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How Are Schizophrenic Patients Treated After Myocardial Infarction?
Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.
Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.
Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.
The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.
The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.
Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”
However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.
The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.
Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.
Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.
Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.
The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.
The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.
Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”
However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.
The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.
Patients with schizophrenia may not always get the cardiac treatment they should following a myocardial infarction (MI), according to researchers from Aalborg University Hospital, Denmark.
Studies have already established that patients with schizophrenia have a higher prevalence of cardiovascular disease (CVD) and that there is a strong correlation between MI and schizophrenia, the researchers say. Patients with schizophrenia also undergo fewer cardiac procedures compared with the general population. To try to find out why that might be, the researchers focused on the 4-stage process from initial admission following MI: offer of examination, acceptance of examination, offer of treatment, and acceptance of treatment.
Of 141 patients with a first MI, 47 also had a diagnosis of schizophrenia.
The researchers say their data show a “clear difference” between the 2 groups studied. Patients with schizophrenia were statistically significantly less likely to be offered and accept examination and to be offered and accept treatment than were the psychiatrically healthy controls. However, when the researchers analyzed each stage separately, none of the secondary results were statistically significant. Still they say, as a whole the stages contribute to the primary outcome of less cardiac treatment for these patients.
The researchers did find 2 significant differences between the 2 groups: Patients with schizophrenia were more likely to be smokers and have a lower familial predisposition to CVD. They also were less likely to be in treatment for diabetes, hypercholesterolemia and hypertension at the first MI, although that did not reach statistical significance. The 2 groups also differed in the treatments offered. Patients with schizophrenia were less often offered invasive coronary angiography (CAG) and more often offered exercise-ECG. In contrast, the controls were more likely to be offered CAG.
Without statistical significance, the researchers could not pinpoint whether physician bias, patients’ unwillingness to receive health care, or both were at the root of the discrepancies. They note that the clinical manifestations of schizophrenia “may be seen as a complication for postoperative care” and influence decisions about cardiac procedures. Those decisions may be based on “tacit assumptions rather than on standard guidelines based on medical outcomes,” the researchers add. Three patients in the study reported that they had previously visited the hospital complaining of typical chest pain but were sent home without examination. The researchers cite another study that found patients with schizophrenia receive care only when their symptoms are “severe enough.”
However, patients with schizophrenia also are known to be more likely to decline treatment, perhaps in part because they do not understand the importance of treatment, the researchers say.
The researchers suggest that the way patients are handled by the treating doctor “needs to be reformed.” It is important, they say, that health care providers are aware of the limits of dealing with a double-diagnosed patient and of the possibility of unintentional bias. A “more personalized approach,” they conclude, might make patients with schizophrenia more willing to cooperate with offers of treatment.
GI leaders recognized by AGA’s prestigious recognition awards
AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”
The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
Distinguished Achievement Award In Basic Science
AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.
William Beaumont Prize
AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
Distinguished Educator Award
AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.
Distinguished Clinician Awards
The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.
AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.
Research Service Award
AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.
Young Investigator Awards
The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.
AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”
The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
Distinguished Achievement Award In Basic Science
AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.
William Beaumont Prize
AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
Distinguished Educator Award
AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.
Distinguished Clinician Awards
The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.
AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.
Research Service Award
AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.
Young Investigator Awards
The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.
AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
AGA has announced the 2019 recipients of the annual recognition awards, given in honor of outstanding contributions and achievements in gastroenterology.
“AGA members honor their colleagues and peers for outstanding contributions to the field of gastroenterology by nominating them for the AGA Recognition Awards,” said David A. Lieberman, MD, AGAF, president of the AGA Institute. “We are proud to announce the 2019 AGA Recognition Prize winners, who are just a few of the distinguished and talented members who help make AGA such an accomplished organization. We are honored that such esteemed individuals are representative of AGA.”
The AGA Recognition Awards will be presented during Digestive Disease Week® 2019, May 18-21, 2019, in San Diego.
Julius Friedenwald Medal
AGA bequeaths its highest honor, the Julius Friedenwald Medal, to John I. Allen, MD, MBA, AGAF, for his incredible contributions to the field of gastroenterology and AGA over several decades. The Julius Friedenwald Medal, presented annually since 1941, recognizes a physician for lifelong contributions to the field of gastroenterology.
Dr. Allen is internationally renowned for bringing unique and critical knowledge about health care delivery and health care economics to the field of gastroenterology, as well as for his decades of AGA leadership. His experience is unique within the national gastroenterology community, encompassing private practice, nonacademic health systems, and leadership within two academic medical centers. As AGA Institute President, he led the development of AGA’s 5-year strategic plan and made AGA a national player at the federal, state, and local levels during a time of massive health care delivery transformation. Dr. Allen is a clinical professor of medicine in the division of gastroenterology and hepatology and chief clinical officer of the University of Michigan Medical Group at the University of Michigan School of Medicine, Ann Arbor.
