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Team identifies new function of Fanconi anemia genes
Image by Sarah Pfau
Research published in Cell has revealed a new function of genes in the Fanconi anemia (FA) pathway, and investigators believe this finding could have
implications for the treatment of FA and related disorders.
The team found that FA genes are required for selective autophagy.
In particular, the FANCC gene plays a key role in 2 types of selective autophagy: virophagy (the removal of viruses inside the cell) and mitophagy (the removal of mitochondria).
Experiments in mice showed that genetic deletion of FANCC blocks virophagy and increases the animals’ susceptibility to lethal viral encephalitis.
The investigators also found that FANCC protein is required for the clearance of damaged mitochondria and decreases the production of mitochondrial reactive oxygen species and inflammasome activation.
And other genes in the FA pathway are required for mitophagy as well—FANCA, FANCF, FANCL, FANCD2, BRCA1, and BRCA2.
“There’s increasing evidence that the failure of cells to appropriately clear damaged mitochondria leads to abnormal activation of the inflammasome—a process that is emerging as an important contributor to many different diseases,” said study author Beth Levine, MD, of UT Southwestern Medical Center in Dallas, Texas.
“The finding that FA genes function in clearing mitochondria and decreasing inflammasome activation provides a potential new inflammasome-targeted avenue of therapy for patients with diseases related to mutations in the FA genes.”
FA pathway genes were already known to play a role in DNA repair. The investigators said this new link to autophagy opens up unexplored horizons for understanding the function of these genes in human health and disease.
“Our findings suggest a novel mechanism by which mutations in FA genes may lead to the clinical manifestations in patients with FA and to cancers in patients with mutations in FA genes,” said study author Rhea Sumpter, MD, PhD, of UT Southwestern Medical Center.
“We’ve shown that this new function of the FA genes in the selective autophagy pathways does not depend on their role in DNA repair.”
In addition, the autophagy function may partly explain why patients with FA are highly susceptible to infection and cancer, Dr Levine said.
While further research is needed to understand how these findings may be used to treat disease, the investigators said they have identified a novel avenue for developing potential therapies for FA and cancer patients.
“I believe the clearest therapeutic possibilities to come from our study results are the development of new FA agents that target the inflammasome and production of interleukin 1 beta (IL-1β), a pro-inflammatory cytokine,” Dr Sumpter said.
“Clinically, IL-1β signaling has been targeted with FDA-approved drugs very successfully in several auto-inflammatory diseases that involve excessive inflammasome activation. Our results suggest that FA patients may also benefit from these therapies.” 
Image by Sarah Pfau
Research published in Cell has revealed a new function of genes in the Fanconi anemia (FA) pathway, and investigators believe this finding could have
implications for the treatment of FA and related disorders.
The team found that FA genes are required for selective autophagy.
In particular, the FANCC gene plays a key role in 2 types of selective autophagy: virophagy (the removal of viruses inside the cell) and mitophagy (the removal of mitochondria).
Experiments in mice showed that genetic deletion of FANCC blocks virophagy and increases the animals’ susceptibility to lethal viral encephalitis.
The investigators also found that FANCC protein is required for the clearance of damaged mitochondria and decreases the production of mitochondrial reactive oxygen species and inflammasome activation.
And other genes in the FA pathway are required for mitophagy as well—FANCA, FANCF, FANCL, FANCD2, BRCA1, and BRCA2.
“There’s increasing evidence that the failure of cells to appropriately clear damaged mitochondria leads to abnormal activation of the inflammasome—a process that is emerging as an important contributor to many different diseases,” said study author Beth Levine, MD, of UT Southwestern Medical Center in Dallas, Texas.
“The finding that FA genes function in clearing mitochondria and decreasing inflammasome activation provides a potential new inflammasome-targeted avenue of therapy for patients with diseases related to mutations in the FA genes.”
FA pathway genes were already known to play a role in DNA repair. The investigators said this new link to autophagy opens up unexplored horizons for understanding the function of these genes in human health and disease.
“Our findings suggest a novel mechanism by which mutations in FA genes may lead to the clinical manifestations in patients with FA and to cancers in patients with mutations in FA genes,” said study author Rhea Sumpter, MD, PhD, of UT Southwestern Medical Center.
“We’ve shown that this new function of the FA genes in the selective autophagy pathways does not depend on their role in DNA repair.”
In addition, the autophagy function may partly explain why patients with FA are highly susceptible to infection and cancer, Dr Levine said.
While further research is needed to understand how these findings may be used to treat disease, the investigators said they have identified a novel avenue for developing potential therapies for FA and cancer patients.
“I believe the clearest therapeutic possibilities to come from our study results are the development of new FA agents that target the inflammasome and production of interleukin 1 beta (IL-1β), a pro-inflammatory cytokine,” Dr Sumpter said.
“Clinically, IL-1β signaling has been targeted with FDA-approved drugs very successfully in several auto-inflammatory diseases that involve excessive inflammasome activation. Our results suggest that FA patients may also benefit from these therapies.”
Image by Sarah Pfau
Research published in Cell has revealed a new function of genes in the Fanconi anemia (FA) pathway, and investigators believe this finding could have
implications for the treatment of FA and related disorders.
The team found that FA genes are required for selective autophagy.
In particular, the FANCC gene plays a key role in 2 types of selective autophagy: virophagy (the removal of viruses inside the cell) and mitophagy (the removal of mitochondria).
Experiments in mice showed that genetic deletion of FANCC blocks virophagy and increases the animals’ susceptibility to lethal viral encephalitis.
The investigators also found that FANCC protein is required for the clearance of damaged mitochondria and decreases the production of mitochondrial reactive oxygen species and inflammasome activation.
And other genes in the FA pathway are required for mitophagy as well—FANCA, FANCF, FANCL, FANCD2, BRCA1, and BRCA2.
“There’s increasing evidence that the failure of cells to appropriately clear damaged mitochondria leads to abnormal activation of the inflammasome—a process that is emerging as an important contributor to many different diseases,” said study author Beth Levine, MD, of UT Southwestern Medical Center in Dallas, Texas.
“The finding that FA genes function in clearing mitochondria and decreasing inflammasome activation provides a potential new inflammasome-targeted avenue of therapy for patients with diseases related to mutations in the FA genes.”
FA pathway genes were already known to play a role in DNA repair. The investigators said this new link to autophagy opens up unexplored horizons for understanding the function of these genes in human health and disease.
“Our findings suggest a novel mechanism by which mutations in FA genes may lead to the clinical manifestations in patients with FA and to cancers in patients with mutations in FA genes,” said study author Rhea Sumpter, MD, PhD, of UT Southwestern Medical Center.
“We’ve shown that this new function of the FA genes in the selective autophagy pathways does not depend on their role in DNA repair.”
In addition, the autophagy function may partly explain why patients with FA are highly susceptible to infection and cancer, Dr Levine said.
While further research is needed to understand how these findings may be used to treat disease, the investigators said they have identified a novel avenue for developing potential therapies for FA and cancer patients.
“I believe the clearest therapeutic possibilities to come from our study results are the development of new FA agents that target the inflammasome and production of interleukin 1 beta (IL-1β), a pro-inflammatory cytokine,” Dr Sumpter said.
