In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”

It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.

The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.

Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.

Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”

Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Photo by Graham Colm

Quest Diagnostics has announced the US launch of QHerit™, a genetic screening service that helps people of multiple ethnicities identify their risk of passing on heritable disorders to their offspring.

The QHerit Pan-Ethnic Expanded Carrier Screen is a panel of tests for the 22 heritable diseases cited in new screening guidelines from the American College of Gynecology (ACOG).

Among the diseases are alpha-thalassemia, Fanconi anemia, and beta-hemoglobinopathies, including sickle cell disease (SCD).

Traditionally, genetic carrier screening has been used for at-risk populations based on specific ancestry assumptions and focused on only a few likely disorders with higher prevalence associated with that ethnicity.

In its new guidelines, ACOG recommends offering pan-ethnic, expanded carrier, and ethnic-specific screening for all women considering pregnancy. The guidelines also state that the partner of a woman who tests positive may be a candidate for screening.

QHerit screens women and men for clinically relevant variants of genes for disorders that could have potentially devastating consequences, result in early death, or create a need for significant early intervention.

The disorders covered by QHerit include:

QHerit is now available for order by US physicians. For more information, visit www.QHerit.com.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Title: Variation in physician spending not associated with patient outcomes

Clinical Question: Is there a variation in spending between physicians in the same hospital, and does it have an effect on patient outcomes?

Background: Not much is known about the presence of variations in individual physician spending within the same hospital and it is not known if higher-spending physicians have better patient outcomes compared to peers within the same institution.

Dr. Rankin is a hospitalist and director of the family medicine residency inpatient service at the University of New Mexico.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Photo courtesy of Novartis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending approval for midostaurin (Rydapt®) as a treatment for acute myeloid leukemia (AML) and systemic mastocytosis (SM).

If approved by the European Commission, midostaurin would be used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation—followed by midostaurin maintenance for patients in complete response—in adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-mutation-positive.

Midostaurin would also be approved to treat adults with aggressive SM, SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).

If approved, midostaurin would be the first targeted treatment available in the European Union for newly diagnosed FLT3+ AML patients and advanced SM patients.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation. The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

Midostaurin in AML

The CHMP’s recommendation for midostaurin in AML is based on results from the phase 3 RATIFY trial, which were recently published in NEJM.

In RATIFY, researchers compared midostaurin plus standard chemotherapy to placebo plus standard chemotherapy in 717 adults younger than age 60 who had FLT3-mutated AML.

The median overall survival was significantly longer in the midostaurin arm than the placebo arm—74.7 months and 25.6 months, respectively (hazard ratio=0.77, P=0.016).

And the median event-free survival was significantly longer in the midostaurin arm than the placebo arm—8.2 months and 3.0 months, respectively (hazard ratio=0.78, P=0.004).

The most frequent adverse events (AEs) in the midostaurin arm (occurring in at least 20% of patients) were febrile neutropenia, nausea, vomiting, mucositis, headache, musculoskeletal pain, petechiae, device-related infection, epistaxis, hyperglycemia, and upper respiratory tract infections.

The most frequent grade 3/4 AEs (occurring in at least 10% of patients) were febrile neutropenia, device-related infection, and mucositis. Nine percent of patients in the midostaurin arm stopped treatment due to AEs, as did 6% in the placebo arm.

Midostaurin in advanced SM

The CHMP’s recommendation for midostaurin in advanced SM was based on results from a pair of phase 2, single-arm studies, hereafter referred to as Study 2 and Study 3.

Data from Study 2 were published in NEJM in June 2016, and data from Study 3 were presented at the 2010 ASH Annual Meeting.

Study 2 included 116 patients, 115 of whom were evaluable for response.

The overall response rate (ORR) was 17% in the entire cohort, 31% among patients with ASM, 11% among patients with SM-AHN, and 19% among patients with MCL. The complete response rates were 2%, 6%, 0%, and 5%, respectively.