Distinguished Achievement Award In Basic Science
AGA honors Harry B. Greenberg, MD, with the AGA Distinguished Achievement Award in Basic Science, for his major accomplishments in basic science research, which have significantly advanced the science and practice of gastroenterology. Throughout his career, Dr. Greenberg’s incredible contributions over several decades contributed to the development of rotavirus vaccines and increased physicians’ understanding of viral pathogenesis, particularly rotavirus, norovirus, and hepatitis. Dr. Greenberg is an associate dean for research at Stanford University School of Medicine, Palo Alto, California.
William Beaumont Prize
AGA honors Timothy C. Wang, MD, AGAF, with the William Beaumont Prize in gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field of gastroenterology. Dr. Wang’s extraordinary contribution to the understanding and practice of modern gastroenterology and digestive science are exemplified through his work, which includes defining the mechanisms and cellular origins of Barrett’s esophagus and gastroesophageal cancer. Dr. Wang, who has served AGA in numerous positions, including as president of the AGA Institute, is currently chief of the division of digestive and liver diseases at Columbia University Medical Center and as the Dorothy L. and Daniel H. Silberberg Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
Distinguished Educator Award
AGA recognizes and honors Deborah D. Proctor, MD, AGAF, with the Distinguished Educator Award, which recognizes an individual who has made outstanding contributions as an educator in gastroenterology on both local and national levels, over a lifelong career. Dr. Proctor is a national expert in gastroenterology training and education who has taught and inspired generations of future gastroenterologists, nurses and physician assistants. Currently serving as the AGA Institute Education & Training Councillor, Dr. Proctor is a professor of medicine, and the medical director of the inflammatory bowel disease program, at Yale School of Medicine, New Haven, Connecticut.
Distinguished Clinician Awards
The AGA Distinguished Clinician Award recognizes members of the practicing community who, by example, combine the art of medicine with the skills demanded by the scientific body of knowledge in service to their patients.
AGA presents the Distinguished Clinician Award, Private Practice, to Naresh T. Gunaratnam, MD, AGAF. Dr. Gunaratnam has made a huge impact on patient care in his community and improved gastroenterology-oncology care by starting the endoscopic ultrasound & interventional GI program at St. Joseph Mercy Ann Arbor hospital in Ypsilanti, Michigan. Dr. Gunaratnam is a director of research and obesity management at Huron Gastro.
AGA is honored to present the Distinguished Clinician Award, Clinical Academic Practice, to Edward V. Loftus Jr., MD, AGAF. Dr. Loftus is an outstanding role model in practice, an effective researcher and a recognized leader who is devoted to treating patients with ulcerative colitis and Crohn’s disease with quality clinical care, including understanding the predictors of treatment response. Dr. Loftus is a practicing gastroenterologist at the Mayo Clinic and a professor of medicine at the Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
Distinguished Mentor Award
AGA bestows the Distinguished Mentor Award to Fred S. Gorelick, MD, which recognizes an individual who has made a lifelong effort dedicated to the mentoring of trainees in the field of gastroenterology and for achievements as outstanding mentors throughout their careers. Dr. Gorelick has been an inspiration to generations of trainees, many of whom have gone on to successful academic careers as faculty members, section chiefs, program directors, department chairs, and institute directors. Dr. Gorelick is a professor of medicine and cell biology at Yale School of Medicine, and deputy director of the Yale MD-PhD Program, New Haven, Connecticut.
Research Service Award
AGA honors Ann G. Zauber, PhD, with the Research Service Award, which recognizes individuals whose work has significantly advanced gastroenterogical science and research. Dr. Zauber’s accomplishments have changed and advanced the practice of gastroenterology. Her work involving colorectal cancer screening and surveillance studies has had far-reaching effects on public policy. She is well-known for her leadership role in the development of colorectal cancer screening guidelines in the U.S., which has significantly reduced mortality and incidence rates. Dr. Zauber is an attending biostatistician in the department of epidemiology & biostatistics at the Memorial Sloan Kettering Cancer Center, New York, New York.
Young Investigator Awards
The AGA Young Investigator Award recognizes two young investigators, one in basic science and one in clinical science, for outstanding research achievements.