“Clinically, IL-1β signaling has been targeted with FDA-approved drugs very successfully in several auto-inflammatory diseases that involve excessive inflammasome activation. Our results suggest that FA patients may also benefit from these therapies.”
Medical errors among leading causes of death in US
while another looks on
Photo courtesy of NCI
In recent years, medical errors may have become one of the top causes of death in the US, according to a study published in The BMJ.
Investigators analyzed medical death rate data over an 8-year period and calculated that more than 250,000 deaths per year may be due to medical error.
That figure surpasses the US Centers for Disease Control and Prevention’s (CDC) third leading cause of death—respiratory disease, which kills close to 150,000 people per year.
The investigators said the CDC’s way of collecting national health statistics fails to classify medical errors separately on the death certificate. So the team is advocating for updated criteria for classifying deaths.
“Incidence rates for deaths directly attributable to medical care gone awry haven’t been recognized in any standardized method for collecting national statistics,” said study author Martin Makary, MD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used.”
Dr Makary noted that, in 1949, the US adopted an international form that used International Classification of Diseases (ICD) billing codes to tally causes of death.
“At that time, it was under-recognized that diagnostic errors, medical mistakes, and the absence of safety nets could result in someone’s death, and because of that, medical errors were unintentionally excluded from national health statistics,” Dr Makary said.
He pointed out that, since that time, national mortality statistics have been tabulated using billing codes, which don’t have a built-in way to recognize incidence rates of mortality due to medical care gone wrong.
For the current study, Dr Makary and Michael Daniel, also of Johns Hopkins, examined 4 separate studies that analyzed medical death rate data from 2000 to 2008.
Then, using hospital admission rates from 2013, the investigators extrapolated that, based on a total of 35,416,020 hospitalizations, 251,454 deaths stemmed from medical error. This translates to 9.5% of all deaths each year in the US.
According to the CDC, in 2013, 611,105 people died of heart disease, 584,881 died of cancer, and 149,205 died of chronic respiratory disease.
These were the top 3 causes of death in the US. The newly calculated figure for medical errors puts this cause of death behind cancer but ahead of respiratory disease.
“Top-ranked causes of death as reported by the CDC inform our country’s research funding and public health priorities,” Dr Makary said. “Right now, cancer and heart disease get a ton of attention, but since medical errors don’t appear on the list, the problem doesn’t get the funding and attention it deserves.”
The investigators said most medical errors aren’t due to inherently bad doctors, and reporting these errors shouldn’t be addressed by punishment or legal action.
Rather, the pair believes that most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability.
“Unwarranted variation is endemic in healthcare,” Dr Makary said. “Developing consensus protocols that streamline the delivery of medicine and reduce variability can improve quality and lower costs in healthcare. More research on preventing medical errors from occurring is needed to address the problem.”
while another looks on
Photo courtesy of NCI
In recent years, medical errors may have become one of the top causes of death in the US, according to a study published in The BMJ.
Investigators analyzed medical death rate data over an 8-year period and calculated that more than 250,000 deaths per year may be due to medical error.
That figure surpasses the US Centers for Disease Control and Prevention’s (CDC) third leading cause of death—respiratory disease, which kills close to 150,000 people per year.
The investigators said the CDC’s way of collecting national health statistics fails to classify medical errors separately on the death certificate. So the team is advocating for updated criteria for classifying deaths.
“Incidence rates for deaths directly attributable to medical care gone awry haven’t been recognized in any standardized method for collecting national statistics,” said study author Martin Makary, MD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used.”
Dr Makary noted that, in 1949, the US adopted an international form that used International Classification of Diseases (ICD) billing codes to tally causes of death.
“At that time, it was under-recognized that diagnostic errors, medical mistakes, and the absence of safety nets could result in someone’s death, and because of that, medical errors were unintentionally excluded from national health statistics,” Dr Makary said.
He pointed out that, since that time, national mortality statistics have been tabulated using billing codes, which don’t have a built-in way to recognize incidence rates of mortality due to medical care gone wrong.
For the current study, Dr Makary and Michael Daniel, also of Johns Hopkins, examined 4 separate studies that analyzed medical death rate data from 2000 to 2008.
Then, using hospital admission rates from 2013, the investigators extrapolated that, based on a total of 35,416,020 hospitalizations, 251,454 deaths stemmed from medical error. This translates to 9.5% of all deaths each year in the US.
According to the CDC, in 2013, 611,105 people died of heart disease, 584,881 died of cancer, and 149,205 died of chronic respiratory disease.
These were the top 3 causes of death in the US. The newly calculated figure for medical errors puts this cause of death behind cancer but ahead of respiratory disease.
“Top-ranked causes of death as reported by the CDC inform our country’s research funding and public health priorities,” Dr Makary said. “Right now, cancer and heart disease get a ton of attention, but since medical errors don’t appear on the list, the problem doesn’t get the funding and attention it deserves.”
The investigators said most medical errors aren’t due to inherently bad doctors, and reporting these errors shouldn’t be addressed by punishment or legal action.
Rather, the pair believes that most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability.
“Unwarranted variation is endemic in healthcare,” Dr Makary said. “Developing consensus protocols that streamline the delivery of medicine and reduce variability can improve quality and lower costs in healthcare. More research on preventing medical errors from occurring is needed to address the problem.”
while another looks on
Photo courtesy of NCI
In recent years, medical errors may have become one of the top causes of death in the US, according to a study published in The BMJ.
Investigators analyzed medical death rate data over an 8-year period and calculated that more than 250,000 deaths per year may be due to medical error.
That figure surpasses the US Centers for Disease Control and Prevention’s (CDC) third leading cause of death—respiratory disease, which kills close to 150,000 people per year.
The investigators said the CDC’s way of collecting national health statistics fails to classify medical errors separately on the death certificate. So the team is advocating for updated criteria for classifying deaths.
“Incidence rates for deaths directly attributable to medical care gone awry haven’t been recognized in any standardized method for collecting national statistics,” said study author Martin Makary, MD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.
“The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used.”
Dr Makary noted that, in 1949, the US adopted an international form that used International Classification of Diseases (ICD) billing codes to tally causes of death.
“At that time, it was under-recognized that diagnostic errors, medical mistakes, and the absence of safety nets could result in someone’s death, and because of that, medical errors were unintentionally excluded from national health statistics,” Dr Makary said.
He pointed out that, since that time, national mortality statistics have been tabulated using billing codes, which don’t have a built-in way to recognize incidence rates of mortality due to medical care gone wrong.
For the current study, Dr Makary and Michael Daniel, also of Johns Hopkins, examined 4 separate studies that analyzed medical death rate data from 2000 to 2008.
Then, using hospital admission rates from 2013, the investigators extrapolated that, based on a total of 35,416,020 hospitalizations, 251,454 deaths stemmed from medical error. This translates to 9.5% of all deaths each year in the US.
According to the CDC, in 2013, 611,105 people died of heart disease, 584,881 died of cancer, and 149,205 died of chronic respiratory disease.
These were the top 3 causes of death in the US. The newly calculated figure for medical errors puts this cause of death behind cancer but ahead of respiratory disease.
