Yazdany codirects the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She also leads ongoing, longitudinal studies of lupus that are investigating health disparities and outcomes in the condition.
 

About Dr. Schmajuk

Dr. Schmajuk is an Associate Professor in the Division of Rheumatology, Department of Medicine at UCSF (@UCSFMedicine) and the San Francisco VA Medical Center. She is a rheumatologist and clinical researcher with expertise in systemic #lupus erythematosus, quality of care, and patient safety. Dr. Schmajuk also co-directs the Quality and Informatics Lab (quil.ucsf.edu), which uses data to drive improvements in health care delivery and outcomes for people with rheumatic diseases. She leads studies to develop patient-facing disease dashboards with the goal of improving patient-provider communication for patients with RA and SLE.


Are you new to Twitter chats? We have included simple steps below to help you join and participate in the conversation.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

PHILADELPHIA – Patients concerned about the recent angiotensin II receptor blocker (ARB) recalls for trace carcinogens can be advised that the absolute risk of cancer is minimal, according to a senior officer of the National Kidney Foundation.

Andrew D. Bowser/MDedge News

“I’ve been telling everyone not to stop on their own,” said Joseph A. Vassalotti, MD, chief medical officer for the National Kidney Foundation and associate clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York.

“The risk of cardiovascular events acutely and the long-term risk of kidney disease progression is much more concerning to me, if they self-discontinue the ARB, than the small risk of cancer,” Dr. Vassalotti said in a meet-the-professor session at the annual meeting of the American College of Physicians.

Put in perspective, the absolute risk of cancer according to the Food and Drug Administration is one new malignancy per 8,000 patients treated with 320 mg of valsartan daily – the highest ARB dose that contained N-Nitrosodimethylamine (NDMA), one of several impurities that led to the recent recalls.

Dr. Vassalotti said that so far, he’s been able to avoid switching patients from one ARB to another by working with pharmacies to get the same medication in a different generic brand not affected by the FDA recalls.

He advised caution in switching ARBs, noting a paucity of head-to-head comparative data between ARBs.

“There may be variable effects,” he said.

If switching is thought to be warranted, he said, some extra tests or visits might be needed to ensure avoidance of hyperkalemia, undertreated hypertension, or hypotension.

Dr. Vassalotti encouraged attendees to review a perspective piece in the New England Journal of Medicine (2019 Mar 13. doi: 10.1056/NEJMp1901657) describing this hypertension “hot potato” resulting from the large-scale voluntary recalls of products containing valsartan, losartan, and irbesartan due to nitrosamine contamination.

Patients may hear about recalls of hypertension drugs, but may not know what products or manufacturers are involved, leaving the burden on clinicians, pharmacies, and health care systems to respond to their concerns, said authors of that perspective piece, led by J. Brian Byrd, MD, of the University of Michigan, Ann Arbor.

“Recalls may trigger unnecessary concern among many people receiving antihypertensive therapy – and may be ignored by people who take ARBs for heart failure or chronic kidney disease,” wrote Dr. Byrd and his colleagues.

The FDA, which said it has worked with manufacturers to “swiftly” remove ARB drug products with impurity levels above acceptable limits, is now maintaining a list of other currently marketed ARB products that are being tested for impurities.

As of the latest update on April 4, the FDA listed more than 40 products with an overall nitrosamine impurity determination of “not present” and more than 300 additional products for which assessments are not yet complete.

“Essentially, we have a safe list now of ARBs that is being developed,” Dr. Vassalotti said. “So if a patient really wanted to change, I would consult that list, and consider picking one that’s been tested already on that list, and the FDA hopefully will complete testing on all the ARB drugs in the near future.”

Dr. Vassalotti is a consultant with Merck, Janssen, and the U.S. Nephrology Advisory Board.

Diagnostic error is the most common allegation against pediatricians when sued by patients and their families, a study finds.

Investigators with The Doctors Company, a national medical liability insurer, examined 1,215 closed claims involving children from the company’s database between 2008 and 2017. Results showed that diagnostic mistakes, including delayed diagnosis, incorrect diagnosis, and failure to diagnose, were the most common accusations among claims that involved children ages 1 through 17. Poor medical treatment was the second most common allegation for claims that involved children aged 1-9, while surgical treatment-related error was the second most frequent accusation for children ages 10-17.