Study 3 included 26 patients with advanced SM. In 3 of the patients, the subtype of SM was unconfirmed.

Among the 17 patients with SM-AHN, there were 10 responses (ORR=59%), including 1 partial response and 9 major responses. In the 6 patients with MCL, there were 2 responses (ORR=33%), which included 1 partial response and 1 major response.

In both studies combined, there were 142 adults with ASM, SM-AHN, or MCL.

The most frequent AEs (excluding laboratory abnormalities) that occurred in at least 20% of these patients were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.

The most frequent grade 3 or higher AEs (excluding laboratory abnormalities) that occurred in at least 5% of patients were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain, and renal insufficiency.

Serious AEs occurred in 68% of patients, most commonly infections and gastrointestinal disorders. Twenty-one percent of patients discontinued treatment due to AEs, the most frequent of which were infection, nausea or vomiting, QT prolongation, and gastrointestinal hemorrhage.

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Micrograph showing FL

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for obinutuzumab (Gazyvaro).

The new proposed indication is for obinutuzumab in combination with chemotherapy for patients with previously untreated, advanced follicular lymphoma (FL). This would be followed by obinutuzumab maintenance in patients who achieved a response.

The European Commission typically adheres to the CHMP’s recommendations and delivers its final decision within 2 to 3 months’ of the CHMP’s recommendation.

The decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway.

If approved for this new indication, obinutuzumab will be authorized for use in the European Economic Area as follows:

• In combination with chlorambucil for the treatment of adults with previously untreated chronic lymphocytic leukemia and comorbidities making them unsuitable for full-dose fludarabine-based therapy.
• In combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with FL who did not respond to, or who progressed during or up to 6 months after, treatment with rituximab or a rituximab-containing regimen.
• In combination with chemotherapy, followed by obinutuzumab maintenance in responders, for the treatment of patients with previously untreated, advanced FL.

GALLIUM trial

The CHMP’s recommendation is based on results of the phase 3 GALLIUM trial, which were presented at the 2016 ASH Annual Meeting.

The study enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

In the almost 30 years since I started surgical residency, the attention to ethical issues in surgery has dramatically changed. Although surgeons still faced ethical dilemmas decades ago, there was little specific attention paid to highlighting these ethical issues in the past. Today, for many reasons, specific attention to the ethical issues in the care of surgical patients is a widespread phenomenon. We see articles in surgical journals about ethical issues and it is commonplace to find sessions devoted to various surgical ethics topics at many surgical society meetings. The American College of Surgeons is even publishing a textbook of surgical ethics in the upcoming months.

This contemporary attention to ethics in surgery seems to be a recent phenomenon. One of my senior colleagues, in commenting on how much more specific attention we pay to ethical issues today, once jokingly stated that he had trained in surgery “before there was ethics.” Although we laughed at the idea that there was a time before ethics, my own experience and my discussions with many retired surgeons, including my father, have led me to believe that things are very different today than several decades ago. I thought that although there were certainly ethically challenging cases in the past that demanded surgeons to make tough choices, such cases I thought were unlikely to be called out as ethics cases.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

As today’s surgical residents complete their residencies and enter practice, we are compelled to ask, Is their level of confidence and independence different from that of, say, the class of 1978? Have circumstances of training changed to such a degree that graduating residents’ beliefs in their own judgment have been undermined?

The answer is yes: The conditions and circumstances of training have changed substantially. Our attendings were strong role models, but they were not as omnipresent as are today’s faculty, particularly in the operating room. We, therefore, felt a greater sense of autonomy than do today’s trainees.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

As today’s surgical residents complete their residencies and enter practice, we are compelled to ask, Is their level of confidence and independence different from that of, say, the class of 1978? Have circumstances of training changed to such a degree that graduating residents’ beliefs in their own judgment have been undermined?