“Top-ranked causes of death as reported by the CDC inform our country’s research funding and public health priorities,” Dr Makary said. “Right now, cancer and heart disease get a ton of attention, but since medical errors don’t appear on the list, the problem doesn’t get the funding and attention it deserves.”
The investigators said most medical errors aren’t due to inherently bad doctors, and reporting these errors shouldn’t be addressed by punishment or legal action.
Rather, the pair believes that most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability.
“Unwarranted variation is endemic in healthcare,” Dr Makary said. “Developing consensus protocols that streamline the delivery of medicine and reduce variability can improve quality and lower costs in healthcare. More research on preventing medical errors from occurring is needed to address the problem.”
CAR T-cell therapy granted orphan designation
The US Food and Drug Administration (FDA) has granted orphan drug designation for the chimeric antigen receptor (CAR) T-cell therapy KTE-C19 as a treatment for several hematologic malignancies.
This includes primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
KTE-C19 previously received orphan designation from the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL).
The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity.
KTE-C19 also has breakthrough therapy designation from the FDA as a treatment for DLBCL, PMBCL, and transformed FL.
About KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target CD19. The product is being developed by Kite Pharma, Inc.
In a study published in the Journal of Clinical Oncology, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Thirteen patients were evaluable for response. The overall response rate was 92%. Eight patients achieved a complete response (CR), and 4 had a partial response (PR).
Of the 7 patients with DLBCL, 4 achieved a CR, 2 achieved a PR, and 1 had stable disease. Three of the CRs were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
Of the 4 patients with CLL, 3 had a CR, and 1 had a PR. All 3 CRs were ongoing at the time of publication, with the duration ranging from 14 months to 23 months.
Among the 2 patients with indolent lymphomas, 1 achieved a CR, and 1 had a PR. The duration of the CR was 11 months at the time of publication.
KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
KTE-C19 is currently under investigation in a phase 2 trial of refractory DLBCL, PMBCL, and transformed FL (ZUMA-1), a phase 2 trial of relapsed/refractory MCL (ZUMA-2), a phase 1/2 trial of relapsed/refractory adult ALL (ZUMA-3), and a phase 1/2 trial of relapsed/refractory pediatric ALL (ZUMA-4).
Results from ZUMA-1 were recently presented at the 2016 AACR Annual Meeting (abstract CT135).
The US Food and Drug Administration (FDA) has granted orphan drug designation for the chimeric antigen receptor (CAR) T-cell therapy KTE-C19 as a treatment for several hematologic malignancies.
This includes primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
KTE-C19 previously received orphan designation from the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL).
The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity.
KTE-C19 also has breakthrough therapy designation from the FDA as a treatment for DLBCL, PMBCL, and transformed FL.
About KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target CD19. The product is being developed by Kite Pharma, Inc.
In a study published in the Journal of Clinical Oncology, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Thirteen patients were evaluable for response. The overall response rate was 92%. Eight patients achieved a complete response (CR), and 4 had a partial response (PR).
Of the 7 patients with DLBCL, 4 achieved a CR, 2 achieved a PR, and 1 had stable disease. Three of the CRs were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
Of the 4 patients with CLL, 3 had a CR, and 1 had a PR. All 3 CRs were ongoing at the time of publication, with the duration ranging from 14 months to 23 months.
Among the 2 patients with indolent lymphomas, 1 achieved a CR, and 1 had a PR. The duration of the CR was 11 months at the time of publication.
KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
KTE-C19 is currently under investigation in a phase 2 trial of refractory DLBCL, PMBCL, and transformed FL (ZUMA-1), a phase 2 trial of relapsed/refractory MCL (ZUMA-2), a phase 1/2 trial of relapsed/refractory adult ALL (ZUMA-3), and a phase 1/2 trial of relapsed/refractory pediatric ALL (ZUMA-4).
Results from ZUMA-1 were recently presented at the 2016 AACR Annual Meeting (abstract CT135).
The US Food and Drug Administration (FDA) has granted orphan drug designation for the chimeric antigen receptor (CAR) T-cell therapy KTE-C19 as a treatment for several hematologic malignancies.
This includes primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).
KTE-C19 previously received orphan designation from the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL).
The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity.
KTE-C19 also has breakthrough therapy designation from the FDA as a treatment for DLBCL, PMBCL, and transformed FL.
About KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target CD19. The product is being developed by Kite Pharma, Inc.
In a study published in the Journal of Clinical Oncology, researchers evaluated KTE-C19 in 15 patients with advanced B-cell malignancies.
The patients received a conditioning regimen of cyclophosphamide and fludarabine, followed 1 day later by a single infusion of KTE-C19. The researchers noted that the conditioning regimen is known to be active against B-cell malignancies and could have made a direct contribution to patient responses.
Thirteen patients were evaluable for response. The overall response rate was 92%. Eight patients achieved a complete response (CR), and 4 had a partial response (PR).
Of the 7 patients with DLBCL, 4 achieved a CR, 2 achieved a PR, and 1 had stable disease. Three of the CRs were ongoing at the time of publication, with the duration ranging from 9 months to 22 months.
Of the 4 patients with CLL, 3 had a CR, and 1 had a PR. All 3 CRs were ongoing at the time of publication, with the duration ranging from 14 months to 23 months.
Among the 2 patients with indolent lymphomas, 1 achieved a CR, and 1 had a PR. The duration of the CR was 11 months at the time of publication.
KTE-C19 elicited a number of adverse events, including fever, hypotension, delirium, and other neurologic toxicities. All but 2 patients experienced grade 3/4 adverse events.
Three patients developed unexpected neurologic abnormalities. One patient experienced aphasia and right-sided facial paresis. One patient developed aphasia, confusion, and severe, generalized myoclonus. And 1 patient had aphasia, confusion, hemifacial spasms, apraxia, and gait disturbances.
KTE-C19 is currently under investigation in a phase 2 trial of refractory DLBCL, PMBCL, and transformed FL (ZUMA-1), a phase 2 trial of relapsed/refractory MCL (ZUMA-2), a phase 1/2 trial of relapsed/refractory adult ALL (ZUMA-3), and a phase 1/2 trial of relapsed/refractory pediatric ALL (ZUMA-4).
Results from ZUMA-1 were recently presented at the 2016 AACR Annual Meeting (abstract CT135).
Autism screening rises after process-based training
A 3- to 6-month learning program for pediatric and family medicine providers significantly improved their screening for autism spectrum disorders (ASD) at 18- and 24-month well child visits, based on data from 26 primary care practices that participated in the program and from 43 physicians who completed surveys before and after the program, according to findings published online May 5 in Pediatrics.
“Unlike traditional continuing medical education, the LC [learning collaborative] focused on improvement of processes of care at the practice level,” wrote Dr. Paul S. Carbone and his colleagues of the University of Utah, Salt Lake City. The first signs of ASD can be present as early as 2 years of age, but often remain undiagnosed for lack of screening at 18- and 24-month visits, they noted.
Rates of documented ASD screening among toddlers increased from 16% before starting the program to 91% during the last month of the program, and 70% of the practices sustained the 91% screening rate 4 years later.