Pediatricians, orthopedic surgeons, and emergency medicine physicians were the most frequently named specialists in claims associated with children older than 1 month. Obstetricians were most frequently defendants in claims involving neonates. For these cases, errors during labor and delivery care were the most common complaints.

Of the 1,215 claims, obstetricians were named in 24% of the cases and pediatricians were named in 15% of the cases. The majority of claims were filed against physicians in the first 3 years following the medical incident alleged, according to the study, published by The Doctors Company.

The average patient payment in each case was $630,456, and the average expense to defend each claim was $157,502, according to the analysis. Claims that involved neonates had the highest average payment ($936,843) and the highest defense costs ($187,117), while claims involving children aged 10-17 years had the lowest average payment ($386,849) and cost the least to defend ($129,816).

For cases involving neonates, the type of therapy selected during labor and delivery and how it was managed were the most common factors contributing to the alleged injury, according to the analysis.

The most frequent factors contributing to patient harm for other age groups involved patient assessment issues and communication problems between the patient/family and the physician. Inadequate patient assessments were closely linked to incorrect diagnoses, while incomplete communication between patients/family members and providers impacted clinicians’ ability to make correct diagnoses, according to the study.

This analysis “shows that pediatric malpractice lawsuits impact nearly every area of medicine,” William F. Getman, MD, a pediatrician in Austin, Tex., said in an interview. “I was surprised to see that the most common age of a patient in a malpractice lawsuit was less than 1 month old. This age group also sustained the most severe injuries and had the highest indemnity paid.”

The study offers several key takeaways, including the importance of identifying system weaknesses in your medical practice and evaluating if improvements are needed, according to Darrell Ranum, vice president for patient safety and risk management for The Doctors Company.

[email protected]

SOURCE: Ranum, D. The Doctor’s Advocate. First Quarter 2019.

Diagnostic error is the most common allegation against pediatricians when sued by patients and their families, a study finds.

Investigators with The Doctors Company, a national medical liability insurer, examined 1,215 closed claims involving children from the company’s database between 2008 and 2017. Results showed that diagnostic mistakes, including delayed diagnosis, incorrect diagnosis, and failure to diagnose, were the most common accusations among claims that involved children ages 1 through 17. Poor medical treatment was the second most common allegation for claims that involved children aged 1-9, while surgical treatment-related error was the second most frequent accusation for children ages 10-17.

Pediatricians, orthopedic surgeons, and emergency medicine physicians were the most frequently named specialists in claims associated with children older than 1 month. Obstetricians were most frequently defendants in claims involving neonates. For these cases, errors during labor and delivery care were the most common complaints.

Of the 1,215 claims, obstetricians were named in 24% of the cases and pediatricians were named in 15% of the cases. The majority of claims were filed against physicians in the first 3 years following the medical incident alleged, according to the study, published by The Doctors Company.

The average patient payment in each case was $630,456, and the average expense to defend each claim was $157,502, according to the analysis. Claims that involved neonates had the highest average payment ($936,843) and the highest defense costs ($187,117), while claims involving children aged 10-17 years had the lowest average payment ($386,849) and cost the least to defend ($129,816).

For cases involving neonates, the type of therapy selected during labor and delivery and how it was managed were the most common factors contributing to the alleged injury, according to the analysis.

The most frequent factors contributing to patient harm for other age groups involved patient assessment issues and communication problems between the patient/family and the physician. Inadequate patient assessments were closely linked to incorrect diagnoses, while incomplete communication between patients/family members and providers impacted clinicians’ ability to make correct diagnoses, according to the study.

This analysis “shows that pediatric malpractice lawsuits impact nearly every area of medicine,” William F. Getman, MD, a pediatrician in Austin, Tex., said in an interview. “I was surprised to see that the most common age of a patient in a malpractice lawsuit was less than 1 month old. This age group also sustained the most severe injuries and had the highest indemnity paid.”

The study offers several key takeaways, including the importance of identifying system weaknesses in your medical practice and evaluating if improvements are needed, according to Darrell Ranum, vice president for patient safety and risk management for The Doctors Company.