AGA honors Sonia S. Kupfer, MD, with the Young Investigator Award in Clinical Science. Dr. Kupfer is nationally and internationally recognized as an expert in colorectal cancer in high-risk populations including individuals with hereditary cancer syndromes and African Americans. During her clinical and translational research to better understand factors that increase the risk of colorectal cancer, Dr. Kupfer identified distinctions in African-American population compared with Caucasians. Dr. Kupfer is an associate professor of medicine at the University of Chicago, and director of the Gastrointestinal Cancer Risk and Prevention Clinic, Illinois.
AGA honors Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His research, work ethic, and innovative approaches have made Dr. Lyssiotis a distinguished leader in pancreatic cancer. His work has broad implications for harnessing the power of the immune system to treat the disease and his laboratory is working to develop new drug therapies that target a pancreatic cancer metabolism-specific enzyme. Dr. Lyssiotis is an assistant professor in the department of molecular and integrative physiology in the division of gastroenterology at University of Michigan Medical School, Ann Arbor.
AGA Legacy Society members bolster research
The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.
Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.
“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.
Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.
A celebration of research support
Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.
The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.
Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.
“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.
Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.
A celebration of research support
Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.
The AGA Research Foundation has funded more than $50 million in research funding since its inception in 1984. Gifts from AGA members have helped fuel discoveries in the GI field. The most generous of AGA members are our Legacy Society members.
Members of the AGA Legacy Society provide tax-deductible gifts to the AGA Research Foundation of $5,000 or more per year for 5 years ($25,000 total) or $50,000 or more in a planned gift, such as a bequest. Legacy Society member donations directly support young GI investigators as they establish independent research careers.
“The support of the AGA Research Foundation indicates that our peers share in our enthusiasm for research and gives me and my group added confidence to pursue questions about the pathology of IBD. Our overall plan is to translate this work into key components of larger federally funded grants in the near future,” states David L. Boone, PhD, Indiana University School of Medicine, Indianapolis, 2017 AGA Research Foundation Pilot Research Award grant recipient.
Donors, who make gifts at the Legacy Society level before Digestive Disease Week® (DDW), will receive an invitation to the annual Benefactors’ Dinner, which will be held at the San Diego Wine and Culinary Center this year. Individuals interested in learning more about Legacy Society membership may contact Stacey Hinton Tuneski, Senior Director of Development at [email protected] or via phone (301) 222-4005. More information on the AGA Legacy Society including the current roster and acceptance form is available on the foundation’s web site.
A celebration of research support
Beginning with a memorable gathering at the United States Library of Congress in 2007, the AGA Benefactors’ Dinner has welcomed members of the AGA Legacy Society and other AGA dignitaries to special locations nationwide. The San Diego Wine and Culinary Center will be the location of the 2019 AGA Research Foundation Benefactors’ Dinner during DDW® in San Diego. Located near the convention center, the San Diego Wine and Culinary Center feels worlds away and will allow guests to relax and enjoy time with friends. Members of the AGA Legacy Society will be among the distinguished honorees at the annual event.
New online resource from the AGA IBD Parenthood Project provides guidance, dispels fears about pregnancy for women with IBD
AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.
Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).
AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.
Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).
AGA launched the IBD Parenthood Project to address misperceptions and fears women with inflammatory bowel disease and their health care providers experience throughout all phases of family planning. This patient-directed initiative, which was created by gastroenterologists, maternal-fetal medicine subspecialists and patients, is led by AGA with support from the Society for Maternal-Fetal Medicine, the Crohn’s & Colitis Foundation, and patient support network, Girls With Guts.
Health care providers are encouraged to visit the program’s new website, www.IBDParenthoodProject.org, which houses medical facts about IBD and pregnancy and share it with their patients. The website provides answers to common questions and provides a downloadable patient toolkit that features visual and patient-friendly information. Resources include easy-to-digest lists of key questions to ask a provider as women are thinking of becoming pregnant, a flow diagram outlining the various HCPs potentially involved in a woman’s care, a guide to postnatal care and provider locator tools. These tools are a direct response to AGA survey findings that reported women with IBD want more and better information about managing their disease (BabyCenter. 2018. IBD and Preconception, Pregnancy, Early Motherhood).
Selinexor hits FDA stumbling block
Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.
By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.
Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.
“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”
The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.
Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.
Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.
This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.
Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.
The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.
Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.
However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.
These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.
Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”
Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.
Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.
Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”
Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.
“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”
Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.
By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.
Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.
“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”
The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.
Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.
Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.
This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.
Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.
The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.
Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.
However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.
These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.
Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”
Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.
Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.
Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”
Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.
“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”
Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.
By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.
Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.
“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”
The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.
Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.
Karyopharm is seeking approval of selinexor in combination with low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory imide drug, and an anti-CD38 monoclonal antibody.
This disease is referred to as “triple-class refractory” multiple myeloma. At this stage, patients have exhausted every effective treatment option and are faced with the choice of supportive care or recycling previously successful drugs. Their median overall survival time is 3-5 months.