Physician self-efficacy improved significantly from baseline to after the program on the nine autism conditions (such as sleep problems, constipation, and attention deficit/hyperactivity disorder [ADHD]) and seven autism needs (such as making referrals, addressing developmental concerns, and identifying community support services) included in the survey. On a scale of 1 to 10, the average physician’s progress rating was 6.5 after completing the program.
“A LC using the methods we describe is a successful approach to improving the early identification and ongoing care of children with ASD in primary care practices,” they researchers said.
Read the whole article at Pediatrics (2016 May. doi: 10.1542/peds.2015-1850).
A 3- to 6-month learning program for pediatric and family medicine providers significantly improved their screening for autism spectrum disorders (ASD) at 18- and 24-month well child visits, based on data from 26 primary care practices that participated in the program and from 43 physicians who completed surveys before and after the program, according to findings published online May 5 in Pediatrics.
“Unlike traditional continuing medical education, the LC [learning collaborative] focused on improvement of processes of care at the practice level,” wrote Dr. Paul S. Carbone and his colleagues of the University of Utah, Salt Lake City. The first signs of ASD can be present as early as 2 years of age, but often remain undiagnosed for lack of screening at 18- and 24-month visits, they noted.
Rates of documented ASD screening among toddlers increased from 16% before starting the program to 91% during the last month of the program, and 70% of the practices sustained the 91% screening rate 4 years later.
Physician self-efficacy improved significantly from baseline to after the program on the nine autism conditions (such as sleep problems, constipation, and attention deficit/hyperactivity disorder [ADHD]) and seven autism needs (such as making referrals, addressing developmental concerns, and identifying community support services) included in the survey. On a scale of 1 to 10, the average physician’s progress rating was 6.5 after completing the program.
“A LC using the methods we describe is a successful approach to improving the early identification and ongoing care of children with ASD in primary care practices,” they researchers said.
Read the whole article at Pediatrics (2016 May. doi: 10.1542/peds.2015-1850).
A 3- to 6-month learning program for pediatric and family medicine providers significantly improved their screening for autism spectrum disorders (ASD) at 18- and 24-month well child visits, based on data from 26 primary care practices that participated in the program and from 43 physicians who completed surveys before and after the program, according to findings published online May 5 in Pediatrics.
“Unlike traditional continuing medical education, the LC [learning collaborative] focused on improvement of processes of care at the practice level,” wrote Dr. Paul S. Carbone and his colleagues of the University of Utah, Salt Lake City. The first signs of ASD can be present as early as 2 years of age, but often remain undiagnosed for lack of screening at 18- and 24-month visits, they noted.
Rates of documented ASD screening among toddlers increased from 16% before starting the program to 91% during the last month of the program, and 70% of the practices sustained the 91% screening rate 4 years later.
Physician self-efficacy improved significantly from baseline to after the program on the nine autism conditions (such as sleep problems, constipation, and attention deficit/hyperactivity disorder [ADHD]) and seven autism needs (such as making referrals, addressing developmental concerns, and identifying community support services) included in the survey. On a scale of 1 to 10, the average physician’s progress rating was 6.5 after completing the program.
“A LC using the methods we describe is a successful approach to improving the early identification and ongoing care of children with ASD in primary care practices,” they researchers said.
Read the whole article at Pediatrics (2016 May. doi: 10.1542/peds.2015-1850).
FROM PEDIATRICS
Seasonal flu holding strong in New Jersey
The 2015-2016 seasonal influenza virus has gotten hold of New Jersey and just won’t let go, according to the latest data from the Centers for Disease Control and Prevention.
For the week ending April 23, 2016, influenza-like illness (ILI) activity in the United States remained at level 10 on the CDC’s 1-10 scale for the 11th consecutive week, even as the country’s overall proportion of outpatient visits for ILI dropped to 2.0%, which is below the national baseline of 2.1%, the CDC reported.
Two other states – Arizona and Arkansas – joined New Jersey in bucking the trend of decreasing ILI activity, as both moved up to level 7 and the high end of the “moderate” range. Arizona had been at level 5 the week before, while Arkansas was at level 4. No other state was above level 5 for the most recent week, and 27 states were at level 1, data from the CDC’s Influenza-like Illness Surveillance Network (ILINet) show.
Four flu-related pediatric deaths were reported during the week ending April 23, only one of which occurred that week. The total number of pediatric deaths rose to 60 for the 2015-2016 season, with 27 states and Puerto Rico reporting deaths so far, the CDC noted.
The CDC also reported a cumulative influenza-associated hospitalization rate for the season of 29.8 such hospitalizations per 100,000 population. This data was based on 8,239 laboratory-confirmed influenza-associated hospitalizations reported between October 1, 2015 and April 23, 2016. The highest rate of hospitalization was among adults aged 65 years or older (79.6 per 100,000 population), followed by adults aged 50-64 (43.1 per 100,000 population) and children aged 0-4 years (40.5 per 100,000 population). Among all hospitalizations, 6,254 (75.9%) were associated with influenza A, 1,905 (23.1%) with influenza B, 41 (0.5%) with influenza A and B co-infection, and 39 (0.5%) had no virus type information.
The 2015-2016 seasonal influenza virus has gotten hold of New Jersey and just won’t let go, according to the latest data from the Centers for Disease Control and Prevention.
For the week ending April 23, 2016, influenza-like illness (ILI) activity in the United States remained at level 10 on the CDC’s 1-10 scale for the 11th consecutive week, even as the country’s overall proportion of outpatient visits for ILI dropped to 2.0%, which is below the national baseline of 2.1%, the CDC reported.
Two other states – Arizona and Arkansas – joined New Jersey in bucking the trend of decreasing ILI activity, as both moved up to level 7 and the high end of the “moderate” range. Arizona had been at level 5 the week before, while Arkansas was at level 4. No other state was above level 5 for the most recent week, and 27 states were at level 1, data from the CDC’s Influenza-like Illness Surveillance Network (ILINet) show.
Four flu-related pediatric deaths were reported during the week ending April 23, only one of which occurred that week. The total number of pediatric deaths rose to 60 for the 2015-2016 season, with 27 states and Puerto Rico reporting deaths so far, the CDC noted.
The CDC also reported a cumulative influenza-associated hospitalization rate for the season of 29.8 such hospitalizations per 100,000 population. This data was based on 8,239 laboratory-confirmed influenza-associated hospitalizations reported between October 1, 2015 and April 23, 2016. The highest rate of hospitalization was among adults aged 65 years or older (79.6 per 100,000 population), followed by adults aged 50-64 (43.1 per 100,000 population) and children aged 0-4 years (40.5 per 100,000 population). Among all hospitalizations, 6,254 (75.9%) were associated with influenza A, 1,905 (23.1%) with influenza B, 41 (0.5%) with influenza A and B co-infection, and 39 (0.5%) had no virus type information.
The 2015-2016 seasonal influenza virus has gotten hold of New Jersey and just won’t let go, according to the latest data from the Centers for Disease Control and Prevention.