[email protected]

SOURCE: Ranum, D. The Doctor’s Advocate. First Quarter 2019.

Diagnostic error is the most common allegation against pediatricians when sued by patients and their families, a study finds.

Investigators with The Doctors Company, a national medical liability insurer, examined 1,215 closed claims involving children from the company’s database between 2008 and 2017. Results showed that diagnostic mistakes, including delayed diagnosis, incorrect diagnosis, and failure to diagnose, were the most common accusations among claims that involved children ages 1 through 17. Poor medical treatment was the second most common allegation for claims that involved children aged 1-9, while surgical treatment-related error was the second most frequent accusation for children ages 10-17.

Pediatricians, orthopedic surgeons, and emergency medicine physicians were the most frequently named specialists in claims associated with children older than 1 month. Obstetricians were most frequently defendants in claims involving neonates. For these cases, errors during labor and delivery care were the most common complaints.

Of the 1,215 claims, obstetricians were named in 24% of the cases and pediatricians were named in 15% of the cases. The majority of claims were filed against physicians in the first 3 years following the medical incident alleged, according to the study, published by The Doctors Company.

The average patient payment in each case was $630,456, and the average expense to defend each claim was $157,502, according to the analysis. Claims that involved neonates had the highest average payment ($936,843) and the highest defense costs ($187,117), while claims involving children aged 10-17 years had the lowest average payment ($386,849) and cost the least to defend ($129,816).

For cases involving neonates, the type of therapy selected during labor and delivery and how it was managed were the most common factors contributing to the alleged injury, according to the analysis.

The most frequent factors contributing to patient harm for other age groups involved patient assessment issues and communication problems between the patient/family and the physician. Inadequate patient assessments were closely linked to incorrect diagnoses, while incomplete communication between patients/family members and providers impacted clinicians’ ability to make correct diagnoses, according to the study.

This analysis “shows that pediatric malpractice lawsuits impact nearly every area of medicine,” William F. Getman, MD, a pediatrician in Austin, Tex., said in an interview. “I was surprised to see that the most common age of a patient in a malpractice lawsuit was less than 1 month old. This age group also sustained the most severe injuries and had the highest indemnity paid.”

The study offers several key takeaways, including the importance of identifying system weaknesses in your medical practice and evaluating if improvements are needed, according to Darrell Ranum, vice president for patient safety and risk management for The Doctors Company.

[email protected]

SOURCE: Ranum, D. The Doctor’s Advocate. First Quarter 2019.

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

ORLANDO – Judge Steve Leifman, who presides over 11th judicial circuit court in Miami-Dade County, Fla., was about to take the bench several years ago when he agreed to see a couple, who then begged him to help their son, who had mental illness. Judge Leifman was about to hear his case.

The man was a Harvard-educated former psychiatrist and at first appeared healthy, but then took on a look of terror and began screaming when the judge asked him a question. Although the man was clearly psychotic, Judge Leifman had no choice but to release him to the streets – he had no authority under the law to involuntarily commit anyone to psychiatric treatment.

There was little doubt that the man would end up committing a crime and being put behind bars.

Judge Leifman, who gave the keynote address at the annual congress of the Schizophrenia International Research Society, now has made it his life’s work to reform a system in which jails are the de facto hospitals for people with mental illness.

“I do not know any other illness that it’s okay to discharge people in the middle of the night, floridly psychotic, and then when they don’t behave the way that we need them to behave, we arrest them,” he said. “And I don’t know why people aren’t angrier about it.”

He quoted figures that are staggering in their illustration of how mental illness has become criminalized. People with mental illnesses in the United States are 9 times more likely to be incarcerated than hospitalized, and 18 times more likely to find a bed in jail than at a state civil hospital, he said. On any given day, about 400,000 people with mental illness are in jail and 800,000 are under correctional supervision. He said that 40% of all people with mental illness in the United States will at some point come into contact with the criminal justice system.

Together, U.S. counties spend $80 billion a year on correctional costs. States spend an additional $71 billion, he said.