Karyopharm submitted its the New Drug Application using the Accelerated Approval pathway, arguing that the drug meets an unmet medical need and can be approved on surrogate endpoints – in this case, overall response rate.
The modified intent-to-treat analysis comprised 122 patients. The overall response rate was 25.4% with a median response duration of 4.4 months. Two patients had a complete response; six had a very good partial response; and 23 had a partial response.
Some committee members, however, said it would be impossible to tease out how much of the response could be due to the co-administration of 20 mg dexamethasone with each dose. In a phase 1 dose-ranging study of selinexor as monotherapy, it produced only one partial response in 56 patients. And, FDA pointed out, historical studies have shown response rates of 10%-27% for high-dose dexamethasone.
However, those in favor of the drug pointed out that the STORM patients were steroid-refractory, and that a 25% response rate would be unlikely on low-dose dexamethasone alone. This is proof of the company’s claim that the steroid works synergistically with selinexor, they said.
These members also pointed out that even a few years ago, there simply were no patients like the STORM cohort. Only recently have these patients lived long enough to develop resistance against all therapeutic lines, so it’s unrealistic to use historical data to judge what a reasonable response rate looks like in this situation.
Committee members also choked on STORM’s adverse event (AE) profile. All patients experienced at least one treatment-emergent AE, and 60% had at least one serious AE. Most (88.6%) required a dose modification due to an AE, and 28.5% discontinued due to one. The most common AEs were thrombocytopenia, anemia, nausea, fatigue, and decreased appetite. The company said these were “typically reversible and manageable with dose reductions.”
Additionally, there were 23 deaths in the trial. About half (13) were due to disease progression, but the remainder were due to a fatal treatment-emergent AE. Two of these (one pneumonia and one sepsis) were directly due to selinexor, the company said.
Despite the committee’s concerns, 16 of the 17 speakers described positive experiences with selinexor. They universally acknowledged that “it’s a hard drug to take,” and that side effects need to be managed proactively. But they also said, universally, that the drug has brought them additional months of good-quality life, decreased lengthy hospital stays, enabled them to participate in important family events, and even travel. Some also expressed the hope that selinexor would be a bridge drug, decreasing their disease burden enough that they could qualify for other clinical trials of new investigational drugs.
Only Stephanie Fox-Rawlings, PhD, of the National Center for Health Research, urged a delay. “Even if these adverse events are manageable, they harm patients’ quality of life,” she said. “This may be acceptable to some, but if the drug can’t provide a meaningful benefit then they are not worth it and in this clinical trial there was no improvement noted in quality of life. This drug has serious risks and we don’t know if it works.”
Dr. Fox said she was “very glad” that Karyopharm has completed recruitment for its phase 3 randomized study, dubbed BOSTON. BOSTON will assign active patients to once-weekly 100 mg selinexor plus weight-dosed bortezomib, plus twice-weekly 20 mg dexamethasone. The comparator group will receive weight-based bortezomib twice a week and 20 mg dexamethasone four times a week. Patients who progress can cross over to the active arm. The company hopes for even better results, saying that the proteasome inhibitor has also shown a synergistic effect with selinexor. Results are expected in 2020.
“The BOSTON study doesn’t solve anything,” retorted committee member David Harrington, PhD, emeritus professor of biostatistics at the Dana-Farber Cancer Institute. “It’s a different clinical profile, different dosing, a different combination of agents, and it doesn’t isolate the single-arm activity of selinexor.”
Paclitaxel drug-coated balloons appear safe for PAD treatment
Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.
“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.
Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.
Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.
There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).
A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.
Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.
“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.
“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.
The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.
SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.
Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.
“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.
Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.
Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.
There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).
A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.
Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.
“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.
“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.
The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.
SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.
Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.
“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.
Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.
Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.
There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).
A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.
Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.
“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.
“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.
The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.
SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Online vitriol’s expansion into doctor discussion sites
The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.
Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.
I don’t do that anymore.
This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.
Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.
Makes it hard to actually kick around thoughts on Ocrevus (or whatever).
Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.
I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.
So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.
Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.
Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.
I don’t do that anymore.
This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.
Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.
Makes it hard to actually kick around thoughts on Ocrevus (or whatever).
Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.
I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.
So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.
Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
The web is full of doctor discussion sites. Sermo, Doximity, and many others. Each is slightly different, but the idea is similar. Give docs a place to joke, discuss cases, etc. A virtual doctors’ lounge.
Roughly 10 years ago I was active on Sermo. It was fun to check in a few days a week after work, ask questions about my own cases, and see if anyone had ideas on them, make a few suggestions on others, occasionally gripe about administrative issues at my hospital and commiserate about such online.