For the week ending April 23, 2016, influenza-like illness (ILI) activity in the United States remained at level 10 on the CDC’s 1-10 scale for the 11th consecutive week, even as the country’s overall proportion of outpatient visits for ILI dropped to 2.0%, which is below the national baseline of 2.1%, the CDC reported.
Two other states – Arizona and Arkansas – joined New Jersey in bucking the trend of decreasing ILI activity, as both moved up to level 7 and the high end of the “moderate” range. Arizona had been at level 5 the week before, while Arkansas was at level 4. No other state was above level 5 for the most recent week, and 27 states were at level 1, data from the CDC’s Influenza-like Illness Surveillance Network (ILINet) show.
Four flu-related pediatric deaths were reported during the week ending April 23, only one of which occurred that week. The total number of pediatric deaths rose to 60 for the 2015-2016 season, with 27 states and Puerto Rico reporting deaths so far, the CDC noted.
The CDC also reported a cumulative influenza-associated hospitalization rate for the season of 29.8 such hospitalizations per 100,000 population. This data was based on 8,239 laboratory-confirmed influenza-associated hospitalizations reported between October 1, 2015 and April 23, 2016. The highest rate of hospitalization was among adults aged 65 years or older (79.6 per 100,000 population), followed by adults aged 50-64 (43.1 per 100,000 population) and children aged 0-4 years (40.5 per 100,000 population). Among all hospitalizations, 6,254 (75.9%) were associated with influenza A, 1,905 (23.1%) with influenza B, 41 (0.5%) with influenza A and B co-infection, and 39 (0.5%) had no virus type information.
Aripiprazole linked to rare but serious compulsion problems
Rare but serious instances of impulse control problems have been reported in people taking the antipsychotic drug aripiprazole, according to a May 3 press release from the Food and Drug Administration.
Pathological gambling is listed as a side effect of aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). Additional side effects seen in patients include compulsive eating, shopping, and sexual actions. The symptoms are rare but can affect anyone taking the medication and can result in serious harm to the patient.
All compulsive symptoms stopped when patients stopped taking aripiprazole or reduced their dosage. The FDA will add new warnings about the symptoms to all drug labels and patient medication guides.
“Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse control problems,” the FDA said in the press release.
Find the full press release on the FDA website.
Rare but serious instances of impulse control problems have been reported in people taking the antipsychotic drug aripiprazole, according to a May 3 press release from the Food and Drug Administration.
Pathological gambling is listed as a side effect of aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). Additional side effects seen in patients include compulsive eating, shopping, and sexual actions. The symptoms are rare but can affect anyone taking the medication and can result in serious harm to the patient.
All compulsive symptoms stopped when patients stopped taking aripiprazole or reduced their dosage. The FDA will add new warnings about the symptoms to all drug labels and patient medication guides.
“Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse control problems,” the FDA said in the press release.
Find the full press release on the FDA website.
Rare but serious instances of impulse control problems have been reported in people taking the antipsychotic drug aripiprazole, according to a May 3 press release from the Food and Drug Administration.
Pathological gambling is listed as a side effect of aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). Additional side effects seen in patients include compulsive eating, shopping, and sexual actions. The symptoms are rare but can affect anyone taking the medication and can result in serious harm to the patient.
All compulsive symptoms stopped when patients stopped taking aripiprazole or reduced their dosage. The FDA will add new warnings about the symptoms to all drug labels and patient medication guides.
“Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse control problems,” the FDA said in the press release.
Find the full press release on the FDA website.
Vedolizumab use linked to high rate of postoperative complications in IBD patients
LOS ANGELES – Overall, 44% of inflammatory bowel disease (IBD) patients on vedolizumab had some form of infectious complication following intra-abdominal or anorectal surgery, results from a small single-center study suggest.
According to lead study author Dr. Samuel Eisenstein, there are currently no published surgical outcomes of patients receiving vedolizumab, an integrin receptor antagonist which was approved in May 2014 for the treatment of adults with moderate to severe ulcerative colitis as well as those with moderate to severe Crohn’s disease. “We’re not trying to alienate people who are proponents of the medication,” Dr. Eisenstein said in an interview in advance of the annual meeting of the American Society of Colon and Rectal Surgeons. “It’s an effective medication for treating Crohn’s and ulcerative colitis. We need to have a high index of suspicion that patients may have complications after these surgeries and to treat them with caution until we have better data.”
Dr. Eisenstein and his associates in the section of colon and rectal surgery at Moores Cancer Center, University of California, San Diego, Health System, retrospectively analyzed the medical records of 26 patients with IBD who underwent intra-abdominal or anorectal surgery at the center following treatment with vedolizumab. The patients underwent a total of 36 operations: 27 that were intra-abdominal and 9 that were anorectal. Their mean age was 31 years and 46% were female.
Dr. Eisenstein reported that 17 of the 26 patients (65%) had a Clavien-Dindo grade II or greater complication following 19 operations. In all, 26 complications occurred following these 19 operations, and 53% were infectious in nature. The overall rate of infectious complications following any operation was 44%. In addition, the rate of anastomotic leak was 15%, and two patients died from culture-negative sepsis following abdominal surgery, for an overall mortality rate of 7.7%.
The researchers also observed that there were 23 visits to the emergency room following surgery and 10 hospital readmissions. The only preoperative characteristics that differed significantly between patients who had complications and those who did not were level of hemoglobin (10.6 g/dL vs. 11.9 g/dL, respectively; P = .02) and platelet count (349 vs. 287 K/mm3; P = .025). No differences in the rate of complications were observed based on the number of biologic medications each patient failed prior to the initiation of vedolizumab (P = .718). Compared with patients who had no postoperative complications, those who did were more likely to have undergone intra-abdominal surgery (17 vs. 10 patients; P = .034), require postoperative transfusion (4 vs. none; P = .045), visit the emergency department (10 vs. none; P less than .001), or require hospital readmission (10 vs. none; P less than .001).
Dr. Eisenstein acknowledged certain limitations of the study including its small sample size, single-center, retrospective design, and the potential for selection bias. “The patients who were getting vedolizumab are the patients who failed all of the anti-TNFs, so we’re really selecting patients with the worst, most medically refractory disease,” he noted. “Because of that we can’t say for sure [if the complications] are due to their severity of disease or due to the medication itself.”
The data are “preliminary and retrospectively analyzed, but there is some concern that patients on these types of medications may have an increased risk of postoperative complications,” he concluded. “What we really need are bigger studies. To that end, we are actually starting an IBD collaborative based on some of the findings we have here, because we really want to analyze these data over a much larger population of patients.”
The researchers reported having no financial disclosures.
LOS ANGELES – Overall, 44% of inflammatory bowel disease (IBD) patients on vedolizumab had some form of infectious complication following intra-abdominal or anorectal surgery, results from a small single-center study suggest.
According to lead study author Dr. Samuel Eisenstein, there are currently no published surgical outcomes of patients receiving vedolizumab, an integrin receptor antagonist which was approved in May 2014 for the treatment of adults with moderate to severe ulcerative colitis as well as those with moderate to severe Crohn’s disease. “We’re not trying to alienate people who are proponents of the medication,” Dr. Eisenstein said in an interview in advance of the annual meeting of the American Society of Colon and Rectal Surgeons. “It’s an effective medication for treating Crohn’s and ulcerative colitis. We need to have a high index of suspicion that patients may have complications after these surgeries and to treat them with caution until we have better data.”