Judge Leifman has helped start an initiative called Stepping Up to lead reform. It’s an effort by the National Association of Counties, American Psychiatric Association Foundation, and the Council of State Government. More than 400 counties over the past few years have passed resolutions saying they’re committed to change.

Judge Leifman organized a summit, with criminal justice and health groups coming together to assess the issue, only to diagnose a system that’s “designed to fail.” Local officials have crafted a new system with links to comprehensive care for people with mental illness that make jail a last resort rather than a first stop. A key component is “crisis intervention team policing,” in which law enforcement officers are trained to identify people with mental illness, deescalate situations, and get them to proper care rather than arrest them. All 36 Miami-Dade County police departments are trained in this program, and it has eased the incarceration and recidivism rates.

“It has been a huge cultural shift,” Judge Leifman said.

“We’ve improved public safety, we’ve reduced police injuries, we’ve helped police officers get back to patrol much quicker, we’ve saved critical tax dollars, we’ve saved lives, and we’ve decriminalized mental illness,” he said. “But we still have plenty to do. Because as good as all this has been, it’s limited. ... Our state’s mental health systems are still too fragmented, they’re still antiquated, and they’re painfully underresourced. And the laws are old and they don’t reflect the science today.”

Judge Leifman reported no relevant disclosures.

ORLANDO – Judge Steve Leifman, who presides over 11th judicial circuit court in Miami-Dade County, Fla., was about to take the bench several years ago when he agreed to see a couple, who then begged him to help their son, who had mental illness. Judge Leifman was about to hear his case.

The man was a Harvard-educated former psychiatrist and at first appeared healthy, but then took on a look of terror and began screaming when the judge asked him a question. Although the man was clearly psychotic, Judge Leifman had no choice but to release him to the streets – he had no authority under the law to involuntarily commit anyone to psychiatric treatment.

There was little doubt that the man would end up committing a crime and being put behind bars.

Judge Leifman, who gave the keynote address at the annual congress of the Schizophrenia International Research Society, now has made it his life’s work to reform a system in which jails are the de facto hospitals for people with mental illness.

“I do not know any other illness that it’s okay to discharge people in the middle of the night, floridly psychotic, and then when they don’t behave the way that we need them to behave, we arrest them,” he said. “And I don’t know why people aren’t angrier about it.”

He quoted figures that are staggering in their illustration of how mental illness has become criminalized. People with mental illnesses in the United States are 9 times more likely to be incarcerated than hospitalized, and 18 times more likely to find a bed in jail than at a state civil hospital, he said. On any given day, about 400,000 people with mental illness are in jail and 800,000 are under correctional supervision. He said that 40% of all people with mental illness in the United States will at some point come into contact with the criminal justice system.

Together, U.S. counties spend $80 billion a year on correctional costs. States spend an additional $71 billion, he said.

Judge Leifman has helped start an initiative called Stepping Up to lead reform. It’s an effort by the National Association of Counties, American Psychiatric Association Foundation, and the Council of State Government. More than 400 counties over the past few years have passed resolutions saying they’re committed to change.

Judge Leifman organized a summit, with criminal justice and health groups coming together to assess the issue, only to diagnose a system that’s “designed to fail.” Local officials have crafted a new system with links to comprehensive care for people with mental illness that make jail a last resort rather than a first stop. A key component is “crisis intervention team policing,” in which law enforcement officers are trained to identify people with mental illness, deescalate situations, and get them to proper care rather than arrest them. All 36 Miami-Dade County police departments are trained in this program, and it has eased the incarceration and recidivism rates.

“It has been a huge cultural shift,” Judge Leifman said.

“We’ve improved public safety, we’ve reduced police injuries, we’ve helped police officers get back to patrol much quicker, we’ve saved critical tax dollars, we’ve saved lives, and we’ve decriminalized mental illness,” he said. “But we still have plenty to do. Because as good as all this has been, it’s limited. ... Our state’s mental health systems are still too fragmented, they’re still antiquated, and they’re painfully underresourced. And the laws are old and they don’t reflect the science today.”

Judge Leifman reported no relevant disclosures.

ORLANDO – Judge Steve Leifman, who presides over 11th judicial circuit court in Miami-Dade County, Fla., was about to take the bench several years ago when he agreed to see a couple, who then begged him to help their son, who had mental illness. Judge Leifman was about to hear his case.