The answer is yes: The conditions and circumstances of training have changed substantially. Our attendings were strong role models, but they were not as omnipresent as are today’s faculty, particularly in the operating room. We, therefore, felt a greater sense of autonomy than do today’s trainees.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

As today’s surgical residents complete their residencies and enter practice, we are compelled to ask, Is their level of confidence and independence different from that of, say, the class of 1978? Have circumstances of training changed to such a degree that graduating residents’ beliefs in their own judgment have been undermined?

The answer is yes: The conditions and circumstances of training have changed substantially. Our attendings were strong role models, but they were not as omnipresent as are today’s faculty, particularly in the operating room. We, therefore, felt a greater sense of autonomy than do today’s trainees.

Dr. Deveney is professor of surgery and vice chair of education in the department of surgery, Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

The Society of Surgical Chairs (SSC) Women’s Committee hosted a leadership symposium for 40 women surgeons April 18–19 at the Union League of Philadelphia, PA, immediately preceding the annual meeting of the American Surgical Association. The event was sponsored by the American College of Surgeons (ACS) Foundation, Johnson & Johnson Ethicon, and the SSC Women’s Committee.

Anne C. Mosenthal, MD, FACS, Benjamin F. Rush, Jr. Endowed Chair and professor and chair of surgery at Rutgers New Jersey Medical School, Newark, and chair of the SSC’s Women’s Committee led the daylong educational program, which featured the following sessions:

• A team from Johnson & Johnson Ethicon spoke on the Changing Healthcare Landscape.

• Larry R. Kaiser, MD, FACS, Lewis Katz Dean, School of Medicine, senior executive vice-president for Health Affairs, Temple University, and president and chief executive officer (CEO), Temple University Health System, Philadelphia, spoke on the Healthcare System and Academic Medicine.

• ACS President-Elect Barbara L. Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX; and Past-Chair of the ACS Board of Regents Julie A. Freischlag, MD, FACS, president and CEO, Wake Forest Baptist Medical Center, Winston-Salem, NC, spoke on leadership challenges.

• Sandra Humbles, vice-president of Global Educational Solutions for One Medical Devices at Johnson & Johnson, and Vice-Chair of the ACS Board of Regents Leigh A. Neumayer, MD, MS, FACS, professor and chair, department of surgery, University of Arizona College of Medicine, Tucson, led a session on Performance, Impact, and Exposure.

• Dr. Mosenthal moderated a panel discussion on advancing women to leadership roles, which included the following panelists: Daniel V. Schidlow, MD, Drexel University, Walter H. and Leonore Annenberg Dean and senior vice-president, medical affairs, at Drexel University College of Medicine; Nancy Spector, MD, executive director, executive leadership in academic medicine, and associate dean for faculty development, Drexel University College of Medicine; Mary T. Hawn, MD, FACS, professor of surgery and chair, department of surgery, Stanford University, CA; and Jeffrey B. Matthews, MD, FACS, Dallas B. Phemister Professor of Surgery and chair, department of surgery, University of Chicago, IL.

The ACS Foundation hosted a dinner for the SSC Women’s Committee members and Shane Hollett, ACS Foundation Executive Director, spoke with them about the future of women in philanthropy.


 

The Society of Surgical Chairs (SSC) Women’s Committee hosted a leadership symposium for 40 women surgeons April 18–19 at the Union League of Philadelphia, PA, immediately preceding the annual meeting of the American Surgical Association. The event was sponsored by the American College of Surgeons (ACS) Foundation, Johnson & Johnson Ethicon, and the SSC Women’s Committee.

Anne C. Mosenthal, MD, FACS, Benjamin F. Rush, Jr. Endowed Chair and professor and chair of surgery at Rutgers New Jersey Medical School, Newark, and chair of the SSC’s Women’s Committee led the daylong educational program, which featured the following sessions:

• A team from Johnson & Johnson Ethicon spoke on the Changing Healthcare Landscape.

• Larry R. Kaiser, MD, FACS, Lewis Katz Dean, School of Medicine, senior executive vice-president for Health Affairs, Temple University, and president and chief executive officer (CEO), Temple University Health System, Philadelphia, spoke on the Healthcare System and Academic Medicine.