Dr. Eisenstein and his associates in the section of colon and rectal surgery at Moores Cancer Center, University of California, San Diego, Health System, retrospectively analyzed the medical records of 26 patients with IBD who underwent intra-abdominal or anorectal surgery at the center following treatment with vedolizumab. The patients underwent a total of 36 operations: 27 that were intra-abdominal and 9 that were anorectal. Their mean age was 31 years and 46% were female.
Dr. Eisenstein reported that 17 of the 26 patients (65%) had a Clavien-Dindo grade II or greater complication following 19 operations. In all, 26 complications occurred following these 19 operations, and 53% were infectious in nature. The overall rate of infectious complications following any operation was 44%. In addition, the rate of anastomotic leak was 15%, and two patients died from culture-negative sepsis following abdominal surgery, for an overall mortality rate of 7.7%.
The researchers also observed that there were 23 visits to the emergency room following surgery and 10 hospital readmissions. The only preoperative characteristics that differed significantly between patients who had complications and those who did not were level of hemoglobin (10.6 g/dL vs. 11.9 g/dL, respectively; P = .02) and platelet count (349 vs. 287 K/mm3; P = .025). No differences in the rate of complications were observed based on the number of biologic medications each patient failed prior to the initiation of vedolizumab (P = .718). Compared with patients who had no postoperative complications, those who did were more likely to have undergone intra-abdominal surgery (17 vs. 10 patients; P = .034), require postoperative transfusion (4 vs. none; P = .045), visit the emergency department (10 vs. none; P less than .001), or require hospital readmission (10 vs. none; P less than .001).
Dr. Eisenstein acknowledged certain limitations of the study including its small sample size, single-center, retrospective design, and the potential for selection bias. “The patients who were getting vedolizumab are the patients who failed all of the anti-TNFs, so we’re really selecting patients with the worst, most medically refractory disease,” he noted. “Because of that we can’t say for sure [if the complications] are due to their severity of disease or due to the medication itself.”
The data are “preliminary and retrospectively analyzed, but there is some concern that patients on these types of medications may have an increased risk of postoperative complications,” he concluded. “What we really need are bigger studies. To that end, we are actually starting an IBD collaborative based on some of the findings we have here, because we really want to analyze these data over a much larger population of patients.”
The researchers reported having no financial disclosures.
LOS ANGELES – Overall, 44% of inflammatory bowel disease (IBD) patients on vedolizumab had some form of infectious complication following intra-abdominal or anorectal surgery, results from a small single-center study suggest.
According to lead study author Dr. Samuel Eisenstein, there are currently no published surgical outcomes of patients receiving vedolizumab, an integrin receptor antagonist which was approved in May 2014 for the treatment of adults with moderate to severe ulcerative colitis as well as those with moderate to severe Crohn’s disease. “We’re not trying to alienate people who are proponents of the medication,” Dr. Eisenstein said in an interview in advance of the annual meeting of the American Society of Colon and Rectal Surgeons. “It’s an effective medication for treating Crohn’s and ulcerative colitis. We need to have a high index of suspicion that patients may have complications after these surgeries and to treat them with caution until we have better data.”
Dr. Eisenstein and his associates in the section of colon and rectal surgery at Moores Cancer Center, University of California, San Diego, Health System, retrospectively analyzed the medical records of 26 patients with IBD who underwent intra-abdominal or anorectal surgery at the center following treatment with vedolizumab. The patients underwent a total of 36 operations: 27 that were intra-abdominal and 9 that were anorectal. Their mean age was 31 years and 46% were female.
Dr. Eisenstein reported that 17 of the 26 patients (65%) had a Clavien-Dindo grade II or greater complication following 19 operations. In all, 26 complications occurred following these 19 operations, and 53% were infectious in nature. The overall rate of infectious complications following any operation was 44%. In addition, the rate of anastomotic leak was 15%, and two patients died from culture-negative sepsis following abdominal surgery, for an overall mortality rate of 7.7%.
The researchers also observed that there were 23 visits to the emergency room following surgery and 10 hospital readmissions. The only preoperative characteristics that differed significantly between patients who had complications and those who did not were level of hemoglobin (10.6 g/dL vs. 11.9 g/dL, respectively; P = .02) and platelet count (349 vs. 287 K/mm3; P = .025). No differences in the rate of complications were observed based on the number of biologic medications each patient failed prior to the initiation of vedolizumab (P = .718). Compared with patients who had no postoperative complications, those who did were more likely to have undergone intra-abdominal surgery (17 vs. 10 patients; P = .034), require postoperative transfusion (4 vs. none; P = .045), visit the emergency department (10 vs. none; P less than .001), or require hospital readmission (10 vs. none; P less than .001).
Dr. Eisenstein acknowledged certain limitations of the study including its small sample size, single-center, retrospective design, and the potential for selection bias. “The patients who were getting vedolizumab are the patients who failed all of the anti-TNFs, so we’re really selecting patients with the worst, most medically refractory disease,” he noted. “Because of that we can’t say for sure [if the complications] are due to their severity of disease or due to the medication itself.”
The data are “preliminary and retrospectively analyzed, but there is some concern that patients on these types of medications may have an increased risk of postoperative complications,” he concluded. “What we really need are bigger studies. To that end, we are actually starting an IBD collaborative based on some of the findings we have here, because we really want to analyze these data over a much larger population of patients.”
The researchers reported having no financial disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point:Patients on vedolizumab have a high rate of postoperative complications.
Major finding: The overall rate of infectious complications following intra-abdominal or anorectal surgery was 44%.
Data source: A retrospective study of 26 patients with IBD who underwent intra-abdominal or anorectal surgery following treatment with vedolizumab.
Disclosures: Dr. Eisenstein reported having no financial disclosures.
Fistula developed after delivery: $50M verdict
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
Fistula developed after delivery: $50M verdict
During delivery of a 31-year-old woman's baby, a nuchal cord was encountered. In order to safely deliver the child, the ObGyn performed an episiotomy.
After delivery, the patient reported an odorous vaginal discharge. The ObGyn explained that the condition was a natural byproduct of delivery and suggested that it would resolve without treatment.
The patient became pregnant a second time shortly after her first delivery and was evaluated by a midwife. The patient again reported the odorous discharge, but the condition was not addressed. At delivery of her second child, the ObGyn determined that the patient had a rectovaginal fistula. The patient underwent 13 repair operations.
PATIENT’S CLAIM:
The fistula was a byproduct of the episiotomy performed during the first delivery. The episiotomy should not have been performed. The ObGyn should have diagnosed and treated the fistula prior to delivery of the second child and performed a cesarean delivery.
DEFENDANT'S DEFENSE:
The ObGyn reported that the patient's medical records showed that she did not report the odorous discharge until after her second delivery.
VERDICT:
A New York $50 million verdict was returned.