The man was a Harvard-educated former psychiatrist and at first appeared healthy, but then took on a look of terror and began screaming when the judge asked him a question. Although the man was clearly psychotic, Judge Leifman had no choice but to release him to the streets – he had no authority under the law to involuntarily commit anyone to psychiatric treatment.

There was little doubt that the man would end up committing a crime and being put behind bars.

Judge Leifman, who gave the keynote address at the annual congress of the Schizophrenia International Research Society, now has made it his life’s work to reform a system in which jails are the de facto hospitals for people with mental illness.

“I do not know any other illness that it’s okay to discharge people in the middle of the night, floridly psychotic, and then when they don’t behave the way that we need them to behave, we arrest them,” he said. “And I don’t know why people aren’t angrier about it.”

He quoted figures that are staggering in their illustration of how mental illness has become criminalized. People with mental illnesses in the United States are 9 times more likely to be incarcerated than hospitalized, and 18 times more likely to find a bed in jail than at a state civil hospital, he said. On any given day, about 400,000 people with mental illness are in jail and 800,000 are under correctional supervision. He said that 40% of all people with mental illness in the United States will at some point come into contact with the criminal justice system.

Together, U.S. counties spend $80 billion a year on correctional costs. States spend an additional $71 billion, he said.

Judge Leifman has helped start an initiative called Stepping Up to lead reform. It’s an effort by the National Association of Counties, American Psychiatric Association Foundation, and the Council of State Government. More than 400 counties over the past few years have passed resolutions saying they’re committed to change.

Judge Leifman organized a summit, with criminal justice and health groups coming together to assess the issue, only to diagnose a system that’s “designed to fail.” Local officials have crafted a new system with links to comprehensive care for people with mental illness that make jail a last resort rather than a first stop. A key component is “crisis intervention team policing,” in which law enforcement officers are trained to identify people with mental illness, deescalate situations, and get them to proper care rather than arrest them. All 36 Miami-Dade County police departments are trained in this program, and it has eased the incarceration and recidivism rates.

“It has been a huge cultural shift,” Judge Leifman said.

“We’ve improved public safety, we’ve reduced police injuries, we’ve helped police officers get back to patrol much quicker, we’ve saved critical tax dollars, we’ve saved lives, and we’ve decriminalized mental illness,” he said. “But we still have plenty to do. Because as good as all this has been, it’s limited. ... Our state’s mental health systems are still too fragmented, they’re still antiquated, and they’re painfully underresourced. And the laws are old and they don’t reflect the science today.”

Judge Leifman reported no relevant disclosures.

Psychological consequences of patient complications seem to be an important occupational health issue for surgeons, according to the results of an extensive literature review published in JAMA Surgery.

wutwhanfoto/iStock/Getty Images Plus

Sanket Srinivasa, PhD, of North Shore Hospital, Auckland, New Zealand, and colleagues assessed studies from MEDLINE, Embase, PubMed, Web of Science, and Google Scholar that examined the consequences of complications, adverse events, or error for surgeons published up to the search date of May 1, 2018. Studies pertaining to burnout alone, studies not conducted on surgeons or surgical trainees, and review articles with no original data were excluded. This final review of consisted of nine studies (10,702 unique participants) that explored the occurrence of patient complications and their affect on surgeons’ psychological well-being and their professional and personal lives.

All of the studies indicated that surgeons were affected emotionally after patient complications, which led to adverse consequences in their professional and personal lives. The study authors identified four themes from the literature.