I don’t do that anymore.
This morning I logged in to see if anyone had previously encountered an unusual case, but was quickly pushed off by venom.
Yes, they do have a political discussion board, but staying away from politics is easier said than done online. Like mud, it tends to ooze into places it doesn’t belong. Even a routine post asking about new treatments for multiple sclerosis quickly degenerates. In a demonstration of Godwin’s Law, any comment about the pros and cons of a new agent devolves into a fight over government vs. private insurance, the United States’ vs. other countries’ health systems, and, inevitably, Trump, Obama, and name calling.
Makes it hard to actually kick around thoughts on Ocrevus (or whatever).
Generally, this won’t happen in a real doctors’ lounge because you know each other. Even if you’re not friends, people generally (not always) tend to be civil in person. Even differences are usually handled with a polite agreement to disagree.
I suspect the majority of people on Sermo and similar sites are reasonable and joined the sites for the same reasons I did. Unfortunately, we’ve been drowned out by a handful of angry voices who hijack these sites by posting intentionally inflammatory statements just to pick a fight or derail a thoughtful discussion on epilepsy management with nasty jabs relating medical issues directly to politics.
So my time using these sites has dropped. Occasionally, if I was bored, I’d log in to see if there were any interesting cases in my field, but even those often get dragged down by the angry as you try to contribute thoughts and answer questions in the comments.
Sadly, this has became the norm rather then the exception. For me, at least, it’s easier to just walk away entirely.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Parsing the fine points of anxiety
Expert prescribes benzodiazepines for excessive anxiety, antidepressants for anxiety disorders
LAS VEGAS –
“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”
Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.
He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”
Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.
“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”
Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.
“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.
The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.
“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”
Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”
According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”
Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.
Expert prescribes benzodiazepines for excessive anxiety, antidepressants for anxiety disorders
Expert prescribes benzodiazepines for excessive anxiety, antidepressants for anxiety disorders
LAS VEGAS –
“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”
Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.
He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”
Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.
“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”
Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.
“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.
The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.
“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”
Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”
According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”
Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.
LAS VEGAS –
“People with anxiety disorders have excessive anxiety, but not everyone with excessive anxiety has a psychiatric disorder,” he said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Any anxiety above baseline can be normal. It’s not necessarily pathological. I think that’s an important point that’s easy to overlook when we’re in clinical practice, and it affects how we approach our patients.”
Anxiety can present in a variety of ways in different individuals. Panic attacks are often the primary chief complaint, and it’s common to hear complaints from family that the person is routinely seeking reassurance. In addition, tics and twitches are not unusual in people with anxiety disorder. “Some of that is brought out by anxiety itself,” said Dr. Hudak, who is a psychiatrist at the University of Pittsburgh. Sleep disturbances or other somatic complaints also are common. “They complain of racing thoughts, increased energy, and depression,” he added. “When someone complains about depression, don’t assume they have a mood disorder. The reason people with anxiety disorders complain about depression is that it really feels awful. Anxiety is incredibly dysphoric.” Physical complaints include shortness of breath, GI distress, dizziness, vague somatic complaints, and skin or gum lesions.
He went on to note that individuals with excessive anxiety virtually never lose consciousness. “The exception is blood/injection/injury phobia,” he said. “That’s the only case in which anxiety will cause loss of consciousness. It happens in virtually no other setting. Ondine’s curse while falling asleep is another symptom that only occurs with anxiety. It’s a sensation that you have to remember to breathe, and breathing is no longer automatic. There are medical conditions that cause Ondine’s curse. However, the patient who complains of Ondine’s curse as they’re falling asleep is pathognomonic for anxiety.”
Dr. Hudak said panic attacks, a discrete period of fear or discomfort, rarely last more than 30 minutes.
“I view panic attacks in three flavors,” he said. “Some people have the cardiovascular flavor with shortness of breath and heart palpitations. Some have what I call the neurological flavor, where the predominant symptoms seem to be dizziness and tingling. Other people have GI flavor, with gut pain, nausea, and diarrhea. Panic attacks are not a psychiatric disorder. It’s a qualifier for any psychiatric disorder.”
Social anxiety disorder, meanwhile, presents as two completely distinct and separate illnesses that have nothing in common with each other.
“The performance subtype of social anxiety really presents like a simple phobia,” Dr. Hudak said. “The treatment for that is really behavioral therapy and cognitive-behavioral therapy, and rarely the use of medications. The generalized type presents with intrusive, [obsessive-compulsive disorder]–like thoughts. Affected individuals describe themselves as ‘paranoid’ or feeling that they are being scrutinized. The categorical versus dimensional diagnosis is being debated.” Individuals with generalized anxiety disorder, on the other hand, have excessive and pervasive worry and anxiety present more days than not for a 6-month period. “The individual finds it difficult to control the worry,” he said. Somatic symptoms include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and insomnia. Different studies show the prevalence rate between 3% and 8%, affecting more women than men.