• ACS President-Elect Barbara L. Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX; and Past-Chair of the ACS Board of Regents Julie A. Freischlag, MD, FACS, president and CEO, Wake Forest Baptist Medical Center, Winston-Salem, NC, spoke on leadership challenges.

• Sandra Humbles, vice-president of Global Educational Solutions for One Medical Devices at Johnson & Johnson, and Vice-Chair of the ACS Board of Regents Leigh A. Neumayer, MD, MS, FACS, professor and chair, department of surgery, University of Arizona College of Medicine, Tucson, led a session on Performance, Impact, and Exposure.

• Dr. Mosenthal moderated a panel discussion on advancing women to leadership roles, which included the following panelists: Daniel V. Schidlow, MD, Drexel University, Walter H. and Leonore Annenberg Dean and senior vice-president, medical affairs, at Drexel University College of Medicine; Nancy Spector, MD, executive director, executive leadership in academic medicine, and associate dean for faculty development, Drexel University College of Medicine; Mary T. Hawn, MD, FACS, professor of surgery and chair, department of surgery, Stanford University, CA; and Jeffrey B. Matthews, MD, FACS, Dallas B. Phemister Professor of Surgery and chair, department of surgery, University of Chicago, IL.

The ACS Foundation hosted a dinner for the SSC Women’s Committee members and Shane Hollett, ACS Foundation Executive Director, spoke with them about the future of women in philanthropy.


 

The Society of Surgical Chairs (SSC) Women’s Committee hosted a leadership symposium for 40 women surgeons April 18–19 at the Union League of Philadelphia, PA, immediately preceding the annual meeting of the American Surgical Association. The event was sponsored by the American College of Surgeons (ACS) Foundation, Johnson & Johnson Ethicon, and the SSC Women’s Committee.

Anne C. Mosenthal, MD, FACS, Benjamin F. Rush, Jr. Endowed Chair and professor and chair of surgery at Rutgers New Jersey Medical School, Newark, and chair of the SSC’s Women’s Committee led the daylong educational program, which featured the following sessions:

• A team from Johnson & Johnson Ethicon spoke on the Changing Healthcare Landscape.

• Larry R. Kaiser, MD, FACS, Lewis Katz Dean, School of Medicine, senior executive vice-president for Health Affairs, Temple University, and president and chief executive officer (CEO), Temple University Health System, Philadelphia, spoke on the Healthcare System and Academic Medicine.

• ACS President-Elect Barbara L. Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX; and Past-Chair of the ACS Board of Regents Julie A. Freischlag, MD, FACS, president and CEO, Wake Forest Baptist Medical Center, Winston-Salem, NC, spoke on leadership challenges.

• Sandra Humbles, vice-president of Global Educational Solutions for One Medical Devices at Johnson & Johnson, and Vice-Chair of the ACS Board of Regents Leigh A. Neumayer, MD, MS, FACS, professor and chair, department of surgery, University of Arizona College of Medicine, Tucson, led a session on Performance, Impact, and Exposure.

• Dr. Mosenthal moderated a panel discussion on advancing women to leadership roles, which included the following panelists: Daniel V. Schidlow, MD, Drexel University, Walter H. and Leonore Annenberg Dean and senior vice-president, medical affairs, at Drexel University College of Medicine; Nancy Spector, MD, executive director, executive leadership in academic medicine, and associate dean for faculty development, Drexel University College of Medicine; Mary T. Hawn, MD, FACS, professor of surgery and chair, department of surgery, Stanford University, CA; and Jeffrey B. Matthews, MD, FACS, Dallas B. Phemister Professor of Surgery and chair, department of surgery, University of Chicago, IL.

The ACS Foundation hosted a dinner for the SSC Women’s Committee members and Shane Hollett, ACS Foundation Executive Director, spoke with them about the future of women in philanthropy.