Related article:
Management of wound complications following obstetric anal sphincter injury (OASIS)
Abdominal wall hematoma during pregnancy: $2.5M award
At 35 weeks' gestation, a 38-year-old woman presented to the emergency department (ED) with right upper abdominal pain. Her pregnancy was at high risk because of her age and the fact that she had thrombophilia involving both factor V and protein S deficiency. During pregnancy she was anticoagulated. She had been coughing from bronchitis, which was treated with antibiotics and an inhaler.
In the ED, laboratory testing determined that her blood was not properly clotting. Upper abdominal ultrasonography (US) showed an abdominal wall hematoma and gall stones. The ED physician, after contacting the on-call ObGyn, told the patient that nothing further could be done until after the baby's birth and prescribed medications for nausea and pain. The patient was discharged.
Thirty-three hours later, the patient was rushed to the hospital after she was found barely responsive, pale, and in severe pain. US results showed that the hematoma had grown extensively. The patient was in hypovolemic shock having lost more than 50% of her blood volume. She was admitted to the intensive care unit.
After induced labor, a stillborn son was delivered. The autopsy report revealed that the child died from either asphyxiation or an hypoxic ischemic event that occurred when the mother went into shock.
PATIENT’S CLAIM:
The ED physician and staff were negligent. Once the hematoma was identified, the standard of care is to monitor the hematoma with regular US. Instead, the ED physician discharged the patient. The ED physician contacted the on-call ObGyn but did not ask for a consult. The patient should have been admitted for monitoring.
DEFENDANT'S DEFENSE:
The ED physician met the standard of care. The mother's condition would likely have been detected during a nonstress test scheduled for the following day but the mother missed the prenatal exam because she had just left the hospital.
VERDICT:
A $2.5 million Missouri verdict was returned.
Incorrect due date, child with brain injuries: $1.2M
When a pregnant woman presented for her first prenatal visit, she was unsure of the date of her last menstrual period. During subsequent prenatal visits, she underwent 3 ultrasounds.
Labor was induced on August 1 because she reported gastrointestinal reflux. The infant appeared healthy at birth but soon went into respiratory distress. He was slow to meet developmental goals and was believed to be autistic. At age 5 years, he was given a diagnosis of periventricular leukomalacia.
PARENT’S CLAIM:
The child, 11 years old at the time of trial, has permanent brain injuries due to premature delivery. The mother's due date should have been projected as August 25 according to prenatal US measurements. The ObGyn misinterpreted the US data and estimated a due date of August 15. Therefore induction on August 1st caused him to be premature.
PHYSICIAN’S DEFENSE:
The standard of care was met. Gestational age evaluation using US is an estimate based on the child's size at specific time points, not an exact calculation, especially if the mother is not sure about the date of her last menses.
VERDICT:
A $1.2 million New Jersey verdict was returned.
Related article:
Three good apps for calculating the date of delivery
Bacterial infection blamed for birth injury
A woman was at 28 weeks' gestation when her membranes ruptured on September 28. She began to leak amniotic fluid and was put on bed rest. She saw her ObGyn on October 13 with signs of a bacterial infection of her membranes. The ObGyn decided to induce labor; a baby girl was born 11 hours later. The child had meningitis at birth and other infection-related complications including a brain hemorrhage. She continues to have permanent neurologic deficits.
PARENT’S CLAIM:
The ObGyn was negligent in not immediately delivering the child via cesarean delivery on October 13. The delay exposed the baby to infection for 11 more hours; the extended exposure led to her permanent injury.
PHYSICIAN’S DEFENSE:
The patient's treatment met the standard of care.
VERDICT:
A Virginia defense verdict was returned.
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
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Food allergy development linked to S. aureus colonization in children with AD
Staphylococcus aureus colonization is associated with development of food allergy in children with atopic dermatitis (AD), according to a letter to the editor from Dr. Andrea L. Jones and her associates.
In a study of 718 patients with AD, median food allergen–specific IgE levels to peanut were highest in patients with methicillin-resistant Staphylococcus aureus (MRSA) at 77.7 kilounits of allergen per liter. Patients with methicillin-sensitive S. aureus (MSSA) had median food allergen–specific IgE (sIgE) levels to peanut of 38.9 kUA/L, and patients without S. aureus had median sIgE levels to peanut of 4.3 kUA/L, below the 95% positive predictive value of oral food challenge reaction in patients of 14 kUA/L.
Total IgE levels were highest in AD patients with MRSA at 4,498 kU/L, but were also elevated in patients with MSSA at 2,709 kU/L, compared with 217 kU/L for patients without S. aureus colonization.
“Studies are needed to assess the association between S. aureus skin colonization and food allergy in patients with AD. Confirmation of our current observations opens up the possibility that therapy directed at eradicating S. aureus colonization will be important in the prevention of food allergen sensitization and possibly food allergy in patients with AD,” the investigators concluded.
Find the full letter in the Journal of Allergy and Clinical Immunology (2016 Apr. doi: 10.1016/j.jaci.2016.01.010).
Staphylococcus aureus colonization is associated with development of food allergy in children with atopic dermatitis (AD), according to a letter to the editor from Dr. Andrea L. Jones and her associates.
In a study of 718 patients with AD, median food allergen–specific IgE levels to peanut were highest in patients with methicillin-resistant Staphylococcus aureus (MRSA) at 77.7 kilounits of allergen per liter. Patients with methicillin-sensitive S. aureus (MSSA) had median food allergen–specific IgE (sIgE) levels to peanut of 38.9 kUA/L, and patients without S. aureus had median sIgE levels to peanut of 4.3 kUA/L, below the 95% positive predictive value of oral food challenge reaction in patients of 14 kUA/L.
Total IgE levels were highest in AD patients with MRSA at 4,498 kU/L, but were also elevated in patients with MSSA at 2,709 kU/L, compared with 217 kU/L for patients without S. aureus colonization.
“Studies are needed to assess the association between S. aureus skin colonization and food allergy in patients with AD. Confirmation of our current observations opens up the possibility that therapy directed at eradicating S. aureus colonization will be important in the prevention of food allergen sensitization and possibly food allergy in patients with AD,” the investigators concluded.
Find the full letter in the Journal of Allergy and Clinical Immunology (2016 Apr. doi: 10.1016/j.jaci.2016.01.010).
Staphylococcus aureus colonization is associated with development of food allergy in children with atopic dermatitis (AD), according to a letter to the editor from Dr. Andrea L. Jones and her associates.
In a study of 718 patients with AD, median food allergen–specific IgE levels to peanut were highest in patients with methicillin-resistant Staphylococcus aureus (MRSA) at 77.7 kilounits of allergen per liter. Patients with methicillin-sensitive S. aureus (MSSA) had median food allergen–specific IgE (sIgE) levels to peanut of 38.9 kUA/L, and patients without S. aureus had median sIgE levels to peanut of 4.3 kUA/L, below the 95% positive predictive value of oral food challenge reaction in patients of 14 kUA/L.
Total IgE levels were highest in AD patients with MRSA at 4,498 kU/L, but were also elevated in patients with MSSA at 2,709 kU/L, compared with 217 kU/L for patients without S. aureus colonization.
“Studies are needed to assess the association between S. aureus skin colonization and food allergy in patients with AD. Confirmation of our current observations opens up the possibility that therapy directed at eradicating S. aureus colonization will be important in the prevention of food allergen sensitization and possibly food allergy in patients with AD,” the investigators concluded.