The medical work-up for excessive anxiety should consist of history and physical exam, complete blood count, the Chem-7 metabolic test, thyroid-stimulating hormone, and EKG if indicated. Both medications and behavioral therapy are used in the treatment of anxiety disorders. Many patients require both in order to achieve maximum treatment response. “Often, people with less severe illnesses can be managed with therapy alone,” Dr. Hudak said.
“In more severe cases, medications can help reduce symptoms to the point where therapy is easier to perform. The bottom line here is that at no time should you treat someone with an anxiety disorder with medications alone. Behavioral therapy is at least as effective as medications, and perhaps more so.”
Many trials of anxiety medications are of short duration and therefore lack evidence of long-term improvement, he said. Commonly used scales often include nonspecific items such as arousal score that can be reduced by sedating medications without improving the actual disorder. If someone has excessive anxiety that is not part of a primary anxiety disorder, Dr. Hudak typically prescribes benzodiazepines. “If someone is anxious because a loved one died, or if they’re nervous about their wedding day, or about taking a board exam, benzos can be used,” he said. “For someone who has an anxiety disorder, I virtually never use benzodiazepines. I generally use medications in the antidepressant category. I probably initiate fewer than five benzodiazepine prescriptions per year for anxiety disorder. There is also data to suggest that using benzodiazepines in patients with anxiety disorder may make cognitive-behavioral therapy more difficult.”
According to Dr. Hudak, selective serotonin reuptake inhibitors seem to have the largest evidence base in panic disorder and are first-line pharmacotherapy for both panic disorder and generalized anxiety disorder, while tricyclic antidepressants (TCAs) usually are considered a second-line therapy. “There is good data behind MAO inhibitors, and there is increasingly good data behind [selective norepinephrine reuptake inhibitors],” he said. “If someone has failed a trial of SSRIs, you may consider trying an SNRI before a TCA. However, I would try multiple SSRIs before ruling out that class of medications. I have had people fail five SSRIs and respond dramatically to the sixth SSRI.”
Dr. Hudak disclosed that he receives royalties from the Cambridge University Press.
EXPERT ANALYSIS FROM NPA 2019
Prevent burnout by tapping into passions
To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.
Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.
Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.
“What do you want to be when you grow up?”
That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.
Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”
At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.
Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.
Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.
Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.
Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.
In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.
As much as early-career physicians need support, so, too, do future leaders.
When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.
Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.
What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.
Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”
Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.
Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.
He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.
“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.
To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.
Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.
Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.
“What do you want to be when you grow up?”
That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.
Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”
At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.
Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.
Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.
Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.
Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.
In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.
As much as early-career physicians need support, so, too, do future leaders.
When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.
Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.
What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.
Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”
Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.
Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.
He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.
“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.
To fight burnout, Griffin Myers, MD, wants more out of the physicians who work at Chicago-based Oak Street Health.
Not more time, or more patients, or more codes billed – but more passion and a more meaningful professional experience, said Dr. Myers, cofounder and chief medical officer of the 42-practice group that cares for Medicare patients.
Oak Street seems to be on to something. According to the health care consultancy The Advisory Board, there are three key ways to avoid physician burnout: involve physicians in strategic decision making, recognize physicians’ contributions, and create time-limited leadership opportunities for physicians.
“What do you want to be when you grow up?”
That’s the question Dr. Myers asks physicians during job interviews. He wants to discover their personal and professional passions.
Health care leaders can’t expect physicians to prevent burnout on their own, insists Dr. Myers. “You have to change the way your organization supports clinicians.”
At Oak Street, that includes supporting physicians with medical scribes and ensuring that they aren’t bogged down with paperwork or “fighting with the fax machines,” said Dr. Myers.
Once a physician is hired at Oak Street, they’re partnered with a medical director who uses the practice’s resources to support the physician’s clinical and professional passions. Specifically, that means providing physicians with administrative time (nonpatient time) and support – both organizationally and financially – for professional development. Medical directors meet with physicians quarterly to check in and assess performance.
Take, for example, Tina Valdez, DO, an internist at Oak Street’s Englewood, Ill., location, who previously practiced at Advocate Lutheran General Hospital in Park Ridge, Ill. During the job interview process, Dr. Myers discovered that Dr. Valdez wanted to keep teaching and mentoring residents as they transitioned to attending physicians.
Dr. Myers was on board, so Dr. Valdez uses her administrative time to meet with early-career physicians on a quarterly basis.