• The adverse emotional influence of complications (including anxiety, guilt, sadness, shame, and interference with professional and leisure activities) after intraoperative adverse events; one study diagnosed acute traumatic stress (using valid diagnostic criteria) in one-third of their participants 1 month after a major surgical complication.
• Coping mechanisms used by surgeons and trainees (including limited discussion with colleagues, exercise, artistic or creative outlets, alcohol and substance abuse); emotion-focused coping strategies reported included rationalization, seeking reassurance, blaming oneself or others, and dissociation with self-distraction. Other adaptive strategies used included engaging in artistic endeavors and exercise, although maladaptive strategies were also adopted by some, including alcohol and substance use disorder.
• Institutional support mechanisms and barriers to support (including clinical conferences, discussion with mentors, and a perception that emotional distress would be perceived as a constitutional weakness). For example, surgical trainees in one study did not believe that morbidity and mortality meetings addressed the emotional needs of trainees, and respondents in another study pointed to poor institutional support with a competitive, unsympathetic surgical culture, with the morbidity and mortality meeting being regarded as accusatory and hostile without providing support.
• The consequences of complications in future clinical practice (including changes in practice, introduction of protocols, education of staff members, and participating in root-cause analysis). Participants in several studies believed that dealing with errors and complications improved their subsequent performance, For example, 92 of 123 respondents (74.8%) in one study believed that their professional ability was not impaired after a complication, and in another study half of the surgeons did not believe they should stop operating for a brief period after an intraoperative death. “However, respondents in other studies described a combination of anxiety and shock affecting their ability to rectify the operative problem in a practical sense immediately after an intraoperative complication. Some respondents reported impairment for weeks after the incident, describing ongoing rumination, difficulties in concentration, adversely affected clinical judgment, and loss of confidence,” according to the researchers. Surgeons in another study described an initial denial and minimization of the severity of the consequence potentially delaying the necessary treatment, while some surgeons reported avoiding or stopping certain operations as well as contemplating early retirement.

“Surgeons across the studies indicated that they deal with these problems in isolation with significant personal and clinical consequences. With primum non nocere remaining a cornerstone of medical practice as applied to patients, a similar philosophy needs to be embraced by the surgical community for the betterment of health of the profession,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Srinivasa S et al. JAMA Surg. 2019 Mar 27. doi: 10.1001/jamasurg.2018.5640.

Psychological consequences of patient complications seem to be an important occupational health issue for surgeons, according to the results of an extensive literature review published in JAMA Surgery.

wutwhanfoto/iStock/Getty Images Plus

Sanket Srinivasa, PhD, of North Shore Hospital, Auckland, New Zealand, and colleagues assessed studies from MEDLINE, Embase, PubMed, Web of Science, and Google Scholar that examined the consequences of complications, adverse events, or error for surgeons published up to the search date of May 1, 2018. Studies pertaining to burnout alone, studies not conducted on surgeons or surgical trainees, and review articles with no original data were excluded. This final review of consisted of nine studies (10,702 unique participants) that explored the occurrence of patient complications and their affect on surgeons’ psychological well-being and their professional and personal lives.

All of the studies indicated that surgeons were affected emotionally after patient complications, which led to adverse consequences in their professional and personal lives. The study authors identified four themes from the literature.

• The adverse emotional influence of complications (including anxiety, guilt, sadness, shame, and interference with professional and leisure activities) after intraoperative adverse events; one study diagnosed acute traumatic stress (using valid diagnostic criteria) in one-third of their participants 1 month after a major surgical complication.
• Coping mechanisms used by surgeons and trainees (including limited discussion with colleagues, exercise, artistic or creative outlets, alcohol and substance abuse); emotion-focused coping strategies reported included rationalization, seeking reassurance, blaming oneself or others, and dissociation with self-distraction. Other adaptive strategies used included engaging in artistic endeavors and exercise, although maladaptive strategies were also adopted by some, including alcohol and substance use disorder.
• Institutional support mechanisms and barriers to support (including clinical conferences, discussion with mentors, and a perception that emotional distress would be perceived as a constitutional weakness). For example, surgical trainees in one study did not believe that morbidity and mortality meetings addressed the emotional needs of trainees, and respondents in another study pointed to poor institutional support with a competitive, unsympathetic surgical culture, with the morbidity and mortality meeting being regarded as accusatory and hostile without providing support.
• The consequences of complications in future clinical practice (including changes in practice, introduction of protocols, education of staff members, and participating in root-cause analysis). Participants in several studies believed that dealing with errors and complications improved their subsequent performance, For example, 92 of 123 respondents (74.8%) in one study believed that their professional ability was not impaired after a complication, and in another study half of the surgeons did not believe they should stop operating for a brief period after an intraoperative death. “However, respondents in other studies described a combination of anxiety and shock affecting their ability to rectify the operative problem in a practical sense immediately after an intraoperative complication. Some respondents reported impairment for weeks after the incident, describing ongoing rumination, difficulties in concentration, adversely affected clinical judgment, and loss of confidence,” according to the researchers. Surgeons in another study described an initial denial and minimization of the severity of the consequence potentially delaying the necessary treatment, while some surgeons reported avoiding or stopping certain operations as well as contemplating early retirement.