Find the full letter in the Journal of Allergy and Clinical Immunology (2016 Apr. doi: 10.1016/j.jaci.2016.01.010).
FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
For Patients With Myasthenia Gravis, Stem Cell Transplants May Lead to Long-Term Remission
A report on seven cases of severe myasthenia gravis suggests that autologous hematopoietic stem cell transplantation (HSCT) may result in long-term remission. The report was published online April 4 in JAMA Neurology.
In this retrospective study, each patient who underwent autologous HSCT from January 1, 2001, through December 31, 2014, in the Ottawa Hospital Bone Marrow Transplant Programme Database was observed. Lead author Adam Bryant, MD, of the Division of Hematology at the University of Ottawa, Canada, and colleagues reported that every patient who received HSCT experienced relief of symptoms and a prolonged period of treatment-free remission. Prior to treatment, the condition of each patient in the study was labeled as moderate (grade III) to life threatening (grade V) by the Myasthenia Gravis Foundation of America's classification system.
Treatment consisted of high-dose chemotherapy and antilymphocyte antibodies to eliminate the autoreactive immune system, followed by an infusion of stem cells previously harvested from the patient. No unexpected acute toxic effects were observed, no patient was admitted to the ICU for treatment-related effects, and there were no treatment-related deaths. Viral reactivation occurred in three patients (43%) as a result of the initial immune dysregulation.
This study suggests that autologous HSCT is rigorous enough to eliminate autoreactivity and that it re-establishes a long-lasting immune system that is functional and self-tolerant, thus eliminating the need for maintenance immunosuppression or additional treatment, the researchers said. HSCT has effectively treated other severe autoimmune neurologic conditions and maybe an option for patients with myasthenia gravis who do not respond to conventional treatment.
In an accompanying editorial, Daniel Drachman, MD, of the Johns Hopkins School of Medicine in Baltimore, explained that HSCT "is a major undertaking, involving skilled and experienced management, hospitalization, and important risks."
Current therapies used for myasthenia gravis, including cyclophosphamide and monoclonal antibodies like rituximab, have led to clinical improvement, but complete remission, as was seen with HSCT, is rare.
—Adaeze Stephanie Onyechi
Suggested Reading
Bryant A, Atkins H, Pringle CE, et al. Myasthenia gravis treated with autologous hematopoietic stem cell transplantation. JAMA Neurol. 2016 April 4 [Epub ahead of print].
Drachman DB. Treatment for refractory myasthenia gravis—new lymphs for old. JAMA Neurol. 2016 April 4 [Epub ahead of print].
A report on seven cases of severe myasthenia gravis suggests that autologous hematopoietic stem cell transplantation (HSCT) may result in long-term remission. The report was published online April 4 in JAMA Neurology.
In this retrospective study, each patient who underwent autologous HSCT from January 1, 2001, through December 31, 2014, in the Ottawa Hospital Bone Marrow Transplant Programme Database was observed. Lead author Adam Bryant, MD, of the Division of Hematology at the University of Ottawa, Canada, and colleagues reported that every patient who received HSCT experienced relief of symptoms and a prolonged period of treatment-free remission. Prior to treatment, the condition of each patient in the study was labeled as moderate (grade III) to life threatening (grade V) by the Myasthenia Gravis Foundation of America's classification system.
Treatment consisted of high-dose chemotherapy and antilymphocyte antibodies to eliminate the autoreactive immune system, followed by an infusion of stem cells previously harvested from the patient. No unexpected acute toxic effects were observed, no patient was admitted to the ICU for treatment-related effects, and there were no treatment-related deaths. Viral reactivation occurred in three patients (43%) as a result of the initial immune dysregulation.
This study suggests that autologous HSCT is rigorous enough to eliminate autoreactivity and that it re-establishes a long-lasting immune system that is functional and self-tolerant, thus eliminating the need for maintenance immunosuppression or additional treatment, the researchers said. HSCT has effectively treated other severe autoimmune neurologic conditions and maybe an option for patients with myasthenia gravis who do not respond to conventional treatment.
In an accompanying editorial, Daniel Drachman, MD, of the Johns Hopkins School of Medicine in Baltimore, explained that HSCT "is a major undertaking, involving skilled and experienced management, hospitalization, and important risks."
Current therapies used for myasthenia gravis, including cyclophosphamide and monoclonal antibodies like rituximab, have led to clinical improvement, but complete remission, as was seen with HSCT, is rare.
—Adaeze Stephanie Onyechi
A report on seven cases of severe myasthenia gravis suggests that autologous hematopoietic stem cell transplantation (HSCT) may result in long-term remission. The report was published online April 4 in JAMA Neurology.
In this retrospective study, each patient who underwent autologous HSCT from January 1, 2001, through December 31, 2014, in the Ottawa Hospital Bone Marrow Transplant Programme Database was observed. Lead author Adam Bryant, MD, of the Division of Hematology at the University of Ottawa, Canada, and colleagues reported that every patient who received HSCT experienced relief of symptoms and a prolonged period of treatment-free remission. Prior to treatment, the condition of each patient in the study was labeled as moderate (grade III) to life threatening (grade V) by the Myasthenia Gravis Foundation of America's classification system.
Treatment consisted of high-dose chemotherapy and antilymphocyte antibodies to eliminate the autoreactive immune system, followed by an infusion of stem cells previously harvested from the patient. No unexpected acute toxic effects were observed, no patient was admitted to the ICU for treatment-related effects, and there were no treatment-related deaths. Viral reactivation occurred in three patients (43%) as a result of the initial immune dysregulation.
This study suggests that autologous HSCT is rigorous enough to eliminate autoreactivity and that it re-establishes a long-lasting immune system that is functional and self-tolerant, thus eliminating the need for maintenance immunosuppression or additional treatment, the researchers said. HSCT has effectively treated other severe autoimmune neurologic conditions and maybe an option for patients with myasthenia gravis who do not respond to conventional treatment.
In an accompanying editorial, Daniel Drachman, MD, of the Johns Hopkins School of Medicine in Baltimore, explained that HSCT "is a major undertaking, involving skilled and experienced management, hospitalization, and important risks."
Current therapies used for myasthenia gravis, including cyclophosphamide and monoclonal antibodies like rituximab, have led to clinical improvement, but complete remission, as was seen with HSCT, is rare.
—Adaeze Stephanie Onyechi
Suggested Reading
Bryant A, Atkins H, Pringle CE, et al. Myasthenia gravis treated with autologous hematopoietic stem cell transplantation. JAMA Neurol. 2016 April 4 [Epub ahead of print].
Drachman DB. Treatment for refractory myasthenia gravis—new lymphs for old. JAMA Neurol. 2016 April 4 [Epub ahead of print].
Suggested Reading
Bryant A, Atkins H, Pringle CE, et al. Myasthenia gravis treated with autologous hematopoietic stem cell transplantation. JAMA Neurol. 2016 April 4 [Epub ahead of print].
Drachman DB. Treatment for refractory myasthenia gravis—new lymphs for old. JAMA Neurol. 2016 April 4 [Epub ahead of print].