Resident physicians are used to having a more senior physician monitor their work, Dr. Valdez noted. Without that oversight, many first-year physicians can get anxious. To support them, she leads small group discussions on topics including patient cases and ways to better work with other members of the care team, such as relying on a medical assistant to capture vital signs and conduct a thorough medication reconciliation.
In the program’s first year, 10 new physicians split into two groups for 2-hour sessions at an off-site meeting location once a quarter.
As much as early-career physicians need support, so, too, do future leaders.
When Andrea Khosropour, MD, first joined Oak Street in 2012, her mentor invested a lot of time in coaching her to become a better leader. For example, her mentor taught her the right way to have difficult conversations.
Dr. Khosropour, now a senior medical director who practices at the group’s Edgewater, Ill., location, said she finds balance at work because Oak Street gives her administrative time to attend to her management responsibilities. She also values the assistance of the medical scribes who document every patient encounter in the EHR. “That’s rare for primary care,” says Dr. Khosropour.
What qualities does Oak Street look for in its physician leaders? Dr. Myers said it starts with a physician who shares the group’s values, demonstrates clinical excellence and “scrappiness,” and has good intentions. He pointed out that Dr. Khosropour, who now oversees four practices, came to Oak Street with no experience running multiple practices.
Dr. Myers said Oak Street can grow its physicians internally as long as they share the group’s cultural values. “You can’t wait for people who already have those skills.”
Oak Street doesn’t rely on a fee-for-service model, in which physicians are paid by the volume of patients they treat. Specifically, that means 80% of its patients are in value-based contracts with private payers and the remaining patients are covered in the Medicare Shared Savings Program. About half of patients are dually eligible for Medicare and Medicaid, Dr. Myers said.
Because the group receives a set amount to manage the care of each of its attributed patients, Oak Street has the flexibility to invest in professional development, scribes, and other programs to support physicians, Dr. Myers said. That’s provided the group can successfully manage the care of their patients and keep them out of the hospital.
He advises practices that are more dependent on fee-for-service contracts to prioritize the following initiatives to prevent burnout: investing in professional development, reducing physicians’ administrative burdens, and celebrating physicians’ victories.
“Our goal is to provide the highest-quality health care employee experience possible. People will stay as long as you set that as a clear goal,” Dr. Myers said.
Primary care physician growth trails population growth
Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.
“ suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.
Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).
In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).
Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.
The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”
The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.
SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.
Resolving the maldistribution of primary care physicians noted by Basu et al. will require a serious commitment to payment reform, according to Sondra Zabar, MD; Andrew Wallach, MD; and Adina Kaler, MD, of New York University.
Along with observing a steady decline in primary care interest overall, Dr. Zabar and her coauthors highlighted the lack of attraction to practicing in rural or urban areas. Among the reasons they cited are desired income, perceived workload, and level of debt. As compared to a well-run subspecialty practice, “most primary care physicians work with minimal support and can see only 2 to 3 patients per hour, and they are likely to receive lower payment than the subspecialty physician for each of those patients,” they wrote.
What solutions are there?
“Our reimbursement system needs to incentivize a realignment in the ratio between primary care and nonprimary care that is associated with the best population health such that primary care physicians no longer shoulder a disproportionate share of administrative work such as medication refills and prior authorizations,” they wrote. The problem has already been somewhat recognized by the Medicare Payment Advisory Commission and the Centers for Medicare & Medicaid Services, but more initiatives like debt forgiveness and innovative medical school curricula are needed to make a serious dent.
“To increase access to primary care, especially in underserved areas, we must align incentives to attract individuals into primary care practice, innovate primary care training, and greatly improve the primary care practice model,” they wrote. “Physician payment reform is a key to making all of this happen.”
These comments are adapted from an accompanying editorial (JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7623 ). No conflicts of interest were reported.
Resolving the maldistribution of primary care physicians noted by Basu et al. will require a serious commitment to payment reform, according to Sondra Zabar, MD; Andrew Wallach, MD; and Adina Kaler, MD, of New York University.
Along with observing a steady decline in primary care interest overall, Dr. Zabar and her coauthors highlighted the lack of attraction to practicing in rural or urban areas. Among the reasons they cited are desired income, perceived workload, and level of debt. As compared to a well-run subspecialty practice, “most primary care physicians work with minimal support and can see only 2 to 3 patients per hour, and they are likely to receive lower payment than the subspecialty physician for each of those patients,” they wrote.
What solutions are there?