“Surgeons across the studies indicated that they deal with these problems in isolation with significant personal and clinical consequences. With primum non nocere remaining a cornerstone of medical practice as applied to patients, a similar philosophy needs to be embraced by the surgical community for the betterment of health of the profession,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Srinivasa S et al. JAMA Surg. 2019 Mar 27. doi: 10.1001/jamasurg.2018.5640.

Psychological consequences of patient complications seem to be an important occupational health issue for surgeons, according to the results of an extensive literature review published in JAMA Surgery.

wutwhanfoto/iStock/Getty Images Plus

Sanket Srinivasa, PhD, of North Shore Hospital, Auckland, New Zealand, and colleagues assessed studies from MEDLINE, Embase, PubMed, Web of Science, and Google Scholar that examined the consequences of complications, adverse events, or error for surgeons published up to the search date of May 1, 2018. Studies pertaining to burnout alone, studies not conducted on surgeons or surgical trainees, and review articles with no original data were excluded. This final review of consisted of nine studies (10,702 unique participants) that explored the occurrence of patient complications and their affect on surgeons’ psychological well-being and their professional and personal lives.

All of the studies indicated that surgeons were affected emotionally after patient complications, which led to adverse consequences in their professional and personal lives. The study authors identified four themes from the literature.

• The adverse emotional influence of complications (including anxiety, guilt, sadness, shame, and interference with professional and leisure activities) after intraoperative adverse events; one study diagnosed acute traumatic stress (using valid diagnostic criteria) in one-third of their participants 1 month after a major surgical complication.
• Coping mechanisms used by surgeons and trainees (including limited discussion with colleagues, exercise, artistic or creative outlets, alcohol and substance abuse); emotion-focused coping strategies reported included rationalization, seeking reassurance, blaming oneself or others, and dissociation with self-distraction. Other adaptive strategies used included engaging in artistic endeavors and exercise, although maladaptive strategies were also adopted by some, including alcohol and substance use disorder.
• Institutional support mechanisms and barriers to support (including clinical conferences, discussion with mentors, and a perception that emotional distress would be perceived as a constitutional weakness). For example, surgical trainees in one study did not believe that morbidity and mortality meetings addressed the emotional needs of trainees, and respondents in another study pointed to poor institutional support with a competitive, unsympathetic surgical culture, with the morbidity and mortality meeting being regarded as accusatory and hostile without providing support.
• The consequences of complications in future clinical practice (including changes in practice, introduction of protocols, education of staff members, and participating in root-cause analysis). Participants in several studies believed that dealing with errors and complications improved their subsequent performance, For example, 92 of 123 respondents (74.8%) in one study believed that their professional ability was not impaired after a complication, and in another study half of the surgeons did not believe they should stop operating for a brief period after an intraoperative death. “However, respondents in other studies described a combination of anxiety and shock affecting their ability to rectify the operative problem in a practical sense immediately after an intraoperative complication. Some respondents reported impairment for weeks after the incident, describing ongoing rumination, difficulties in concentration, adversely affected clinical judgment, and loss of confidence,” according to the researchers. Surgeons in another study described an initial denial and minimization of the severity of the consequence potentially delaying the necessary treatment, while some surgeons reported avoiding or stopping certain operations as well as contemplating early retirement.

“Surgeons across the studies indicated that they deal with these problems in isolation with significant personal and clinical consequences. With primum non nocere remaining a cornerstone of medical practice as applied to patients, a similar philosophy needs to be embraced by the surgical community for the betterment of health of the profession,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Srinivasa S et al. JAMA Surg. 2019 Mar 27. doi: 10.1001/jamasurg.2018.5640.