“Our reimbursement system needs to incentivize a realignment in the ratio between primary care and nonprimary care that is associated with the best population health such that primary care physicians no longer shoulder a disproportionate share of administrative work such as medication refills and prior authorizations,” they wrote. The problem has already been somewhat recognized by the Medicare Payment Advisory Commission and the Centers for Medicare & Medicaid Services, but more initiatives like debt forgiveness and innovative medical school curricula are needed to make a serious dent.
“To increase access to primary care, especially in underserved areas, we must align incentives to attract individuals into primary care practice, innovate primary care training, and greatly improve the primary care practice model,” they wrote. “Physician payment reform is a key to making all of this happen.”
These comments are adapted from an accompanying editorial (JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7623 ). No conflicts of interest were reported.
Resolving the maldistribution of primary care physicians noted by Basu et al. will require a serious commitment to payment reform, according to Sondra Zabar, MD; Andrew Wallach, MD; and Adina Kaler, MD, of New York University.
Along with observing a steady decline in primary care interest overall, Dr. Zabar and her coauthors highlighted the lack of attraction to practicing in rural or urban areas. Among the reasons they cited are desired income, perceived workload, and level of debt. As compared to a well-run subspecialty practice, “most primary care physicians work with minimal support and can see only 2 to 3 patients per hour, and they are likely to receive lower payment than the subspecialty physician for each of those patients,” they wrote.
What solutions are there?
“Our reimbursement system needs to incentivize a realignment in the ratio between primary care and nonprimary care that is associated with the best population health such that primary care physicians no longer shoulder a disproportionate share of administrative work such as medication refills and prior authorizations,” they wrote. The problem has already been somewhat recognized by the Medicare Payment Advisory Commission and the Centers for Medicare & Medicaid Services, but more initiatives like debt forgiveness and innovative medical school curricula are needed to make a serious dent.
“To increase access to primary care, especially in underserved areas, we must align incentives to attract individuals into primary care practice, innovate primary care training, and greatly improve the primary care practice model,” they wrote. “Physician payment reform is a key to making all of this happen.”
These comments are adapted from an accompanying editorial (JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7623 ). No conflicts of interest were reported.
Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.
“ suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.
Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).
In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).
Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.
The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”
The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.
SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.
Although the total number of primary care physicians increased from 2005 to 2015, disproportionate losses across counties and general population increases have created an imbalance that may affect life expectancy, according to a study of U.S. population data and individual-level claims data linked to mortality.
“ suggesting that observed decreases in primary care physician supply may have important consequences for population health,” wrote lead author Sanjay Basu, MD, PhD, of Stanford (Calif.) University and his coauthors. The study was published online in JAMA Internal Medicine.
Dr. Basu and his colleagues gathered data from 3,142 U.S. counties, 7,144 primary care service areas, and 306 hospital referral regions over a 10-year period to determine whether primary care physician supply was correlated with changes in life expectancy and cause-specific mortality. They found that, from 2005 to 2015, the total number of primary care physicians increased from 196,014 to 204,419. However, mean primary care physician supply decreased from 46.6 per 100,000 population (95% confidence interval, 0.0-114.6 per 100,000 population) to 41.4 per 100,000 (95% CI, 0.0-108.6).
In the researchers’ fully adjusted models, an increase of 10 primary care physicians per 100,000 population was associated with a 51.5-day increase in life expectancy (95% CI, 29.5-73.5 days; 0.2% increase). This effect was more favorable than the foreseen result of a similar increase of 10 specialist physicians per 100,000 population, which was associated with a 19.2-day increase in life expectancy (95% CI, 7.0-31.3).
Almost 300 (296) counties had no primary care physicians in 2015, while 128 counties had more than 100 per 100,000 population. On average, rural areas saw a larger decrease than urban areas (–7.0 per 100,000 population vs –2.6 per 100,000 population). Primary care physician supply did not disproportionately decrease by county poverty level or racial/ethnic demographics.
The coauthors shared their study’s limitations, including the use of private insurance data to conduct individual-level analyses and the possibility for unobserved confounding. However, they also noted that their results reinforced earlier findings on primary care physician density and overall life expectancy, calling for “future investigations [to] acquire data on the quality and comprehensiveness of primary care, types of primary care physician training and service delivery offerings, and effective access rather than just supply.”
The study was supported by the National Institutes of Health; data was accessed through the Stanford Center for Population Health Sciences Data Core, which is supported by the National Center for Advancing Translational Sciences and by Stanford University. One author reported being a senior adviser at the Center for Medicare & Medicaid Innovation; another reported being an adviser to Bicycle Health. No conflicts of interest were reported.
SOURCE: Basu S et al. JAMA Intern Med. 2019 Feb 18. doi: 10.1001/jamainternmed.2018.7624.
FROM JAMA INTERNAL MEDICINE